Showing posts with label Health News. Show all posts
Showing posts with label Health News. Show all posts

Mar 24, 2020

Health News: U.S. has potential of becoming coronavirus epicenter, says WHO

Reuters Editorial



A deserted Times Square is pictured following the outbreak of coronavirus disease (COVID-19), in the Manhattan borough of New York City, New York, U.S., March 23, 2020. REUTERS/Carlo Allegri
GENEVA (Reuters) - The World Health Organization said on Tuesday it was seeing a “very large acceleration” in coronavirus infections in the United States which had the potential of becoming the new epicenter.
Over the past 24 hours, 85 percent of new cases were from Europe and the United States, WHO spokeswoman Margaret Harris told reporters. Of those, 40 percent were from the United States.
Asked whether the United States could become the new epicentre, Harris said: “We are now seeing a very large acceleration in cases in the U.S. So it does have that potential.
...They (the United States) have a very large outbreak and an outbreak that is increasing in intensity,” Harris added.
Overall, the global outbreak was accelerating very rapidly and she expected large increases in case numbers and deaths from the 334,981 cases and 14,510 deaths reported.
Reporting by Emma Farge and Stephanie Nebehay; Writing by Nick Macfie; Editing by Alison Williams

Jan 13, 2020

Health News: Acasti's krill oil-derived drug fails late-stage study, shares tumble

Reuters Editorial

2-3 minutos - Source: Reuters


(Reuters) - Acasti Pharma Inc said on Monday its krill oil-derived drug had failed to beat placebo by a large margin in reducing a type of fat found in blood that increases the risk of heart diseases, sending its shares spiraling down nearly 67%.
The company said the drug, CaPre, derived from shrimp-like crustaceans called krill, showed a 36.7% median reduction in triglyceride levels after 26 weeks of treatment, compared with an average of 28% reduction among those on placebo.
Though the difference at 26 weeks was in favor of CaPre, due to an unexpectedly large positive placebo response, CaPre’s response did not meet statistical significance in the late-stage study, Acasti said.
The larger-than-expected declines in triglyceride levels in the placebo group remain unexplained and highly unusual, the study’s main investigator Dariush Mozaffarian said.
A high placebo response at 5 enrolling sites out of a total of 54, disproportionately contributed to the overall placebo response and is being further investigated, Acasti said.
An outcome from the investigation is expected by the end of February.
CaPre, like Amarin Corp Plc’s fish-oil derived therapy Vascepa and GlaxoSmithKline Plc’s heart pill Lovaza, contains omega-3 fatty acids - substances found in foods and dietary supplements such as fish oil.
Capre is a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) - two omega-3 fatty acids found in fish and other seafood.
Amarin’s Vascepa, which is purified EPA only, won U.S. approval to lower high triglycerides in 2012 and for its expanded use in reducing the risk of heart attacks and strokes in high-risk patients last month.
Acasti is also testing CaPre in another late-stage study, results from which are now expected to be delayed to mid-February. The study’s results may provide more insight into the placebo response seen in the latest trial, the company said.
The company’s U.S.-listed shares were down at 72 cents before the opening bell, while those of Amarin were up about 6% at $20.07.
Reporting by Manojna Maddipatla and Trisha Roy in Bengaluru; Editing by Maju Samuel and Shinjini Ganguli

Jan 6, 2020

Drug developers take fresh aim at 'guided-missile' cancer drugs

Ludwig Burger



FRANKFURT/ZURICH (Reuters) - Dozens of drugmakers are conducting human trials for a record 89 therapies that pair antibodies with toxic agents to fight cancer, evidence of renewed confidence in an approach that has long fallen short of its promise, an analysis compiled for Reuters shows.
FILE PHOTO: A scientist studies cancer cells inside white blood cells through a microscope at the GlaxoSmithKline (GSK) research centre in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls

These antibody-drug conjugates, or ADCs, from companies including AztraZeneca and GlaxoSmithKline, are described by researchers as “guided missiles” packing a powerful anti-cancer punch.
They are engineered to zero in on tumors and then release cytotoxins that deliver up to 10,000 times the potency of standard chemotherapy, while minimizing damage to healthy tissue.
The approach has for decades been a major biotech industry focus. Many experimental ADCs, however, failed due to the complexity of pairing the right antibody with the appropriate toxic agent. Some were abandoned as too weak; others were too harmful.
From 2000 to 2018, only five ADCs won approval. Just one, Roche’s (ROG.S) Kadcyla, approved in 2013 for breast cancer, has surpassed $1 billion in annual sales after data last year showed it boosted disease-free survival for some patients compared with the standard treatment, Roche’s Herceptin.
Over time, however, scientists devised better ways to connect payloads and antibodies and more precisely reach tumors. There is a growing understanding, too, of how to design ADCs to kill even surrounding cancer cells that previously evaded destruction.
“What we’re seeing now are the benefits of the science becoming mature,” said ADC pioneer Chris Martin, CEO of Switzerland’s ADC Therapeutics ADCT.N. “It took at least a decade, probably more like 15 years, to really begin to turn the art into a science.”
In 2019, U.S. regulators approved three ADCs, the most ever in a single year, as last-ditch treatments based on studies showing they helped patients whose survival outlook was bleak.
They include AstraZeneca’s (AZN.L) and Daiichi Sankyo’s (4568.T) breast cancer drug, Enhertu, which was shown to help patients who had failed numerous previous treatments survive a median of more than 16 months before their disease worsened.
Astellas’ (4503.T) and Seattle Genetics’ (SGEN.O) bladder cancer drug, Padcev, also received expedited approval in December, based on evidence that 44% of patients who had failed immunotherapy showed improvement, and in some cases, no evidence of cancer, when they were assessed after treatment.
Roche’s (ROG.S) Polivy was green-lighted against lymphoma in June after producing complete response rates, with no signs of disease, in 40% of patients when combined with two other therapies.

