FDA lifts clinical hold on Mersana study, but shares slide

Mersana will soon restart the paused trial of a cancer candidate with modified dosing and tweaked protocols. Markets, though, didn't seem all that relieved.

By Suzanne Elvidge • Sept. 18, 2018

More data bolster AstraZeneca's 3-in-1 inhaler as other assets face setbacks

After clinical misses from Fasenra and Bevespi Aerosphere, AstraZeneca is hoping PT010 could give it another product to play with in the COPD market.

By Jacob Bell • Sept. 17, 2018

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

Pfizer showcases JAK pipeline with mid-stage results

The pharma will advance its JAK3 inhibitor in alopecia areata, while focusing its TYK2/JAK1 blocker on psoriasis, Crohn's and ulcerative colitis.

By Suzanne Elvidge • Sept. 17, 2018

UK accelerator secures cell and gene therapy production licenses

Autolus, Cell Medica, Adaptimmune and Freeline are some of the companies already working with the accelerator.

By Suzanne Elvidge • Sept. 13, 2018

Bristol-Myers' psoriasis drug proves itself in mid-stage study

Known for its prowess in cancer, the pharma trails rivals in developing new drugs for inflammation-related conditions.

By Ned Pagliarulo • Sept. 12, 2018

Vital Therapies plunges on liver treatment failure

Shares of the San Diego biotech plummeted 90% as its only product candidate flopped in a pivotal trial, leaving the company in a precarious position.

By Andrew Dunn • Sept. 12, 2018

Bavencio combo shows benefits in kidney cancer

Pfizer and Merck KGaA are playing catch up with Bavencio as the rest of the checkpoint inhibitor market charges ahead.

By Suzanne Elvidge • Sept. 12, 2018

FINCH-2 data bodes well for Gilead, Galapagos JAK inhibitor

The rheumatoid arthritis study showed no patients taking filgotinib experienced deep venous thrombosis, a key concern leading up to the data readout.

By Jacob Bell • Updated Sept. 12, 2018

Merck's pneumonia antibiotic stacks up in pivotal study

Dubbed ASPECT-NP, the study showed Zerbaxa was non-inferior to meropenem in treating two kinds of bacterial pneumonia.

By Jacob Bell • Sept. 11, 2018

GSK touts Nucala data after COPD miss

After last week's bruising slate of news, GSK was quick to highlight research showing a competitive edge for its lung drug in severe asthma.

By Suzanne Elvidge • Sept. 11, 2018

GSK's pitch for Nucala in COPD turned down by FDA

The Complete Response Letter GSK received Friday isn't entirely unexpected: An FDA advisory panel last month found the lung drug's data in COPD lacking.

By Ned Pagliarulo • Sept. 7, 2018

Gilead, Galapagos build case for JAK inhibitor with Phase 2 win

Though filgotinib offers significant benefits to patients with ankylosing​ spondylitis, the drug's real test seems to be whether it can compete in the rheumatoid arthritis market.

By Jacob Bell • Sept. 6, 2018

Sangamo pitches gene therapy progress, yet investors stay skeptical

The biotech's zinc finger gene therapy showed signs of efficacy in two patients with Hunter syndrome. Other findings, though, raised questions.

By Ned Pagliarulo • Sept. 5, 2018

With 12 more patients dosed, Bluebird reinforces strong profile for Lenti-D

Updated data from the STARBEAM trial underscored the gene therapy's efficacy and safety, positioning it well for a 2019 approval filing.

By Jacob Bell • Sept. 5, 2018

AstraZeneca's lupus drug fails in pivotal trial

The British drugmaker's candidate, once considered a potential blockbuster, failed to meet its primary endpoint.

By Andrew Dunn • Aug. 31, 2018

Pfizer shutters DMD program following failed study

The decision means a Phase 2 trial and an open-label extension study will be shut down.

By Jacob Bell • Aug. 30, 2018

Alnylam's Onpattro cleared in Europe as ICER sets pricing battle

Regulators OK'd the first RNA interference therapy in Europe, but a new report finds the list price between 967% and 1,821% above value thresholds.

By Andrew Dunn • Aug. 30, 2018

MassBio: Massachusetts dominates IPO market, VC funding in 2017

While other states and cities have tried to make their mark in biotech, industry activity remains concentrated in Boston and California. 

By Andrew Dunn • Aug. 29, 2018

FDA approves Tetraphase's antibiotic Xerava

The company hopes to commercially launch the antibiotic this fall, targeting a list price between $175 and $250.

By Andrew Dunn • Aug. 28, 2018

Xarelto falls short in two large Phase 3 studies

The disappointing results could weigh on J&J and Bayer's plans to expand use of the anticoagulant drug.

By Barbara Boughton • Aug. 27, 2018

Eisai's weight-loss drug proves safe, but delivers no heart benefit

While the results mark a cardiovascular milestone for Belviq, they may not do much to move the needle for the drug's diminished commercial prospects.

By Andrew Dunn • Aug. 27, 2018

Pfizer's tafamidis cuts risk of death in rare disease study

Patients with a heart condition caused by deposits of misfolded protein were 30% less likely to die than those given placebo, results showed.

By Ned Pagliarulo • Aug. 27, 2018

Esperion clears another milestone in bet on cholesterol pill

Still to come are results from a fifth Phase 3 study that the biotech hopes will definitely answer safety worries raised earlier this year.

By Ned Pagliarulo • Aug. 27, 2018

FDA cautions drugmakers on using placebos in cancer drug studies

Draft guidance from the agency reinforces the practice of measuring experimental cancer drugs against active controls.

By Barbara Boughton • Aug. 24, 2018

Novartis' trial success revives PI3K potential in breast cancer

Alpelisib improved progression-free survival in certain advanced breast cancer patients, burnishing the clinical profile of the experimental PI3K inhibitor. 

By Ned Pagliarulo • Aug. 23, 2018