Tag:
FDA
Latest Headlines
Latest Headlines
India's Torrent, Alembic jump on FDA Abilify nod
Shares in India's Torrent Pharmaceuticals jumped more than 4% on Wednesday after it won U.S. FDA approval for one of the first generic versions of Abilify, an antipsychotic from Japan's Otsuka Pharmaceuticals and Bristol-Myers Squibb for treating schizophrenia and bipolar disorder.
FDA issues new guidelines on acceptance of data from overseas clinical trials
The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both US and foreign regulators."
FDA, industry scrambling to clarify or design new regs covering lab-developed tests
Science is rapidly shaping the landscape of the diagnostics industry, from the research into genetics and new materials like graphene, to the regulatory science practiced at the FDA.
Chinese API maker cited with second FDA warning letter
The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.
Shifting positions, Genervon now admits it has yet to file for ALS drug OK
The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.
Potency worries prompt GSK flu vaccine recall
To cap off one of the least effective seasons for flu vaccines in recent memory, vaccine producer GlaxoSmithKline announced the recall of all remaining doses of a quadrivalent, affecting roughly 1.7 million jabs.
Gunning for a spot in the next-gen autoimmune market, Lilly med hits goals in latest trial
Eli Lilly's closely watched autoimmune treatment ixekizumab met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.
FDA approves new device for surgical sealing during cranial procedures
The FDA approved HyperBranch Medical Technology's Adherus AutoSpray Dural Sealant to provide watertight closure during cranial procedures, according to a March 30 approval letter. Approval came via the stringent PMA pathway, which included a clinical trial, after which Adherus was deemed noninferior to Integra LifeSciences' surgical sealant system.
Otsuka scrambles to persuade judge to block Abilify copycats
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
FDA stepping up efforts to replenish U.S. saline solution supplies
The FDA said it's stepping up its efforts to address the shortage of saline solution for humans and animals by increasing the importation of intravenous fluids from producers not previously approved by the regulatory agency.
