Feeds:
Posts
Comments

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.

—––

Subscribe to the Impactiviti blog via e-mail

Subscribe to the Impactiviti blog via RSS

Impactiviti is a pharma consultancy focused on helping pharma/biotech/medical devices companies identify optimal vendors for training/marketing needs.

Reblog this post [with Zemanta]

Read Full Post »

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…

—–

Subscribe to the Impactiviti blog via e-mail

Subscribe to the Impactiviti blog via RSS

Reblog this post [with Zemanta]

Read Full Post »

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).

Reblog this post [with Zemanta]

Read Full Post »

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..

Reblog this post [with Zemanta]

Read Full Post »

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.

Reblog this post [with Zemanta]

Read Full Post »

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

Reblog this post [with Zemanta]

Read Full Post »

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.

Reblog this post [with Zemanta]

Read Full Post »

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

Craig Audet, VP, US Regulatory Affairs Marketed Products, Sanofi-Aventis: Laying the Groundwork for Engagement in Social Media

- Pharma needs to engage – more. 87% of people using Wikipedia to search for health info think it is reliable. Media professionals are looking for story leads.

- Those who have dared – some of the unbranded excursions into Social Media. J&J. Pfizer. Filtered/vetted  comments.

- We’ve been here before – early DTC. 14 years from first broadcast to formal DTC guidance.

- Adverse event and Off-label discussions on websites are 2 key problem areas. Details about what that means: 4 specific criteria for adverse events – Identifiable patient [what is the due diligence between identified, and identifiable?]; etc.

- Questions company must ask selves: Whether corporate culture is social-media friendly; how company interprets FDA regs; tolerance for uncertainty.

- How will you handle negative commentary?

- Ready to be the market leader?

- How will you resource (note: lots of ongoing monitoring work – can’t just launch-and-leave -SW)

- Maybe start with advertising on soc med websites as a toe in the water.

:: You WILL engage in social media at some point. Wade in and test the waters to start.

Reblog this post [with Zemanta]

Read Full Post »

King begins hostile takeover proceedings with Alpharma – Brain Markison, King’s ceo, is disappointed that Dean Mitchell, Alpharma’s ceo, hasn’t responded to his initial offer $1.4 billion offer, which amounted to $33 a share. So Markison raised the bid to $37, or $1.6 billion, and is going directly to shareholders…more

J&J’s Christine Poon to retire.

ImClone to BMS: maybe we’re already dating – The drugmaker calls the $60-a-share bid by Bristol-Myers Squibb ‘inadequate,’ and goes on to say in a statement this morning that famed corporate raider Carl Icahn, who chairs ImClone’s board, has had ’several conversations with the ceo of a large pharmaceutical company,’ which was not named…more And more BMS-to-ImClone here, and on the response here.

Meanwhile, BMS grounding its fleet – Bristol-Myers Squibb is preparing to shut down its aviation operation at Trenton-Mercer Airport, sell four aircraft and dismiss about 32 employees as the drugmaker and leading Mercer County employer seeks to cut costs, according to sources familiar with the company’s plans…more

Amgen violating patents?

Can Botox relieve migraines?

FDA reports rare brain infection/death with Rituxan – The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec…more

Sanofi fills top job with Viehbacher from Glaxo – Chris Viehbacher, GlaxoSmithKline Plc’s head of North American operations, is to take a top job with French drugmaker Sanofi-Aventis, a person familiar with the situation said on Tuesday…more

Januvia, 2 years in: thumbs up – Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed…more

Experimental diabetes drug (BMS/AZ) promising – Bristol-Myers Squibb and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday…more

Fast track for cancer drug Afinitor – An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer. Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given the medicine’s potential to help patients who fail to respond to standard therapy…more

Tysabri for cancer? - Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies said on Friday…more

Celgene gets a fast track for lung cancer drugCelgene Corporation (NASDAQ: CELG) today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy…more

Is Pfizer interested in Bayer?

Sample trouble: drives up costs? – Free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run, according to a new retrospective study in the Southern Medical Journalmore

The Allergan-Medicis “death match” – Allergan and Medicis have been locked in a highly profitable death-match for several years, with both companies bringing out me-too versions of the others’ products, just like Coke and Pepsi…more

But will it be posted in the Post Office? The FDA 20The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed…more

Zimmer growing some spine.

GSK and Valeant on epilepsy drug tie-up.

Pfizer and Medivation to work together on Alzheimer’s/Huntington’s treatment.

Genentech and Roche acting merged: facilities closing - The fallout from Roche’s looming acquisition of Genentech has started. Roche will close a research facility in Palo Alto, Calif., where a 1,000 people work, the San Jose Mercury News reports. Back in July Roche said it would pull the plug on the lab in Stanford Research Park, but the company hedged, saying the closure would happen if the bid for Genentech were successful. Genentech has demurred so far, but most people think it’s just a matter of time before the deal happens. And now, Roche told the Mercury News it’s closing the plant, no matter what…more

No vigil for Provigil at TakedaCephalon Inc. will end its co- promotion agreement with Takeda Pharmaceutical Co. in North America for the sleep-disorder drug Provigil, because net sales dropped to less than $850 million this year…more

UCB: Yep, we’re specialty now. Translation: downsizing – If you can’t buy a biopharmaceutical company, you might as well become one. UCB Pharma last week announced that it will trim 17 percent of its work force—about 2,000 employees—in order to reestablish the company as specialty drug firm….more

Every once in a while you want to visit here – Forbes’ New Drugs to Watch page.

This is way cool – A little-used cancer drug called bryostatin can repair brain tissue if it’s administered within 24 hours after a stroke, according to U.S. researchers. Current stroke treatments must be administered within three hours and aren’t able to repair damaged brain tissue, the scientists said…more

Shire and Vyvanse for ADHD – One of the recent unheralded successes of the drug world was Shire Pharmaceuticals‘ launch of Vyvanse, a new, long-acting treatment for attention deficit and hyperactivity disorder. The fact that so little attention has been paid to Vyvanse is a shame because the take-up of this drug has been impressive — it appears to be well on its way to supplanting Adderall XR as the king of the ADHD drugs…more

I kinda think this one’s a no-win for Genentech – Negative public opinion just keeps piling on to Genentech regarding its pricing policy on Lucentis and Avastin. This weekend saw a big Associated Press story describe how the company is refusing to ask the FDA to approve Avastin for use in treating “wet age-related macular degeneration,” an eye condition that leads to blindness. Genentech is doing this, most people believe, because Avastin would be a much cheaper treatment for wet AMD than Lucentis, another Genentech drug. It costs about $60 per dose to use Avastin on the disease, and $2,000 to use Lucentis…more

Speaking of no-win – releasing Vytorin data…more

Reblog this post [with Zemanta]

Read Full Post »

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

Zemanta Pixie

Read Full Post »

Follow

Get every new post delivered to your Inbox.

Join 27 other followers