NICE says no to Kymriah for adult lymphoma despite offer on price

NHS recently agreed to cover Kymriah for certain pediatric leukemia cases. However, in its other indication, the Novartis therapy has hit a snag.

By Andrew Dunn • Sept. 19, 2018

Senate passes bill for FTC scrutiny of biosimilar 'pay-for-delay' deals

The legislation would require biologic and biosimilar makers to report settlement pacts to the Federal Trade Commission.

By Andrew Dunn • Sept. 18, 2018

FDA lifts clinical hold on Mersana study, but shares slide

Mersana will soon restart the paused trial of a cancer candidate with modified dosing and tweaked protocols. Markets, though, didn't seem all that relieved.

By Suzanne Elvidge • Sept. 18, 2018

AdvaMed supports FDA combination product GMP plan

The agency wants to streamline quality compliance mechanisms for drug-device combinations.

By Nick Paul Taylor • Sept. 18, 2018

Cigna-Express Scripts merger cleared by DOJ

Federal regulators believe the $67 billion deal is "unlikely to result in harm to competition or consumers."

By Samantha Liss • Sept. 17, 2018

Teva wins much-needed US approval of migraine drug

Ajovy will carry an annual list price of $6,900, matching the cost of Amgen and Novartis' rival preventive therapy Aimovig.

By Ned Pagliarulo • Sept. 14, 2018

Inbrija delay poses question: How far can Acorda fall?

Regulators need more time to assess the biotech's Parkinson's drug. Their final decision, when it comes, will be the difference between Acorda shares trading at $5 or $30 apiece, according to one analyst.

By Jacob Bell • Sept. 13, 2018

Amgen, Sandoz begin biosimilar trial with top-selling Enbrel at stake

In the still unsettled biosimilar market, the result could hold far-reaching consequences. "You are going to start hearing about this," one top Wall Street analyst predicted.

By Andrew Dunn • Sept. 13, 2018

Federal court rules Ampyra patents invalid, sinking Acorda stock

In a 2-1 vote, a U.S. appeals court upheld a previous ruling to toss out four patents on grounds of obviousness for the biotech's lead drug.

By Andrew Dunn • Sept. 10, 2018

Merck extends I/O lead as EU OKs Keytruda in first-line lung cancer

Even as the immuno-oncology race between Keytruda and Opdivo remains tight, Merck's drug has secured a dominant position in treating lung cancer.

By Andrew Dunn • Sept. 10, 2018

FDA closes door to speedy OK for Amicus rare disease drug

Amicus had hoped positive data from an early study of its Pompe disease therapy would support accelerated approval. Yet the biotech isn't giving up.

By Ned Pagliarulo • Sept. 10, 2018

Roche hits roadblock in UK over Ocrevus price

Final guidance from NICE advised against covering the MS drug for primary progressive patients, despite a lack of other disease-modifying therapies.

By Suzanne Elvidge • Sept. 10, 2018

Biotech billionaire Phillip Frost charged by SEC, sending Opko shares sliding

The SEC alleged the Opko CEO and ex-Teva chairman, along with nine others, manipulated stock prices in "classic pump-and-dump schemes."

By Andrew Dunn • Updated Sept. 8, 2018

BlueCross BlueShield Tennessee drops Oxycontin in favor of Collegium's competitor

While still tiny next to the Oxycontin franchise, Xtampza has gained momentum as a challenger to Purdue's market dominance.

By Andrew Dunn • Updated Sept. 7, 2018

Invokana gains heart labeling in Europe

Among diabetes drugs, competition has increasingly been driven by the ability of companies to demonstrate the cardiovascular safety of their medicines.

By Ned Pagliarulo • Sept. 7, 2018

As valsartan recall persists, FDA touts facility inspection transparency

FDA Commissioner Scott Gottlieb released a document detailing how the agency prioritizes which plants it inspects.

By Andrew Dunn • Sept. 6, 2018

FDA delays key Tecentriq decision by 3 months

Roche had hoped to secure a first-line approval for the immunotherapy in lung cancer by this week. Now, it will have to wait until December after an FDA review extension.

By Ned Pagliarulo • Sept. 6, 2018

Novartis CAR-T therapy snags UK coverage, cutting list price 23% from US

One of the fastest funding deals in U.K. history leaves Novartis ahead of rival Gilead in the battle to secure commercial returns for CAR-T across the pond.

By Andrew Dunn • Sept. 5, 2018

Chi-Med wins landmark cancer drug approval in China

Fruquintinib is the first cancer medicine discovered and developed by a Chinese company to secure an unconditional OK in the country. Partner Eli Lilly will sell the drug there.

By Ned Pagliarulo • Sept. 5, 2018

Lupin's Tarapur facility gets clean bill of health from FDA

Amid widespread problems with valsartan production, a cGMP inspection has alleviated concerns at one of Lupin's Indian plants.

By Suzanne Elvidge • Sept. 5, 2018

FDA knocks back Sunovion's ADHD drug

It's two steps forward and one step back for the Massachusetts drugmaker, which received a Complete Response Letter for dasotraline.

By Suzanne Elvidge • Sept. 4, 2018

What you need to know about the evolving regulatory landscape

BioPharma Dive takes an in-depth look at how the FDA has changed in recent years — and where it might be headed.

By Jacob Bell • Aug. 31, 2018

FDA warns of link between some diabetes drugs and serious infection

SGLT2 inhibitors, a kind of Type 2 diabetes medication, have been connected with a rare and sometimes life-threatening genital infection.

By Suzanne Elvidge • Aug. 30, 2018

Pfizer calls out pharma peers for 'scare tactics' on biosimilars

Frustrated by slow uptake of its biosimilars, Pfizer is petitioning the FDA to set ground rules for what biologic makers can say about copycat rivals.

By Ned Pagliarulo • Updated Aug. 29, 2018

FDA warns 21 websites selling unapproved opioids

Scott Gottlieb has upped the agency's oversight of illegal online pharmacies that put the U.S. public at risk through counterfeit or contaminated opioids.

By Suzanne Elvidge • Aug. 29, 2018