FDA: Page 98
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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FDA draft guidance seeks to restrict the amount of time a biologic can be used after repackaging by a compounder.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 -
Bluebird cuts deal with regulators, plots path to first-ever US gene therapy approval
The biotech's gene therapy LentiGlobin for beta-thalassemia will have an accelerated approval pathway in the U.S. and Europe.
By Sy Mukherjee • May 19, 2015 -
FDA
Unregulated stem cell clinics doing big business in the US
The field is being compared to the "Wild West" amid a dearth of regulations.
By Nicole Gray • May 19, 2015 -
A rare win for US pharma: Indian court stops Glenmark sales of Merck diabetes copycats
Copies of Januvia and Janumet can no longer be sold in India.
By Nicole Gray • May 18, 2015 -
FDA sued by ADHD generics maker for revoking drug's Concerta bioequivalence
Mallinckrodt and UCB are engaged in a scuffle with the agency that could have industry-wide implications.
By Nicole Gray • May 18, 2015
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