EU approves BMS's Daklinza for hep C combo therapy

Using Bristol-Myers Squibb's (BMS) Daklinza (daclastavir) in combination with Sovaldi on advanced HPV-C patients yielded up to a 100% cure rate in clinical trials.

By Nicole Gray • Aug. 28, 2014

GSK's Promacta scores FDA approval for rare bone marrow disorder

This is the second FDA approval GlaxoSmithKline (GSK) has received for Promacta (eltrombopag).

By Nicole Gray • Aug. 28, 2014

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

GSK's Ebola vaccine gets FDA go-ahead for phase I human trials

The trials could begin as early as next week. There are now eight companies working on Ebola treatments.

By Sy Mukherjee • Aug. 27, 2014

The biosimilars are coming: Why Basaglar and Zarzio are harbingers of a new pharma landscape

Biosimilars. Follow-on biologics. Subsequent-entry biologics. Call them what you want -- generic versions of branded biologics are a reality. But there's still work to be done on improving these products' approval pathway.

By Nicole Gray • Aug. 27, 2014

Pfizer, Merck team up to develop metastatic cancer immunotherapy

The two companies are exploring the therapeutic potential of Pfizer’s Xalkori (crizotinib) with Merck’s investigational P-1 antibody, pembrolizumab. 

By Nicole Gray • Aug. 27, 2014

Alexion vies to add another eculizumab indication with kidney graft trial

Up to 50% of deceased-donor kidney transplant cases are affected by delayed graft function (DGF), which prevents the kidneys from functioning properly.

By Nicole Gray • Aug. 27, 2014

Experts call for an end to alternative medicine clinical trials

David Gorski and Steven Novella refer to homeopathy, reiki, and traditional Chinese medicine as "pseudoscience" and say trials using them ill-serve patients and waste valuable research funding. 

By Nicole Gray • Aug. 25, 2014

Auxilium's CCH reduces cellulite in phase IIa trial

The injectable therapy left 68% of CCH-treated women either "satisfied" or "very satisfied."

By Nicole Gray • Aug. 25, 2014

Lilly's psoriasis drug scores big in phase III trials

The new monoclonal antibody, ixekizumab, met both primary and secondary endpoints in three separate phase III trials.

By Nicole Gray • Aug. 25, 2014

Migalastat generates positive phase III results in Fabry patients

Amicus Therapeutics’ focus on orphan drug development seems to be paying off with migalastat, which successfully helped normalize kidney function in patients with a rare lysosomal storage disorder. 

By Nicole Gray • Aug. 22, 2014

Illumina to provide personalized oncology diagnostics for big-pharma studies

AstraZeneca, Sanofi, and Johnson & Johnson will use Ilumina’s next-generation sequencing (NGS) platform to better understand the individualized genomics of study subjects. 

By Nicole Gray • Aug. 22, 2014

Amgen kidney drug for dialysis patients hits phase III targets again

Results from a second phase III trial show that AMG 416 reduces thyroid levels in kidney disease patients. 

By Nicole Gray • Aug. 20, 2014

US Justice Department stops investigation of AstraZeneca's Brilinta trial

DOJ says there is no evidence of wrongdoing associated with the PLATO study, which is evaluating the effect of Brilinta (ticagrelor) in more than 19,000 patients. 

By Nicole Gray • Aug. 19, 2014

Amgen's multiple myeloma drug fails in phase III single-drug study

Kyprolis (carflizomib) did not meet its primary endpoint -- overall survival -- in phase III. Amgen's stock dropped on Wednesday, but rebounded this morning after investors took other factors into consideration.

By Nicole Gray • Aug. 15, 2014

Black box warnings and drug market withdrawals, by the numbers

The rise of FDA-approved drug market withdrawals and black box warnings corresponds with faster approval times and a reliance on industry fees to fund the agency's budget.

By Sy Mukherjee • Aug. 15, 2014

AstraZeneca's severe asthma drug breezes into phase III trials

AZ presented strong mid-stage data at this year’s American Thoracic Society (ATS) meeting. 

By Nicole Gray • Aug. 14, 2014

Pfizer, 23andMe team up to study the genetics of bowel disease

The goal of this collaboration is to explore the underlying biology of inflammatory bowel disease (IBD) and ulcerative colitis (UC) by learning more about the genetic profiles of those living with the conditions.

By Nicole Gray • Aug. 14, 2014

Celltrion submits FDA filing for biosimilar Remicade

This South Korean company is making history by filing the first submission for a biosimilar monoclonal antibody using the FDA’s new biosimilar pathway. 

By Nicole Gray • Aug. 14, 2014

AstraZeneca drug routs gout in phase III trials

Lesinurad reduced serum uric acid (sUA) levels in gout patients, achieving primary endpoints in a phase III trial. 

By Nicole Gray • Aug. 13, 2014

UPDATED: WHO endorses experimental treatments for Ebola patients

"[I]n the special circumstances of this Ebola outbreak, it is ethical to offer unregistered interventions as potential treatments or prevention," said WHO assistant director general Marie-Paule Kieny.

By Sy Mukherjee • Aug. 12, 2014

Intercept Pharma's shares fly high on positive liver drug results

Shares were up as much as 65% as the market closed on Monday.

By Nicole Gray • Aug. 12, 2014

All gone for now: Ebola drug ZMapp supply exhausted

Mapp Biopharmaceutical says it is out of its much-sought experimental Ebola treatment, ZMapp, after sending doses to West African countries afflicted by the epidemic.

By Sy Mukherjee • Aug. 12, 2014

Astellas, Cancer Research Technology team up for pancreatic cancer research

Cancer Research Technology (CRT) is the commercial arm of Cancer Research UK. Research will be conducted in the UK.

By Nicole Gray • Aug. 11, 2014

WHO panel to debate ZMapp, ethics of experimental Ebola treatments

The World Health Organization (WHO) is convening a panel on Monday to discuss the ethical issues surrounding administering largely untested experimental treatments during public health emergencies. 

By Sy Mukherjee • Aug. 11, 2014

GSK eases expectations on Ebola vaccine: 'Long, complex process'

GlaxoSmithKline has been developing an early-stage Ebola vaccine with the National Institutes for Health (NIH) -- but don't expect approval anytime soon, the pharma giant warns.

By Sy Mukherjee • Aug. 11, 2014