FDA halts Advaxis immuno-oncology trials after patient death

A woman with cervical cancer died during a clincal trial involving axalimogene, stoking fears that the drug was involved. The company says it wasn't.

By Nicole Gray • Oct. 8, 2015

Study: Merck hep C combo effective in kidney disease patients

Although Merck will most likely be third to market with its next-generation HCV drug, it's aiming to democratize treatment options even further.

By Nicole Gray • Oct. 7, 2015

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Roche looks to Cotellic melanoma combo to boost Zelboraf sales

Cotellic (cobimentinib) combined with Zelboraf (vemuratenib) improved outcomes in melanoma patients compared with Zelboraf alone.

By Nicole Gray • Oct. 7, 2015

Spark inches closer to a pioneering US gene therapy approval

Recent results from a pivotal trial evaluating SPK-RPE65 therapy in patients with inherited night blindness were encouraging, sending the biotech's shares flying Monday. 

By Nicole Gray • Oct. 6, 2015

Amicus delays regulatory submission for Fabry drug

When Amicus announced that it would delay submission of Galafold (migalastat), the stock fell by 53% and lost $760 million in market value. It's rebounded 11% in early trading Monday.

By Nicole Gray • Oct. 5, 2015

Where are the women in HIV drug trials?

Women represent only 11% of the participants in HIV-related clinical trials, although they comprise half the global population of those who are HIV-infected.

By Nicole Gray • Oct. 5, 2015

WHO pushes for far more aggressive worldwide use of HIV meds

The agency says that anyone with an HIV diagnosis should start anti-retroviral therapy (ART) immediately.

By Nicole Gray • Oct. 1, 2015

10 top trends driving the biopharma industry today

From pricing controversies to the continued deluge of M&As, to put-up-or-shut-up moments for hotly anticipated drug candidates, here are 10 of the most important industry trends that biopharma professionals need to understand.

By Sy Mukherjee • Oct. 1, 2015

Sanofi hopes to broaden diabetes portfolio as FDA accepts lixisenatide submission

The investigational therapy is in the same class as Novo's Victoza and Lilly's Trulicity.

By Nicole Gray • Sept. 30, 2015

Can Lilly & Incyte elbow their way into a crowded market with promising RA drug?

Baricitinib is an oral JAK inhibitor intended for the treatment of rheumatoid arthritis (RA). 

By Nicole Gray • Sept. 30, 2015

Pioneering Novavax RSV vaccine passes protection to newborns, wins $89M from Gates Foundation

Mid-stage trial data on third-trimester pregnant women showed the vaccine protected infants, without any negative effects on the mothers. 

By Nicole Gray • Sept. 30, 2015

Aiming to cure blindness, UK team implants embryonic retinal cells in AMD patient

This regenerative surgery was carried out by Professor Lyndon Da Cruz at Mooresfield Eye Hospital, and was funded by Pfizer. 

By Nicole Gray • Sept. 30, 2015

Another kidney cancer hopeful: Exelixis med reduces tumor progression, death risk

Bristol-Myers' Opdivo wasn't the only cancer drug making news at the European Cancer Congress.

By Sy Mukherjee • Sept. 29, 2015

Arrowhead hep B treatment shows early promise, sends shares flying

Although the stock came back down by the end of Thursday, it's up about 5% in early Friday trading.

By Nicole Gray • Sept. 25, 2015

Amgen-Allergan's Avastin biosimilar shows promise in lung cancer trials

If the results hold, this could be a huge deal for U.S. biosimilars—and a major test for their savings prowess.

By Nicole Gray • Sept. 24, 2015

How the FDA is trying to demystify clinical trial data

The Safety Graphics Working Group has created a publicly available, web-based database of graphical designs for reporting clinical trial data. 

By Nicole Gray • Sept. 24, 2015

After Harvoni: A pangenotype hep C combo could be Gilead's next breakthrough

In three phase 3 trials, Sovaldi combined with velpatasvir provided a durable cure in 98% of patients 12 weeks after therapy.

By Nicole Gray • Sept. 22, 2015

Merck's antibody-in-development reduces risk of C. difficile re-infection

In pivotal studies, bezlotoxumab reduced the risk of Clostridium difficile (C. difficile) recurrence from 25% to 15% in infected patients. 

By Nicole Gray • Sept. 21, 2015

Lilly/BI's Jardiance found to be first diabetes med to cut CV deaths in study

CV death risk plunged nearly 40% with Jardiance, according to the study.

By Nicole Gray • Sept. 21, 2015

Aerie Pharma's glaucoma eye drop shows promise in late-stage trial

In a phase 3 study, Rhopressa demonstrated non-inferiority to timolol. 

By Nicole Gray • Sept. 17, 2015

Merck's once-weekly diabetes med as effective as daily Januvia in study

If the results hold steady in trials, Merck could have a diabetes med with a major convenience factor on its hands. 

By Nicole Gray • Sept. 17, 2015

Intra-Cellular shares fly as schizophrenia drug shown effective at higher doses

The company's stock is up nearly another 8% in Thursday morning trading after surging on Wednesday.

By Nicole Gray • Sept. 16, 2015

Xenoport shares dive as psoriasis drug shows serious GI side effects

22% to 40% of patients treated with the drug experienced diarrhea, compared with 15% of placebo-treated patients. 

By Nicole Gray • Sept. 16, 2015

The next hope for GW Pharma's cannabis med: Schizophrenia treatment

In mid-stage trials, GW's drug cannabidiol was superior to placebo for treatment of schizophrenia in patients who were non-responsive to antipsychotics.

By Nicole Gray • Sept. 16, 2015

2 new studies show Gilead's Truvada extremely effective for HIV prevention

According to data used by Gilead to obtain the drug's indication, PrEP prevents HIV infection in 92% of at-risk individuals who take it. Now there is new data confirming those findings. 

By Nicole Gray • Sept. 14, 2015