Topic:

Pipeline

Latest Headlines

Latest Headlines

French immuno-oncology biotech OSE eyes an EU IPO

The U.S. boom in biotech IPOs has largely failed to drift across the Atlantic and galvanize many floats in Europe, but France's OSE Pharma is looking to buck that trend in hopes of bankrolling late-stage studies for its immuno-oncology candidate.

Cubist makes Euro landfall with a $400M purse for antibiotics R&D

The antibiotics-focused Cubist Pharmaceuticals has opened up shop in Europe with a Swiss international headquarters, part of its plan to spend $400 million on infectious disease R&D this year and spotlight new treatments for global scourges.

FDA advisers shoot down Clarus' pitch for a new low-T drug

Amid widespread safety concerns surrounding testosterone drugs, an FDA panel has recommended against Clarus Therapeutics' oral treatment, dimming the future for the company's sole product.

Merck's weekly diabetes drug stacks up to blockbuster Januvia in Phase III

Merck's new, once-a-week treatment for diabetes measured up to the company's top-selling Januvia in its first Phase III test, setting the stage for a Japanese regulatory application and stoking the drugmaker's hopes of another blockbuster in the space.

UPDATED: Oral low-T drugs in the pipeline face a showdown with the FDA

An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.

Flexion tanks as FDA clamps a hold on its lead osteoarthritis drug

Just months after pulling off a successful IPO, Flexion Therapeutics is left watching its shares plummet after the FDA forced it to halt a trial on its top prospect.

Tokai pockets $97M in IPO cash to get its cancer drug into Phase III

Cambridge, MA, biotech Tokai Pharmaceuticals pulled off a $97.2 million Wall Street debut, raising the money it needs to get its three-in-one treatment for prostate cancer into late-stage development.

Gilead's oncology contender comes up short in pancreatic cancer

Gilead Sciences' simtuzumab failed to meet its main goal in a Phase II pancreatic cancer trial, denting the potential of a therapy the company hopes can treat a wide range of malignancies.

Parkinson's biotech NeuroDerm joins the IPO queue with a $65M pitch

Israel's NeuroDerm is developing a wearable treatment solution for patients with Parkinson's disease, and the biotech is plotting a $65 million IPO to get its lead candidates across the finish line.

Cyramza, key to Lilly's oncology hopes, comes through in colorectal cancer

Eli Lilly's Cyramza (ramucirumab) met its primary endpoint in a study on metastatic colorectal cancer, good news for a key cog in the drugmaker's plans to capitalize on oncology.