FDA: Page 100
-
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FDA draft guidance seeks to restrict the amount of time a biologic can be used after repackaging by a compounder.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 -
FDA warns popular Lilly, AZ, J&J, Boehringer diabetes meds could cause ketoacidosis
The agency's warning is directed at the widely used, newer class of diabetes drugs known as SGLT2 inhibitors.
By Nicole Gray • May 18, 2015 -
US class action against India's Ranbaxy cites dishonesty, manipulation of FDA rules
The Indian pharma giant, recently purchased by Sun Pharma, is being accused of large-scale deception on its generic drug applications.
By Nicole Gray • May 15, 2015 -
Deep Dive
Industry, advocate pressure helps revive key 21st Century Cures exclusivity incentives
The newest draft of 21st Century Cures reinstates orphan drug exclusivity measures that were nixed in the previous one. Can stakeholder lobbying resurrect even more of them?
By Sy Mukherjee • May 14, 2015 -
Deep Dive
Analysts answer: How long will it take the first Copaxone generics to gain market share?
We spoke with two DRG analysts about how the first generic substitutable version of Copaxone will change treatment of multiple sclerosis over the next five to 10 years.
By Nicole Gray • May 13, 2015 -
Challenges ahead for Vertex's controversial Kalydeco combo despite FDA panel nod
Price tag and efficacy will remain significant hurdles for payers.
By Nicole Gray • May 13, 2015
Previous
