Swiss drug maker Roche will not be allowed to sell its anemia drug Mircera in the US until July 2014 under terms of a settlement with Amgen Inc., the companies reported. According to Amgen, "a US District Court in Boston ruled that Mircera infringes on five patents supporting Amgen's anemia drugs Aranesp and Epogen." Roche had acknowledged that the disputed patents are valid and enforceable. But, the settlement does not cover any payments between the companies. The disputed "patents cover critical steps in the production of" a "genetically engineered protein" called erythropoietin.
UK drug regulators back Yondelis after Zeltia agrees to cover some of the cost. Zeltia SA's Yondelis [trabectedin] will be offered by the UK's National Health Service as a treatment for soft- tissue sarcoma after the company agreed to pay for any patient who needs more than five cycles of the drug." The UK's National Institute for Health and Clinical Excellence "reversed an earlier recommendation rejecting the drug as too expensive. NICE has recommended its use where other treatments have failed or cannot be tolerated because of side effect."
Austria makes morning-after pill available without prescription.
Austria's health ministry says the contraceptive morning-after pill is now available in pharmacies without a prescription." The health ministry "said that women of all ages can now buy the pill...over the counter."
FDA begins hearings on Internet marketing of medical products.
The Food and Drug Administration "is hearing from dozens of drug and advertising executives at a two-day meeting on Internet marketing of medical products." After complaints from both web companies and the pharmaceutical industry that marketing guidelines were too restrictive for the medium, "the agency has agreed to consider developing rules for online ads." Yahoo "is testing a new type of ad that would contain an extra link to detailed drug information, including risks," while Google "is proposing a similar design that would list a short summary of drugs risks, followed by a link to full prescribing information."
Cephalon, Barr settle patent infringement suit.
Cephalon Inc. will give Barr Pharmaceuticals Inc. a license to sell a generic version of the pain drug Fentora in 2018 as part of a patent lawsuit settlement, according to a Securities and Exchange Commission filing. Under the deal, Cephalon "will give Barr a non-exclusive, royalty-free right to sell a generic version of Fentora in October of 2018," even though "the patent is not set to expire until 2019." But, "if another generic version of Fentora reaches the US market before October 2018, Barr is allowed to launch its version..
Cancer prevention drugs said to be widely ignored.
Some researchers state that "the few medicines proved to deter cancer are widely ignored," because "people are not enthusiastic about taking anticancer pills, or are worried about side effects or not really convinced the drugs work." As a result, drug makers say that "it makes little economic sense to spend decades developing drugs to prevent cancer," and instead, "the better business plan seems to be looking for drugs to treat cancer." Meanwhile, researchers say that many "measures that are often assumed -- and marketed -- as ways to prevent cancer may not make much difference." In fact, studies linking cancer to such measures typically "cannot assess cause and effect," while studies that do come up with these associations "are likely to be published, even though often the associations turn out to be spurious."
Canadian officials nix recommendation for second flu shot in children.
Federal health officials in Canada have determined that "all but the youngest children need only a single half-dose of H1N1 vaccine." The new recommendation will "free up vaccine and make more shots available to the general public sooner," and also "means many parents of healthy children who have already endured waits hours long to have them vaccinated will not have to line up again for a second shot."
Also at http://www.qa-expert.com/2010/01/drug-regulatory-qa-updates.html