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

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