FDA: Page 39
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Novartis secures speedy review for sickle cell drug
Priority review from the FDA sets up an early 2020 decision on approval of crizanlizumab in the genetic blood disorder.
By Ned Pagliarulo • July 16, 2019 -
ICER unconvinced peanut allergy drugs are better than just avoiding the food
The influential cost watchdog group argues that treatments from DBV and Aimmune haven't shown long-term benefits — or, more broadly, quality-of-life improvements.
By Jacob Bell • July 11, 2019 -
Billion-dollar settlement gets Reckitt out of federal opioid probes
Company spinout Indivior, however, is still facing criminal charges related to marketing of Suboxone film, an opioid dependence treatment.
By Jonathan Gardner • July 11, 2019 -
White House pulls drug rebate rule to relief of payers
Withdrawal of the rule, which drugmakers supported, puts greater focus on the administration's plans for an international price index for certain drugs.
By Ned Pagliarulo • July 11, 2019 -
In win for pharma, Trump TV drug price rule struck down
The federal district court sided with drugmakers, which argued the government overstepped its authority in forcing price transparency in advertisements.
By Jonathan Gardner • July 9, 2019 -
BioMarin confirms timeline for hemophilia gene therapy, putting pressure on rivals
The biotech plans on submitting valrox to U.S. and European regulators in the fourth quarter, which could bring approval decisions by mid-2020.
By Jacob Bell • July 8, 2019 -
BioPharma Dive's 10 biggest stories of the spring
Developments in gene therapy, cancer treatments, drug pricing and dealmaking kept the industry in the headlines.
By Jacob Bell • July 3, 2019 -
FDA set for 'exceptionally light month' of generic drug approvals in June
After generic drug approvals by the FDA hit all-time highs last year, one Wall Street analyst wonders if June data shows the start of a slowdown.
By Andrew Dunn • June 28, 2019 -
Amgen bone drug application knocked back in Europe
While both the U.S. and Japan have approved Evenity, the EMA's drugs committee judged its heart risk didn't outweigh its potential benefit.
By Ned Pagliarulo • June 28, 2019 -
Zogenix boosted on FDA about-face for seizure drug application
The regulator agreed to permit resubmission of Zogenix's drug with a corrected dataset, while waving off a potentially time-consuming toxicology study.
By Jonathan Gardner • June 27, 2019 -
Federal court bars stem cell sales by Florida company in win for FDA oversight
FDA leaders Ned Sharpless and Peter Marks said the legal action "sends a strong message to others manufacturing violative stem cell products."
By Andrew Dunn • June 27, 2019 -
AbbVie deal for Allergan not about the taxes, thanks to 2017 law
AbbVie will stay in the U.S. if its deal goes through — a departure from Pfizer's plan in a failed 2015 attempt to merge with the Ireland-based Allergan.
By Jonathan Gardner • June 26, 2019 -
FDA officials see 'missed opportunity' with patient outcomes in clinical trials
The information is viewed as a valuable tool for improving trial design, guiding drug approvals and supporting label decisions, but its reach has been limited.
By Jacob Bell • June 26, 2019 -
Bristol-Myers price for Celgene now includes Otezla sell-off
A Federal Trade Commission review spurred the divestiture plan, as the combined company would otherwise have two marketed drugs and one experimental project in inflammatory disease.
By Jonathan Gardner • June 24, 2019 -
Courtesy of AbbVie
FDA lifts hold on AbbVie multiple myeloma study
However, nine other studies for Venclexta remain suspended for safety concerns.
By Andrew Dunn • June 24, 2019 -
Jacob Bell/BioPharma Dive
Merck racks up another FDA approval for Keytruda cancer drug
The blockbuster immunotherapy wins its first approval for treating small cell lung cancer.
By Kristin Jensen • June 18, 2019 -
FTC demands could mean months-long delay for Roche-Spark deal
A rare "second request" for info on Roche's cash buyout tasks both companies with providing extensive documents and executive testimony.
By Jonathan Gardner • June 12, 2019 -
FDA weighs role of high-dose opioids as two-day expert meeting begins
Amid a nation-wide epidemic of addiction and overdose, the agency is considering whether highly potent opioids have a place in the healthcare system.
By Andrew Dunn • June 11, 2019 -
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
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