FDA: Page 97
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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 -
7 drugs get SMC backing
The Scottish Medicines Consortium agreed to provide coverage for Takeda's Entyvio, along with two blood cancer drugs, but it also rejected a handful of others.
By Nicole Gray • May 12, 2015 -
What the Tories' election victory means for the NHS and UK pharma
The ruling Conservative party won a majority of seats last week and has promised more funding for the NHS.
By Nicole Gray • May 11, 2015 -
FDA
FDA staff raises red flags over new Vertex cystic fibrosis med's cost
Agency staff is questioning whether Orkambi is worth the price.
By Nicole Gray • May 11, 2015 -
Liberia declared Ebola-free
But experts warn that Sierra Leone and Guinea are still at risk.
By Nicole Gray • May 11, 2015 -
AbbVie, Roche nab FDA breakthrough designation for top leukemia prospect
It's particularly promising news for AbbVie, since the experimental treatment could be paired with Imbruvica.
By Nicole Gray • May 8, 2015 -
Mark your calendars: FDA will hold public meeting on off-label use this summer
A coalition of pharma companies is advocating for looser rules around off-label advertising.
By Nicole Gray • May 8, 2015 -
Congress calls for gender equity in clinical trials
Proposed legislation also aims to ensure that drugs approved through an expedited approval pathway are safe and effective for women.
By Nicole Gray • May 7, 2015 -
Deep Dive
7 questions you might have about biosimilarity, answered
We interviewed FDA and pharma vet David Rosen, who has been tracking the emergence of biosimilars in the U.S., for a Q&A on the evolving role of the products.
By Nicole Gray • May 6, 2015 -
FDA
Study: FDA bends over backwards to accommodate orphan drug developers
The authors note that only eight of the 27 orphan drugs approved between July 2010 and June 2014 were held to "conventional" standards.
By Nicole Gray • May 5, 2015 -
Amgen successfully defends melanoma hopeful T-Vec, gets positive FDA feedback
But panel members still expressed frustrations to the biotech.
By Nicole Gray • May 4, 2015
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