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

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

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

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

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