New name, but same old problems for Posimir as FDA hits Durect again

Ben Adams Durect may have changed the name of its post-pain gall bladder surgery drug from "Posidur" to "Posimir" this year, but this has not stopped its run of ...

FDA flags particle problems in latest Hospira warning letter

Tracy Staton Hospira's FDA woes have moved to Australia. The agency scolded the U.S.-based company in a warning letter based on an injectables plant inspection in late February ...

Could automating production solve India’s manufacturing problems?

Carly Helfand Some drugmakers–like Dr. Reddy's Laboratories–are wondering whether manufacturing troubles could be reduced by taking human workers out of the equation. FiercePharma ...

Lupin recalls more Suprax on purity problems, adding to Indian pharma’s quality questions

Tracy Staton In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for ...

Ranbaxy scrambles to fix problems that challenge its exclusives

Eric Palmer In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs ...

Vaccine plant problems put Sanofi shot supplies in dire straits

Tracy Staton Last year, the FDA came down hard on a Sanofi Pasteur plant in Toronto. The ensuing trouble triggered serious supply problems–and, in turn, a shortage of childhood ...

Possible hair in tablet one of rampant problems at Ranbaxy plant

Eric Palmer Ranbaxy Laboratories calls its plant in Mohali, India, an ultra-modern facility, but FDA inspectors found rampant problems during visits last year. They found toilets without ...

Congressman rails at Pfizer over problems with sarin gas antidote

Eric Palmer Pfizer's Meridian unit that makes the injector "has received millions of taxpayer dollars for doses of this drug, some of which do not meet specifications," ...

Compounding Problems: Anthem Restricts Coverage Of Some Compounded Meds

esilverman More fallout from the compounding controversy. Anthem Blue Cross Blue Shield, one of the nation’s largest insurers, has decided to end reimbursement of certain compounded ...

FDA Warns Genentech Trial Investigator Over Data Problems

esilverman An investigator for a Phase III trial for the Lucentis macular degeneration treatment, which is sold by Genentech, has received a warning letter from the FDA for ...

New problems for GSK in China as authorities say GSK employees confess to bribery

Eric Palmer GlaxoSmithKline has for weeks been saying that it could find no evidence to confirm allegations that any of its employees in China were bribing doctors to buy its drugs. ...

J&J consumer operations face problems in Asia but close to resolving them in U.S.

Eric Palmer J&J expects its McNeil Consumer Healthcare division to be set free of a two-year-old FDA consent decree by year's end. That order has kept its main OTC plant ...
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