FDA News Update for 3/6/13

FDA News Update for 3/6/13

March 1st, 2013 // 6:16 pm @

Which FDA District Offices Are The Best and Worst to Work With? Which Inspectors Are the Best and Worst for Your Audit?

Find Out March 13!



3/6 Specialty Drug Costs Have PBM’s Scratching Heads
– PBM’s working on tactics to rein in wildly expensive costs including political pressure to push biosimilars
Spending on Traditional Drugs Drops as Specialty Medicines Rise … Americans are spending less on pills and other conventional medications for the first time in two decades, and more on complex injected drugs … biosimilars, is necessary to offer more affordable medication for patients afflicted with  …[Bloomberg]
Rise of Generics, Specialty Drugs Prompt Shift in Drug Spending … Specialty drug costs are absolutely on the radar screen of payers …  cancer and multiple sclerosis that can cost thousands each month … difficulties health plans face restraining their prices commonly need up-front approval … [Dow Jones]
Editor’s Note: The Dow Jones report is 873 words, MUST READ.  Contains thought provoking stats  – for instance, cancer drug use rose 3.4% last year but cancer drug spending rose 22.3%.  The bottom line is that PBM’s are going to change the blank check paradigm or the system will crash.   Express Scripts is is spent about $2.5 Million on lobbying in 2010.  (Fear not, PhRMA spent $18.5 Million on lobbying).

3/6 Australia Invalidates Crestor Patents
– Crestor already generic in Canada
Australian Setback for AstraZeneca … three patents protecting its cholesterol management drug, Crestor (rosuvastatin) were rendered invalid by the Federal Court of Australia. The three patents including a formulation patent were set to expire by 2020-21…[Zacks]

3/6 Celebrex Patent Extended 1 Year; Was 2014 – Now 2015
Pfizer Gets Reissued Celebrex Patent, Extends Exclusivity … U.S. patent office decision extends Celebrex exclusivity to December 2015 from May 2014 … Decision could stave off competition from low-cost generics for an extra 18 months … Claims in re-issued patent similar to those in prior patent that was struck down …[NASDAQ]

3/6 Report: Lilly’s Future Dimmest Of The Big Pharma Co’s
Who’s the Frailest Big Pharma of All? … withstood the patent cliff better than several of the others, the impending loss of exclusivity Cymbalta, Humalog, and Evista will be very tough … doesn’t appear to have anything on the radar that will replace the revenue drop that is sure to come …[Motley Fool]

3/6 Pancreatitis Scare Publicity Apparently Has
No Impact On Doc, Patient Attitudes
Janu-“Meh”: pancreatitis study fails to cause uproar … Patients also seem unconcerned so far …  American Diabetes Association said it has yet to receive a single patient inquiry regarding the study … study focused on hospitalizations resulting from pancreatitis among GLP-1/DPP4 patients as opposed to pancreatitis incidents as a whole … [MM&M]

Why Isn’t Vivus Promoting Its Erectile Dysfunction Drug 
Should VIVUS Just Forget This Drug? … If VIVUS doesn’t launch Stendra in the U.S. by the end of the year, it could lose its license to the drug … company has been looking for partners to help commercialize Stendra for quite a while now and still doesn’t have any solidly lined up … Motlet Fool]

3/4 Baby With HIV Apparently cured
– High doses given early seem to have done the trick
Scientists say baby born with HIV apparently cured …  doctor gave this baby faster and stronger treatment than is usual, starting a three-drug infusion within 30 hours of birth …  some remnants of genetic material that don’t appear able to replicate …[AP]

3/4 Why Do So Many Alzheimer Drugs Fail?
101 Reasons to Stay Away From Drugs for This Disease … we don’t know enough about Alzheimer’s disease to know how to treat it … awful lot of drugs to fail in a single disease over a 15-year period … Most investors would be best off staying away from Alzheimer’s drugs given the high failure rate; don’t become failed attempt No. 102 if you don’t have to …[Motley Fool]

3/4 Not Very Effective, Mat Cause Cancer: The Latest OOPS Drug
– Miacalcin, Fortical skating on thin ice, accused of causing cancer
Salmon Hormone May Contain Too Much Cancer Risk … FDA advisers plan to meet next week to decide if the risks and level of efficacy mean they should recommend sales of calcitonin-salmon drugs be discontinued … potential for a cancer risk associated with calcitonin salmon therapy raises concerns …[Bloomberg]

3/4 Why Tresiba Rejection Is Not The End Of The World For Novo Nordisk
Even without Tresiba, Novo’s a money machine
How This Drugmaker Will Deal With A Diabetes Delay … insulin is the company’s core market, with a 49% share of the world market … no debt on its balance sheet and a large cash balance … market position in diabetes should provide it ample opportunity to continue growing …[Motley Fool]
Editor’s Note: Hints that Tresiba new info filing  will probably be delayed until 2014, possibly as late as 2015.

3/1 ADA, ACE Downplay Pancreatitis Risk Of DDP-4’s, GLP-1’s
American Association of Clinical Endocrinologists, American Diabetes Association Issue Joint Response to published JAMA Article … only two additional cases per 100 patients over a three-year period. This same population of adults, between the ages of 18-64 with type 2 diabetes, had a greater risk of hospitalization for acute pancreatitis if they used tobacco, consumed alcohol or were obese.…[American Diabetes Association]

Diabetes drugs tied to pancreatitis: study …  new study will not change how he treats patients, but it may influence him to go over his patients’ risk factors for pancreatitis … supporters say the drugs are safe and offer some advantages over older medications …[Reuters]

3/1 FDA Green Lights Once Per Month Abilify Jab
FDA Approves Once-Monthly ABILIFY MAINTENA™ for the Treatment of Schizophrenia … first commercialized product from the long-term global alliance between Otsuka and Lundbeck  …  sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly …[Otsuka Press Release]

See Also: Package Insert … Recommended starting and maintenance dose is 400 mg administered monthly as a single injection  … In conjunction with first dose, take 14 consecutive days of concurrent oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic … Some patients may benefit from a reduction to a 300 mg dose …

3/1 Takeda; Actos Trial Day 1, Mudslinging Begin
Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says … sales representatives never warned a doctor for California resident Jack Cooper in more than 195 visits … representatives first mentioned the drug’s increased risk of cancer in August 2011. The doctor stopped writing new prescriptions that month and banned sales representatives from his office …

2/28 FDA Goes After “FaceBook Like Button” On Pharma Oriented Sites
– Expect to see “Like” buttons disappear;  FDA sees them as testimonial
What’s Not To Like? Facebook And The FDA … FDA referred to a Facebook ‘like’ as a testimonial, because this may have real implications for the pharmaceutical industry …  “FDA’s interpretation that a ‘like’ implies endorsement could be a precedent-setting action by an agency that has been slow to issue a formal social media policy.”

Which FDA District Offices Are The Best and Worst to Work With? Which Inspectors Are the Best and Worst for Your Audit? Find Out March 13!

2/28 Another Brick In The “GSK Flu Shot Gave Me Narcolepsy” Wall
UK study confirms GSK flu shot link to rare sleep disorder … at least 14-fold increased risk they … Studies in Finland, Sweden and Ireland have also found a Pandemrix link to narcolepsy, and GSK says more than 800 cases linked to the shot have been reported in Europe …


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