Trevena shares sink on FDA concerns ahead of key panel meeting

Briefing documents from FDA staff revealed the agency hadn't agreed to parts of Trevena's plans to measure its candidate's safety profile. 

By Ned Pagliarulo • Oct. 9, 2018

Approval puts Bausch step closer to dermatology turnaround

It's welcome news for Bausch's struggling dermatology portfolio, which saw the FDA reject another key psoriasis candidate in June.

By Jacob Bell • Oct. 8, 2018

FDA clears rare disease therapy from Akcea, Ionis

Tegsedi will challenge Alnylam's rival drug Onpattro, which is OK'd for the same condition. A black box warning, however, could weigh on Tegsedi's prospects. 

By Ned Pagliarulo • Oct. 5, 2018

FDA to call out drugmaker misuse of citizen petitions

Agency chief Scott Gottlieb aims to dissuade companies from abusing citizen petitions as a means of delaying generic competition. 

By Suzanne Elvidge • Oct. 3, 2018

Regeneron wins early approval for cancer immunotherapy

Although Libtayo arrives years behind its PD1-blocking peers Keytruda and Opdivo, Regeneron is convinced it can still become an immuno-oncology player.

By Ned Pagliarulo • Sept. 29, 2018

Cancer drug approval expands Pfizer's targeted therapy ambition

While Pfizer lags its rivals in immuno-oncology, approval of Vizimpro should help the pharma treat lung cancer patients with specific mutations.

By Ned Pagliarulo • Sept. 28, 2018

Lilly's migraine drug wins US approval, pressuring rivals Amgen, Teva

Two rival drugs are already OK'd for sale, setting the migraine market up for fierce competition. Who wins out may depend on how payers react.

By Ned Pagliarulo • Sept. 27, 2018

GW Pharma clears last big hurdle for cannabis-based Epidiolex with DEA rescheduling

The first plant-derived cannabinoid medicine OK'd by the FDA has been reclassified from Schedule I to Schedule V, opening the door for marketing.

By Jacob Bell • Sept. 27, 2018

Sarepta clears up clinical hold for gene therapy

The micro-dystrophin program for Duchenne muscular dystrophy looks back on track roughly two months after regulators put it on pause.

By Jacob Bell • Sept. 24, 2018

UK High Court OKs Avastin off-label use in wet AMD

Doctors in the north of England have won the right to use Avastin to treat wet age-related macular degeneration.

By Suzanne Elvidge • Sept. 24, 2018

Sarepta strikes out again with European regulators

Despite backing more than a dozen other drugs at its September meeting, the CHMP for a second time refused to support eteplirsen's marketing OK.

By Jacob Bell • Sept. 21, 2018

Acadia shares rise after FDA review of Nuplazid

Following reports of increased risks to Acadia's Parkinson's drug, an analysis by the regulator turned up no new safety findings.

By Suzanne Elvidge • Sept. 21, 2018

Pharming knocked back with CRL from FDA

Regulators are looking for more data from Pharming to support an expanded approval of the company's HAE drug Ruconest. 

By Suzanne Elvidge • Sept. 20, 2018

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