NEW RECORD

While all three drugs must prove their mettle in further studies, the industry is growing optimistic that ADCs’ time may have arrived.
The number of ADC drug candidates is at unprecedented levels, according to data from consultancy Beacon Targeted Therapies compiled for Reuters, based on a review of companies’ pipelines. Dozens more ADC prospects are in pre-clinical review.
London-based Beacon advises drugmakers on targeted therapies, helping them decide whether to pursue prospective drugs or redirect efforts, based on industry trends.
Current ADC projects include GlaxoSmithKline (GSK.L) testing its belantamab mafodotin against multiple myeloma.
ADC Therapeutics, part-owned by private equity firm Auven Therapeutics, has several studies on experimental drugs, including with Danish partner Genmab (GMAB.CO), on blood cancers and solid tumors.
U.S. biotech Immunomedics’ (IMMU.O) market capitalization gained more than 60% to $4.3 billion in the last six months, ahead of the U.S. Food and Drug Administration’s late-December decision to review its ADC against triple-negative breast cancer, which is hard to treat and has poor prognosis.
Massachusetts-based ImmunoGen (IMGN.O), hit by past trial failures, got a lift in December for its ADC against ovarian cancer when the FDA indicated it may become a candidate for accelerated approval.
The surge in ADC investment has been fueled, in part, by improvements in the so-called “linker” technology that binds the antibody to its cancer-killing toxins, keeping them stable in the circulatory system until the poison can be unleashed on the targeted tumour.
ADCs are generally delivered via repeated infusions, similar to chemotherapy.
“There is a revival again because there is a new generation of molecules in which the linker is more efficient,” Giuseppe Curigliano, clinical director of early drug development at Milan’s European Institute of Oncology, told Reuters.

BETTING ON GROWTH

This optimism has contract manufacturers like Merck KGaA (MRCG.DE) and Lonza (LONN.S) ramping up facilities, in hopes drugmakers will farm out complex ADC production.
Merck expects the overall ADC market to grow by more than 20% in coming years, boosting its business, which includes manufacturing of monoclonal antibodies, linkers and cytotoxic agents.
Rival Lonza, which helps make Roche’s two ADCs and sees annual 9% growth for the so-called bioconjugates market, is investing millions of dollars in its Swiss site, where it produces ADCs for other drugmakers.
“What we see over time at Lonza is a good request for capacity,” said Iwan Bertholjotti, Lonza’s bioconjugate commercial development head. “That’s a good sign that the market is booming.”
GRAPHIC: Global ADC clinical pipeline here
Reuters Graphic
GRAPHIC: ADC clinical development here
Reuters Graphic
Still, enthusiasm is not universal.
AbbVie (ABBV.N) in August abandoned its ADC candidate Rova-T after flunking a lung cancer trial and wrote off most of the $5.8 billion it paid for the drug’s developer, Stemcentrx, in 2016.
Roche, which helped pioneer ADCs with Kadcyla and Polivy, has also backed off. In 2013, the Basel-based company had about a dozen experimental ADCs. Today, only one remains, and it is being developed for Staph infections, not cancer.
“We have shifted our technology priorities,” Roche CEO Severin Schwan told Reuters. “Maybe others will be luckier, but we failed to master the complexity.”
AstraZeneca aims to do just that.
In March, the Cambridge, England-based drugmaker struck a $7 billion deal with Japan’s Daiichi Sankyo for rights to Enhertu, getting $1.35 billion up-front, and more if it challenges Roche drugs’ dominance in breast cancer.
Some industry analysts see Enhertu sales eventually reaching up to $7 billion annually.
“Our plan is to expand the number of studies in different tumor types,” said Gilles Gallant, head of oncology R&D at Daiichi Sankyo. “This agent has potential.”
Reporting by Ludwig Burger in Frankfurt and John Miller in Zurich; Editing by Michele Gershberg and Dan Grebler

Dec 19, 2019

Novartis plans to give away world's costliest therapy to some patients

John Miller



ZURICH (Reuters) - Novartis aims to give away 100 doses of its $2.1 million-per-patient Zolgensma for spinal muscular atrophy (SMA) in 2020 in a free-drug program that one patient group worried was a “health lottery” that could neglect some babies.
FILE PHOTO: The company's logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann/File Photo

Starting Jan. 2, Novartis’s AveXis unit which developed Zolgensma will allocate 50 doses of the world’s costliest single-dose treatment through June for babies under 2 years old, Novartis said on Thursday, with up to 100 total doses to be distributed through 2020.
The program applies to countries where the medicine is not yet approved for the rare genetic disorder affecting 1 in 10,000 live births, but which can lead to death and profound physical disabilities.
Zolgensma, with sales of $175 million through September, won U.S. approval in May and has been touted as potentially curative for babies treated before symptoms begin.
But regulatory decisions in Europe and Japan have been delayed until 2020, curbing access Novartis hopes to partially address with free Zolgensma where such giveaways are allowed.
Families in Belgium, Hungary and Israel have launched crowd-funding programs for treatment.
“AveXis’ intention is for this to be a long-term commitment,” a Novartis spokesman said. “AveXis designed a program anchored in principles of fairness, clinical need and global accessibility to best determine the equitable global distribution of a finite number of doses that doesn’t favor one child or country over another.”
Novartis said manufacturing constraints — it has one licensed U.S. facility, with two plants due to come on line in 2020 — necessitated a focus on providing treatment to countries where the medicine is approved or pending approval.
Zolgensma, hit by turmoil including data manipulation allegations and suspension of a trial over safety concerns, is the second SMA treatment, after Biogen’s Spinraza.
Swiss drugmaker Roche is expecting approval for its medicine risdiplam by May.
TreatSMA, a British SMA advocacy group, applauded Novartis’s free Zolgensma initiative but had reservations about the program in which an independent commission would conduct bi-weekly draws of eligible babies. “Unlucky” patients not chosen would be entered into subsequent draws until eligibility expired, the group said.
“Given the lack of access to any SMA treatment in many places, we are yet to be convinced that a health lottery is an appropriate way of meeting the unmet medical needs,” TreatSMA said, adding it is gathering feedback before formulating a formal position.
TreatSMA added it was unlikely British rules would let patients participate in Novartis’s program.
Roche’s risdiplam is also set for a free drug program, including in India, helping extend SMA therapies to developing countries where high prices — Spinraza runs $750,000 in the first year and $375,000 thereafter — limit access.
Roche’s program for risdiplam, the price of which has not been disclosed, would initially target patients with type 1 SMA, the most severe form.
“The program will be expanded to patients with Type 2 SMA at the moment of filing of the regulatory application for risdiplam in each country,” Roche told Reuters, adding “not every country will initiate a program”.

