FDA: Page 80
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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 -
Two for two: FDA panel gives green light to Novartis' Enbrel biosim
Earlier this week the same committee had supported approval of Amgen's biosimilar of Humira.
By Nicole Gray • July 14, 2016 -
Amgen touts new dosing option for underperforming cholesterol drug
Repatha is competing with Sanofi and Regeneron's rival PCSK9 drug Praluent.
By Nicole Gray • July 13, 2016 -
FDA approves broader use of Pfizer's pneumonia vaccine
Prevnar is now approved for use in adults between the ages of 18 and 49.
By Nicole Gray • July 13, 2016 -
FDA
FDA panel unanimously recommends approval of Amgen's Humira biosimilar
But Amgen's win is tempered by the biosimilar threat to its own blockbuster biologic Enbrel, with a copy made by Novartis under review today.
By Nicole Gray • July 13, 2016 -
Juno restarts suspended CAR-T trial after FDA lifts clinical hold
The surprise reversal comes just days after the trial was stopped following three patient deaths.
By Ned Pagliarulo • July 12, 2016 -
Shire's dry eye drug wins long-awaited FDA approval
Xiidra is projected to enter the market as the first drug treating both signs and symptoms of dry eye disease.
By Edwin Lopez • July 12, 2016 -
EMA says benefits of Gilead's Zydelig outweigh risks
The European regulator had begun a review of the cancer drug four months ago after higher rates of adverse events, including patient deaths, were observed in clinical trials.
By Nicole Gray • July 11, 2016 -
FDA panel to review Humira, Enbrel biosimilars this week
Amgen and Novartis, respectively, are both aiming to wrest market share away from the two blockbuster biologics, although Amgen finds itself both pushing for and defending itself from biosim competition.
By Edwin Lopez • July 11, 2016 -
Gilead secures European approval for new hepatitis C drug
Epclusa is the first drug approved to treat all six genotypes of the liver disease.
By Nicole Gray • July 11, 2016 -
Facing major penalties, Theranos could be forced to change business
The blood-testing company acknowledged it might cease operations at both its California and Arizona labs if sanctions recently imposed by regulators are upheld.
By Ned Pagliarulo • July 11, 2016 -
Pfizer's leukemia drug approved by UK cost watchdog after previous rejection
Bosulif is the first treatment previously rejected by NICE to be reconsidered and approved for coverage.
By Nicole Gray • July 8, 2016 -
FDA staff backs Amgen biosim of AbbVie's Humira
An independent advisory panel is set to review Amgen's application early next week.
By Ned Pagliarulo • July 8, 2016 -
NHS England to cover PTC's Duchenne drug after access deal
PTC Therapeutics has been hit hard since the FDA said its application for U.S. approval of the drug was incomplete.
By Edwin Lopez • July 8, 2016 -
Theranos founder banned from blood-testing business
Health regulators also stripped a certification from the company's Newark, CA lab as part of the severe penalties levied on the company for testing violations.
By Ned Pagliarulo • July 8, 2016 -
FDA
Juno CAR-T trial halted by FDA after three patient deaths
The deaths occurred in a study evaluating the immunotherapy JCAR015 in patients with acute lymphoblastic leukemia.
By Ned Pagliarulo • July 7, 2016
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