Senate passes tax bill that repeals individual mandate

Lawmakers will now attempt to work out the differences between the Senate bill and a similar tax bill the House passed last month that preserves the mandate.

By David Lim • Dec. 2, 2017

Prescribed Reading: Industry CEOs talk PRVs, IPR, PCSK9

Leschly suggests PRVs should be an alternative source of revenue for biotechs; ear health R&D is all clogged up; and execs agree the IPR process should be thrown out. 

By Lisa LaMotta • Dec. 1, 2017

Sanofi to propose limits on use of dengue vaccine after safety signal

Recently analyzed clinical data showed the shot could intensify subsequent cases of the disease for individuals who had not previously been infected.

By Ned Pagliarulo • Nov. 30, 2017

FDA knocks generic maker for misbranding sleep aid

The warning letter to Magna Pharmaceuticals is only the third such notice issued this year by the FDA office in charge of regulating prescription drug promotion.

By Ned Pagliarulo • Nov. 29, 2017

Catalyst eyes 2018 filing for rare disease drug candidate

Positive data from a second Phase 3 study has Catalyst on track to resubmit Firdapse for potential U.S. approval.

By Suzanne Elvidge • Nov. 28, 2017

BioMarin sells latest PRV for $125M

The biotech monetized its coveted priority review voucher, boosting its finances.

By Lisa LaMotta • Nov. 27, 2017

FDA pushes for more abuse-deterrent opioid generics

Under new Commissioner Gottlieb, the FDA has been looking to increase competition across markets by ushering more drugs through the system more efficiently. 

By Jacob Bell • Nov. 21, 2017

EMA lands new home in Amsterdam

The European drugs regulator will leave London to take up residence in Amsterdam after the U.K.'s Brexit vote forced a relocation.

By Lisa LaMotta • Nov. 20, 2017

New FDA framework points to boost for cell and gene therapies

The framework may act as a bonus for the industry by speeding development of cell and gene therapies while improving safety and efficacy.

By Suzanne Elvidge • Nov. 20, 2017

Proposed Medicare policy could shift drug rebates to consumers

Currently, rebates and discounts for Part D drugs are "rarely" passed on directly to consumers, although they can lower overall premiums. 

By Ned Pagliarulo • Nov. 17, 2017

Prescribed Reading: FDA on approval streak, I/O shines

The regulatory agency granted seven approvals this week, including the first pill with a digital sensor, as well as the go-ahead for a new hemophilia drug. 

By Lisa LaMotta • Nov. 17, 2017

Ultragenyx wins first drug approval, valuable PRV

The FDA OK'd Mepsevii for a rare genetic disease sometimes known as Sly syndrome. But the priority review voucher UltraGenyx received in the process might end up being just as valuable. 

By Lisa LaMotta • Nov. 16, 2017

What you need to know about the new nominee to lead HHS

Alex Azar's previous stint at the agency is a plus in the eyes of many, but his more recent time as an executive for pharma giant Eli Lilly casts doubt on the Trump administration's promise to rein in drug prices.

By Shannon Muchmore • Nov. 15, 2017

AstraZeneca wins US approval for asthma biologic

The British drugmaker, long a leader in respiratory disease, has turned to biologics like Fasenra to fuel growth over the next decade.

By Ned Pagliarulo • Nov. 15, 2017

Hospitals file lawsuit to block 340B drug payment cut

Plaintiffs including the AHA argue the reimbursement change exceeds the authority of the HHS secretary and is "arbitrary and capricious."

By Shannon Muchmore • Nov. 14, 2017

Trump nominates former pharma exec Azar for head of HHS

Alex Azar was deputy secretary for HHS under President George W. Bush and more recently served as president of Lilly USA up until January.

By Shannon Muchmore • Nov. 13, 2017

Ocrevus, Mvasi and 8 other drugs get CHMP go-ahead

The EMA advisory committee's latest approval recommendations included copycat and generic offerings that could sap money from blockbuster franchises.

By Jacob Bell • Nov. 10, 2017

Prescribed Reading: Buyer's remorse for biopharma

Most of the major deal developments of late have been companies handing back the rights to assets they previously licensed as they try to right-size portfolios. 

By Lisa LaMotta • Nov. 10, 2017

Dynavax finally pushes hep B vaccine over the finish line

After two rejections and multiple regulatory delays over the past half decade, Heplisav-B has finally been approved by the FDA. 

By Lisa LaMotta • Nov. 9, 2017

FDA timetables: 5 Things to know about the evolving requirements for SEND

It's been one year since the implementation of SEND, but attention is already shifting to the next set of requirements that will be rolling out soon.

Nov. 7, 2017

FDA lifts clinical hold on Cellectis CAR-T

Cellectis agreed to several changes to two Phase 1 trials testing its allogeneic CAR-T candidate, both of which had been halted after a patient death in late August.

By Ned Pagliarulo • Nov. 7, 2017

FDA agrees to review TherapeuticsMD drug, dropping safety demands

The regulator will no longer require the company to complete a new safety study before resubmitting its vaginal pain treatment for approval. 

By Ned Pagliarulo • Nov. 6, 2017

Prescribed Reading: Cancer market facing several shake-ups

Merck pulled a Keytruda application in Europe, and AstraZeneca got a key approval for Calquence — decisions that could have dramatic impacts on different areas of the oncology space. 

By Lisa LaMotta • Nov. 3, 2017

FDA to recognize GMP inspections by 8 EU drug regulators

The agreement marks a major step toward closer collaboration between the FDA and its European counterparts to regulate the production of medical products. 

By Ned Pagliarulo • Nov. 2, 2017

AstraZeneca secures US approval for 'cornerstone' cancer drug

The British pharma hopes Calquence jumpstarts its entry into treatment of blood cancers, but AbbVie's Imbruvica blockbuster will prove tough competition. 

By Ned Pagliarulo • Nov. 1, 2017