FDA: Page 35
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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 -
Jacob Bell/BioPharma Dive
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 -
Courtesy of Gilead Sciences
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 -
Permission granted by Novartis
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 -
Brian Tucker/BioPharma Dive
Congress is going after drug prices. Pharma CEOs aren't panicking, yet
A Senate Finance bill could emerge as the most palatable option for an industry seeking to limit losses in an election cycle already targeting pricing as an issue.
By Ned Pagliarulo • Aug. 2, 2019 -
White House backs importing drugs from abroad
The Trump administration's latest drug price plan features ideas Republicans traditionally oppose and breaks with past claims about the FDA's ability to safely oversee importation.
By Jonathan Gardner • July 31, 2019 -
How Mylan ended as a junior partner in its Pfizer deal
Following a failed deal for Perrigo in 2015, Mylan's fortunes turned south as change came quickly to the generic drug industry.
By Jonathan Gardner • July 30, 2019 -
Senate advances drug pricing bill, setting up September vote
PhRMA's CEO, along with a number of drugmaker executives, met with President Trump this week to lay out their opposition to the bill.
By Jonathan Gardner • July 26, 2019 -
European regulators back Bayer, GW drugs, but with caveats
The CHMP recommended conditional approval of Vitrakvi while also advising Epidiolex be used as adjunctive therapy, an opinion one analyst described as "disappointing."
By Jacob Bell • July 26, 2019 -
FDA cancels panel review for Intra-Cellular drug, stirring investor confusion
"This is obviously a frustrating situation," one analyst wrote, as the biotech's stock plummeted on concerns of a delayed regulatory timeline for the schizophrenia drug.
By Andrew Dunn • July 24, 2019 -
Senate committee targets drug price increases with broad bill
Legislation is newly in focus after the White House dropped a bid to ban certain Medicare rebates, and saw another pricing plan defeated in court.
By Jonathan Gardner • July 23, 2019 -
Opioid and price fixing legal liabilities mount for generic companies
Potential liabilities for Teva, Mylan, Amneal and Endo could reach as high as $14.7 billion, per estimates from SVB Leerink.
By Jonathan Gardner • July 22, 2019 -
Amgen, Allergan launch first US biosimilars of Roche's Herceptin and Avastin
The copycat drugs will test how well Roche has prepared for competition to what for years have been among its top-selling products.
By Andrew Dunn • July 19, 2019 -
Merck urges caution on use of its newly approved antibacterial
The FDA approval of triple therapy Recarbrio comes with a reminder that overuse of antibiotics can cause resistance.
By Jonathan Gardner • July 17, 2019 -
As Trump's drug pricing plan falters, Dem challengers pitch ideas for 2020
Former Vice President Joe Biden and Sen. Kamala Harris both unveiled this week their plans to confront the drug industry.
By Andrew Dunn • July 16, 2019 -
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
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