Reporting by John Miller; editing by Jason Neely

Dec 17, 2019

Alnylam gene-silencing therapy to treat kidney disorder succeeds in late-stage study

Tamara Mathias



(Reuters) - Alnylam Pharmaceuticals Inc’s gene-silencing therapy for a rare kidney disorder met the main goal of a late-stage study on Tuesday, bringing the company a step closer to marketing the first approved treatment for the condition.
The study tested Alnylam’s experimental drug, lumasiran, against placebo in patients aged six and above with primary hyperoxyluria type 1 (PH1), a life-threatening condition that is estimated to affect one in 58,000 people globally.
Alnylam plans to file for the drug’s approval in the United States and Europe early next year and hopes to launch the drug before the end of 2020.
The company’s president, Barry Greene, estimates the market opportunity for PH1 treatments to be over $500 million.
Lumasiran works using a mechanism called RNA interference (RNAi) to target and “silence” the genetic material involved in making excess amounts of a chemical called oxalate.
Excess oxalate builds up in the kidneys of patients with PH1, eventually leading to kidney and bladder stones. In severe cases, they may have to undergo dialysis, kidney or liver transplants.
In the trial, lumasiran was found to significantly reduce the production of oxalate in patients taking a monthly dose for three months, followed by maintenance doses, compared to those administered with a placebo.
Needham analyst Alan Carr had forecast global peak sales of between $450 million and $500 million for lumasiran in 2032, before the trial results were announced.
Alnylam already has two gene-silencing treatments in the market for rare hereditary disorders.
In 2018, Onpattro, Alnylam's treatment targeting a symptom of a potentially fatal condition called hereditary ATTR amyloidosis, became the first RNAi treatment to be approved in the United States. (reut.rs/2sEXmHR)
In November, the company received approval for Givlaari to treat acute hepatic porphyria, a rare disorder that can lead to severe pain and paralysis, respiratory failure and seizures.
Reporting by Ruhi Soni and Tamara Mathias; Editing by Vinay Dwivedi

Dec 16, 2019

Health News: Novartis drops asthma drug fevipiprant after trial failures

Reuters Editorial





FILE PHOTO: The company's logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann

ZURICH (Reuters) - Swiss drugmaker Novartis on Monday said it is jettisoning what it had hoped would be a billion-dollar-selling asthma drug, fevipiprant, from its development program after the medicine failed another set of key trials.
The drug’s star fell in October when the Basel-based company announced it had failed a pair of trials in moderate asthmatic patients.
Now, fevipiprant has flopped in two additional studies in moderate-to-severe patients, spelling the end to its development for asthma.
Novartis chief drug developer John Tsai had continued to hold out hope that the trial failures in moderate patients were a fluke and that the drug would be more effective in patients hit harder by the respiratory disorder.
Instead, fevipiprant failed to reduce exacerbations — an acute episode of symptoms growing worse — compared to a placebo over a 52-week treatment period for either the 150 mg or 450 mg dose of the drug.
“The totality of these results do not support further development of fevipiprant in asthma,” said Novartis, which had hoped the medicine would become an alternative for patients for whom existing therapies like inhaled corticosteroids did not bring sufficient improvement.
Despite the failure, Novartis continues to hold out hope that it has about two dozen potential blockbuster medicines — those that will exceed $1 billion in annual sales — in its pipeline.
Reporting by John Miller; editing by Tassilo Hummel and Jason Neely

Health News: Axsome depression drug meets late-stage study goal, shares soar 56%

Reuters Editorial




(Reuters) - Axsome Therapeutics Inc said on Monday its drug succeeded in reducing symptoms of major depressive disorder in a late-stage trial, sending the company’s share soaring 56% before the bell.
The trial results take the company a step closer to acquiring a share of the multi-billion dollar market for depression drugs.
Major depressive disorder is a chronic condition that makes patients feel low, experience guilt and worthlessness. In extreme cases, it may lead to suicide.
Axsome said its oral tablet, AXS-05, improves the communication between brain cells and increases levels of serotonin, noradrenaline and dopamine, all of which help regulate mood.
The company said patients on AXS-05, which has been granted a breakthrough therapy designation by the FDA, showed statistically significant improvement as compared to the placebo on several goals after one week.
Axsome said it would file marketing application for AXS-05 in the second half of 2020.
Apart from major depressive disorder, AXS-05 is being tested for treatment-resistant depression and agitation, associated with Alzheimer’s disease. It is also being developed to help people quit smoking.
Axsome shares were trading at $73.14 in early trading.
Reporting by Vishwadha Chander in Bengaluru; Editing by Vinay Dwivedi

Dec 5, 2019

Health News: Sage's oral depression therapy fails in late-stage trial; shares plunge

Saumya Joseph



(Reuters) - Sage Therapeutics Inc said on Thursday its experimental drug failed to improve condition of patients with severe depression in a late-stage study, setting up the drugmaker to lose about $4 billion in valuation when the market opens.
The hotly anticipated data was expected to allow the company to widen its reach in the multi-billion dollar depression market it entered with its first-approved drug, Zulresso, for postpartum depression.
SVB Leerink analyst Marc Goodman had said in a note ahead of the trial results that a late-stage trial failure would be a major disappointment to investors and a setback for the company as it would be the first “chink in the armor” in the Sage story.
The oral therapy, SAGE-217, did not produce a statistically significant improvement in patients scored across 17 different parameters, including anxiety and insomnia, at the 15-day mark during the trial.
SAGE-217 works by targeting receptors of a neurotransmitter known as GABA, helping restore the normal balance in the brain.
The company expects to change the treatment paradigm for depression with SAGE-217, a once-daily night time pill, that is taken for a course of 14 days, unlike currently available antidepressants that are required to be taken for months, even years.
“We think that’s really important just to take away the idea that depression is part of your identity and to treat it like what it is, which is a brain health disorder that not only ought to be treated, but to be treated effectively,” Chief Medical Officer Dr. Steve Kanes, told Reuters before the data was published.
The drug is also being developed as an oral treatment for postpartum depression and is expected to be an alternative to Zulresso, a 60-hour continuous intravenous infusion therapy.
Shares of the company fell 56% to $67.25 before the bell.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli

