Here’s this week’s pharma news capsule – Phispers (Pharmaceutical Whispers) – which includes compliance issues at a Spanish vaccine manufacturer, positive news on diabetes drug metformin and Sanofi’s
takeover bid for Medivation.
Capsules in India may
turn veg, as regulator plans ban on animal-derived gelatin First it was the ban on cow slaughter, then it was the ban
of fixed dose combination (FDC) drugs and now the Indian drug authority is considering
a proposal to replace the use of gelatin in capsules with cellulose. While a
majority
of capsules (around 95 percent) are made from gelatin, there have been concerns
over the safety of animal derived gelatin in the past. Drug used by 40
percent pork producers maybe carcinogenic; FDA takes step to withdraw itThe FDA took the first step toward rescinding its
approval for the use of carbadox to treat swine because “the drug may leave trace amounts of a carcinogenic residue.” Carbadox,
sold commercially as Mecadox, was
first approved in the early 1970s. An estimated 40 percent pork producers rely on the medicine to treat and prevent disease in swine, as well as fatten the animals. The manufacturer of Mecadox – Phibro Animal Health – intends to request a hearing and refute the allegations. Metformin found safe
by the FDA for patients with reduced kidney function There have been questions on how Metformin,
one of the most commonly prescribed treatments for type 2 diabetes, should be used in patients with reduced kidney function. Last week, the FDA Concluded from the review of studies published in medical literature that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” A Dutch
review had reached a similar conclusion earlier. Pfizer spinout, RaQualia’s next-gen ‘Nexium’ getting ready for China launchA spin-out of Pfizer
Japan, RaQualia has been evaluating tegoprazan (CJ-12420) as the
next-generation version of AstraZeneca’s ‘purple-pill’, Nexium. While still in Phase III clinical trials, the product received a shot in the arm with RaQualia’s Korean
partner CJ Group, reaching a development and
licensing deal with China’s Shandong
Luoxin Pharmaceutical Group. The deal, estimated to reap US $ 91 million in profit, will
sell this new version of Nexium in China. Nexium treats gastroesophageal reflux
disease. Multi-billion-dollar
shareholder lawsuit against Pfizer revivedA federal appeals court in
the US revived a class-action
lawsuit accusing Pfizer of causing tens of billions of dollars of losses to shareholders by misleading them about the safety of its pain-relieving drugs – Celebrex and Bextra. The lawsuit began in 2004, and covers
investors who bought Pfizer stock between October 31, 2000 and October 19,
2005. Compliance issues at
Spanish vaccine manufacturerSpanish regulator has issued a recall of vaccines produced
at an Inmunotek
facility in Madrid and temporarily suspended the plant's manufacturing license
after an inspection last month found critical issues with production and
sterility at the company's San Sebastian de los Reyes site. FDA problems drag
Ipca into more troubleIndia’s Ipca
Laboratories had received a
warning letter from the FDA for its API plants in February with inspectors citing data manipulation and falsification. Now, the warning letter has dragged Ipca into more problems. The shares of Ipca plummeted by over 14 per cent after an international financing organization – The
Global Fund – decided not to allocate any volume of artemisinin-based combination therapy (ACTs) to the company in light of recent FDA warning issued to Ipca. Medivation snubs Sanofi’s initial takeover bidAmerican biopharmaceutical company Medivation Inc is learnt
to have rebuffed a recent
takeover bid from French drug maker Sanofi. Medivation, which focuses on
treatments for hard-to-cure cancers, is seeking a higher price than what the initial
proposals have indicated. If news reports are accurate, there are other suitors
for Medivation too. Sanofi, on the other hand, is also open to making a hostile
bid, a Bloomberg news report said. Are we entering an
era of responsible drug pricing?KaloBios Pharmaceuticals Inc – a biotechnology company that was earlier led by controversial former drug executive Martin Shkreli – has vowed
not to engage in aggressive pricing and to develop a transparent and 'responsible' pricing model for its products. KaloBios fired its chief executive Shkreli last December following his arrest on charges of securities fraud. Shkreli had sparked outrage last year when as the head of Turing Pharmaceuticals he had raised the price of a drug to treat a parasitic infection from US $ 13.50 to US $750. Let’s hope the KaloBios vow is a signal that the world of pharmaceuticals is entering an era of responsible drug pricing. FDA’s Warning Letter trends in FY2016In case you’re interested in learning how active the FDA has been halfway through their fiscal year, Barbara Unger has shared her compilation
of warning letter trends and compared them with previous years.
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