10/1 Pfizer Abandons Obesity, Cardio, GI To Focus On Cancer, Pain
Pfizer to focus on more profitable diseases … cancer and pain are typically more profitable because the makers can charge a higher price, and there is less competition … Development will end on at least 11 drugs, including 6 studied for obesity and heart disease and three for digestive disorders …[ International Herald Tribune]
Editor's Note:  Implies that Pfizer may be the Imclone mystery bidder.
See Also: Similar Report From Reuters
See Also: Pfizer Touts Pipeline Progress, but Doubters Remain …[Wall Street Journal; FREE]

10/1 Govt.  May Flip-Flop On Mandatory Gardasil For Immigrant Gals
Gardasil Requirement for Immigrants Stirs Backlash … We don't want someone coming into the U.S. who hasn't been vaccinated against measles or chickenpox … HPV can only be communicated by sexual contact…[Wall Street Journal; $$$]

10/1 Weird Eyeball Side Effect To Bisphosphonates Reported
Zometa, Reclast, Boniva Infusions Linked to Eye Inflammation …  letter in the NEJM, a 57-year-old man who received an infusion of zoledronic acid (Zometa or Reclast) and three people who received infusions of Boniva developed inflammatory eye disease ...treated with corticosteroids and improved in days … [NewsInferno.com]

10/1 Glaxo Forced To Fire 850 Scientists In Bid To Save Money
Glaxo to shed 850 research jobs in drive for efficiency … further improve GSK's productivity. Regrettably some job reductions are necessary and we will do everything we can to support those employees who are affected …[ Guardian UK]
See Also> Similar Report From Wall Street Journal; FREE

10/1 Expert Says Amylin Over Valued
Amylin Pharma Still Overvalued … tied to the success or failure of … exenatide LAR. Although the data on LAR presented last month at ADA looked good, we are unconvinced that it will be enough to drive the kind of profitability that justifies …[Zacks]

10/1 Before You Take That Pill
Whimsical musings of a medical doctor and researcher on drug and health news … variety of topics ranging from droughts to prayer, politics and chiggers (a small parasite found in forests of the Southern US) …[ Drug News and Health Blog, by Doug Bremner MD]

10/1 Sciele: Experimental Topical Penile Lidocaine Spray Delays Ejaculation
Sciele Pharma: Plethora Solutions Has Completed European Phase III Trial of PSD502 for Premature Ejaculation  … shown to increase ejaculation latency time significantly when compared with placebo … In May 2007, Sciele signed an exclusive licensing agreement with Plethora Solutions to market PSD502 in the U.S. …[ Sciele Press Release]
Editor's Note:  PS502 is a metered dose spray containing a mixture of lidocaine and prilocaine that is applied directly to the penis.  Therapeutically it is similar to over-the-counter products such as  Durex' Play Pleasure-Enhancing Lubricant Longer, whose active ingredient is 7.5% benzocaine (cost = $5.99 for a bottle). 

10/1 Novo: March 23 = Liraglutide PDUFA Date
Novo Nordisk Takes On All Comers … if liraglutide can significantly outperform Januvia when results are announced next year, Novo Nordisk will likely have a very profitable compound… [Motley Fool]

10/1 Aclasta Gets EU Nod For Men
Once-yearly Aclasta® approved in EU to treat osteoporosis in men and to reduce risk of new fractures … Despite the severity and the large numbers affected, osteoporosis in men has received very little attention …[Novartis Press Release]

10/1 Internet Drug News Miscellaneous Short Takes:
Anti-Obesity Drugs Could Fight Viral Infections
Washington Post
Media Doesn't Often Mention Pharma Funding on Research
HealthDay
Danish study finds HRT does not raise heart attack
Reuters
Fewer doses of anthrax vaccine protect just as well
Reuters
Many cancer patients forgo painkillers
Reuters
Birth Size Linked to Breast Cancer Risk
HealthDay

9/30 Docs Don't Like Pods, Too Many Reps
Wanted: smarter reps, says survey … want to see fewer reps in their practices (90%), fewer "mirrored" or "pod" sales teams (72%) and fewer traditional primary care reps (69%) … [MM&M]

9/30 Coumadin Brain Bleeding
Blood Thinner Linked to Increased Brain Bleeding … amount of bleeding in the brain that occurs when a blood vessel bursts and causes a stroke is greater for some people who take the clot-preventing drug warfarin (Coumadin) …[HealthDay]

9/30 Cephalon Settles Whistleblower Off Label Fraud Suit For $425 Mln
Ohio Sales Rep's Information Launched Massive Government Investigation of Cephalon … agreed to wear a wire to a company sales conference to help the government gather evidence … whistleblowers will receive a reward totaling $46 million for their information … sales representative, Bruce Boise, refused to follow company-ordered sales strategies to convince doctors to prescribe Cephalon's Actiq, Gabitril and Provigil drugs for unapproved ("off-label') uses…[ MarketWatch]
Under Sweeping Settlement, Cephalon Will Disclose Doctor Payments …  state and federal probes of its sales and marketing practices ...agreed to plead guilty to promoting painkiller Actiq, narcolepsy pill Provigil and the epilepsy treatment Gabitril for uses that weren't approved by FDA….[Wall Street Journal; FREE]
See Also: Similar Report From Reuters

9/30 Unbranded Ads: Big Dogs Question ROI
Unbranded Ads Also Unpopular … Spend in the first half of the year for such ads, which describe an ailment but don't plug the branded solution, fell 3% to $2.4 billion … Building the category is a very noble aspiration, but I just don't know if that's the way we make our numbers."…Pfizer, however, is one company that is actually  increasing its … [BrandWeek]

