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

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

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

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