May 28, 2019

Health News | Oklahoma, Johnson & Johnson face off in first opioid crisis trial

Nate Raymond



(Reuters) - Drugmaker Johnson & Johnson is set to face trial in a multibillion-dollar lawsuit by the state of Oklahoma aimed at pinning the blame for the opioid epidemic on its painkiller marketing.
FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake
Lawyers for the state and J&J are scheduled to appear on Tuesday in a state court in Norman, Oklahoma, to deliver their opening statements at the start of the first trial to result from more than 2,000 similar lawsuits against opioid manufacturers nationally.
The lawsuits by state and local governments seek to hold the J&J and other companies responsible for a drug abuse epidemic that the U.S. Centers for Disease Control and Prevention says led to a record 47,600 opioid-related overdose deaths in 2017.
Oklahoma Attorney General Mike Hunter alleges J&J, along with OxyContin maker Purdue Pharma LP and Teva Pharmaceutical Industries Ltd, carried out deceptive marking campaigns that downplayed opioids’ addictive risks while overstating their benefits.
Hunter alleges J&J, which marketed the painkillers Duragesic and Nucynta, was “the kingpin behind this public health emergency,” growing and importing the raw materials other drugmakers used for their products.
The state claims the companies’ actions created an oversupply of painkillers and a public nuisance that will cost $12.7 billion to $17.5 billion to remedy.
Oklahoma resolved its claims against Purdue in March for $270 million and against Teva on Sunday for $85 million, leaving only J&J as a defendant in the nonjury trial before Cleveland County District Judge Thad Balkman.
“We believe our evidence is persuasive and compelling with regard to their legal responsibility for thousands of deaths and hundreds of thousands of addictions in the state,” Hunter said.
J&J denies wrongdoing, arguing that its marketing efforts were proper and that the state cannot prove it caused the opioid epidemic given the role doctors, patients, pharmacists and drug dealers played.
“We acted responsibly in providing FDA-approved pain medications, and we are ready for trial,” J&J said in a statement on Sunday.
But J&J also said it was open to an “an appropriate resolution” that would avoid the expense and uncertainty of a trial.
The case is being closely watched by plaintiffs in other opioid lawsuits, particularly the 1,850 cases consolidated before a federal judge in Ohio, who has been pushing for a settlement agreement ahead of an October trial.
Some plaintiffs’ lawyers have compared the opioid cases to litigation by states against the tobacco industry that led to a $246 billion settlement in 1998.
Reporting by Nate Raymond in Boston; Editing by Scott Malone and Jonathan Oatis

Source: Reuters

Apr 30, 2019

Health News | Novartis's Sandoz strikes deal for biosimilar of Herceptin

1-2 minutes



FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo
ZURICH (Reuters) - Novartis’s Sandoz division has struck a deal with Taiwan’s EirGenix Inc to market a biosimilar version of Roche’s Herceptin that is now in late-stage development to treat some cancer tumors.
Novartis said the accord covers the trastuzumab biosimilar in Phase III development for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors.
EirGenix will be responsible for development and manufacturing, while Sandoz has the right to commercialize the product in all markets except China and Taiwan.
EirGenix will receive an upfront payment, milestone payments, and a share of profits from sales, Novartis said, giving no more financial details.
The deal - the third biosimilar collaboration for Sandoz in 18 months - expands the existing Sandoz cancer portfolio of four oncology biosimilar medicines.
Reporting by Michael Shields; editing by Jason Neely

