FDA: Page
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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 -
Merck submits NDA for new 2-in-1 hepatitis C treatment
The FDA will review grazoprevir/elbagavir, an investigational single tablet regimen (STR), for treatment of hepatitis C genotypes 1, 4 and 6.
By Nicole Gray • May 29, 2015 -
Boehringer Ingelheim nabs US approval for COPD combo
Stiolto Respimat Inhalation Spray is a once-daily treatment for the respiratory disorder.
By Nicole Gray • May 27, 2015 -
Hypertension drug from India no longer banned in EU—but 100s of others still are
Nearly 700 generic drugs are still suspended in Europe because of flawed trials in Hyderabad, India.
By Nicole Gray • May 26, 2015 -
UPDATE: Amgen's PCSK9 cholesterol med beats Sanofi's to an EU recommendation
The EMA's Committee for Medicinal Products for Human Use just gave Repatha a big boost and likely marketing advantage in the hotly contested new therapeutic field. But will it beat Sanofi to a U.S. approval?
By Nicole Gray • May 22, 2015 -
House committee unanimously passes 21st Century Cures FDA reform bill
The vote was 51-0—reportedly the first time in nearly three decades that a major bill passed the Energy and Commerce Committee without a single "no" vote.
By Sy Mukherjee • May 21, 2015 -
Deep Dive
Why biosimilars may not be the huge cost-saver people hope
A DRG analyst cautions biosimilar optimists to take the long view in terms of cost-savings.
By Nicole Gray • May 20, 2015
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