Showing posts with the label Health News

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

Reuters Editorial 2minutos - Source: Reuters 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,

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 o

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

Ludwig Burger 7-8 minutes - Source: Reuters 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

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

John Miller 4minutes - Source: CNBC 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.

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

Tamara Mathias 2-3 minutes - Source: Reuters (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 oxalat

Health News: Novartis drops asthma drug fevipiprant after trial failures

Reuters Editorial 2minutes - Source: Reuters 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,

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

Reuters Editorial 2minutes - Source: Reuters (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 appl

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

Saumya Joseph 2-3 minutes - Source: Reuters (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 tr

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

Nate Raymond 3-4 minutes (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

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 mon

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

Jonathan Allen 5-6 minutes 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 loc

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

Reuters Editorial 2 minutes 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

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

Reuters Editorial 2 minutes 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

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

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 o

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 account

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: ) How well the patents hold up in court remains to be seen. If th

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

Image 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 gener

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 Scri

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

Image 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 Re