Source: Reuters

Apr 9, 2019

Health News | In New York, confusion reigns in the emerging CBD edibles business

Jonathan Allen



NEW YORK (Reuters) - New York state officials told food growers and processors in mid-December that they had the state’s blessing to produce and sell tea and chocolates laced with CBD, the cannabis derivative reputed to ease anxiety and other ills without marijuana’s high.
Products are displayed at Dorothy Stepnowska's Flower Power Coffee House, a CBD cafe, in the Queens borough of New York City, U.S., March 6, 2019. Picture taken March 6, 2019. REUTERS/Brendan McDermid
But since then, New York City health inspectors have seized thousands of dollars worth of CBD-infused food and drinks at the Fat Cat Kitchen and other local cafes and restaurants, and warned owners to stop selling them or face penalties. The crackdown came just weeks after federal law explicitly made CBD legal across the country.
The New York City crackdown highlights the inconsistencies that have emerged in federal, state and local rules governing CBD, bewildering the small but growing number of businesses selling edibles in New York and other states.
“I’m trying to be compliant with the law, but no one seems to be fully aware of what the law is and isn’t,” said C.J. Holm, the owner of the Fat Cat Kitchen, which touts CBD coffee and cookies on a sidewalk chalkboard.
Consumer interest in CBD tinctures, topical creams and edibles has grown in recent years in step with the piecemeal legalization of marijuana, which is now permitted as either a medical or recreational drug in 33 states while still banned by the federal government.
In 2018, U.S. consumers spent an estimated $300 million on CBD food and drinks, according to a report by Cowen Washington Research Group. The Coca-Cola Company and other food giants have expressed interest in the sector.
The 2018 Farm Bill, enacted in December, was intended in part to clear up the legal status of CBD by legalizing cannabis extracts derived from strains of the plant, known as hemp, that contain very low concentrations of THC, the main psychoactive compound in marijuana.
But the law also created new confusion for businesses wanting to sell CBD food or drink. For some, it is impossible to follow one set of regulations without being in breach of another.
In New York, for example, officials at the state Department of Agriculture issued guidance in December saying it was legal to sell “CBD tea,” “chocolates with CBD drizzle” and other CBD edibles, so long as the products are made and marketed as dietary supplements, which are governed by more stringent standards than ordinary food.
But the department also warns that doing this will run afoul of rules issued by the U.S. Food and Drug Administration, which said it was unlawful to add CBD to food or to market it as a dietary supplement. That is because the agency, for the first time last year, had approved a drug that contained CBD as the active ingredient.
New York City health inspectors have taken the FDA rule seriously. At the Fat Cat Kitchen, Holm was startled when a health inspector impounded her CBD powder, honey, snacks and raw cookie dough in February. Similar scenes played out at four other eateries in the city.
Soon afterward, Holm and other restaurateurs received a letter from the department saying inspectors would resume the seizures after July 1.
It is unclear whether the city’s Health Department will allow cafes and restaurants to sell CBD edibles even as a dietary supplement, despite New York state officials saying such products are legal.
When asked, Michael Lanza, a Health Department spokesman, repeated the department’s position that it is following the FDA ban on CBD food and drink in any form. An FDA spokesman declined to comment on New York’s regulations.
Colorado, Maine and other states have attempted to clarify the status of CBD-laced edibles by passing laws allowing the addition of CBD to food.
The FDA has said it may make an exception for CBD, allowing it as a food additive or dietary supplement even though it is now a listed drug. It will hold a public forum on the issue in Maryland on May 31.
Slideshow (21 Images)
With the conflicting rules and at best haphazard enforcement, Holm and other CBD vendors say they are pressing ahead, devising their own strategies that they feel are at least a gesture toward compliance.
Igor Yakovlev, who stirs CBD into honey on New York’s Staten Island, prints a disclaimer on each Beezy Beez Honey jar stating that the FDA has not “evaluated or approved” his product.
Holm, in consultation with a lawyer, noted that the FDA bans CBD being added to food for “interstate commerce,” and reasons she is fine to sell CBD coffee so long as the extract is produced and processed in New York.
“It is so confusing because you can ask three different attorneys and get three different answers,” said Allan Gandelman, a farmer in Cortland who founded the New York Cannabis Growers and Processors Association earlier this year. “So you decide you’re going to blaze a path forward, and produce a product that customers really want, and go for it until the government gets its act together.”
Reporting by Jonathan Allen in New York; Editing by Frank McGurty and Dan Grebler

Source: Reuters


Mar 12, 2019

Health News | Lilly's combo therapy succeeds in late-stage lung cancer study

Reuters Editorial




FILE PHOTO: The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg, France, February 1, 2018. REUTERS/Vincent Kessler
(Reuters) - Eli Lilly and Co’s combination cancer treatment met the main goal of a late-stage clinical trial testing it on patients with a form of lung cancer, the drugmaker announced on Tuesday.
Previously untreated patients with metastatic non-small cell lung cancer taking a combination of Lilly’s Cyramza and Roche’s erlotinib went longer before their disease started to worsen, study results showed.
Lung cancer is the leading cause of cancer death among both men and women, and each year, more people die of lung cancer than of colon, breast, and prostate cancers combined, according to the American Cancer Society.
Cyramza, which made more than $800 million in revenue for Lilly in 2018, is approved in the United States to treat other forms of cancers, including stomach and another type of lung cancer.
The Indianapolis-based drugmaker plans to start global regulatory submissions for its Cyramza combination therapy in mid-2019.
Reporting by Aakash Jagadeesh Babu and Saumya Sibi Joseph in Bengaluru; Editing by Arun Koyyur and Sai Sachin Ravikumar

Source: Reuters

Feb 28, 2019

Health News: BAT says would fight menthol cigarette ban if proposed in U.S.

Reuters Editorial



FILE PHOTO: People walk past the British American Tobacco offices in London, Britain October 21, 2016. REUTERS/Stefan Wermuth/File Photo
LONDON (Reuters) - British American Tobacco would challenge restrictions on menthol cigarettes by U.S. health regulators, due to its belief that they would have no impact on smoking rates, its chief executive told Reuters on Thursday.
The U.S. FDA said in 2017 it would consider possibly banning menthol flavoring in tobacco products as part of efforts to curb underage smoking.
“We don’t see any scientific research so far that proves (banning mentholated cigarettes) reduces youth consumption or reduces uptake of cigarettes to youngsters,” Chief Executive Nicandro Durante said. “So we are going to challenge.”
He said Canada’s 2017 menthol ban had no impact on smoking rates. In any event, any such regulation is likely five to nine years away, he said.
On the other hand, Durante said BAT supported the FDA’s efforts to reduce under-age vaping.
“BAT doesn’t target underage consumers and I think everything the FDA could do in order to avoid this to happen, you have the full support of BAT,” he said.
Reporting by Martinne Geller; editing by Jason Neely

Source: Reuters

Dec 27, 2018

China eases pig transport ban to ensure supplies amid African swine...

Reuters Editorial


FILE PHOTO: Pigs are seen at a backyard farm on the outskirts of Harbin, Heilongjiang province, China September 5, 2018. REUTERS/Hallie Gu
BEIJING (Reuters) - China has loosened the rules on the transportation of breeder pigs and piglets in provinces that are affected by the African swine fever, the agriculture ministry said on Thursday.
The move, which came after Beijing reported more than 90 cases of the highly contagious disease since August, was put in place to ensure pig production and pork supplies, the Ministry of Agriculture and Rural Affairs said on its website.
Breeder pigs and piglets from counties without outbreaks of the disease will be allowed to be transported to other provinces, the ministry said.
Breeder pigs and piglets from infected counties will be allowed to be moved within the infected province, it added.
Market pigs produced at farms with high biosecurity levels in infected counties can also be targeted - sold to slaughterhouses with 150,000 pigs per year or above slaughtering capacity in the province, according to the statement.
Beijing had previously banned the transport of live pigs from regions infected with the disease, leading to a steep drop in prices in major production areas in the north that usually sell pigs to other regions.
Farmers in some major production areas in the north were forced to raise their pigs to much more than the usual weight due to the ban, and became reluctant to replenish herds on worries of the African swine fever disease.
Beijing has been looking for ways to ensure supplies of the country’s favorite meat, as the deadly virus hit the world’s largest pig herd.
China will strengthen supplies of pork and its alternative products during New Year and Spring Festival holidays, the Ministry of Commerce also said in a statement on Thursday.
Reporting by Hallie Gu and Ryan Woo; Editing by Christian Schmollinger and Louise Heavens

Source: Reuters

Dec 12, 2018

FDA declines to approve Mallinckrodt's abuse-deterrent opioid...

