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Posts Tagged ‘U.S. Food and Drug Administration’

Will pharma sales forces drop (overall) by another 20% in the coming years? ZS Associates thinks yes. Interesting perspectives in this article.

FDA missing yet another drug review deadline (Takeda’s experimental gout drug). Question: if these pharma companies are paying additional fees to ensure that the FDA gives prompt reviews, why is there no accountability when FDA is chronically late?? Perhaps the FDA should undergo the sanctions that pharma companies receive for false claims…

DTC spending. Heading down.

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FDA approves sharing unapproved drug uses with doctors. “The public health may be advanced by healthcare professionals’ receipt of medical journal articles … on unapproved new uses,” the agency states. Such uses may even “constitute a medically recognized standard of care,” according to the agency.

The Medicines Company to acquire TargantaTarganta’s lead product, oritavancin, is an innovative antibiotic with potent bactericidal (killing) activity against a broad range of gram-positive bacteria including staphylococcal strains with resistance to methicillin (MRSA) and vancomycin.

Roche to up the bid for GenentechGenentech stock rose from around $84 to around $86 on news that Roche is indeed going ahead with its bid to acquire the company. The FT reports Roche is look at $95 a share for the 44 percent of the company that it does not yet own. The timing of the bid will before early February…

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More job cuts coming up at Sanofi U.S. – Chris Viehbacher, the new CEO of Sanofi-Aventis, isn’t a man to let the grass grow under his feet. Just two days in his new job, and Sanofi is cutting its U.S. sales force, Dow Jones Newswires reports…more (Update: the number is 10%)

Generic heart medicines: just as good as brand-name stuff? – Generic heart drugs work just as well as the brand-name treatments they mimic at a fraction of the cost, according to a new analysis that challenges why some people still have doubts about generics’ benefits after almost 25 years…more But, take a look at this fresh data on adding a CCB to standard treatment.

Novartis’ new malaria treatment looking good at the FDA – Swiss drugmaker Novartis AG’s widely-used malaria drug, Coartem, appears safe and effective in the treatment of malaria, a U.S. advisory panel overwhelmingly said on Wednesday…more

Was DTC advertising a mistake? – U.S.-style direct advertising to consumers has been a big mistake for the global drug industry, undermining the reputation of the sector in the eyes of patients, according to a top executive at Roche…more

The drug cost/benefit calculus in Britain – For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer…more

J&J to pay a billion for Mentor – Expansion is the theme here. The health care giant is snapping up Mentor, which sells silicone-filled breast implants (see the site) as it moves into the market for cosmetic and reconstructive medicines, even as the lousy economy raises questions about consumer willingness to pay for such things (J&J statement)…more

Will Pfizer turn it around? Some think yes. And, here’s some post-mortem learning from the torcetrabip (failed) trials.

Interesting and promising early results treating sickle cell pathology in the lab (using virus-aided gene therapy).

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Glaxo: more big cuts, and the U.S. HQ needle pointing south – GlaxoSmithKline (GSK) announced that it will reduce its sales personnel by 12% to 7,500 down from 8,500. The company will slash 1,800 jobs resulting in a total of 1,000 layoffs. Some positions have already been eliminated while other personnel will be reassigned to new areas. The company is also consolidating operations and moving personnel from its Philadelphia facility to Research Triangle Park in North Carolina, where it employs about 5,000 people…more

Gilead gets a boost from new HIV treatment guidelines – The DHHS named Gilead’s Truvada, a combination of the company’s HIV treatments Emtriva and Viread, the lone preferred regimen for previously untreated HIV patients. Gilead’s shares added 3.2% to $47.31 in regular trading…more

Genzyme pours serious cash into Osiris – Genzyme Corp. will pay Osiris Therapeutics Inc. as much as $1.38 billion to develop therapies that use stem cells to treat blood cancers, inflammation and joint damage. ..more

Amylin’s Byetta LAR gets extended delay for extended release – Shares of Amylin Pharmaceuticals have collapsed after it emerged that US regulators have rejected data for a once-weekly version of its diabetes drug Byetta…more

UCB gets OAB drug approval – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency…more

What does Jupiter have to do with cholesterol treatments? A lot!

But will Winnie be used to sell obesity treatments? Pooh characters as Seroquel sales aids? Hmmm…

Cephalon’s Treanda gets another indication – on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL)…more

CV Therapeutics’ Ranexa gets a first-line approval – CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa® (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes…more

Promising experimental Hep-C treatment in the Schering pipeline – results being reported.

Obesity drugs: everybody bails out – For those of you hoping that America’s obesity crisis could be solved with a pill, think again. Pfizer announced late Wednesday that it is scrapping its anti-fat drug, the as-yet unnamed “CP-945,598,” for essentially political reasons. Sanofi-Aventis today also announced that it was ending its trials on Acomplia/Zimulti, an obesity pill that was approved and then yanked in Europe. And Merck a couple of weeks ago pulled its fat pill taranabant, from its pipeline…more

Why did J&J consolidate its drug advertising biz between 2 big agency holding companies?

Big Pharma’s loss may be Little Pharma’s gain - as big drugmakers continue to trim jobs, smaller biopharmaceutical makers and specialty pharma are benefiting from the downsizing, according to David Poling, director of state business operations at Aerotek, a staffing firm…more

The 10 weirdest drug stories of the month.

First glimpse of the secrets of the cancer genome. Fascinating.

If you’re not up on the latest pharma/legal issue called pre-emption, you need to be. Go here for the latest.

Want even more news? Chris Truelove over at Pharmalive has a big roundup this week – lots of interesting tidbits and links..

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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche - here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? - After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…more

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Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Mark Gaydos, Senior Director US Regulatory Affairs Marketed Products, Sanofi-Aventis: Mobilizing your Company for more complete Web 2.0

- Establish a Dedicated Team – need to have representation from all stakeholders (Commercial/Mkting, PR, Reg, Legal, etc.). It’s good for Reg key players to look ahead, and anticipate, and have strategies in place.

- Non-marketers need to think like Marketers – Just Don’t Say “No”! Imagine possibilities. Partner, not oppose.

- Identify Initiatives to be Pursued – advertise on soc med website. Host moderated community. Host moderated KOL blog. Conversation monitoring. Start small and develop a roadmap for moving forward. btw, FDA’s not waiting; they’re using soc med (have own YouTube channel).

- Gain Sr. Mgmt. Approval – know your risks, and have credible/defensible interpretations and policies in place.

- Move forward in Stages “try it on,” learn, evolve, adjust.

- Progress…with Caution

Example of FDA warning letter to Shire for Ty Pennington on YouTube video – but soc med not the problem, it was bread and butter violations of fair balance, etc.

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