Aquinox scraps bladder pain drug after Phase 3 failure

Shares plummeted nearly 85% after the biotech's only clinical candidate crashed out of late-stage testing.

By Suzanne Elvidge • June 28, 2018

Summit turns from DMD after trial miss

The biotech will discontinue development of ezutromid and switch gears to antibiotics. 

By Lisa LaMotta • June 27, 2018

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

Global Blood bets sickle cell drug success will convince FDA

Following initial positive Phase 3 results for voxelotor, the biotech hopes to submit the drug for an accelerated approval.

By Ned Pagliarulo • June 27, 2018

FDA to pub surrogate endpoints used in cancer drug approvals

It's part of a broader effort to reassess how the agency evaluates treatment benefit amid rapid clinical advances. But the approach is not without critics.

By Ned Pagliarulo • Updated June 26, 2018

Jardiance shows potential in type 1 diabetes, clearing Phase 3 tests

Already approved for the more common type 2 diabetes, the drug has become an important asset for Lilly and Boehringer.

By Ned Pagliarulo • June 26, 2018

Immunotherapy advances spur new look at cancer vaccines

Researchers have long been intrigued by the idea of a cancer vaccine, drawn in by hints of an immune role in cases of "spontaneous" remissions to cancer.  Now, the immunotherapy boom is opening up new areas of research.

By Ned Pagliarulo • June 25, 2018

Merrimack pancreatic drug fails, development halted

The oncology company, which saw its shares lose a third of their value Monday, is shifting focus to two earlier-stage assets, as well as its pre-clinical portfolio.

By Lisa LaMotta • June 25, 2018

Roche aims for first-mover edge in small cell lung cancer

A late-stage trial win from a Tecentriq and chemotherapy pairing could put the Swiss pharma ahead of rivals in the less common lung cancer type.

By Ned Pagliarulo • June 25, 2018

Nanbiotix rockets up after it blasts soft tissue sarcoma

Investors showed their approval Friday, sending shares higher after the rare cancer drug met its primary and secondary endpoints.

By Suzanne Elvidge • June 25, 2018

FDA pulls back biosimilar draft guide amid industry concern

The agency appears to be sympathetic to the cost concerns raised by biosimilar drugmakers, saying it will address them in future guidance.

By David Lim • June 22, 2018

Boehringer invests $268M to further build out biologics

Several expansions of the German pharma's biologics business reflect how the large-molecule drugs have beefed up its bottom line.

By Jacob Bell • June 22, 2018

FDA limits first-line bladder cancer labels for Keytruda, Tecentriq

Labels for the checkpoint inhibitors will now include a requirement for PD-L1 expression testing. 

By Suzanne Elvidge • June 22, 2018

Disruptive innovation – the impact on clinical trials

Senior pharma executives weigh in on how the industry is experiencing a digital disruption, impacting the entire spectrum of drug development.

June 21, 2018

Novo's case for oral semaglutide bolstered by Phase 3 trial wins

The key diabetes drug for Novo beat out the Danish drugmaker's own Victoza as well as Merck & Co.'s Januvia in two late-stage studies. 

By Ned Pagliarulo • June 21, 2018

Incyte preps Jakafi expansion into graft-versus-host disease

With positive topline results from the pivotal REACH1 study in hand, Incyte plans to file an application next quarter.

By Jacob Bell • June 21, 2018

Heron shares jump on pain drug's Phase 2b successes

The biotech plans to submit the non-opioid analgesic to the FDA later this year, aiming to secure an approval in postoperative pain management. 

By Suzanne Elvidge • June 21, 2018

Anika shares slump on Phase 3 miss

The regenerative medicine company's osteoarthritis treatment failed to meet its goal, spurring investor worries about approval in the U.S. 

By Ned Pagliarulo • June 20, 2018

3 patients add $2.5B to Sarepta's value

Preliminary results from a few DMD patients given the biotech's gene therapy widely beat expectations, stoking hopes of a truly disease-modifying treatment.

By Jacob Bell • June 19, 2018

Electronic platforms drive improvements in vaccine study efficiency and data quality

Electronic diary (eDiary) cards are helping sponsors overcome the unique data collection challenges associated with vaccine trials.

By Tim Davis, VP Digital Patient, ERT • June 19, 2018

Vertex opens doors to new research site in San Diego

Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.

By Suzanne Elvidge • June 19, 2018

Ziopharm shares tumble as clinical hold delays CAR-T

The FDA put a halt to the company's Phase 1 trial before it even began, seeking more information on the company's manufacturing plans.

By Suzanne Elvidge • June 19, 2018

Solid finds its footing as FDA lifts trial hold

Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.

By Ned Pagliarulo • June 18, 2018

Valeant hit with CRL for key dermatology drug

While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business. 

By Ned Pagliarulo • June 18, 2018

ObsEva's endometriosis win puts it back in investors' good graces

The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.

By Jacob Bell • June 18, 2018

Cytokinetics says early SMA treatment shows promise

Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.

By Suzanne Elvidge • June 18, 2018