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

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

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Draft guidance from the agency reinforces the practice of measuring experimental cancer drugs against active controls.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

AstraZeneca's COPD drug fails to beat out GSK rival

AstraZeneca continues to play catch-up with GlaxoSmithKline in the market for lung disease treatments. New Phase 3 data doesn't look like it will help.

By Andrew Dunn • Aug. 23, 2018

AbbVie extension study tees up elagolix for uterine fibroids

Success in the Phase 3 study comes on the heels of a snub from the FDA for Allergan's rival drug Esmya. 

By Suzanne Elvidge • Aug. 23, 2018

AbbVie brings Argenx drug onboard amid immuno-oncology push

Licensing ARGX-115 will give AbbVie a platform to explore the potential of TGF-beta, the latest candidate in the race to improve how cancer immunotherapies work.

By Ned Pagliarulo • Aug. 22, 2018

MC2 Therapeutics' psoriasis drug succeeds in Phase 3 trial

The private Danish company unveiled topline data showing its topical cream was superior to Taclonex, supporting plans to file an NDA in 2019.

By Andrew Dunn • Aug. 21, 2018

Seven deadly sins of trial supply management: Is penny-pinching worth it?

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Aug. 21, 2018

Regeneron, Teva boast positive Phase 3 results for osteoarthritis drug

Data showed significant improvements in pain and function, although safety worries for the anti-NGF drug class have tempered expectations.

By Barbara Boughton • Aug. 20, 2018

Eisai-Merck partnership picks up first-line Lenvima approval

While Keytruda combo trials remain in progress, the companies secured an important OK for the kinase inhibitor in hepatocellular carcinoma.

By Suzanne Elvidge • Aug. 20, 2018

Fewer worries for Biohaven as it reports positive anxiety data

The biotech's sublingual riluzole hit a Phase 2/3 trial's primary endpoint on social anxiety disorder and public speaking anxiety.

By Suzanne Elvidge • Aug. 17, 2018

Catalyst gives positive hemophilia update as 2 more subjects complete study

Consistent with the first patient, all three who have wraped up the Phase 2/3 trial of MarzAA have yet to exhibit bleeding or develop anti-drug antibodies.

By Andrew Dunn • Aug. 16, 2018

J&J, ViiV tout positive data for two-drug HIV therapy

The ATLAS study provides even more evidence to back up the two-drug approach to HIV.

By Jacob Bell • Aug. 15, 2018

Entasis optimistic on safety trial results for UTI drug

Both the privately-held biotech's treatment and placebo achieved 100% clinical success in the Phase 2 trial.

By Suzanne Elvidge • Aug. 15, 2018

Realm Therapeutics faces another Phase 2 failure in eczema

The small biotech saw its only clinical trial fail, leaving its stock tattered and execs with a murky path forward.

By Andrew Dunn • Aug. 14, 2018

Gemphire's lead drug worsened disease, investigators conclude in ending trial

Shares in the Michigan-based biopharma have plunged nearly 80% this week, as its only drug candidate has suffered multiple setbacks.

By Andrew Dunn • Aug. 10, 2018

Torque touts modular approach to T cell manufacturing

Dubbed "Slipstream," Torque's platform is designed to be scalable and less labor-intensive than current cell manufacturing methods.

By Suzanne Elvidge • Aug. 9, 2018

Bellerophon halts Phase 3 trial for futility after interim data check

The biotech turned its focus to two Phase 2 programs, but the setback sunk shares in the company. 

By Barbara Boughton • Aug. 8, 2018