Ann Arbor, MI, biotech Esperion Therapeutics finally resolved the FDA snag standing in the way of its ambitious plans for a new cholesterol drug, clearing the company to begin late-stage trials with its potentially disruptive pill.
Japanese drugmaker Chugai Pharmaceutical is planning a major expansion of its Singapore research outpost, laying out 476 million Singapore dollars ($374 million) over 7 years as it hits the gas on antibody research.
Generics giant Mylan is shouldering its way into the blockbuster market for COPD treatments, signing a $265 million deal with the respiratory experts at Theravance Biopharma to get its hands on a late-stage contender.
Partners Eli Lilly and Boehringer Ingelheim picked up FDA approval for a first-of-its-kind diabetes treatment, combining two existing drugs into a single tablet.
Four months after getting a promising readout on its lead drug in a Phase IIb study for irritable bowel syndrome, AstraZeneca-partnered Ardelyx reported another study win today, but investors zeroed in on a disturbing safety issue and ripped up the company's shares soon after the release went out.
A biotech with scientific roots at the University of Oxford and a new approach to treating Duchenne muscular dystrophy is coming to America with a $40 million IPO.
Bluebird bio nabbed the FDA's breakthrough drug title for LentiGlobin BB305 as a new treatment for beta-thalassemia major, putting one of the industry's top experimental gene therapies back squarely in a promising spotlight.
A U.S./Japanese hybrid biotech chaired and co-founded by Gregory Verdine, the high-profile Harvard investigator now laboring as CEO of Warp Drive Bio, has gathered together $18 million in a transpacific venture round and set its sights on developing a "revolutionary" new class of nucleic acid drugs based on a potentially breakthrough approach to drug design.
You can add another clinical stage program for remyelination to your watch list. Acorda's early-stage drug for targeting the root cause of multiple sclerosis has cleared its first hurdle in the clinic, passing its Phase I safety challenge with a set of patient cohorts that detected none of the preliminary toxicity issues or side effects that could derail it early on.
Cancer drug developer Tracon Pharmaceuticals pulled in $36 million in an IPO, pricing well below its expected range as it works to get its top drug into late-stage trials.
President Barack Obama is asking Congress for $215 million to sequence the genomes of 1 million Americans and help develop a new generation of medicines, part of a sweeping plan to accelerate biomedical R&D.
Pfizer is walking away from a $70 million collaboration with Waltham, MA's Repligen, handing back some early-stage treatments for the rare spinal muscular atrophy.
Spark Therapeutics, at work on one-time treatments for rare diseases, pulled off a $161 million IPO, pricing above its range and keeping biotech's Wall Street hot streak rolling.
Astellas Pharma is teaming up with biotech Immunomic Therapeutics on a vaccine that could relieve a common allergy that affects millions in its native Japan.
Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.
In this week's EuroBiotech Report, Belgian biotech ThromboGenics, having seen its stock price peak at €45 two years ago, has experienced a series of share slides, the latest of which was triggered by its partner Novartis. And more.
When you want to develop a drug for, say, cancer, objective measures such as survival rate can tell regulators just how effective it is compared to a standard drug or placebo. But in diseases involving the brain, scientists often have to settle for crude measures for assessing how patients perform or feel after treatment. And the wild card here is a placebo effect that can be very difficult to factor into studies and has been fingered for the death of multiple development programs.
President Barack Obama's plot to bolster personalized medicine research would lean heavily on a planned bank of patient genetic information, Science magazine reports, pooling existing databases to create a huge R&D utility. But the promise of a so-called Precision Medicine Initiative has left some scientists cold, hearkening back to overblown efforts past.