Reuters Editorial



(Reuters) - The U.S. Food and Drug Administration has declined to approve an abuse-deterrent version of Mallinckrodt Plc’s opioid painkiller Roxicodone, saying some parts of the company’s application need further evaluation.
The treatment is a reformulated version of the company’s commonly abused painkiller Roxicodone, intended to make the drug less desirable and more difficult to be abused by snorting or injecting.
Mallinckrodt’s shares fell 4.4 percent to $20.02 in premarket trading on Wednesday.
The decision comes after an advisory panel to the FDA voted 10-7 in favor of the drug, saying it should be labeled as abuse deterrent only by the nasal route.
“While all the abuse deterrent properties of this medication are perhaps not as robust as we might like, it is an important advance over the existing formulation,” Brian Bateman, a panel member who had voted in favor of the drug’s approval, had then said.
Mallinckrodt is one of the nation’s largest manufacturers of oxycodone - the most commonly abused prescription painkiller after hydrocodone in 2016.
The panel members, during the Nov. 14 meeting, also raised concerns of Mallinckrodt’s treatment creating the same problem as Endo International Plc’s reformulated Opana ER did.
Endo withdrew the drug from the market last year after postmarketing data showed that while the rates of nasal abuse associated with Opana fell, rates of intravenous abuse rose. (bit.ly/2QGXzS5)
Mallinckrodt, Endo and other drugmakers including Johnson & Johnson have been sued by state and local governments alleging the companies of contributing to the national drug addiction epidemic through their marketing and promotion of opioids.
“We are evaluating the FDA’s letter and will request a meeting in the coming weeks to discuss it further,” Matt Harbaugh, president of the company’s specialty generics unit said in a statement.
Reporting by Tamara Mathias and Saumya Sibi Joseph in Bengaluru; Editing by Saumyadeb Chakrabarty

Dec 5, 2018

Vietnam steps up measures to prevent African swine fever

Reuters Editorial



HANOI (Reuters) - Vietnamese authorities on Wednesday conducted drills to prevent the spread of African swine fever should there be an outbreak of the disease in the country, as the risks of transmission from neighboring China increase.
The highly contagious fever has killed around a million pigs worldwide and recently spread rapidly across China, which has reported 80 cases since early August.
In footage shown on state-run Vietnam Television (VTV), officials covered from head to toe in protective clothing were seen taking samples from dead pigs and spraying corpses before burying them in a large pit in the ground.
“The fever is only 150 kilometers away from our border, so it’s necessary to understand the risk and danger...if it reaches our 27 millions pigs,” said Tong Xuan Chinh, vice head of the agriculture ministry’s livestock department.
Vietnam has more than 27 millions pigs, most of which are consumed domestically, with pork accounting for three quarters of total meat consumption in the Southeast Asian nation of 95 million people, Chinh said.
“If this fever infects our pigs, it will be a major hit to the economy, society, environment and food security,” Chinh said. He added that authorities were tightly controlling the transportation of pigs and pork products from China and had banned pork products from other infected countries such as Poland and Hungary.
Last month, China reported outbreaks of African swine fever in several provinces, including Yunnan, a border province with Vietnam.
There is also a danger of the disease spreading into Vietnam through smuggled pigs of unknown origin. Smuggling is a regular occurrence, especially in the northern border provinces with China, the agriculture ministry said last week.
Authorities in Vietnam have destroyed 324 pigs and nearly 17 tonnes of pork products that have been smuggled or which do not have clear origins in 63 cases since August, the ministry said in a statement on its website.
Reporting by Mai Nguyen; Editing by Kirsten Donovan



Source: Reuters

Nov 29, 2018

Patents on pot? U.S. lawsuit puts cannabis claims to the test


Jan Wolfe


(Reuters) - In October, the U.S. government issued Axim Biotechnologies Inc (AXIM.PK) a patent for a cannabis-based suppository to treat irritable bowel syndrome.
FILE PHOTO: Droplets of oil form on the surface of a marijuana plant at Tweed Marijuana Inc in Smith's Falls, Ontario March 19, 2014. REUTERS/Blair Gable
Britain’s GW Pharmaceuticals Plc (GWPRF.PK), which recently brought to market a drug derived from marijuana for epilepsy, is now seeking patent protection for another one to treat eczema.
With marijuana now fully legal in Canada and at least partially legalized in the majority of U.S. states, companies are rushing to patent new formulations of the age-old botanical. This year, the U.S. Patent and Trademark Office has issued 39 patents containing the words cannabis or marijuana in their summaries, up from 29 in 2017 and 14 in 2016.
(Graphic: tmsnrt.rs/2Ri9sON)
How well the patents hold up in court remains to be seen. If they do, a handful of companies could be in position to demand licensing fees from the rest of the industry.
The first U.S. case is now winding its way through the courts. In a July lawsuit, Colorado-based United Cannabis Corp (CNAB.PK), accused Pure Hemp Collective Inc of infringing its patent covering a liquid formulation with a high concentration of CBD, a non-psychoactive cannabis ingredient touted for its health benefits.
One of the key issues in this case and others, experts say, is whether the patent is overly broad or obvious in light of “prior art,” the existing level of science or technology against which an invention’s novelty can be judged.
Given the long history of experimentation with marijuana, patents claiming new formulations or methods of using the drug could have trouble withstanding legal challenges, said John Stewart, a board member at Canadian cannabis company Emblem Corp.
Still, one factor that could help patent holders defend their products is the lack of documented previous research. Because marijuana has been illegal, many of its uses have not been written about in the sort of scientific articles typically presented as prior art in patent cases.
“Because of 80 years of prohibition, there is a massive lack of prior art documentation for cannabis,” said Beth Schechter, executive director of the Open Cannabis Project, a nonprofit that opposes cannabis patents. “Folk knowledge and information that is clear to the industry might not be seen or considered by the patent office.”

