Drug firms like J&J cautious on FAAH inhibitors in wake of trial death in France

On January 15, six patients who were being tested with Bial's developmental FAAH inhibitor were seriously harmed, one of whom later died. Janssen subsequently suspended its own (separate) FAAH trial.

By Nicole Gray • Jan. 21, 2016

After patient deaths, new Zafgen obesity med data revives approval hopes

Beloranib, for the treatment of obesity tied to compulsive overeating in Prader-Willi syndrome patients, has faced major stumbling blocks in its quest for approval, including a complete FDA clinical hold on testing.

By Sy Mukherjee • Jan. 21, 2016

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Biden pushes Cancer MoonShot to corporate leaders in Davos, pitches faster approvals

Vice President Joe Biden focused on how to expedite the drug approval process for promising cancer drug combinations. 

By Nicole Gray • Jan. 21, 2016

Nivalis grabs a key orphan designation for its cystic fibrosis drug

The firm recently began a phase II trial to evaluate the drug in combination with Vertex's Orkambi. 

By Nicole Gray • Jan. 20, 2016

Gavi commits $5 million in advance for Merck's Ebola vaccine

The global government and NGO vaccines alliance signed the advance purchase committment based on an understanding that Merck will submit its in-development vaccine for regulatory approval in 2017. 

By Ned Pagliarulo • Jan. 20, 2016

Eleven Bio shares fall off a cliff as ophthalmic drug fails second phase 3 trial

With another failure for its lead candidate drug, Eleven Bio is in a precarious financial position. 

By Nicole Gray • Jan. 19, 2016

CORRECTED: French drug trial suspended after participant left brain dead, five others critically ill

Six people, including the one declared brain dead, were hospitalized after participating in a clinical trial in France. 

By Ned Pagliarulo • Jan. 15, 2016

ASCO: Reform the 'clinical pathways' approach to cancer

The American Society for Clinical Oncology (ASCO) this week released new policy recommending the 'clinical pathways' approach be made more transparent and consistent. 

By Nicole Gray • Jan. 14, 2016

Cancer MoonShot 2020: Independence Blue Cross to cover genome sequencing costs

Billionaire biotech entrepreneur Patrick Soon-Shiong says that he and other collaborators will try to get more insurers on board to cover the costs associated with genomic sequencing for cancer patients.

By Nicole Gray • Jan. 13, 2016

Study: PPIs for heartburn linked to increased risk of kidney disease

That includes proton pump inhibitors such as Prilosec, Prevacid, and Zegerid.

By Nicole Gray • Jan. 12, 2016

Biotech Moderna partners with CRO to advance promising RNA therapies into trials

Since 2012, Moderna has raised $1 billion in venture funding for messenger RNA therapies. However, it has not yet tested any candidates in clinical trials. 

By Nicole Gray • Jan. 11, 2016

Positive hemophilia B gene-therapy results boost UniQure stock

UniQure's AMT-060 therapy for treatment of hemophilia B induced a positive response in treated patients.

By Nicole Gray • Jan. 8, 2016

Could an old Roche arthritis med become a pioneering PAH treatment?

The UK government wants to find out if tocilizumab has potential in treating pulmonary arterial hypertension, a deadly progressive disease. 

By Sy Mukherjee • Jan. 7, 2016

Gilead grabs priority review for pangenotype hep C combo; Hep B med shown to be safe

The combo, which includes the megablockbuster Sovaldi, won priority review just as the biotech announced its experimental hep B drug was proven as effective and safer than its current med. 

By Ned Pagliarulo • Jan. 6, 2016

Teva's MS hopeful takes another big hit in phase 3

But despite new dosing problems in a phase 3 trial, Teva plans on continuing work on laquinimod. 

By Nicole Gray • Jan. 4, 2016

The year ahead: 11 execs & experts predict what's in store for biopharma in 2016

With a record-setting year behind us, we can only imagine what’s ahead for the industry in the coming months. Fortunately, industry execs and experts from Sanofi, Boehringer, Bain, amfAR, Novocure, and others shared some of their own predictions with BioPharma Dive.

By Nicole Gray • Jan. 4, 2016

Bionor Pharma's 'kick and kill' HIV therapy shows promise

Bionor's therapy reduced the size of the latent HIV reservoir by an average of 40% across 17 patients. 

By Nicole Gray • Dec. 23, 2015

11 biopharma execs & experts look back on 2015: A record year for record-breaking

We spoke with bigwigs from Sanofi, the Biosimilars Council, Novocure, Accenture, Bain, amfAR, Boehringer Ingelheim, and more on what they considered the most significant events that drove biopharma this past year.

By Nicole Gray • Dec. 22, 2015

UC Davis & Moffitt Cancer Center suspend KaloBios cancer trial after Shkreli debacle

Even through Martin Shkreli has been ousted as the biotech's CEO, the Moffitt Center wants no part in the clinical study. 

By Nicole Gray • Dec. 22, 2015

AstraZeneca's hopes for major cancer hopeful durvalumab dim

The firm's projected peak sales of $6.5 billion for the candidate now seem like they may be too optimistic.

By Nicole Gray • Dec. 21, 2015

UPDATED: House passes $1.1T spending bill with NIH boost, pediatric review voucher extension

The vote was 316 to 113.

By Sy Mukherjee • Dec. 18, 2015

Narcan is just the beginning: Unleashing the power of opioid antagonism

We spoke with Roger Crystal, CEO of Lightlake Therapeutics, about new ways to use old drugs to address opioid overdose and other addiction-related disorders.  

By Nicole Gray • Dec. 18, 2015

With eye on the future, AstraZeneca to beef up manufacturing, R&D presence in China

Investing directly in manufacturing and R&D capabilities in the country is seen as critical for future drug approvals in the market. 

By Nicole Gray • Dec. 17, 2015

Glaxo's IL-6 antibody shows promise in rheumatoid arthritis

GlaxoSmithKline is co-developing sirukumab with Janssen, with plans for a 2016 filing. 

By Nicole Gray • Dec. 17, 2015

Advaxis soars as FDA releases patient death-related clinical hold on its drugs

Shares have flown more than 55% since Tuesday afternoon.

By Nicole Gray • Dec. 17, 2015