LONDON/NEW YORK (Reuters) – U.S. health regulators have approved two new GlaxoSmithKline drugs for treating advanced melanoma, in the latest sign that companies are having more success getting novel medicines to market.
The Food and Drug Administration (FDA) gave the green light to Tafinlar and Mekinist late on Wednesday, bringing the tally of new drugs approved by the U.S. agency so far this year to 13, compared with 11 at the same stage in 2012.
NEW YORK, May 27 (Reuters) – Americans accustomed to
immediate access to the newest technology may be shocked to find
that is not the case when it comes to devices that treat ailing
U.S. approval requirements for cardiac devices are much more
stringent than in Europe, where there is no centralized
decision-making body. But a growing number of U.S. heart doctors
feel the regulations are so demanding that patients are being
denied access to beneficial therapies.
By Bill Berkrot
(Reuters) – First Manhattan Company (FMC) added some heavyweight muscle on Thursday to its bid to shake up the board of drugmaker Vivus Inc (VVUS.O: Quote, Profile, Research, Stock Buzz) by naming former Carl Icahn top lieutenant Alex Denner and two others to its slate of proposed nominees.
Vivus shares rose as much as 11 percent after First Manhattan, which has nearly a 10 percent stake in Vivus, expanded its slate of proposed directors from six to nine, including Denner.
NEW YORK (Reuters) – Little known biotechnology company Merrimack Pharmaceuticals Inc has quietly built a large pipeline of experimental cancer treatments that it aims to deliver at a fraction of the cost spent by larger rivals.
That could translate into lower-cost treatments for large unmet needs, such as pancreatic cancer, at precisely the time when pressure is mounting to reduce runaway healthcare spending.
By Bill Berkrot
(Reuters) – An experimental leukemia treatment that Roche Holding AG hopes will improve upon its best-selling cancer drug Rituxan delayed disease progression twice as long as chemotherapy, according to preliminary trial data released on Wednesday.
Switzerland-based Roche aims to fend off cheaper competition for Rituxan, which loses patent protection in Europe later this year, threatening a product with nearly $7 billion in annual sales.
May 15 (Reuters) – An experimental Roche Holding AG
drug that helps the immune system attack tumors was well
tolerated and demonstrated an impressive effect against a
variety of cancers, according to preliminary trial results
released on Wednesday.
While clinical testing of the drug is still in its early
phases, the Roche treatment is considered one of the most
promising in a new class of immunotherapies being developed by
By Bill Berkrot
(Reuters) – Generic drugmaker Actavis Inc, formerly Watson Pharmaceuticals, said on Friday that it was in early stage discussions to buy specialty pharmaceutical company Warner Chilcott Plc.
Actavis said no agreement had been reached and that it would have no further comment on the talks.
NEW YORK (Reuters) – Europe must start paying more for new medicines and take some of the cost burden of supporting pharmaceutical drug development off the United States, Novo Nordisk’s (NOVOb.CO: Quote, Profile, Research, Stock Buzz) Chief Executive Lars Sorensen said.
“Europe in general has gotten away with completely underpaying for innovation,” Sorensen told the Reuters Health Summit on Tuesday.
NEW YORK (Reuters) – Teva Pharmaceutical Industries Ltd (TEVA.TA: Quote, Profile, Research, Stock Buzz) has yet to make any serious inroads into China, but its chief executive believes the company is better suited than its rival drugmakers to serve the world’s fastest growing health care market.
Teva is late to the party in China as most major drugmakers over the past several years have poured resources into establishing a presence in a country that IMS Health has forecast will become the world’s second biggest healthcare market, behind the United States, by 2016. Big investors in the country include Pfizer (PFE.N: Quote, Profile, Research, Stock Buzz), Novartis (NOVN.VX: Quote, Profile, Research, Stock Buzz) and AstraZeneca (AZN.L: Quote, Profile, Research, Stock Buzz).
(Reuters) – Gilead Sciences Inc on Thursday said almost all patients taking a fixed-dose combination of two of its experimental hepatitis C drugs appeared to have eliminated the liver virus after either eight weeks or 12 weeks of treatment in a small mid-stage study.
The data should strengthen the widely held perception that Gilead is leading the race among many companies to bring to market a highly curative, all-oral regimen with shorter treatment durations for the serious liver disease. Gilead shares rose 5 percent after the data was released.