Roche lines up February decision date for hemophilia prospect

If approved, emicizumab could threaten both Shire and Novo Nordisk's respective hemophilia businesses.

By Ned Pagliarulo • Aug. 24, 2017

Pfizer secures patent in India for pneumonia vaccine

Aid groups expressed concern that the patent grant would limit access to the life-saving vaccine.

By Ned Pagliarulo • Aug. 23, 2017

Intra-Cellular swings up on latest go-ahead from FDA

The biotech secured a green light from the regulator to move forward with testing and a mid-2018 filing of its lead compound. 

By Lisa LaMotta • Aug. 23, 2017

Cardiome shaken by FDA no-go on heart drug refiling

The Canadian drugmaker's stock fell by almost a quarter after disclosing the data package for Brinavess wasn't sufficient for a resubmitted New Drug Application.

By Jacob Bell • Aug. 22, 2017

Ironwood wins FDA approval for combo gout drug

The biotech expects the oral therapy to further grow its gout franchise, established last year with the acquisition of U.S. rights to Zurampic from AstraZeneca. 

By Ned Pagliarulo • Aug. 21, 2017

Trump signs FDA user fee reauthorization into law

Congress effectively ignored the administration's demand to fund the regulator entirely through user fees and instead moved forward with a package already negotiated with industry. 

By Suzanne Elvidge • Aug. 21, 2017

Expanded label boosts AstraZeneca and Merck's Lynparza

Securing a broader indication for earlier treatment of ovarian cancer should help Lynparza fend off competition from rival PARP inhibitors.

By Ned Pagliarulo • Aug. 18, 2017

Pfizer locks down US approval for Besponsa

The drug is the first CD22-targeting antibody-drug candidate to gain approval for a specific population of acute lymphoblastic leukemia patients.

By Suzanne Elvidge • Aug. 18, 2017

House Democrats to probe 'skyrocketing' prices for MS meds

Two top Democrats on the House Oversight Committee plan to investigate the pricing strategies of seven leading drugmakers in the space.

By Ned Pagliarulo • Aug. 17, 2017

Mylan finalizes $465M settlement for EpiPen

The payment, though, is just a fraction of the $1.3 billion the U.S. government says it may have overpaid for the epinephrine autoinjectors.

By Jacob Bell • Aug. 17, 2017

FDA flags drugmaker's testing of potentially poisonous powders

The agency took a dim view of Homeolab USA's manufacturing processes, including those for its belladonna-containing powder blend.

By Jacob Bell • Aug. 17, 2017

Biocon pulls EU application for Herceptin biosimilar

The European Medicines Agency informed Biocon it would need to re-inspect the Indian manufacturer's drug product facility, triggering the withdrawal. 

By Suzanne Elvidge • Aug. 17, 2017

Adapting to industry changes: Moving to an agile operating structure

With new field roles being introduced, a new challenge emerges: How will these roles report up into the organization?

By Karan Dhundia co-wrote this blog post with Jude Konzelmann • Aug. 17, 2017

Drug pricing — what you need to know

Controversy over rising drug prices has put industry on the defensive in recent years. In this Spotlight, BioPharma Dive explores the trends fueling the debate, as well as emerging responses. 

By Lisa LaMotta • Aug. 15, 2017

Take two: Portola's reversal agent secures FDA review

Regulatory setbacks have kept Andexxa from market. But with a resubmission of the drug now accepted by the FDA, Portola hopes to secure approval by February.

By Jacob Bell • Aug. 15, 2017

5 Trends influencing drug pricing

When pricing medications, drugmakers now weigh consumer outrage, negotiating power and calls for transparency.

By Jacob Bell • Aug. 14, 2017

FDA gives OK, Cel-Sci clinical hold finally lifted

Well into its second decade of clinical development, a Phase 3 study of Multikine inches forward. 

By Suzanne Elvidge • Aug. 14, 2017

Prescribed Reading: Merger as a band-aid for biotech troubles

Multiple biotechs with ongoing problems discovered solutions this week by merging with privately held companies, which could offer a needed boost. 

By Lisa LaMotta • Aug. 11, 2017

Trump says he will declare opioid crisis a national emergency

Details have not been released, but the order would likely free up funding for fighting the epidemic and give relevant agencies more leeway and resources.

By Shannon Muchmore • Aug. 11, 2017

Vernalis hit with second CRL this year

Rejection for CCP-08 is another setback for the British biotech's U.S. cough and cold franchise.

By Lisa LaMotta • Aug. 7, 2017

Dynavax dips as its hep B drug faces another setback

The FDA's request for more information on a planned, post-marketing study of Heplisav-B is pushing back an approval decision.

By Jacob Bell • Aug. 4, 2017

Jazz trumpets FDA approval of AML drug

Days after Celgene secured approval for its AML drug Idhifa, the FDA OK'd another treatment option for the aggressive blood cancer.

By Suzanne Elvidge • Aug. 4, 2017

Prescribed Reading: More portfolios reshuffled

Restructuring continued throughout the industry, as more companies attempt to cut costs or excess programs. Meanwhile, the FDA kept up its rapid pace of drug approvals.

By Lisa LaMotta • Aug. 4, 2017

J&J set back by negative panel vote for sirukumab

Safety concerns led an advisory panel to recommend the FDA reject the IL-6 blocker.

By Ned Pagliarulo • Aug. 3, 2017

Imbruvica finds new use as GvHD drug

AbbVie and J&J's blood cancer medication got an FDA go-ahead as a treatment for chronic graft-versus-host disease.

By Lisa LaMotta • Aug. 2, 2017