Disappointment for Incyte as phase 3 failure prompts halt on Jakafi solid tumor trials

The company had hoped to expand the blood cancer med's indication to spur future growth. 

By Ned Pagliarulo • Feb. 12, 2016

Obama budget's $825 million NIH boost could hit big snags over funding structure

The president's FY2017 budget increases NIH funding to $33.1 billion, a 2.6% increase over 2016, and more or less keeps the FDA budget flat. But some advocacy groups and lawmakers are wary of its reliance on mandatory funding. 

By Sy Mukherjee • Feb. 10, 2016

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

BIO CEO 2016: What it will take to achieve Cancer MoonShot 2020

Experts from Bristol-Myers Squibb, Friends of Cancer Research, and others discussed the promise and the perils surrounding the ambitious effort and the development of next-gen cancer meds during a panel at the BIO CEO & Investor Conference in New York.

By Nicole Gray • Feb. 10, 2016

Update: After patient deaths, FDA puts CTI BioPharma's myelofibrosis on full clinical hold

The phase 3 myelofibrosis therapy pacritinib has been issued a full clinical hold after regulators found that patients in the study's drug arm were starting to die at higher rates compared to the placebo group. 

By Sy Mukherjee • Feb. 8, 2016

An Indian biotech is already developing two Zika vaccine candidates

Bharat Biotech claims it likely is the first company to file for a global patent for a Zika vaccine candidate. 

By Ned Pagliarulo • Feb. 8, 2016

Statisticians question methods used in deadly Bial study

The phase I study led to one patient death and a number of hospitalizations. 

By Nicole Gray • Feb. 4, 2016

UK to funnel $160 million into clinical research infrastructure

The funding will be spread over five years, between 2017 and 2022, for renewing investment in clinical research facilities after the current funding expires in March 2017.

By Ned Pagliarulo • Feb. 4, 2016

New study: Pfizer's Chantix no more effective than nicotine patches

The findings could be bad news for Pfizer, which has seen Chantix sales fall since 2008. 

By Nicole Gray • Feb. 3, 2016

Insulin wars heat up as Novo's Tresiba bests Lantus in major safety outcomes trial

Tresiba's safety data has the potential to shake up the long-lasting insulin market, especially with Lilly and Boehringer Ingelheim's copycat Basaglar now approved in the U.S. 

By Nicole Gray • Feb. 2, 2016

21st Century Cures progress may be hitting a partisan buzzsaw

Could a split in priorities derail the legislation, which once seemed destined for easy passage?

By Nicole Gray • Feb. 2, 2016

Obama seeks $755M for Cancer MoonShot, boosts to NIH & FDA

Next week's budget proposal from President Obama to Congress includes $195 million earmarked for the National Institutes of Health (NIH), along with funding for a new "virtual" cancer center for the FDA.

By Nicole Gray • Feb. 2, 2016

UK scientists win regulatory clearance to edit human embryo genes in CRISPR-Cas9 milestone

This is the first time that a national regulatory board has officially sanctioned the editing of genes in human embryos. The research will focus on the earliest stages of human development.

By Sy Mukherjee • Feb. 1, 2016

How the brain disease model of addiction drives innovation in drug development

We spoke with Dr. Tom McLellan, co-founder and board chair of the Treatment Research Institute and a contributor to this week’s issue of NEJM, about whether abuse-deterrent opioids work. 

By Nicole Gray • Jan. 29, 2016

Looking ahead at Lilly's 2016 prospects after a challenging 2015

Lilly's revenues and profits barely grew in 2015 as some of its older drugs faltered. While the company's pipeline took some major hits, renewed investment in oncology and diabetes may spur a better year ahead. 

By Ned Pagliarulo • Jan. 29, 2016

Top NCI scientist: 'Autologous' cell approach of firms like Kite, Juno will be main CAR-T focus

Dr. James Kochenderfer, a top scientist at the National Cancer Institute, thinks that the main trend of CAR-T going forward will be autologous T-cells thanks to a reduced chance of host rejection. 

By Nicole Gray • Jan. 28, 2016

NEJM editor Drazen hit with big backlash over 'research parasites' comments

Members of the research community took offense at the use of the term in an editorial co-written by Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine (NEJM). 

By Nicole Gray • Jan. 26, 2016

Akashi suspends Duchenne trial in another blow to treatment hopes

The firm suspended the Phase 1b/2a trial after a patient experienced "serious, life-threatening health issues." 

By Ned Pagliarulo • Jan. 26, 2016

The biggest implications of ICJME's new clinical trial data sharing proposal

Assuming that the International Committee of Medical Journal Editors guidelines are implemented, failure to submit a data-sharing plan will prevent authors from publishing in the New England Journal of Medicine and other top-tier research publications.

By Nicole Gray • Jan. 25, 2016

Researchers probing links between Down syndrome and Alzheimer's

More than 75% of people with Down syndrome aged 65 or older have Alzheimer's disease. 

By Nicole Gray • Jan. 25, 2016

Alkermes' depression drug flunks phase 3, shares nearly sliced in half

The drug, ALKS-5461, failed to reach primary endpoints in two of three phase 3 clinical trials.

By Nicole Gray • Jan. 21, 2016

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

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