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Posts Tagged ‘Johnson & Johnson’

Genentech‘s Raptiva: TroubleThe FDA said today that patients taking the Genentech drug Raptiva are at risk of developing a potentially fatal condition known as PML, or progressive multifocal leukoencephalopathy. The drug’s label already carried a warning about this possibility. But last week, Genentech sent a letter to alert doctors that a third case of PML had been confirmed in a Raptiva patient, following two other cases reported last fall. Meanwhile, Roche still raising cash to try to take over Genentech.

U.S. government joins in on whistleblower suit against J&J biz unit SciosThe U.S. government is joining two lawsuits against Johnson & Johnson and its Scios unit, accusing the companies of promoting heart failure drug Natrecor for unapproved uses, the Department of Justice said on Thursday. The drug is approved to treat patients with acutely decompensated congestive heart failure who experience shortness of breath. But DOJ officials said in a statement their investigation found Scios aggressively began marketing the drug to patients with less severe heart failure soon after its approval in 2001.

Crestor cuts stroke risk in half (Jupiter study) – A new analysis from the JUPITER study presented today at the International Stroke Conference (ISC) in San Diego, California describes details of the stroke data according to gender, ethnicity and baseline risk factors. This data adds to the primary analysis of the JUPITER study which demonstrated that CRESTOR® (rosuvastatin calcium) 20mg significantly reduced the risk of stroke by nearly half (48%; p=0.002), compared to placebo among men and women with elevated high-sensitivity C-reactive protein (hsCRP) but low to normal cholesterol levels.

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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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J&J found not liable in Motrin case – Johnson & Johnson on Thursday won a lawsuit brought by the family of an 11-year-old girl who became blind after using the drug Children’s Motrin in 2003…more

Preemption reversed? – US District Court Judge David Hamilton has reversed his prior opinion in which he had dismissed a Paxil suicide case based on preemption, which says that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. The FDA and drugmakers argue preemption exists by maintaining agency actions are the final word on safety and effectiveness. The case is now re-opened…more

Teva pays Barr tab – The world’s largest maker of generic drugs is expanding once again. Teva has agreed to pay $66.50, or a total of $7.46 billion plus the assumption of net debt of approximately $1.5 billion…more

AZ and Ethical pharma – AstraZeneca is training staff in a new Code of Conduct that aims to ensure employees at all levels and locations act appropriately. The Code was introduced in May and covers a number issues, including interactions with healthcare professionals, conflicts of interest and the ethics of R&D. It goes further than the recently revised EFPIA or PhRMA rules and explicitly spells out dos and don’ts on additional issues, such as political donations and insider trading…more

You’ve heard about the HR helicopter? Some folks take this literally.

PhRMA says, “Bag the Schwag” – A ubiquitous element of pharmaceutical marketing is scheduled to vanish next January 1, as the revised marketing code of the Pharmaceutical Research and Manufacturers of America goes into effect. Gone will be the non-educational freebies—the pens, pads, mugs, toys, and miscellaneous tchotchkes?that pharma companies distribute by the carload…more. And more here from Pharmalot.

The Washington D.C. rules and regs for pharma sales reps.

Glaxo to pay billions for a good night’s sleep – The drugmaker has agreed to pay that much for the licensing rights to Actelion’s investigational drug, almorexant…more

BI cutting neuro sales force – The neurology sales team, which peddles Aggrenox to neurologists for treating transient ischemic attacks and strokes, met last week in Chicago, where BI managers told them they are going to restructure…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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