OBVIOUS OR INVENTIVE?

Marijuana-based patents could never really be put to the test as long as cannabis was broadly illegal. Even if companies had potential grounds to challenge a rival’s product for patent infringement, they were often reluctant to call attention to potentially criminal activities.
But in a climate of increasing tolerance the number of marijuana formulas and extracts being brought to market has exploded, opening the door to challenges from patent-holders. The worldwide cannabis industry is expected to reach $75 billion by 2030, according to Cowen & Co, making it one of the world’s fastest growing industries.
Slideshow (2 Images)
At the center of the United Cannabis case is the patent covering its formulation of CBD, which has become trendy as a health supplement and is widely available in U.S. cafes and wellness shops.
While the U.S. Drug Enforcement Agency considers CBD products to be illegal, federal prosecutors are not bringing criminal cases against sellers.
United Cannabis’ patent covering a highly-concentrated CBD formulation could potentially apply to most of the CBD products now on the market, said Neil Juneja, a patent lawyer in Seattle.
United Cannabis general counsel Jesus Vazquez declined a request for an interview but referred to a blog post from August in which he defended the company’s patented technology as “novel and inventive.”
Others say similar formulations have been used for decades.
Geneticist in baby gene-editing case says he's proud
“There are plenty of people who know the facts about cannabis extracts and biochemistry who are just up in arms over this patent,” said Dale Hunt, a patent lawyer in California.
Donnie Emmi, a lawyer for Pure Hemp, said he believed the company had a good chance of invalidating United Cannabis’ patent. In a court filing, Pure Hemp said highly concentrated liquid CBD formulations are “ubiquitous” and “were not invented in this millennium.”

INDUSTRY NEEDS TO ‘WAKE UP’

Still in its infancy, experts say the marijuana industry is largely ill-prepared for patent litigation and battles over licensing fees that may lie ahead.
“The cannabis industry needs to wake up to this business reality,” said Reggie Gaudino, a vice president at cannabis research firm Steep Hill Inc.
Part of the reason companies have been slow to recognize the threat, analysts and investors say, is that patents are foreign to the open-source, laissez-faire culture that has historically surrounded marijuana.
“This industry has traditionally been made up of people who really believed in this cause, this plant, and the health benefits,” said Kris Krane, a cannabis industry consultant.
“Most of the new players getting involved now are getting into it from a business perspective and they will look at patents as more of a business consideration.”
Reporting by Jan Wolfe; Editing by Anthony Lin and Paul Thomasch

Source: Reuters

Nov 15, 2018

Novartis 'completely committed' to Sandoz, has no split-off plan


John Miller


ZURICH (Reuters) - Swiss drugmaker Novartis is “completely committed” to its $10 billion-per-year Sandoz generics business, a spokesman said on Thursday, after a newspaper reported Chief Executive Vas Narasimhan planned to split the unit off.
FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo
“We’re completely committed to the Sandoz business, and we’re looking at transforming it and making it as strong as it can be in the global generics business,” Novartis spokesman Sreejit Mohan told Reuters.
Earlier, Swiss newspaper Tages-Anzeiger reported the Basel-based drugmaker was preparing to split off Sandoz, citing an employee representative as well as participants in a Novartis investor event last week in London.
According to the newspaper, Narasimhan outlined plans for the generics business to become an independent unit for which Novartis was reviewing “all strategic options”.
Mohan said that Sandoz will be given more autonomy to navigate the dynamic generics environment, where the company has been under price pressure and in September sold its U.S. pills business to Indian’s Aurobindo.
Still, keeping Sandoz as a pillar of Novartis remains “the fundamental focus right now”, he said.
“The whole goal is to try to make Sandoz as agile as possible, to compete in that environment, to give it the autonomy to be as agile as possible,” Mohan added.
“That’s essentially been the message that we’ve been delivering, so I have no idea how that led to saying ‘split off.’”
Sandoz has faced headwinds beyond U.S. pricing pressure.
Earlier this month, for instance, Sandoz abandoned its pursuit of U.S. regulatory approval for a copy of Roche’s $7 billion-per-year blockbuster rituximab, a medication used to treat cancer and rheumatoid arthritis.
Novartis concluded others would be first to market in the United States before it could generate data required by the U.S. Food and Drug Administration.
Even so, Novartis has said it remains committed to Sandoz’s biosimilars portfolio — near copies of biological medicines from rivals that have lost patent protection — that it hopes will eventually boost the division’s margins.
“When you think about how we’re going to drive Sandoz moving forward, a lot of it is about executing a strategy of transformation and shifting the focus to complex generics and biosimilars,” Narasimhan told analysts last month after releasing third-quarter earnings.
Bayer profit flat as weak animal health offsets strong Xarelto
“I think Sandoz is on the right track,” he said. “Challenging environment, but I think we’re taking the steps necessary to put the division in a place where it can succeed.”
Novartis is spinning off its Alcon eyecare unit, with a plan to give the division to shareholders in the first half of 2019.
Reporting by John Miller; Editing by Adrian Croft

