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

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

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

Study: Common heartburn meds linked with kidney failure risk in elderly

Older patients who take proton pump inhibitors are twice as likely to be hospitalized for kidney failure, according to a new study. 

By Nicole Gray • April 17, 2015

Ibrance late-stage trial stopped early amid impressive results

Pfizer's advanced breast cancer drug has been proven effective in women with advanced breast cancer who had previously been treated with anti-estrogen drugs. 

By Nicole Gray • April 16, 2015

GW Pharma's cannabis-based epilepsy drug cuts seizure rates by 50%

Epidiolex is an oral drug made from cannabidiol, a non-psychoactive part of the marijuana plant.

By Nicole Gray • April 15, 2015

IBM joins forces with J&J, Medtronic, Apple in ambitious clinical research data pact

IBM's new Watson Health unit will use its supercomputer namesake to sift through millions of healthcare data points to give clinical researchers a boost.

By Sy Mukherjee • April 15, 2015

Roche's aggressive 2015 goal: 11 cancer immunotherapy drugs in late-stage trials

The cancer immunotherapy R&D race between Roche, Bristol-Myers, and AstraZeneca is heating up. 

By Nicole Gray • April 14, 2015

Ebola phase III studies underpopulated as epidemic wanes

With only 30 confirmed cases of Ebola reported in West Africa last week, vaccine trial investigators have too few study subjects. 

By Nicole Gray • April 13, 2015

Merck's HCV drug candiate gets another breakthrough therapy designation

Merck had lost a Breakthrough designation in the face of next-gen HCV drugs from Gilead and AbbVie.

By Nicole Gray • April 9, 2015

Report questions acetaminophen's efficacy in lower back, joint pain

Researchers found that acetaminophen is no better than placebo for back and joint pain and is associated with side effects and serious risks.

By Nicole Gray • April 9, 2015

Report: Viagra most effective ED treatment, but has more side effects

That's according to a new comparative scientific analysis of seven common erectile dysfunction (ED) treatments.

By Nicole Gray • April 8, 2015

Shire bullish on 2017 approval of new, longer-lasting ADHD pill

Approval of SHP465 could allow Shire to maintain dominance of the ADHD market for more than a decade. 

By Nicole Gray • April 7, 2015

Did Novartis try to sabotage Avastin ophthalmic trials?

Novartis and Roche manufacture Lucentis (ranibizumab) for wet AMD—a considerably more expensive treatment option than Avastin (bevacizumab).

By Nicole Gray • April 6, 2015

UK scientists push back against animal testing critics

The British Union for the Abolition of Vivisection wants to end all animal experiments.

By Nicole Gray • April 6, 2015

PETA hawks animal testing alternatives to CROs in San Diego

Animal rights' issues were part of the conversation at the Society of Toxicology meeting in San Diego last week.

By Nicole Gray • March 31, 2015

Guinea becomes focus of Merck Ebola vaccination study

A total of 10,000 at-risk residents will be vaccinated with VSV-EBOV. There will be no placebo arm.

By Nicole Gray • March 25, 2015

RA drug that caused 'elephant man' side effect gets another chance

Researchers have changed the dosing protocol for TGN1412.

By Nicole Gray • March 25, 2015