FDA's Woodcock: 'The clinical trial system is broken'

The CDER director said the current system doesn't serve the interests of patients and noted support for trials capable of answering multiple clinical questions at once. 

By Andrew Dunn • Nov. 20, 2018

FDA clears new Adcetris use in speedy review

Through an experimental real-time process, the regulator approved Seattle Genetics' application for the drug in just two weeks.

By Suzanne Elvidge • Nov. 19, 2018

Roche pulls EU application for Tecentriq in kidney cancer

The immunotherapy delivered positive results back in February, but Roche no longer believes that data to be supportive of a label extension.

By Suzanne Elvidge • Nov. 19, 2018

CMS approves Michigan Medicaid drug value-based payment plan

Administrator Seema Verma also previewed forthcoming agency action on protected classes of drugs in Medicare Part D, hinting that CMS plans to further open the space to private negotiation.

By David Lim • Nov. 14, 2018

UK calls Vertex on contentious Orkambi negotiations

A key committee has asked for more information from Vertex on its case for the cystic fibrosis drug, including the price offered to NHS.

By Suzanne Elvidge • Nov. 12, 2018

Coherus biosimilar to launch in US at 33% discount to Neulasta

Udenyca will be the second biosimilar in the U.S. to challenge Amgen's Neulasta when it hits markets in early January.

By Suzanne Elvidge • Nov. 9, 2018

Morgantown restructuring costs weigh on Mylan

High restructuring costs and reduced manufacturing at the West Virginia plant have poked a hole in Mylan's finances.

By Suzanne Elvidge • Nov. 8, 2018

5 election takeaways for pharma

Democrats took back the House on Tuesday, raising the prospect of more scrutiny on drug pricing. Experts, however, don't expect a major deal with President Trump.

By Ned Pagliarulo • Nov. 7, 2018

Sage depression drug to cost between $20K and $35K, if approved

Zulresso is currently under review by the FDA for postpartum depression, with a decision expected in December.

By Suzanne Elvidge • Nov. 7, 2018

Beleaguered Akorn hit with lengthy FDA inspection report

Already under fire for data integrity issues, Akorn has been issued a Form 483 detailing a slate of quality control violations. 

By Suzanne Elvidge • Nov. 6, 2018

Another opioid approval incites questions, criticism

The chairman of an FDA advisory committee has warned Dsuvia's approval will lead to diversion, abuse and death.

By Andrew Dunn • Nov. 5, 2018

Pfizer extends cancer drug approval streak with OK for Lorbrena

Lorbrena is Pfizer's third oncology therapy to be cleared by the FDA within the past two months, following Vizimpro and Talzenna.

By Suzanne Elvidge • Nov. 5, 2018

FDA panel vote lifts approval prospects for Sage's Zulresso

A key question, though, centers on how Sage's drug should be administered if approved. A strict REMS requirement could limit commercial prospects.

By Suzanne Elvidge • Nov. 5, 2018

9 state healthcare battles to watch Tuesday

It's not just Congress up for grabs in today's midterm elections. From Medicaid expansion to dialysis treatments, here's a snapshot of key votes, the odds and what they could mean for the industry.

By David Lim , Tony Abraham , Rebecca Pifer Parduhn , Samantha Liss • Nov. 2, 2018

Alkermes depression drug approval odds slim after negative FDA panel vote

An agency advisory panel voted 21-2 against recommending approval for ALKS-5461, sending shares in the company sliding. 

By Ned Pagliarulo • Nov. 2, 2018

HHS proposes start date for 340B ceiling price after hospital suit

After delaying the start date five times, the department has proposed enforcing ceilings for the drug pricing program beginning Jan. 1. 

By Tony Abraham • Nov. 1, 2018

Novartis wins US nod for Humira biosimilar, but focus now on Europe

A settlement deal blocks market launch in the U.S. until 2023. In Europe, however, the battle for market share is just beginning. 

By Ned Pagliarulo • Oct. 31, 2018

Merck's Keytruda secures broader lung cancer approval

The pharma's star cancer drug is now the first PD-1 inhibitor OK'd for initial treatment of squamous non-small cell lung cancer, expanding its market.

By Ned Pagliarulo • Oct. 31, 2018

Alkermes' depression drug set to test flexibility of FDA

Briefing documents prepared by agency staff suggest the regulator has several major issues with the application, not least of which is the mixed clinical track record for ALKS-5461. 

By Ned Pagliarulo • Oct. 29, 2018

FDA hits Regeneron with CRL for Eylea syringe

The biotech still expects, however, to launch the pre-filled syringe version of its blockbuster eye drug sometime next year.   

By Suzanne Elvidge • Oct. 26, 2018

FDA approves flu drug with new mechanism of action

Just in time for the flu season, the newly OK'd antiviral treatment could be the viral boost that Roche needs.

By Suzanne Elvidge • Oct. 25, 2018

FDA's Gottlieb 'extremely worried' on CAR-T reimbursement

The FDA head referenced how radiopharmaceuticals were treated in reimbursement, "underpaying hospitals and forcing them to lose money." He warned the same thing is happening now with CAR-T.

By Andrew Dunn • Oct. 24, 2018

Cryoport, in pursuit of smoother cell therapy logistics, opens new facility

Located in Livingston, New Jersey, the center is in close proximity to major cell therapy players like Novartis and Celgene.

By Jacob Bell • Oct. 24, 2018

Advair copy approval 'imminent,' Mylan says, but investors jittery

An FDA decision was expected in mid-October after the company was hit with a CRL in June. Hundreds of millions of dollars could be on the line.

By Ned Pagliarulo • Oct. 23, 2018

First Amendment takes center stage in DTC price fight

A string of court decisions have bolstered commercial speech rights for industry. The Trump administration's push to require prices in TV ads could become the next legal battleground.

By Andrew Dunn • Oct. 22, 2018