Nov 13, 2018

Express Scripts offers new formulary for lower list-price drugs


Deena Beasley


(Reuters) - Express Scripts Holding Co on Tuesday announced a new drug reimbursement list with lower U.S. prices for brand-name medications, as a way to encourage drugmakers to move away from paying rebates after a prescription is filled. The manager of prescription drug benefits for large corporate employers and government health plans said its new National Preferred Flex Formulary will be available as of Jan. 1 to all clients.
So far two drugs from a Gilead Sciences Inc unit will be on the new formulary, which Express Scripts said in a statement it hoped would encourage more drugmakers to keep list prices low.
Drug rebates have come under fire from the Trump Administration and consumer groups as patients find themselves paying much higher insurance co-payments and deductibles tied to a drug’s sticker price.
“This is all in an effort to normalize rebates in the marketplace,” Steve Miller, Express Scripts’ chief medical officer, said in an interview. “We have talked to dozens of pharmaceutical manufacturers. Many have expressed tremendous interest in this.”
He said the new formulary may appeal to employers and health insurers seeking to reduce patient out-of-pocket costs and reliance on brand rebates, but plan sponsors who prefer the current price system and rebates “can stick to that.”
He acknowledged that drugmakers would still offer rebates as a lever to influence payers deciding coverage terms for similar medications. The new coverage list is largely identical to Express Scripts’ National Preferred Formulary, which covers some 3,000 branded and generic drugs for nearly 25 million people.
Gilead in September slashed the list prices of two hepatitis C therapies, Epclusa and Harvoni, to $24,000 per course of treatment from close to $100,000. The company said that competition among hepatitis C therapies, rebates and discounts had already shaved more than 60 percent off the average U.S. price paid for the drugs.
At least one other drugmaker has cut list prices to limit patient costs and help make sure prescriptions get filled.
Amgen Inc last month slashed the U.S. list price for its cholesterol drug Repatha by 60 percent to $5,850 a year, citing the need to reduce out-of-pocket costs for patients on Medicare, the federal government’s health plan for seniors.
Rival cholesterol drug Praluent, from partners Regeneron Pharmaceuticals Inc and Sanofi SA (SASY.PA>, is the preferred option on Express Scripts’ largest formulary through 2019. But Miller said Amgen’s Repatha could displace Praluent on the new formulary.
Miller said other categories in which lower list prices and minimal rebates would make sense for drugmakers, payers and patients are insulins, high-priced respiratory drugs and emergency allergy injections.
Reporting by Deena Beasley; Editing by Richard Chang

Nov 9, 2018

U.S. regulators snip red tape for medical devices to curb opioid... I Health News I Reuters


Tamra Mathias


(Reuters) - Laura Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic migraines.
FILE PHOTO: A sign reads "Drug testing in session," on the bathroom door of an outpatient treatment center in Indiana, Pennsylvania, U.S. on August 9, 2017. REUTERS/Adrees Latif/File Photo
She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based treatments, diagnostic tests and mobile medical apps to address the country’s opioid crisis.
When President Donald Trump declared a public health emergency over the abuse of heavy-duty painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from opioid overdoses.
The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. These range from Stimwave’s Halo to painkilling products made by Abbott Laboratories and other industry heavyweights as an alternative to opioids.
“We’re pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb said.
Perryman’s Halo devices, which look like angel hair pasta and are so small they can be injected into a nerve, took four years to get U.S. approval under other names for easing leg and back pain.
She hopes a spot on the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat an estimated 50 percent of patients who come to emergency rooms with migraines.
“This is kind of perfect for something like ours...since the device is shown to be safe already,” said Perryman, who founded privately-held Stimwave in South Florida seven years ago.
The FDA has been increasingly reluctant to greenlight new opioids for market but earlier this month approved a potent opioid-based painkiller from AcelRx Pharmaceuticals Inc placing tight restrictions on its distribution and use. In a rare move, Gottlieb made a public statement at the time, explaining the decision.
The regulator’s push for alternatives to opioids has helped drive interest from venture capital funds and institutional investors this year in firms promising to develop alternatives, according to interviews with device companies, financial services firms and brokerage Cowen & Co.
For example, privately-held Virpax Pharmaceuticals, which makes an aerosol spray that delivers a non-opioid pain drug, said it had four or five banks interested in running its Series A investment round this summer versus just one in the past.

STIMULATION

Abbott, like rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants which stimulate the nervous system to mask pain signals before they reach the brain.
Abbott has submitted an entry for the competition in the hope it will slash waiting times, which often stretch several months just to get an initial meeting, according to Dr. Allen Burton, Abbott’s medical director of neuromodulation.
“Devices that are part of this (program) will be streamlined... their meeting will go to the top of the pile,” said Burton.
While neuromodulation is only a small part of Abbott’s large medical device business, the unit is seen as a growth engine for the company. Burton estimates between 10-to-20 percent of the growth Abbott has seen in its neuromodulation business could be tied to doctors prescribing its devices for pain after surgery or from injury to patients that are opioid averse.
Boston Scientific did not apply for the contest, but the company is investing “heavily” in its neuromodulation unit, which was its fastest-growing at nearly 23 percent in the latest quarter, according to Maulik Nanavaty, senior vice president at the device maker.
“We continue to make external investments in early (neuromodulation) technology,” he told Reuters.
To be sure, these devices are not seen as a silver bullet for opioid addiction. Nirad Jain, a partner at consulting firm Bain & Co, believes many of the solutions on the table are just tinkering at the edges of a problem that needs to be solved by doctors simply settling for fewer or less potent opioids.

ADDICTION

Academics and charitable groups dealing with the social fallout of the crisis say the bulk of the rise in deaths stems from misuse of prescription painkillers. That has put the onus on regulators in September to issue new rules cracking down on prescribing by doctors.
“The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed,” Gottlieb said in a statement at the time.
“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids.”
Although the FDA contest is limited to devices and app-based solutions for pain and addiction, the current regulatory climate is also conducive to companies developing opioid-alternative pharmaceuticals.
Drugmakers including Pfizer Inc, Eli Lilly and Co, Regeneron Pharmaceuticals Inc and Teva Pharmaceutical Industries Inc have been packing their pipelines with potential solutions to the crisis and there are 120 non-opioid drugs under FDA review this year, up some 650 percent since 2013, according to business intelligence firm Informa.
(For non-opioid drug applications surge interactive, click tmsnrt.rs/2ReUI2H)
Privately-held SPR Therapeutics Inc told Reuters it has entered its “temporary” neuromodulation device in the contest. Similarly to Stimwave’s, its product is implanted into the body but can be surgically removed after about two months. Josh Boggs, a senior executive at the company, expects to get quicker feedback from the FDA and shorter review times in the wake of the crisis.
After years in the business, he believes the crisis has increased the agency’s desire to collaborate with medical technology companies like his.
“I feel like (FDA) people are coming well prepared to meetings and are very engaged in it. It feels like an atmosphere that’s conducive to finding a solution,” he said.
Reporting by Tamara Mathias in Bengaluru; editing by Patrick Graham and Edward Tobin

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