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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
(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
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 GRAPHIC: ADC clinical development here
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
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”.
(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
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
(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
(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
(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
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
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
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
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
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
(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
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
(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
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.
(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
(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
