GW Pharma moves CEO to US to lay groundwork for cannabis-epilepsy med approval

Justin Gover is moving from London, where GW is headquartered, to Southern California. And the company's riding high off results from an epilepsy trial.

By Nicole Gray • May 20, 2015

Sanofi/Regeneron reports glowing phase 2b results for versatile asthma hopeful

Earlier this year, Sanofi EVP Pascale Witz told BioPharma Dive that dupilumab was one of the company's most exciting in-development products thanks to its potential in multiple, diverse therapeutic categories.

By Nicole Gray • May 20, 2015

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

Bluebird cuts deal with regulators, plots path to first-ever US gene therapy approval

The biotech's gene therapy LentiGlobin for beta-thalassemia will have an accelerated approval pathway in the U.S. and Europe. 

By Sy Mukherjee • May 19, 2015

Amgen boasts promising phase II results for migraine drug

But the candidate would enter a busy therapeutic field.

By Nicole Gray • May 18, 2015

Hotly anticipated AZ lung cancer combo effective, but side effects remain a problem

The British pharma giant will be unveiling full data during the American Society of Clinical Oncology (ASCO) conference at the end of May.

By Nicole Gray • May 15, 2015

A preview of the new lung cancer data Roche will debut at ASCO

At the end of this month, attendees of the major oncology conference will be able to learn more about trials involving the PD-L1 inhibitor MPDL3280A.

By Nicole Gray • May 15, 2015

UPDATE: Takeda threatens to break off Orexigen collab after Contrave data drama

Orexigen is defending itself after the Cleveland Clinic released trial results contradicting the firm's heart safety claims (without permission). But now it's facing even more hurdles surrounding its obesity med.

By Sy Mukherjee • May 13, 2015

How do you test an Ebola vaccine when almost no one has Ebola?

Liberia has been declared Ebola-free and there are only a handful of cases in Guinea and Sierra Leone.

By Nicole Gray • May 13, 2015

Study: Measles vax may protect against other infections

The protective effect can last for up to three years, according to researchers.

By Nicole Gray • May 8, 2015

Congress calls for gender equity in clinical trials

Proposed legislation also aims to ensure that drugs approved through an expedited approval pathway are safe and effective for women.

By Nicole Gray • May 7, 2015

7 questions you might have about biosimilarity, answered

We interviewed FDA and pharma vet David Rosen, who has been tracking the emergence of biosimilars in the U.S., for a Q&A on the evolving role of the products. 

By Nicole Gray • May 6, 2015

New report: Digoxin risky for certain patients

It's just one study. But it's troubling news for a pharmaceutical mainstay.

By Nicole Gray • May 6, 2015

UN: New Ebola cases fall to lowest level since mid-2014

But the virus is still not quite eradicated.

By Nicole Gray • May 6, 2015

Oklahoma gov OKs marijuana derivative for epilepsy clinical trial

Gov. Mary Fallin signed the law permitting the trial on Thursday.

By Nicole Gray • May 1, 2015

Merck antibiotic combo Zerbaxa shows efficacy in complicated infections

Zerbaxa is intended for use in treating complicated urinary tract infections and complicated intra-abdominal infections.

By Nicole Gray • April 30, 2015

Can the new FDA guidance on biosimilarity expedite development and approval?

New biosimilars guidance from the FDA may decrease existing barriers to entry for companies trying to break into the biosimilar market. Two analysts explain why.  

By Nicole Gray • April 30, 2015

Merck gains advantage over AZ, Takeda as top diabetes med determined heart safe

DPP-4 inhibitors have come under increased FDA scrutiny in recent months.

By Nicole Gray • April 29, 2015

Bristol-Myers, Gilead hep C combo shines in late-stage trial

The data is here, and it looks pretty good for BMS.

By Nicole Gray • April 28, 2015

3 key lessons industry leaders have learned from the latest Ebola crisis

Leaders from Merck, GlaxoSmithKline, J&J, Novavax, the FDA, and the NIH shared their thoughts on what we've learned about preparing for infectious epidemics like Ebola.

By Sy Mukherjee • April 28, 2015

Biogen ups the phase III ante on Alzheimer's breakthrough hopeful

The company is launching two large Alzheimer's disease (AD) studies focused on the effect of BIIB037 on early-stage AD patients later this year. 

By Nicole Gray • April 27, 2015

New study: Alcoholic hepatitis drugs not effective

Use of prednisolone and pentoxifylline did not significantly reduce death in patients with alcoholic hepatitis. 

By Nicole Gray • April 24, 2015

Merck, Gilead duke it out with next-gen hep-C combos

New hepatitis C therapies are now being judged on effectiveness in specific sub-populations and speed.

By Nicole Gray • April 24, 2015

What biopharma needs to know about CAR-T cancer therapies

Pharmaceutical companies, government agencies, and high profile advocacy groups are developing collaborative alliances to unlock the potent therapeutic potential of CAR-T.

By Nicole Gray • April 24, 2015

Small, early Novartis CAR-T trial shows promise in solid tumors

(Very) preliminary data from Novartis shows CAR-T's potential for treating solid tumors, with early signs of safety. But there are plenty of questions yet to be answered.

By Nicole Gray • April 21, 2015

Merck files Keytruda for lung cancer, drug bests Bristol-Myers' Yervoy in melanoma

The PD-1 cancer immunotherapy race is as hot as ever. But can BMS' Opdivo be beaten?

By Nicole Gray • April 20, 2015