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

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

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

Price, safety will test blockbuster billing for AbbVie's new arthritis drug

Rinvoq​ adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year. 

By Jacob Bell • Aug. 16, 2019

CMS chief declines to provide details on Trump healthcare plan

Seema Verma did reiterate Thursday, though, the agency is pressing forward on the proposed plan for an International Pricing Index, calling it a "top priority."

By Rebecca Pifer Parduhn • Aug. 16, 2019

Celgene wins approval for drug key to Bristol buyout

Inrebic, which Celgene acquired in 2018 via its acquisition of Impact Biomedicines, is now approved for adults with a certain type of myelofibrosis.

By Ned Pagliarulo • Aug. 16, 2019

Roche cancer drug the 3rd approved for pan-tumor use

Entrectinib, which will be sold as Rozlytrek, joins Bayer's Vitrakvi as a treatment for solid cancers featuring a rare genetic fusion.

By Ned Pagliarulo • Updated Aug. 15, 2019

Nonprofit under pressure to make new TB drug affordable

Doctors Without Borders is calling on the TB Alliance to set a low price for the drug, and to put money from a sale of a regulatory fast pass toward patient access.

By Jacob Bell • Aug. 15, 2019

Lawmakers charge Mylan, Teva obstructed 2014 drug pricing probe

Renewing demands for information, Sen. Bernie Sanders and Rep. Elijah Cummings say Teva, Mylan and Heritage coordinated to "stonewall" past inquiries.

By Kristin Jensen • Updated Aug. 16, 2019

Lawmakers up pressure on Novartis in wake of data manipulation

Republican Senator Chuck Grassley demanded the Swiss pharma give a full account of its handling of faulty data used in winning approval for the gene therapy Zolgensma. 

By Ned Pagliarulo • Aug. 13, 2019

In rebuke of Novartis, FDA making 'statement for the world'

"This is a rapidly evolving field where there are going to be accelerated approvals," former FDA chief Robert Califf told BioPharma Dive. "The quality of the data is critical."

By Ned Pagliarulo • Aug. 9, 2019

FDA decision on Amarin heart drug delayed as agency to hold expert review

The biotech previously indicated an advisory committee meeting was unlikely. Investors seemed to have taken that to heart, reacting negatively to the surprise disclosure. 

By Ned Pagliarulo • Aug. 8, 2019

Hospitalized gene therapy patient triggers Sarepta sell off

An erroneous report of rhabdomyolysis in a patient enrolled in a Duchenne trial was the latest safety worry to send shares in a gene therapy biotech spiraling. 

By Jonathan Gardner • Aug. 8, 2019

Gilead's Descovy set for PrEP approval, but not without data, access concerns

An expert panel recommended the FDA extend approval of Gilead's drug for preventive use, though advisers pushed for further study in cisgender women.

By Jacob Bell • Aug. 8, 2019

Medicare boosts CAR-T cancer therapies with expanded coverage

A long-awaited decision from CMS marks a step forward in addressing reimbursement hurdles for the expensive drugs.

By Ned Pagliarulo • Aug. 8, 2019

Novartis CEO on defense as data scandal clouds gene therapy approval

"We tried to do all of the right things," said company chief Vas Narasimhan, after the FDA disclosed manipulated testing data was included in Novartis' application for Zolgensma.

By Ned Pagliarulo • Aug. 7, 2019

Novartis used manipulated data in winning Zolgensma approval, FDA says

AveXis, the Novartis unit which developed Zolgensma, knew of the data issue more than two months before the therapy's landmark OK, the FDA said.

By Ned Pagliarulo • Aug. 6, 2019