FDA: Page 96
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FDA approves Brio's brain implant for Parkinson's
This is the second FDA-approved device for Parkinson's and essential tremor.
By Nicole Gray • June 15, 2015 -
FDA committee endorses Glaxo's severe asthma drug
But the committee voted 10-4 against approving mepolizumab for children.
By Nicole Gray • June 12, 2015 -
Glaxo, Sanofi slammed with regulatory fines in India over vaccines
India's Competition Commission has fined GSK $9.4 million for "collusive bidding" on a government vaccines contract.
By Nicole Gray • June 12, 2015 -
FDA blunders labeling for Vanda sleep drug
Hetlioz (tasimelteon), intended for treatment of non-24 hour sleep-wake disorder, was mislabeled—twice.
By Nicole Gray • June 12, 2015 -
Deep Dive
How 21st Century Cures could change communications between biopharma, providers, & patients
Some are worried that expanding regulations around biopharma communications could lead to a "wild West" situation. But experts consider the proposed changes "modest."
By Nicole Gray • June 11, 2015 -
Pennsylvania's Melior wins a Parkinson's patent
The patent covers L-dopa-associated dyskinesia.
By Nicole Gray • June 11, 2015 -
Amgen PCSK9 drug gets FDA staff rec, but panelists express concerns
Several committee members seemed concerned that doctors may prematurely pull patients off of statins, while others wanted to see more lengthy studies. There's also the question of CVD outcomes.
By Sy Mukherjee • June 10, 2015 -
Sanofi diabetes drug ready to take on FDA with safety study in the rearview
Lixisenatide just made it through a rigorous, long-term safety study.
By Nicole Gray • June 10, 2015 -
FDA finally responds to demand for Duchenne Muscular Dystrophy guidance
The new guidance includes an extensive section on efficacy endpoints—long an area of contention.
By Nicole Gray • June 10, 2015 -
UPDATED: Sanofi/Regeneron's PCSK9 blockbuster-in-waiting gets prelim FDA nod
The vote moves the drug closer to final approval and potentially billions of dollars in sales.
By Nicole Gray • June 9, 2015 -
Lilly's Lantus biosimilar will finally launch in Europe in Q3
Abasaglar could be a game-changer for the insulin market.
By Nicole Gray • June 9, 2015 -
FDA
NIH halts drug production for pharma trials after FDA finds fungus
...Awkward.
By Nicole Gray • June 8, 2015 -
Orexigen, Takeda take Actavis to court over obesity med Contrave generic
As Actavis tries to move in the weight-loss market, the makers of Contrave are claiming patent infringement in a Delaware district court.
By Nicole Gray • June 8, 2015 -
Genzyme nabs breakthrough designation for rare enzyme disorder
Olipudase alfa is intended to replace missing enzymes in patients with ASMD—a condition which often lead to severe neurological symptoms.
By Nicole Gray • June 5, 2015 -
Australia to big pharma: Pay more taxes
Australia's Senate committee is holding a public hearing on July 1 to discuss pharma companies' tax avoidance.
By Nicole Gray • June 5, 2015 -
EU votes not to abolish animal testing despite rising advocate pressure
In a major setback to the Stop Vivisection animal rights group, the commission says that it not time to stop animal testing—yet.
By Nicole Gray • June 5, 2015 -
UPDATE: FDA panel recommends women's libido drug despite safety concerns
Public pressure seems to be pushing flibanserin towards an FDA approval.
By Nicole Gray • June 4, 2015 -
AstraZeneca chief slams UK over NICE's Lynparza decision
Pascal Soriot expressed displeasure over the agency's refusal to approve the ovarian cancer med for funding.
By Nicole Gray • June 4, 2015 -
FDA panel to review Lilly's lung cancer combo drug
The meeting is scheduled for July 9.
By Nicole Gray • June 3, 2015 -
USDA
White House meeting focuses on reducing use of antibiotics
Hospitals, food producers, and others were encouraged to pledge a reduction in their use of antibiotics to combat resistance.
By Nicole Gray • June 3, 2015 -
Could new FDA compounding guidelines stop Avastin use in AMD?
FDA draft guidance seeks to restrict the amount of time a biologic can be used after repackaging by a compounder.
By Nicole Gray • June 2, 2015 -
WHO calls for report on vaccine pricing and access
Issues related to vaccine pricing and access for low- and middle-income countries were discussed by member nations at a meeting in Geneva.
By Nicole Gray • June 1, 2015 -
US orders major review as suspect anthrax samples found in multiple labs
The Pentagon has advised all labs that work with anthrax to stop working with any "inactive" samples sent from the Department of Defense.
By Nicole Gray • June 1, 2015 -
Teva to pay record $1.2B settlement in Provigil case
The pharma firm will pay the FTC for moving to stop generic competitors from entering the market for its sleep disorder drug.
By Randy Lilleston • May 29, 2015 -
FDA
Report: Public health threat lurking at biolabs nationwide
An investigative report from USA Today finds that the 200-plus biolabs nationwide are rife with lapses in protocol that could threaten the entire population.
By Nicole Gray • May 29, 2015
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