Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"
A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.
Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.
The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.
FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.
Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.
The regulator and patients will chat for two days in October.
Not long after acquiring Shire to add to its orphan-drug portfolio, the drugmaker scored an orphan designation from both FDA and EMA last week.
Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.
The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The new rules are expected to do away with the haphazard nature of facility inspections.
A greenlight could garner Pfizer $1B in sales.
A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.
Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.
The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.
The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.
Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.
The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.
The pharma payment verification site has been temporarily shut down by CMS due to incorrect information, ProPublica reported today.
The cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December
The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.
Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research
Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.
ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.
The FDA greenlighted the drug for three cancers.
It's the second for this cancer drug in two weeks.
The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.