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

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

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

Lilly's long-acting insulin not ready for prime time

Despite positive phase 3 data on peglispro, the company's long-acting insulin-in-development, evidence of liver toxicity will delay FDA review at least two years—and potentially forever.

By Nicole Gray • Feb. 24, 2015

Biotech battle: Regeneron's Eylea bests Genenetch's Lucentis in head-to-head

In a head-to-head diabetic macular edema study, Eylea improved vision more than both Lucentis and Avastin.

By Nicole Gray • Feb. 19, 2015

EMA defends data black-out policy for AbbVie's Humira

Transparency experts are fuming over the European Medicine Agency's decision to omit certain data from a Humira Clinical Study Report (CSR).

By Nicole Gray • Feb. 12, 2015

Former MN gov demands more trial transparency at UMN in wake of '04 suicide

Former Gov. Arne Carlson also called for additional details about the death of a University of Minnesota study subject in 2004.

By Nicole Gray • Feb. 11, 2015

New research: Could Novartis CVD game-changer increase dementia risk?

French researchers have raised concerns that an investigational heart failure drug from Novartis could increase the risk of dementia.

By Nicole Gray • Feb. 10, 2015

A faster cure? Achillion med mixed with Sovaldi clears hep C in just 6 weeks

Achillion's ACH-3102 (in combination with Sovaldi) is even more impressive than Harvoni in mid-stage trials.

By Sy Mukherjee • Feb. 9, 2015

Promising Roche Parkinson's med causes lung toxicity in monkey trials

For the last 10 years, researchers have pinned their hopes on LRRK2 inhibitors as a possible breakthrough for treating some Parkinson's patients. That effort just took a serious blow. 

By Nicole Gray • Feb. 5, 2015

US to launch large-scale universal flu shot testing in 2016

After news that this year's flu vaccine is only 23% effective, researchers have ratcheted up development efforts of a universal flu vaccine.

By Nicole Gray • Feb. 4, 2015

Chimerix shifts from Ebola focus to adenoviruses, CMV as outbreak wanes

As the Ebola outbreak in West Africa wanes, Chimerix is withdrawing as a participant in Ebola-focused clinical trials in West Africa. 

By Nicole Gray • Feb. 3, 2015

Roche's Tamiflu vindicated in new analysis of data

Roche's Tamiflu has been found to be effective at cutting flu symptoms by one day and helping some patients avoid hospitalization, according to an article published in the Lancet last week. 

By Nicole Gray • Feb. 2, 2015

Study: Parkinson's patients' response doubles with 'expensive' placebo

Patients told they were receiving a $1500 injection experienced two-fold improvement in motor function compared with patients who were told they were receiving a $100 injection. 

By Nicole Gray • Jan. 29, 2015

4 things you need to know about the sweeping FDA reform bill Congress just proposed

The 21st Century Cures initiative has bipartisan support. And it could be the biggest U.S. healthcare shakeup since Obamacare, transforming core elements of the regulatory and clinical trials pathway.

By Sy Mukherjee • Jan. 28, 2015

NIH to launch Down syndrome research portal

Reams of de-identified personal data of individuals with Down syndrome will provide researchers and life science professionals more data to gain insight into the condition.

By Nicole Gray • Jan. 28, 2015

EMA suspending almost 50 drugs over flawed CRO clinical studies

The FDA has yet to take action on the issue, which involves serial data manipulation by an India-based CRO.

By Nicole Gray • Jan. 26, 2015

Regulators get creative on Ebola vaccine testing as infections decline

Ebola infection rates have been declining recently, making it harder for vaccine developers to recruit for clinical trials.

By Nicole Gray • Jan. 23, 2015

The M.D. perspective: Who stands to benefit from clinical trial transparency?

The stakes are high for clinical trial data availability and transparency—and not just for biomedical researchers. A practicing physician explains why having all the data matters so much.

By Nicole Gray • Jan. 22, 2015

4 key industry trends that will impact biopharma in 2015

From increasing industry consolidation and collaboration to all-out marketing wars, here are the four trends that will matter most to the industry in the coming months and years.

By Sy Mukherjee • Jan. 19, 2015

Blast from the past: Roche's dalcetrapib, HDL-raising meds could work for some patients

After being consigned to the pharmaceutical R&D dustbin in late 2012, Roche's cholesterol treatment, dalcetrapib may be resuscitated as researchers found data indicating that it may work in a subset of patients.

By Nicole Gray • Jan. 15, 2015

Sarepta fights back, Sanofi/BI partner, and more from the last day of JPM15

On the final day of this year's JP Morgan Healthcare Conference, Sarepta struck back at BioMarin, whose CEO had called out the former company over its Duchenne drug in no uncertain terms on Monday.

By Sy Mukherjee • Jan. 15, 2015

Johnson & Johnson to release trial data

The data transparency movement has scored an important victory. 

By Nicole Gray • Jan. 15, 2015