Vical axes CMV vaccine and half its staff in bid to stay afloat

After a Phase 3 failure last month, Vical is scrambling to restructure, narrowing its focus to candidates for HSV-2 and fungal infection.

By Suzanne Elvidge • Feb. 1, 2018

Vertex looks to own CF market before shifting focus

The biotech revealed the two triple combo regimens it's taking into Phase 3 as it closes in on serving 90% of the cystic fibrosis market.

By Jacob Bell • Jan. 31, 2018

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

Patient death, clinical hold sink Bellicum shares

Three patients treated with the biotech's BPX-501 developed encephalopathy, causing the FDA to halt all U.S.-based trials of the drug.

By Jacob Bell • Jan. 31, 2018

FDA to decide on Mylan, Theravance's inhaled COPD drug by November

An approval later this year would add a new treatment to the increasingly competitive COPD space. 

By Suzanne Elvidge • Jan. 30, 2018

Sunovion Parkinson's drug scores in Phase 3

An under-the-tongue version of apomorphine significantly outperformed placebo, aiding Sunovion's bid to file the drug for approval this spring.

By Jacob Bell • Jan. 30, 2018

When real-world evidence becomes a real headache

After devoting considerable time and resources to find out how a product works in everyday life, drugmakers can be left with more questions than answers.

By Jacob Bell • Jan. 29, 2018

5 Drivers spurring use of real-world evidence

Healthcare shifts are driving drugmakers, payers and regulators alike toward greater use of data collected outside the randomized clinical trial setting. 

By Ned Pagliarulo • Jan. 29, 2018

Payers wade into real-world evidence, but tread lightly

Insurers and pharmacy benefit managers are wary about the quality of data underlying real-world evidence.

By David Lim • Jan. 29, 2018

Nordic biopharmas seek turn in spotlight

As the EMA prepares to move to Amsterdam, biotech companies in various parts of Europe hope to capitalize on the regulator's proximity. 

By Suzanne Elvidge • Jan. 26, 2018

AbbVie shares boom on rosy outlook

A much-reduced tax bill and stronger-than-expected hepatitis C sales led to what one analyst called a "jaw-dropping" bump in AbbVie's earnings forecast for 2018.

By Ned Pagliarulo • Jan. 26, 2018

New COPD data aid AstraZeneca in uphill battle with GSK

AstraZeneca's three-in-one inhaler beat out Symbicort and Bevespi, but whether the drug can stand against Trelegy Ellipta remains to be seen.

By Jacob Bell • Jan. 26, 2018

Prescribed Reading: Art of the deal, pharma dines with Trump

Just a few weeks into the year, M&A showed signs of life. Meanwhile, pharma execs schmoozed in Davos and Q4 earnings were all about the art of the deal. 

By Lisa LaMotta • Jan. 26, 2018

UK's biotech pipeline the strongest in Europe: report

Life science in the U.K. appears resilient despite political challenges, according to a new report from British trade group BIA.

By Suzanne Elvidge • Jan. 25, 2018

Amarin on track to report CV outcomes data

Positive results from the REDUCE-IT study could ramp up the target market for Amarin's prescription fish oil Vascepa.

By Meg Bryant • Jan. 24, 2018

FDA debuts paper on quality standards, aiming to decrease review times

The Office of Pharmaceutical Quality is aiming to give manufacturers clarity on standards, in line with other FDA initiatives to increase efficiency. 

By David Lim • Jan. 24, 2018

Novartis predicts growth pick-up on back of Cosentyx, Entresto

Incoming CEO Vas Narasimhan will soon step into the role, as the Swiss pharma looks to rebound from several years of declining operating profits.

By Ned Pagliarulo • Jan. 24, 2018

Teva's Cinqair fails to deliver in Phase 3 asthma studies

The failure is the latest setback for the embattled drugmaker, which is struggling with high debt and declining revenues.

By Meg Bryant • Jan. 23, 2018

Biotech CEOs: Working with CROs is challenging

Unlike their big pharma brethren, smaller biotechs don't always get preferential treatment. But most find ways to capitalize on those interactions. 

By Lisa LaMotta • Jan. 23, 2018

Astellas, Vical's CMV vaccine comes up short in Phase 3

Topline results from the late-stage trial showed the vaccine missed both its primary and second endpoints. 

By Ned Pagliarulo • Jan. 23, 2018

Opdivo-Yervoy combo 'encouraging' in colorectal cancer

New data from the Phase 2 CheckMate-142 trial points to clinical benefit in hard-to-treat colorectal cancer.

By Suzanne Elvidge • Jan. 22, 2018

Prescribed Reading: Murmurs of M&A, backlash over CRLs

Celgene may make another acquisition, while the FDA Commissioner gets his first negative marks for reneging on a promise. 

By Lisa LaMotta • Jan. 19, 2018

Exelixis details Phase 3 cabozantinib results

Full results showed the drug helped improve survival in previously treated liver cancer patients, but shares fell — likely on some safety worries.

By Ned Pagliarulo • Jan. 17, 2018

AveXis builds out SMA program with new studies

Although Biogen is the current leader in SMA, AveXis is hoping to create a stronger case for its lead candidate with three new trials.

By Jacob Bell • Jan. 17, 2018

Eiger plummets on blood pressure trial fail

The company is axing ubenimex in PAH after a miss in Phase 2.

By Suzanne Elvidge • Jan. 17, 2018

Keytruda aces another lung cancer study

Positive results for Merck in the first-line setting should ease worries about threats from competition.

By Lisa LaMotta • Jan. 16, 2018