9/30 Monday Morning Quarterbacks Pick Apart Friday's Prasrugrel No-Go
Eli Lilly shares fall on blood-thinner concerns … second time the regulatory agency has asked for more time … FDA has had several opportunities and sufficient time to issue such a decision. Therefore the delayed decision suggests that there is little reason to believe a negative decision is forthcoming …[ AP]

9/30 FDA: Can't Prove Statins Cause Lou Gherig's, But …
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease" … given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted … FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins …[FDA Press Release]
See Also: Similar Report From Reuters

9/30 Colombia Labs: Intravaginal Lidocaine For Dysmenorrhea Fails
Columbia Labs' lidocaine fails a mid-stage study … There are no current therapies approved for dysmenorrheal … failed to hit the primary endpoint in a mid-stage trial for prevention and treatment of dysmenorrheal, or painful menstruation. The therapy was no better than a placebo in treating the condition. …[ Fierce Biotech]
See Also: Similar Report From Reuters

9/30 Imclone To Reveal Mystery Buyer  Wed Afternoon
ImClone: USD 70 per share proposal submitted by US-based large pharma; Takeda not 'mystery bidder' … US companies that have been cited as possible bidders by sources and market investors include Celgene, Amgen, Eli Lilly  and Pfizer …[FT.com]
ImClone could name $70-a-share bidder on Wednesday … will be revealed by end of day Wednesday regardless of whether the pharmaceutical company makes a firm proposal … wouldn't surprise me at all if Pfizer's taking a look … [AP]

9/30 Internet Drug News Miscellaneous Short Takes
Watson Hypes Experimental Alpha 1 Antagonist For Prostate
Watson Press Release
Genentech dips below Roche offer amid deal nerves
Reuters
Lilly's Alimta OK'd as front-line lung cancer drug
Reuters
Walgreen pays $9.9 mln to settle Medicaid case
Reuters
Doctors Demand More Value from Sales Representatives
Publicis Press Release


9/29 Prasugrel Delayed Again; Lilly, Sankyo Remain Sanguine
Lilly's Prasugrel Delayed as U.S. Continues Review … consensus of analysts is that the FDA will approve prasugrel with restrictions on use … best guess at this point is that while the Effient review is not yet complete, a final decision by FDA is not likely to require that Lilly and Daiichi-Sankyo generate new clinical data…[Bloomberg]
FDA Delays Decision on Lilly Heart Drug ... decision was initially due in June, but the FDA said then that new analyses filed by the companies required additional time to review…[Wall Street Journal; $$$]
See Also: Similar Report From Reuters
See Also:  Lilly Press Release … Sankyo and Lilly will not speculate on the timing or what the outcome will be. However, the review is very far along, and we remain optimistic ...

9/29 Eprex: High Dose Trial Saw Apparent Increased Mortality;
JNJ Transparency Appears To Have Limited Damage
J&J Gets Proactive About Bad News … Sometimes being proactive can be your best bet in countering a bad situation. … early communications often come out before the FDA has had time to investigate the underlying cause of the problem …[Forbes]
Editor's Note:  Explains how JNJ's transparency regarding releasing negative clinical data translated into investor confidence in the company. 
See Also:  FDA probing deaths in J&J anemia drug study …[Reuters]
See Also: FDA reviews experimental use of anemia drugs …[AP]

9/29 Hyperactivity Drugs: 5 Companies Get Letters For Misleading Tactics
US criticizes Lilly, J&J, Shire for misleading drug ads … Shire drew objections for a webpage and video testimonial posted on YouTube  … Lilly overstated the effectiveness of its drug Strattera and minimized important risks ...suggested use for patients for whom the drug is not approved… materials for Concerta extended-release tablets were "false and misleading ...overstated the efficacy of Concerta and omit … [Reuters]
FDA Warns Five Drugmakers Over ADHD Ads … Manufacturers will always try to go right to the limit in making their promotional claims to doctors, and doctors tend to follow their claims, …[Pharmalot]
9/29 Drug For Stuttering:
Indevus Perks Up Over Drug News …  pagoclone, a drug meant to treat stuttering … potential to become a highly significant commercial product ...ground-breaking therapy to the nearly three million Americans and millions of patients around the world …[Forbes]

9/29 Glaxo Walks Away From Iffy Experimental Osteoporosis Drug
GlaxoSmithKline ends deal with NPS for bone drug … ending phase II trials of the drug, known as Ronacaleret … citing the treatment's lack of efficacy …[ Philadelphia Business Journal]
See Also: Similar Report From Reuters
Editor's Note: Ronacaletet  (AKA SB-751689) was a Phase II calcium antagonist that was hoped to be useful in  osteoporosis & fracture healing [source = GSK SEC Form 20-F Pg. 23/357]

9/29 Liraglutide Will Be Marketed As "Victoza" - Novo Releases Early Data
Novo Nordisk: Research Update … intended brand name for liraglutide: Victoza® …  reduction in HbA1c of 0.3 percentage points ...decrease in fasting plasma glucose of 0.9 mmol/L … weight loss of approximately 1 kg … reduction in systolic blood pressure of close to 4 mmHg …[ Novo Press Release]

9/29 Internet Drug News Miscellaneous Short Takes:
Pat D Rates Set To Increase 31% In '09
Wall Street Journal; FREE
Alpharma rejects King Pharma's unsolicited bid as inadequate
Reuters
Broker sees Glaxo's Advair losing sales to Spiriva
Reuters
Lilly Sinks After Hours on Effient Delay
Seeking Alpha
Tamiflu, Relenza: Roche, GSK urge employers to stockpile flu drugs
AP
Pharma Soothsayer On Pfizer: Deep Cuts Coming
Derek Lowe; In The Pipeline
Pfizer shares up on layoff speculation
TheDay


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