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

Regeneron and Sanofi's Dupixent gains asthma approval

An OK from the FDA broadens the addressable market for Regeneron and Sanofi's biologic, but Dupixent will face stiff competition in asthma.

By Suzanne Elvidge • Oct. 22, 2018

FDA delays decision on Bristol-Myers' lung cancer combo

A longer review for the pharma's pairing of Opdivo and Yervoy in first-line non-small cell lung cancer appeared to trigger a 5% stock drop Monday.

By Suzanne Elvidge • Oct. 22, 2018

FDA unconvinced by Novartis pitch for canakinumab

The agency knocked back an application for approval of the drug, already on the market as Ilaris, as a treatment for cardiovascular risk reduction. 

By Jacob Bell • Oct. 19, 2018

Acacia Pharma pitches quick path to refiling Barhemsys

A Complete Response Letter from the FDA earlier this month derailed Acacia's plans for its lead drug, but it hopes to soon get back on track.

By Suzanne Elvidge • Oct. 18, 2018

CMS' Verma blasts Medicare for all, touts efforts on drug costs

Verma also hinted at further options for Medicare Part D to lower prices. "We are working toward additional regulatory flexibility in this area, so stay tuned," she said.

By Samantha Liss • Oct. 17, 2018

Alnylam nixes accelerated approval plans for givosiran, pushing back timeline

The biotech will begin a rolling filing to the FDA this year, but doesn't anticipate completing submission of the RNAi therapy until the middle of next year.

By Andrew Dunn • Oct. 15, 2018

FDA sets another record in 2018 for generic drug approvals

Approvals climbed higher for the second consecutive year, as the agency has prioritized approving copycat drugs to boost competition.

By Suzanne Elvidge • Oct. 12, 2018

Trevena's opioid gets thumbs down from FDA adcomm

While the FDA doesn't have to follow the advice of the panel, the negative vote doesn't bode well for the fate of oliceridine. 

By Suzanne Elvidge • Oct. 12, 2018

Regulators wary of how McKesson handles illegitimate drugs

A Form 483 issued in July found the drug distributor didn't have proper systems for addressing illegitimate products when they came through its facilities.

By Jacob Bell • Oct. 11, 2018

US tightens scrutiny of foreign investment into biotech sector

New rules put in place by the Treasury Department would expand review of foreign investments in biotechnology R&D and 26 other critical industries.

By Ned Pagliarulo • Oct. 11, 2018

As clock ticks, EMA launches 3rd phase of Brexit plan

The agency has started to scale back non-urgent activities as its move to Amsterdam draws closer.

By Suzanne Elvidge • Oct. 11, 2018

Congress expands Sunshine payment reporting rules

Under a bill expected to be signed by President Trump, companies would report payments to a longer list of healthcare professionals, including physician assistants and nurse practitioners.

By Nick Paul Taylor • Oct. 11, 2018

FDA clears Vertex, CRISPR to test gene-editing therapy in sickle cell patients

With a clinical hold dating back to May resolved, the companies said they plan to start a Phase 1/2 study of CTX001 in the U.S. by year's end.

By Jacob Bell • Oct. 10, 2018

Trump signs law allowing FTC to scrutinize biosimilar deals

A former FTC lawyer said the new law, which also deals with pharmacy gag clauses, will clarify the commission's authority to routinely review such deals.

By Andrew Dunn • Updated Oct. 10, 2018