New Brilinta data supports extending use beyond one year

AstraZeneca already projects strong sales for Brilinta, with forecasts of $1.3 billion by 2020 and $3.5 billion by 2023.

By Nicole Gray • Jan. 15, 2015

AbbVie's Humira/hep C plans, bluebird bio, NIH funding, and even more from JPM15

Everything you need to know from day 3 of the JP Morgan Healthcare Conference and the Biotech Showcase 2015—including some surprising news from AbbVie.

By Sy Mukherjee • Jan. 14, 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

Express Scripts, PCSK9s, Gilead, and Shire: More from JPM15 and BTS15

There was plenty of news Tuesday out of San Francisco. But Express Scripts' comments on drug pricing and Pfizer's PCSK9 pronouncements really had attendees talking.

By Sy Mukherjee • Jan. 13, 2015

BioMarin, Merck, and Sanofi: The biggest news so far from 'JPM15' and 'BTS15'

The biggest U.S. biopharma and healthcare conference of the year began on Monday in San Francisco, and companies like Merck are already making news at the event.

By Sy Mukherjee • Jan. 13, 2015

Biogen Idec's novel optical nerve repair therapy shows promise, but only some

The results did not reach statistical significance. Still, researchers are encouraged by the unprecedented biological repair in the CNS.

By Nicole Gray • Jan. 9, 2015

Study reveals no Gardasil-MS link

Despite anecdotes suggesting a link between the HPV vaccine and demyelinating diseases, a new JAMA study shows no correlation. 

By Nicole Gray • Jan. 8, 2015

Promising late-stage trial bodes well for Cempra's next-gen antibiotic

Cempra's oral solithromycin, a safer macrolide, met its main goal in a trial of community-acquired bacterial pneumonia (CAP) patients. 

By Sy Mukherjee • Jan. 5, 2015

Tekmira, Oxford University team up to test new investigational Ebola therapy

The International Severe Acute Respiratory and Emerging Infection Consortium (SARIC) is starting to conduct clinical studies of Tekmira's new Ebola drug—​TKM-Ebola-Guinea—with funding from Wellcome.

By Nicole Gray • Dec. 23, 2014

HHS's BARDA grants $30M Ebola vax development contract to NewLink

All of the clinical development, testing, and manufacturing of the rVSV-EBOV vaccine will be handled by BioProtection Systems—a subsidiary of NewLink.

By Nicole Gray • Dec. 23, 2014

GSK shingles vax shows major promise, could challenge Merck's Zostavax

GSK's phase III clinical trials have been going on for four long years. But the efforts are paying off in a big way.

By Nicole Gray • Dec. 19, 2014

Will this Pfizer orphan drug emerge as the Duchenne victor?

Pfizer, BioMarin, and Sarepta are all working on drugs to treat Duchenne muscular dystrophy (DMD), which overwhelmingly affects boys.

By Nicole Gray • Dec. 18, 2014

Abbott closes Veropharm deal amidst US-Russia political tension

Abbott has completed a deal to buy Veropharma from billionaire Roman Avdeev for $305 million, in spite of ongoing political tensions between the West and Russia.

By Nicole Gray • Dec. 15, 2014

Novartis psoriasis drug bests J&J's Stelara in head-to-head trial

After 16 weeks, patients treated with Cosentyx (secukinumab) achieved clear or almost clear skin

By Nicole Gray • Dec. 15, 2014

ICYMI: 3 charts that show why 2014 was a milestone year for US novel drug approvals

"What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening disease," said FDA Commissioner Maggie Hamburg.

By Sy Mukherjee • Dec. 12, 2014

Merck, NewLink Ebola vax trial suspended over joint pain complaints

4 participants out of 59 complained of joint pain in their hands and feet, prompting the University of Geneva Hospital to take temporary precautions.

By Sy Mukherjee • Dec. 11, 2014

Bluebird shares skyrocket on promising gene therapy-blood disorder data

Investors flocked to bluebird bio inc. after the company presented data at the American Society of Hematology showing a 100% cure rate of patients with beta-thalassemia.

By Nicole Gray • Dec. 10, 2014

Merck, BMS PD-1 drugs continue to roll, show promise for Hodgkin's lymphoma

Big news out of the American Society of Hematology meeting: Keytruda (pembrolizumab) and Opdivo (nivolumab) showed significant response in Hodgkin's patients. But one performed better than the other.

By Nicole Gray • Dec. 8, 2014

Why CRO employee turnover is still so high

In a global survey of public and private contract research organizations, HR+ Survey Solutions found that overall employee turnover is still high despite being slashed in recent years.

By Nicole Gray • Dec. 8, 2014

Promising Biogen Alzheimer's drug leapfrogs from phase I to phase III

In the last 15 years, more than 100 investigational Alzheimer's therapies have failed. Could Biogen Idec finally break through the AD development morass?

By Nicole Gray • Dec. 3, 2014

Puma Biotech plummets in after hours trading after delaying breast cancer NDA

Neratinib (PB272), Puma's investigational breast cancer drug for metastatic HER-2 positive breast cancer, has performed exceptionally well in phase III clinical trials.

By Nicole Gray • Dec. 3, 2014

The key to successful clinical trial recruitment? Patient empowerment

Researchers at the University of Sussex have produced a white paper linking patient empowerment and a streamlined recruitment process with clinical recruitment success.

By Nicole Gray • Dec. 1, 2014

Glaxo/NIH Ebola vaccine elicits immune response in human trials

GSK and the National Institute of Allergy and Infectious Diseases have been developing a preventive Ebola vaccine since September. The preliminary results are promising.

By Nicole Gray • Dec. 1, 2014

Trouble for J&J? Amgen/AZ plaque psoriasis drug bests Stelara in phase III

In a 12-week head-to-head trial, brodalumab, for the treatment of moderate-to-severe plaque psoriasis, outperformed both J&J's Stelara (ustekinumab) and placebo. 

By Nicole Gray • Nov. 26, 2014

A lead investigator reveals how Baxter's Hyqvia got its hard-won approval

When Hyqvia was denied FDA approval in 2012, Baxter's clinical research team took a step back and found a way forward. BioPharma Dive spoke to its lead investigator to learn more.

By Nicole Gray • Nov. 25, 2014

UK life sciences minister: Hospitals must aid in clinical trial process

George Freeman, like many other opinion leaders, believes the era of the blockbuster has come and gone. Up next: Making hospitals a key part of the drug-development ecosystem.

By Nicole Gray • Nov. 24, 2014