FDA: Page 38
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Roche wins speedy OK for lymphoma drug Polivy
Polivy is approved in a similar setting as Gilead's Yescarta, adding a new option for lymphoma patients whose cancers are relapsed or refractory to treatment.
By Ned Pagliarulo • June 11, 2019 -
NASH drugmaker stocks rebound after dip on FDA guidance
Madrigal, Viking, Intercept and GenFit each saw small gains Monday, as investors appeared less concerned about new FDA guidance on approval standards for certain NASH drugs.
By Jacob Bell • June 10, 2019 -
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
In a wide-ranging interview, CDER chief Janet Woodcock pushed back against concerns the agency is clearing new drugs too quickly.
By Andrew Dunn • June 5, 2019 -
Getty / Edited by BioPharma Dive
Bluebird gene therapy approved in Europe in first for severe blood disorder
Zynteglo is intended as a one-time, lifelong treatment for patients with transfusion-dependent beta thalassemia.
By Ned Pagliarulo • June 3, 2019 -
At cancer conference, debate over speedy drug approvals in the spotlight
An unsuccessful Phase 3 study of Eli Lilly's Lartruvo made for an unusual feature in the ASCO annual meeting's top trial showcase.
By Ned Pagliarulo • June 3, 2019 -
Mitsubishi pulls EU application for ALS drug, citing 'unwarranted' data request
Regulators had concerns that data from a key study that has helped Radicava in other markets isn't strong enough to warrant approval in the bloc.
By Jacob Bell • May 31, 2019 -
Vertex chooses its cystic fibrosis future
Following positive late-stage readouts for two combination regimens, Vertex has selected the triplet it intends to file with regulators later this year.
By Jacob Bell • May 30, 2019 -
Epizyme moves forward with cancer drug, eyes 2020 launch
The biotech is seeking an accelerated approval from the FDA for tazemetostat, an experimental treatment for a rare, aggressive tissue cancer.
By Andrew Dunn • May 30, 2019 -
Sponsored by ZS
How to survive in pharma's payer-empowered world
Success in the new payer-empowered world of value and affordability requires two fundamental changes in pharma companies’ corporate decision-making.
By Ed Schoonveld • May 30, 2019 -
Amarin wins speedy FDA review for Vascepa heart label
Regulators will rule on a new indication for the fish oil-based pill by late September instead of early 2020, but it's still unclear if the drug will face an advisory panel.
By Andrew Dunn • May 29, 2019 -
BioMarin readies hemophilia gene therapy for FDA submission
But the debate over valrox's durability has not dissipated, as factor expression continued to decline in clinical trial patients.
By Jonathan Gardner • May 28, 2019 -
Pay-for-delay deals disappearing, FTC says
The federal agency conceded branded and generic makers may be striking non-monetary deals that impede price competition on off-patent drugs.
By Jonathan Gardner • Updated May 24, 2019 -
Yujin Kim/BioPharma Dive
Could Novartis' gene therapy have more than one price?
Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to Novartis too.
By Jonathan Gardner • May 23, 2019 -
Medicare decides against tighter management of HIV drugs
A finalized regulation codifies step therapy and prior authorization practices in five of the Medicare Part D "protected" drug classes, but spares HIV.
By Jonathan Gardner • May 17, 2019 -
Gilead CEO pressured on PrEP pricing at House hearing
Critics of Gilead contend it had little to do with the research behind Truvada's use as a preventive therapy — a charge CEO Daniel O'Day rebutted Thursday.
By Ned Pagliarulo • May 17, 2019 -
FDA highlights manufacturing quality efforts after recalls, regulatory criticism
An agency report found the industry's average inspection score didn't change much over the last two years, though there remain concerns about quality control in China and India.
By Kristin Jensen • May 16, 2019 -
FDA schedules Aimmune's peanut allergy drug for September expert review
Set to convene earlier than analysts had expected, the advisory committee will discuss what would be the first-ever drug approval for a food allergy.
By Ned Pagliarulo , Andrew Dunn • May 16, 2019 -
Cost-effectiveness agency clears Biogen's Spinraza for UK patients
Private meetings between Biogen and NICE last week cleared way for a "managed access agreement" that will allow time to assess effectiveness data.
By Jonathan Gardner • May 15, 2019 -
Yujin Kim/BioPharma Dive
Generics price-fixing lawsuit focuses on Teva's role as catalyst
A ranking system of competitors' willingness to follow price increases was one piece of evidence offered by 44 state attorneys general in a sweeping lawsuit.
By Jonathan Gardner • May 13, 2019 -
FDA finalizes interchangeable biosimilar advice, with insulin focus
The agency will generally require switching studies for biologic copycats seeking a valuable interchangeable license.
By Andrew Dunn • May 13, 2019 -
Fibrogen confuses as it tries to explain blood-boosting drug data
The company claims roxadustat is as safe as Epogen when used to treat anemia in kidney-disease patients, but can't say whether the FDA will agree.
By Jonathan Gardner • May 10, 2019 -
Deep Dive
Biopharma happily takes the tax cuts, but the jobs are harder to find
The tax burden of U.S.-based drugmakers shrank by nearly one-quarter following the 2017 Republican tax bill, but jobs edged up only slightly, a BioPharma Dive analysis found.
By Jonathan Gardner • May 9, 2019 -
Approval of $225,000-a-year tafamidis comes early for Pfizer
The FDA sped up approval by months, and surprised Pfizer by giving an OK to two formulations of the rare disease drug.
By Jonathan Gardner • May 6, 2019 -
Rebate ban not a magic balm, federal budget forecasters say
The Trump administration plan to eliminate certain rebates would increase federal spending by $177 billion over a decade, the CBO found.
By Jonathan Gardner • May 3, 2019 -
Sanofi's dengue vaccine wins limited FDA approval
The French pharma is eyeing a 2020 launch but will face a challenging U.S. market given restrictions on the vaccine's use.
By Andrew Dunn • May 2, 2019
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