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

Barriers remain for a drug industry ready to blossom in Brazil

A poor patient population, a tricky tax code and turmoil within the government have created obstacles for pharma companies entering the Brazilian market. 

By Jacob Bell • Oct. 30, 2017

Prescribed Reading: Disappointing quarters all around

With some exceptions, third quarter reports so far have largely been a letdown for the sector, lowering expectations as investors turn toward 2018. 

By Lisa LaMotta • Oct. 27, 2017

FDA hands PTC its latest rejection

After a disastrous advisory committee meeting and a refusal-to-file letter, the regulatory agency has issued another rejection for the DMD drug.

By Lisa LaMotta • Oct. 25, 2017

Vaccine approval buoys GSK new drug push

An FDA OK for GSK's shingles vaccine puts the British drugmaker in direct competition with Merck's Zostavax franchise.

By Ned Pagliarulo • Oct. 23, 2017

Prescribed Reading: Blockbuster potential thwarted; generics consolidate

The past week saw multiple companies discontinue development of potential blockbusters, while a tightening generics market prompted a new merger.

By Lisa LaMotta • Oct. 20, 2017

Novo's new diabetes drug secures backing of FDA panel

Approval for semaglutide, a GLP-1 analog, could help the Danish drugmaker fend off Eli Lilly's rival treatment Trulicity, which has been rapidly gaining share. 

By Suzanne Elvidge • Oct. 19, 2017

Gilead wins US approval for CAR-T cancer therapy

Approval of the drug, which Gilead acquired in an $11.9 billion deal for Kite Pharma, puts the biotech alongside Novartis at the leading edge of cell therapy.

By Ned Pagliarulo • Oct. 18, 2017

In Congressional spotlight, drug industry groups blame each other

At a Senate hearing Tuesday, officials from trade groups representing the industry's many players disagreed over who's to blame for rising costs. 

By Ned Pagliarulo • Oct. 18, 2017

Prescribed Reading: A week of game-changers in pharma

A new gene therapy is poised to hit the market; one dose of Anaptysbio's drug is all it took to clear some patients' skin; and a late-stage failure is hurting Lilly's oncology prospects.

By Lisa LaMotta • Oct. 13, 2017

Spark's gene therapy for blindness takes major step toward approval

If OK'd in January, Spark's Luxturna would be the first gene therapy approved for an inherited disease, a major milestone for the field but one that will test how such drugs are covered and paid for. 

By Ned Pagliarulo • Oct. 12, 2017

Biocon manufacturing problems stall another one of its biosimilars

The FDA rejected Biocon and Mylan's version of Neulasta as the agency awaits more chemistry, manufacturing and controls data for a recently modified facility.

By Jacob Bell • Oct. 12, 2017

FDA rejection blocks another AcelRx drug from US market

Three years after issuing a CRL for Zalviso, the agency has shot down another pain medication from the West Coast biotech.

By Jacob Bell • Oct. 12, 2017

Generon moving ahead with Phase 3 trial following SPA

The FDA has agreed to the study protocol, which will test the Chinese biotech's lead candidate as a treatment for chemotherapy-induced neutropenia.

By Jacob Bell • Oct. 11, 2017

Flexion secures US approval for osteoarthritis drug

The biotech is highlighting the drug as a non-opioid, non-surgical option for knee pain associated with the chronic condition. 

By Ned Pagliarulo • Oct. 9, 2017

EMA warns relocation could deliver major hit to budget

The EU drugs regulator has cautioned that moving its headquarters to a new country could lead to "massive staff losses," an event that might batter its budget.

By Suzanne Elvidge • Oct. 9, 2017

Prescribed Reading: DMD, MS and other acronyms

Another DMD drug struggles to get closer to market, a blockbuster MS drug now faces multiple generic competitors, and a deal is inked to increase competition in the Tyk2 inhibitor space. 

By Lisa LaMotta • Oct. 6, 2017

Teva hit with surprise Copaxone generic, Mylan celebrates

The Israeli drugmaker is now facing generic competition to its best-selling product, putting more than $4 billion of revenue in jeopardy.

By Lisa LaMotta • Oct. 4, 2017

10 Topics pharma execs were talking about in Q3

With the third quarter coming to a close, BioPharma Dive revisits the stories that sparked the most reader interest during the July-to-September period. 

By Lisa LaMotta • Oct. 3, 2017