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Posts Tagged ‘Food and Drug Administration’

Huge cuts at Schering-Plough: 1,000 sales jobs going away – As part of a reorganization already under way, the drugmaker is eliminating 1,000 sales jobs – or 20 percent of its sales force – by October. Many of the 4,000 or so surviving reps, meanwhile, will be shifted to pitch different types of docs or work in other territories. A Schering-Plough spokesman confirmed the cuts…more

New Roche arthritis biologic delayed – In a setback for the drugmaker, the agency has issued a ‘complete response’ letter for Actemra, a biologic Roche hopes to market for treating rheumatoid arthritis. An FDA advisory committee endorsed its use last July by a 10-1 vote, but the agency wants “additional documentation” about manufacturing and other unspecified info, some of which relates to final labeling, according to Roche…more

Merck’s Gardasil: OK for vaginal cancer – U.S. health regulators have approved Merck and Co’s Gardasil vaccine to protect women against rare vaginal and vulvar cancers, the Food and Drug Administration said on Friday…more

GSK’s Tykerb: OK for head and neck cancer (maybe) – New clinical data supports the use of GlaxoSmithKline’s drug Tykerb as a treatment for head and neck cancer, endorsing the company’s move to push ahead with a final Phase III study in this indication…more

UCB’s Keppra XR: OK for sale – Belgian pharma group UCB said on Monday that U.S. health authorities had approved epilepsy drug Keppra XR and that it would go on sale just before its mother drug loses patent protection…more

Impactiviti’s Recommendra: Now prescribed for all training recommendations (OK, just checking to see if you were reading…)

J&J putting some heat on Enbrel for psoriasis – Johnson & Johnson said on Thursday its experimental psoriasis drug proved more effective than top-selling treatment Enbrel in a late-stage trial, was just as safe and required far fewer injections…more

Memory Pharmaceuticalsforget about jobs for half of employees.

An interesting new avenue of diabetes research unveiled – new class of hormones produced by body fat identified.

On the pharma marketing front….

Reuters and The Doctor’s Channel collaborate for streaming video healthcare “snacking.”

On-line detailing taking off.

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Prasugrel review extended – Daiichi Sankyo Company, Limited, and Eli Lilly and Company said that the U.S. Food and Drug Administration (FDA) has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period…more

Heart trials for diabetes medicines? – The agency wants its Endocrinologic and Metabolic Drugs Advisory Committee to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large…more

Paxil and pregnancies – Much of the hoopla one reads about the controversial antidepressant concerns the risk of suicide and the extent to which the drugmaker disclosed – or did not disclose – meaningful clinical trial data…more

Doctors under the Influence?

Breathing easier at Merck and Schering? – Could it be? Are they getting a divorce over Vytorin? No, sorry to excite you. But the drugmakers are ending their respiratory joint venture and their eight-year effort to market a combination of their Claritin and Singulair medications, which are used to treat allergic rhinitis…more

Analyst takes up news space with BMS conjecture – The drugmaker looks increasingly attractive and a sale is a “distinct possibility,” according to Tim Anderson, a pharma analyst at Sanford Bernstein…more

Pharma’s sinking reputation – The latest Harris Interactive poll that examines American attitudes toward corporate America offers a sobering view of and for the pharmaceutical industry. Only 26 percent of Americans view the industry favorably…more

Can’t make this stuff up – A drug developed using nanotechnology and a fungus that contaminated a lab experiment may be broadly effective against a range of cancers, U.S. researchers reported on Sunday…more

Sweet home Alabama – A state court jury decided the two drugmakers defrauded Alabama in a long-running Medicaid drug pricing scheme and ordered them to pay more than $114 million in damages, the Associated Press reports…more

Pfizer rocking the CME funding world – In what may be a first, a drugmaker will still support continuing medical education courses at academic institutions, teaching hospitals and those supported by medical societies, but no longer directly support CME courses offered by for-profit medical-education and communication companies, Dow Jones reports…more

Xience (drug-eluting stent from Abbott) gets approval.

They do pass laws in D.C., after all – Earlier this year, the city became the first in the country to license sales reps, whose licenses can be revoked if their activities are deemed fraudulent. The bill was passed in hopes of enforcing good business practices on people who have undue influence over docs, and therefore patients…more

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Cymbalta approved for Fibromyalgia – The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced today…more

Takeda’s Actos may help prevent diabetes – Actos, a pill to treat diabetes, can prevent development of the disease in people with early symptoms, U.S. researchers reported…more

Amylin’s once-weekly Byetta looks promising for lowering blood sugar – Amylin Pharmaceuticals Inc said on Monday that a once-weekly version of its Byetta type 2 diabetes medicine led to additional improvements in blood sugar levels over the currently available drug that must be injected twice a day…more However, their stock was pounded after many positive news reports of competitive drugs.

Ranbaxy up for grabsDaiichi makes bid. Also, strikes deal with Pfizer over generic Lipitor.

Elan/Wyeth experimental Alzheimer’s drug continues to progress in clinical trials – A closely watched Phase II study of an experimental Alzheimier’s drug being developed by Elan and Wyeth shows the med appears to be effective in some patients. Known as bapineuzumab, the drug failed to achieve statistically significant results in the primary outcomes, but managed to do so in subgroups lacking a higher genetic risk to develop the disease…more

J&J, Red Cross, call it quits on legal fight – The lawsuits had an absurdist, has-it-really-come-to-this quality about them. Johnson & Johnson and the Red Cross — Band-Aids and baby powder, blood drives and disaster relief — were suing each other over the rights to the red cross emblem that both had long shared. Now, after getting most of its suit against the Red Cross tossed out by a judge, Johnson & Johnson has picked up its legal toys and gone home. The company said today that it is dismissing its remaining claims against the august nonprofit. And the Red Cross, for its part, threw out its counterclaims against J&J. The companies’ statement is online here more

FDA and Genentech in a staredown – Last year, Genentech caused a ruckus by restricting distribution of its Avastin med to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis was approved to treat the malady, but at $2,000 a dose will cost about 40 times as much…more

Cancer drug Gleevec may help with strokes? Very cool – A highly effective leukemia pill may reduce complications and boost the effectiveness of a treatment for the most common type of stroke, an international team of researchers said on Sunday. Studies in mice showed giving Gleevec or imatinib, a drug made by Novartis AG, significantly reduced bleeding in the brain associated with the clot-busting drug known as tissue plasminogen activator or tPA…more

Millennium/Takeda’s Velcade gets expanded approval – Takeda Pharmaceutical Co, Japan’s largest drugmaker, won U.S. approval to promote its cancer drug Velcade for earlier treatment of multiple myeloma, the company said on Friday…more

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