FDA: Page 79
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UK court orders coverage of Gilead's HIV drug in England
The National Health Service England plans to appeal the decision, claiming it is not responsible for covering preventative treatments.
By Nicole Gray • Aug. 3, 2016 -
FDA
Big Pharma benefits more from breakthrough therapy designations: report
Since the designation was introduced by the FDA in 2012, most of the tagged drugs to reach the market were developed by large pharma companies rather than small biotechs.
By Nicole Gray • Aug. 2, 2016 -
Teva will provide long-term API contracts to producers in 15 markets
U.S. regulators set the condition to ensure Teva does not use API supply contracts to force competitors to raise product prices.
By Edwin Lopez • July 28, 2016 -
FDA approves Sanofi's next-gen diabetes treatment
The long-delayed approval will allow Sanofi's Adlyxin to compete with Novo Nordisk's Victoza and Eli Lilly's Trulicity in the U.S.
By Randy Lilleston • July 28, 2016 -
J&J, Genmab line up second-line use for multiple myeloma med
Approved last year in the U.S., Darzalex is the first monoclonal antibody cleared by the FDA for treatment of multiple myeloma.
By Nicole Gray • July 27, 2016 -
FDA strengthens warnings on class of antibiotics
Fluoroquinolones such as Levaquin and Cipro should now be reserved for last resort use in certain patients.
By Nicole Gray • July 26, 2016 -
Regulators to expedite review of Merck's Ebola vaccine
Merck plans to submit its Ebola vaccine to regulatory authorities on both sides of the Atlantic next year, aiming to win approval and launch V920 by the end of 2017.
By Nicole Gray • July 26, 2016 -
Stuck in regulatory limbo, PTC considers further trials for DMD drug
While US regulators found PTC's application for Translarna to be insufficient for filing last year, the drug has been on the market in Europe under a conditional approval.
By Edwin Lopez • July 25, 2016 -
FDA delays decision on Merck's C. diff drug
The regulator asked for more clinical trial data on bezlotoxumab and pushed its target action date back by three months.
By Nicole Gray • July 25, 2016 -
Japanese government to set new controls on specialty drugs: report
Amgen's Repatha and Bristol-Myers' Opdivo will be the first drugs targeted by new guidelines, according to the Nikkei Asian Review.
By Nicole Gray • July 25, 2016 -
EU regulator recommends market suspension for dozens of generics
The European Medicines Agency concluded bioequivalence studies conducted by an India-based contract researcher to support generic approvals were "flawed."
By Edwin Lopez • July 25, 2016 -
After scandal, China begins vaccine inspections nationwide
Citizens were outraged earlier this year when police in China uncovered a $90 million black market for illegal vaccines, which had been sold throughout the country for years.
By Nicole Gray • July 25, 2016 -
Fresh off Relistor win, Valeant hits FDA roadblock for eye drug
The regulator issued a complete response letter to Valeant, citing manufacturing deficiencies at the Bausch & Lomb facility used to produce the eye drops.
By Ned Pagliarulo • July 22, 2016 -
Theranos expands compliance team with new execs, committee
But Theranos' efforts to strengthen compliance may be too late. Federal regulators recently decided to ban CEO Elizabeth Holmes from the business for two years over continued violations.
By Nicole Gray • July 22, 2016 -
Montgomery County Planning Commission
Glaxo failed to resolve contamination at UK plant, FDA says
The FDA "strongly urged" Glaxo to dedicate the site to only penicillin production in light of repeated contamination problems.
By Edwin Lopez • July 20, 2016 -
Zafgen shuts down development of obesity drug, cuts staff
The FDA had halted development of the drug, called beloranib, last December after two patient deaths.
By Nicole Gray • July 20, 2016 -
FDA
Valeant wins backing of FDA panel for psoriasis drug
While the recommendation is welcome news for a company still struggling to remake its image, Valeant could face significant competition for brodalumab.
By Ned Pagliarulo • July 20, 2016 -
US, EU regulators to review Opdivo for new cancer indication
Bristol-Myers Squibb submitted yet another marketing application for Opdivo, this time in head and neck cancer.
By Nicole Gray • July 19, 2016 -
FDA: Flood of orphan drug applications slowing review process
Last year the FDA received a record 472 requests for orphan drug designations, and this year's pace looks set to surpass that mark.
By Nicole Gray , Ned Pagliarulo • July 19, 2016 -
PDUFA 6 procedures will include patients, biomarkers for 2018-2022
Two major biopharma industry associations, PhRMA and BIO, applauded the new iteration of the drug regulation act.
By Nicole Gray • July 18, 2016 -
Celgene picks up broader EU approval for key cancer drug
A mainstay treatment in multiple myeloma, Celgene's Revlimid is now approved for use against mantle cell lymphoma in both the E.U. and the U.S.
By Nicole Gray • July 18, 2016 -
Samsung Bioepis continues biosimilar push with EU submission of Humira copy
AbbVie's Humira is one of the top-selling drugs in the world but faces new competition from Amgen, Samsung and others.
By Nicole Gray • July 17, 2016 -
Santhera hopes for accelerated approval of Duchenne drug dashed
The FDA told the small Swiss company that it would wait until a second Phase 3 trial is completed before reviewing the drug.
By Nicole Gray • July 15, 2016 -
FDA
FDA staff raises safety concerns for Valeant psoriasis drug
Six suicides occurred during clinical testing of the drug, which Valeant had licensed from AstraZeneca last year.
By Ned Pagliarulo • July 15, 2016 -
FDA bans imports from four Indian and Chinese drugmakers
Unlike previous import bans, the four companies were cited for failing to pay annual user fees to the FDA.
By Nicole Gray • July 14, 2016
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