FDA: Page 37
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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 -
Aimmune faces crucial FDA panel vote on first peanut allergy drug
The allergy-focused biotech faces a critical test today. Here's what to expect from the FDA advisory committee's review.
By Andrew Dunn • Sept. 12, 2019 -
ICER dings Novo's new oral diabetes drug
The semaglutide pill is less effective than Jardiance and more expensive if priced similarly to the drug's injectable form, ICER said in a draft report.
By Jonathan Gardner • Sept. 11, 2019 -
After scandal, Novartis pledges faster action on data integrity
CEO Vas Narasimhan committed to informing the FDA within five business days of any credible data integrity issues tied to a pending drug application.
By Ned Pagliarulo • Sept. 9, 2019 -
MD Anderson official emerges as top choice to run FDA, reports say
Nominating Stephen Hahn, an oncologist and chief medical executive at the Texas cancer center, would be a change of course from acting agency head Ned Sharpless.
By Ned Pagliarulo • Sept. 6, 2019 -
AstraZeneca gets lupus win but past failure could slow progress
A miss in anifrolumab's first Phase 3 trial a year ago raises questions over whether regulators will need a third study to see the drug through to market.
By Jonathan Gardner • Aug. 29, 2019 -
Jacob Bell/BioPharma Dive
FDA issues safety warning for newer hepatitis C drugs following patient deaths
More than 60 cases filed in the FAERS database detail how patients experienced worsening liver health after taking AbbVie's Mavyret, Merck & Co.'s Zepatier or Gilead's Vosevi.
By Jacob Bell • Aug. 28, 2019 -
Getty / Edited by BioPharma Dive
Gene editing companies oppose altering of embryos
Editing should be restricted to altering faulty genes in tissues, said Sangamo, Bluebird bio and 11 other biotechs in a statement of principles.
By Jonathan Gardner • Updated Aug. 27, 2019 -
To patients, Sarepta repeats message on surprise rejection of Duchenne drug
But company CEO Doug Ingram won't release text of the FDA's letter that cited Vyondys' safety risks, saying he wishes to be "respectful" to the agency.
By Jonathan Gardner • Aug. 22, 2019 -
Nabriva wins FDA's favor on pneumonia antibiotic
Xenleta is the biotech's first approved drug, but now faces a tough commercial challenge in a market dominated by generics.
By Andrew Dunn • Aug. 20, 2019 -
Sarepta Duchenne drug rejected by FDA in surprise setback
Regulators cited infection risk and preclinical kidney toxicity as reasons for the Complete Response Letter to Sarepta, which had hoped to expand its offerings for the muscular dystrophy.
By Jonathan Gardner • Updated Aug. 19, 2019 -
FDA boxed warning for AbbVie's JAK inhibitor clouds Gilead's
AbbVie and Gilead both expect billion-dollar sales from their arthritis drugs. But regulatory cautions on safety could weigh on those plans.
By Andrew Dunn • Aug. 19, 2019
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