FDA: Page 37
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Third Neulasta biosimilar on its way as Sandoz wins long-delayed FDA approval
Novartis' drug will be third to market, but copycat drugs have already taken a chunk of the market away from Amgen's branded version.
By Jonathan Gardner • Nov. 5, 2019 -
As fateful FDA review nears, Amarin makes case for Vascepa
Company CEO John Thero said he expects an FDA advisory panel will ask "intentionally tough" questions and challenge Vascepa's data at a meeting set for Nov. 14.
By Andrew Dunn • Nov. 5, 2019 -
Aveo's cancer drug runs into a skeptical FDA
The regulator told the Cambridge, Massachusetts-based biotech to hold off on filing its cancer drug, sending shares in the company down 40%.
By Andrew Dunn • Nov. 4, 2019 -
Stephen Hahn, top MD Anderson official, will be next FDA chief
After more than a month of speculation, Trump selected the oncologist and MD Anderson executive to be his next commissioner.
By Ned Pagliarulo • Nov. 1, 2019 -
Jacob Bell/BioPharma Dive
FDA blames market failures for drug shortages
High-profile shortages of drugs like EpiPen and the chemotherapy vincristine have brought attention to a chronic problem, one that's spurred in part by what the FDA termed a "broken marketplace."
By Kristin Jensen • Oct. 31, 2019 -
Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma
A partial trial suspension threatens to delay the gene therapy's expansion into older children, as the FDA works through safety findings from an animal study.
By Jonathan Gardner • Oct. 30, 2019 -
FDA panel backs withdrawal of Amag drug to prevent preterm birth
An advisory committee narrowly recommended the FDA rescind approval for Makena, which showed no benefit in a confirmatory study.
By Ned Pagliarulo • Oct. 30, 2019 -
Vertex wins speedy approval for cystic fibrosis triplet
With Trikafta cleared by the Food and Drug Administration, Vertex estimates its drugs can treat as much as 90% of patients with the lung condition.
By Jacob Bell • Oct. 21, 2019 -
Courtesy of Eli Lilly
Lilly's 1-drug migraine business gets support with new approval
An OK for Reyvow, an acute migraine drug, complements Lilly's preventive therapy Emgality and could strengthen the company's footing in an increasingly crowded market.
By Ned Pagliarulo • Oct. 11, 2019 -
Jacob Bell/BioPharma Dive
Australian drugmaker's decade-long journey ends in FDA approval
U.S. regulators cleared Clinuvel's Scenesse for a rare skin disease that causes sensitivity to light.
By Ned Pagliarulo • Oct. 9, 2019 -
Former FDA chief Gottlieb predicts Trump-pitched pricing model easy to game
"I don't want to give too much away, because I'll tell people how to game around this," said the former commissioner, who now sits on Pfizer's board.
By Andrew Dunn • Oct. 8, 2019 -
FDA leaders worry agency will lose out on talent in gene therapy, cancer fields
Peter Marks, director of the FDA's biologics center, said the agency is competing with industry to keep its staff.
By Andrew Dunn • Oct. 7, 2019 -
Getty / Edited by BioPharma Dive
Sarepta, in shadow of FDA setback, marks gene therapy progress
The biotech released the first functional data from a trial of an experimental gene therapy treating a different type of muscular dystrophy than Exondys 51.
By Jonathan Gardner • Oct. 4, 2019 -
Gilead's follow-on PrEP drug gets broad label, but with a notable exclusion
The FDA approved Descovy to prevent HIV infection in adults and adolescents, but not for cisgender women.
By Jacob Bell • Oct. 4, 2019 -
FDA calls generic Zantac carcinogen levels 'unacceptable,' but pushes back against lab claims
Regulators say the third-party lab isn't using a suitable method in tests showing even higher levels of NDMA, a probable human carcinogen.
By Kristin Jensen • Oct. 3, 2019 -
FDA knocks back AstraZeneca's respiratory ambitions
The rejection of AstraZeneca's triple respiratory inhaler puts the company further behind its U.K. rival, GlaxoSmithKline.
By Jonathan Gardner • Oct. 1, 2019 -
Alphabet hires ex-FDA chief Califf to lead health strategy, policy
The appointment of the former FDA commissioner comes roughly a year after Google hired ex-Geisinger CEO David Feinberg to lead health strategy.
By Rebecca Pifer Parduhn • Oct. 1, 2019 -
FDA warning slowed immunotherapy use in bladder cancer
Doctors appeared to shift their prescribing following an FDA decision to limit the approvals of Keytruda and Tecentriq in the tumor type, new research found.
By Ned Pagliarulo • Sept. 25, 2019 -
Permission granted by Novartis
Novartis to speed AveXis integration in wake of data manipulation
AveXis will be folded into Novartis' quality organization as a result of a scandal involving altered testing data for the company's gene therapy Zolgensma.
By Ned Pagliarulo • Sept. 24, 2019 -
Novo gains approval for first oral diabetes drug of its kind
The list price for Rybelsus will be competitive within the GLP-1 drug class, Novo said, which may make it more expensive than other glucose-lowering pills.
By Jonathan Gardner • Updated Sept. 24, 2019 -
FDA
Novartis stops distributing generic Zantac as carcinogen concerns rise
While the FDA continues to investigate NDMA contamination in generic Zantac, Canadian regulators moved to halt distribution of the heartburn drug.
By Kristin Jensen • Sept. 19, 2019 -
In first, cancer drugs simultaneously approved in US, Canada, Australia
Under a new project led by the FDA's oncology center, regulators for the three countries collaboratively reviewed a Keytruda combination for use in endometrial cancer.
By Ned Pagliarulo • Sept. 18, 2019 -
Regulatory barriers limit alternative state drug payment models
Forced to balance higher costs with public health goals, more states are looking at alternative payment models for prescription drugs in Medicaid.
By Samantha Liss • Sept. 18, 2019 -
Vertex hits a biomarker bump on road to new drug
Following an FDA workshop, analysts believe Vertex will need to show its drug for AAT deficiency offers some functional benefit rather than just a biomarker effect.
By Jacob Bell • Sept. 17, 2019 -
Aimmune's peanut allergy drug secures FDA panel support, along with criticism
Winning the advisory committee's backing is a major step toward approval, but experts pressed Aimmune with questions on the drug's safety.
By Andrew Dunn • Sept. 13, 2019
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