Prescribed Reading: Checkpoint inhibitors change cancer

Approvals and failures of checkpoint inhibitors have dramatically changed the cancer landscape, and could even have an impact on how the FDA approaches approvals. Elsewhere, Pfizer's getting into genes and Advair avoids competition.

By Lisa LaMotta • May 12, 2017

Second Advair copy rejected, giving GSK short-term respite

Hikma Pharmaceuticals said it had received a complete response letter from the FDA, likely meaning GSK will dodge generic competition to its bestseller this year. 

By Ned Pagliarulo • May 11, 2017

EMA trumpets achievements ahead of Brexit

The European healthcare regulatory authority is touting its success as it hunts for a new home.

By Suzanne Elvidge • May 11, 2017

J&J discloses DOJ investigations into marketing, advisory practices

U.S. officials are looking into the healthcare heavyweight's sales protocols for four drugs: Remicade, Stelara, Olysio and Simponi.

By Jacob Bell • May 10, 2017

Senate confirms Scott Gottlieb as FDA chief

Gottlieb will have to strike a balance between the Trump administration's push to deregulate and defending the FDA's "gold standard" for reviewing the safety and efficacy of new drugs. 

By Ned Pagliarulo • May 10, 2017

Roche's Tecentriq fails trial, raising questions about approval

The late-stage failure in bladder cancer now calls into question the FDA's initial decision to OK the drug.

By Lisa LaMotta • May 10, 2017

Bavencio snags bladder cancer approval ahead of goal date

The FDA's accelerated approval of Merck KGaA and Pfizer's checkpoint inhibitor means more competition in second-line bladder cancer.

By Suzanne Elvidge • May 10, 2017

Scynexis stock slumps as clinical hold continues

The FDA's request for more analysis of preclinical and clinical data looks like it will push further clinical development of Scynexis' IV antifungal even further back. 

By Suzanne Elvidge • May 10, 2017

FDA rejection sets back TherapeuticsMD

The FDA's request for 12-month safety data on TherapeuticsMD's hormone product for post-menopausal women could mean a missed chance at market. 

By Suzanne Elvidge • May 9, 2017

FDA clears new ALS drug for US market

Radicava, only the second drug ever approved specifically for ALS in the U.S., will retail for over four times its price tag in Mitsubishi Tanabe's homeland, Japan.

By Suzanne Elvidge • May 8, 2017

Prescribed Reading: Deals to come, but when?

Pfizer and Gilead could be in a deal-making mood, while the FDA continues to approved drugs at a rapid clip and clinical failures keep coming. 

By Lisa LaMotta • May 5, 2017

House narrowly passes GOP plan to replace ACA

The measure dismantles key ACA provisions such as essential health benefits and pre-existing condition protections.

By Jeff Byers , Shannon Muchmore • May 4, 2017

Q1 Biotech earnings highlights: Clovis, Bluebird, Rigel, Vanda

Unlike their big pharma counterparts, small biotechs don't have much revenue to report, but earnings updates can still be valuable. 

By Lisa LaMotta • May 4, 2017

Insulin makers targeted in pricing inquiries

Eli Lilly disclosed it is under investigation by the attorneys general of Washington and New Mexico. Rival Novo Nordisk is under similar scrutiny. 

By Suzanne Elvidge • May 3, 2017

FDA casts doubts on Intra-Cellular safety data

Pre-clinical safety data came back to haunt Intra-Cellular as it prepared to submit lumateperone for approval in schizophrenia.

By Suzanne Elvidge • May 2, 2017

AstraZeneca gains FDA approval for durvalumab

The British pharma's PD-L1 inhibitor will enter a hotly contested market. The real test, though, will come later this year in the crucial MYSTIC study. 

By Lisa LaMotta • May 1, 2017

FDA gives thumbs up to Takeda's lung cancer drug

Alunbrig will enter the market as a second-line treatment for non-small cell lung cancer, competing with drugs from Roche and Novartis.

By Jacob Bell • May 1, 2017

Novartis wins US approval of Rydapt for rare type of AML

Rydapt is also the first drug approved for treatment of advanced systemic mastocytosis, an ultra-rare group of conditions that includes mast cell leukemia. 

By Suzanne Elvidge • May 1, 2017

Medeor gets FDA go-ahead for Phase 3

The biotech is developing an immunotherapy that could replace immunosuppressants for transplant patients should it be successful. 

By Suzanne Elvidge • May 1, 2017

Radius targets quick ramp up for newly approved osteoporosis drug

Tymlos, priced at a wholesale acquisition cost of $19,500 per year, will challenge Eli Lilly's aging Forteo for market share. 

By Ned Pagliarulo • April 30, 2017

Prescribed Reading: Rough start for pharma, but optimism abounds

First quarter earnings were not particularly strong, but there were several bright spots; Gottlieb confirmation rolls forward; and The Medicines Co. lays down cash for its CV outcomes trial.

By Lisa LaMotta • April 28, 2017

BioMarin's Batten disease drug gets a yes at a cost of $702K

Brineura, BioMarin's drug for the ultra-rare CLN2 pediatric brain disorder, could have a price tag of almost half a million dollars a year, even after discounts. 

By Suzanne Elvidge • April 28, 2017

FDA busts 14 companies for selling bogus cancer cures

The regulator sent warning letters to all 14 firms demanding removal of the mostly digital ads and videos that fraudulently touted miraculous new treatments. 

By Ned Pagliarulo • April 25, 2017

Cel-Sci withdraws 2016 study protocol amendment

Could this be the light at the end of the tunnel for Cel-Sci's Multikine development?

By Suzanne Elvidge • April 25, 2017

Biogen, BioMarin secure orphan drug endorsements in Europe

The European regulator also recommended approval of three biosimilar drugs, all from Novartis' generics unit, Sandoz, in its April review meeting. 

By Ned Pagliarulo • April 24, 2017