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

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

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

U of Minnesota called out for clinical trial practices—again

The university claims that its clinical trial conduct is consistent with the highest ethical standards. But a new report suggests otherwise. 

By Nicole Gray • March 24, 2015

Here comes the blockbuster: Novartis' Cosentyx bests Stelara in psoriasis trials

Since the drug's approval in January, Novartis has been racking up positive clinical trial data for Cosentyx, showing superiority to both Amgen's Enbrel and now J&J's Stelara.

By Nicole Gray • March 23, 2015

Biogen soars as Alzheimer's drug data shows sharp slowdown in cognitive decline

BIIB037 has high expectations as a potential Alzheimer's breakthrough. On Friday, Biogen revealed more data supporting the drug's case.

By Sy Mukherjee • March 20, 2015

9 important things to know about PCSK9 cholesterol drugs

From the democratic nature of their trials to ease of use, PCSK9 drugs are a fascinating advancement for pharma.

By Nicole Gray • March 20, 2015

Glaxo's combo respiratory drug deemed safe by FDA staff

Amid concerns about vilanterol-related asthma deaths, Breo Ellipta, which contains a corticosteroid and vilanterol, was extensively tested.

By Nicole Gray • March 18, 2015

FDA panel: Pharmacyclics' Imbruvica cancer data strong enough to unblind

Combo treatment with Imbruvica (ibrutinib) and two other drugs showed promise in previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia.

By Nicole Gray • March 17, 2015

Could Biogen's Alzheimer's therapy become a breakthrough?

The company's stock has risen about 30% in less than three months, driven in part by early encouraging data. 

By Nicole Gray • March 17, 2015

Study: AZ's Brilinta shows promise, but comes with risks

Some experts believe the benefits of the drug will outweigh the risk of bleeding. 

By Nicole Gray • March 16, 2015

Amgen, Sanofi PCSK9 drugs shown to cut CVD risk in half

Some impressive data from a class of drugs expected to rake in billions. But researchers warn that some efficacy questions still linger.

By Sy Mukherjee • March 16, 2015

Neuralstem shares tank on discouraging ALS stem cell therapy data

In a phase II clinical trial, only 47% of patients treated with Neuralstem's surgical stem-cell therapy responded to therapy at all.

By Nicole Gray • March 13, 2015

Is that clinical trial doc getting pharma money? Patients want to know

87% of MS patients who had never participated in a clinical trial believed that a doctor should disclose any payments from biopharma sponsors.

By Nicole Gray • March 10, 2015

Vanda's atopic dermatitis drug fall flat in mid-stage trial

But Vanda plans to add more studies.

By Nicole Gray • March 6, 2015

Could Sangamo's gene therapy 'cure' HIV?

Sangamo Biosciences is initiating a clinical study in humans to test a gene therapy technique that has some observers particularly excited.

By Nicole Gray • March 4, 2015

Orexigen shoots itself in foot with early disclosure of positive Contrave heart data

Disclosure of interim evidence that Contrave (naltrexone) may prevent heart attacks (instead of causing them) should be a good thing. But Orexigen broke FDA rules and Data Monitoring Committee protocol. 

By Nicole Gray • March 4, 2015

Positive phase II Provenge data a good early sign for ambitious Valeant

Valeant just cleared its deal with Provenge manufacturer Dendreon and is already touting the phase II data.

By Nicole Gray • Feb. 27, 2015