Trump backs lawsuit against opioid companies

Bipartisan lawmakers are also working on a bill allowing more physicians to prescribe medication-assisted treatment and a restriction on prescriptions.

By David Lim • March 2, 2018

Prescribed Reading: Sketchy subgroup analyses, puzzling probes

Several companies used creative thinking when evaluating clinical trial results, while others played the game of excluding details when informing investors.

By Lisa LaMotta • March 2, 2018

Allergan's Esmya delayed in US amid EU liver injury cases

While details from Allergan are scarce, the FDA has pushed back Esmya's target action date to late summer.

By Lisa LaMotta • March 1, 2018

Portola investors are sick of AndexXa delays

FDA feedback indicates Portola will have to run another clinical trial for its reversal agent, likely postponing the drug's market entry even further.

By Jacob Bell • March 1, 2018

Benzo overprescribing risk may be overlooked amid opioid crisis

A new commentary in the New England Journal of Medicine argues for greater monitoring and physician education around benzodiazepine use.

By Ned Pagliarulo • Feb. 28, 2018

Collegium warned for opioid drug marketing

The company was hit with a warning letter from the FDA after failing to prominently disclose the risks of the drug at a recent conference. 

By Jacob Bell • Feb. 28, 2018

Celgene's ozanimod hit with Refusal to File in latest setback

The agency's decision not to accept the NDA for the MS drug puts billions in potential revenue at stake. 

By Lisa LaMotta • Feb. 28, 2018

Hemlibra headed for Europe, eyes wider market

Some peg $5 billion in peak sales for Roche's new hemophilia drug, but that's only if it wins new indications in the U.S. and Europe.

By Jacob Bell • Feb. 27, 2018

Lilly wins broader Verzenio approval, drawing even with rivals

Verzenio is now OK'd in the U.S. as a first-line treatment for advanced breast cancer. Yet Pfizer's Ibrance has built a commanding lead in that market.

By Ned Pagliarulo • Feb. 27, 2018

Drug compounding oversight rises, but spotty: Pew

A new report highlights the challenges and safety issues still prevalent in compounding pharmacies.

By Jacob Bell • Feb. 26, 2018

EU turns down Puma breast cancer drug

The CHMP gave a negative opinion on Puma's Nerlynx, indicating efficacy might be an issue.

By Lisa LaMotta • Feb. 26, 2018

AMA wants payment, delivery changes to combat opioid crisis

The doctors group suggested creating a seventh protected class of drugs under Medicare Part D for medication-assisted treatment and put forward ideas for eliminating payment barriers.  

By Les Masterson • Feb. 26, 2018

KemPharm nabs opioid approval, but no abuse-deterrent label

After several setbacks, the specialty pharma got a green light from the FDA, but not the broad label it wanted.

By Lisa LaMotta • Feb. 26, 2018

Bellicum outlines path to restart US studies of cell therapy

Investors appear relieved by the relatively modest nature of changes required by the FDA to lift a clinical hold on trials of BPX-501.

By Ned Pagliarulo • Feb. 23, 2018

Prescribed Reading: Deals sputter in, warning letter frenzy

Small bolt-on deals and acquisitions keep trickling in, unloved therapeutic areas get positive data, and CDER warnings letters rise under Gottlieb. 

By Lisa LaMotta • Feb. 23, 2018

CDER in warning letter frenzy as pharma struggles with quality control

While the FDA issued significantly fewer warning letters in 2017, the number coming from its CDER unit has nearly doubled since 2014, according to PwC.

By Jacob Bell • Feb. 21, 2018

Amazon selling private-label medications

The e-commerce company is offering an exclusive line of over-the-counter medications, thanks to healthcare supplier Perrigo.

By Daphne Howland • Feb. 21, 2018

Apricus plummets after ED drug rejection

Already approved in Europe, Vitaros didn't gain favor with U.S. regulators, who found CMC and safety issues with the erectile dysfunction drug.

By Jacob Bell • Feb. 16, 2018

Prescribed Reading: Landscape-changing deals and Alzheimer's shake-ups

A relatively large research collaboration could change the deal landscape. Elsewhere, the Alzheimer's development picture is getting a makeover. 

By Lisa LaMotta • Feb. 16, 2018

FDA pushes pharma to continue efforts in Alzheimer's

In new guidance to industry, the regulator signaled greater flexibility around the use of biomarkers in studying the neurodegenerative disease.

By Suzanne Elvidge • Feb. 16, 2018

J&J gets first-of-its-kind prostate cancer approval

The FDA greenlighted apalutamide for non-metastatic CRPC based on a new endpoint: metastasis-free survival. 

By Lisa LaMotta • Feb. 14, 2018

BIO: Pain pipeline lacking as opioid crisis continues

The analysis comes as a new Senate report calls into question drugmaker ties to advocacy groups in fighting the epidemic.

By Suzanne Elvidge • Feb. 14, 2018

Trump pitches changes to 180-day generic exclusivity

The administration's budget includes a proposal to prevent generic drugmakers from abusing the current system.

By David Lim • Feb. 13, 2018

Fewer regs could lower drug costs: White House council

The Council of Economic Advisers also suggested creating an independent agency to oversee the 340B prescription drug program.  

By Les Masterson • Feb. 12, 2018

Pharma to pay more under 2-year budget deal

Staving off an extended government shutdown, the pact includes higher payments from drugmakers for Medicare recipients and more funds to fight the opioid crisis.

By David Lim • Feb. 9, 2018