InterMune and Boehringer Ingelheim have spent the last year or so jockeying for the spotlight with in-development treatments for a rare lung disease, hoping to take pole position upon reaching the market. Now, as the FDA has decided to approve both drugs at once, the two companies will set off from equal starting points in the race for dominance.
Investigators working on Novartis' personalized CTL019 CAR-T program at the University of Pennsylvania say that 90% of a small group of children suffering from very advanced cases of treatment-resistant acute lymphoblastic leukemia achieved complete remission after being treated in the newly updated trial.
This summer, as Merck inched closer and closer to its $3.9 billion buyout of Idenix Pharmaceuticals, one of the company's employees tipped off a friend that a deal was imminent, federal prosecutors say. With that information, the pair made hundreds of thousands of dollars on insider trades, according to the SEC, the latest scandal for an industry increasingly vulnerable to such manipulation.
It took a while, but San Diego-based Orexigen has just earned a $70 million milestone from its deal with Takeda on the obesity drug Contrave.
It's become a matter of commonly accepted faith in the biopharma biz that it takes more than $1 billion and 10 years to develop a new drug. Industry associations like to cite that factoid as a reason for the big prices we're seeing on new therapies, often while prodding the FDA for faster action.
Danish drug developer Forward Pharma came through with one of the year's biggest biotech IPOs, raising $221 million to support its plot to battle Biogen Idec in the blockbuster multiple sclerosis market.
Selecta Biosciences has banked a $20 million-plus round designed to get its lead treatment into the clinic with an eye to providing some basic proof-of-concept data to show that their vaccine particle technology platform will be useful for a full slate of programs.
DNAtrix, at work on viral treatment that selectively infects brain cancer cells, picked up $20 million in venture cash, funds the company said will help speed its candidate into late-stage study.
AbbVie to Shire: Maybe that idea about merging regardless of what the Obama administration thinks wasn't so hot after all.
AstraZeneca is expecting word from European regulators next week on whether they'll recommend approval for its new ovarian cancer treatment, a drug the company hopes can bring in $2 billion a year at its peak.
Japan's Astellas Pharma is the latest big drugmaker allured by the promise of gene therapy, mounting an R&D effort that could lead to a new treatment for an inherited eye disease.
GW Pharmaceuticals' in-development treatment for ulcerative colitis missed its primary endpoint in a midstage trial, a setback for the U.K. drugmaker and its pipeline of cannabinoid treatments.
Germany's Wilex has long been on the way out of biotech, but a new collaboration with Roche provides the company with some cash up front and a shot at down-the-line royalties.
While Atlas Venture was busy putting together a syndicate for Raze in Cambridge, MA, the venture group was also engaged in hatching a $32 million round across the Atlantic in the scientific hotbed of Cambridge, U.K. Atlas partnered with SV Life Sciences and three corporate venture arms--Novartis Venture Fund, GlaxoSmithKline's SR One and Astellas Venture Management--to back Bicycle Therapeutics.
Atlas Venture is launching one of its newly built biotechs with a Series A of $24 million, a founding partner on the board, a pair of its entrepreneurs heading the crew and some marquee investors in the syndicate, which includes Novartis. They've begun a voyage of discovery with Raze Therapeutics, part of Atlas's growing fleet of startups, to see how far they can go down a pathway that offers its investigators a shot at throwing a monkey wrench into the metabolic processes cancer uses to thrive.
Eisai and partner Helsinn secured the FDA's blessing to market Akynzeo, a combination treatment designed to prevent nasuea and vomiting among cancer patients undergoing chemotherapy.
Alnylam's in-development RNAi treatment successfully staved off nerve damage related to a rare disease in an ongoing study, the biotech said, early but promising results as the company heads into Phase III with partner Sanofi in tow.
Massachusetts General Hospital investigator Rudy Tanzi has created a new "Alzheimer's-in-a-dish" approach to growing brain cells that he claims provides clear proof of the much-debated amyloid hypothesis as well as a solid target for the disease. And now he reportedly plans to race ahead with his new research process to find a potential megablockbuster drug that can stop the disease in its tracks.
Pfizer has picked up a priority review designation for its closely watched cancer drug palbociclib, potentially slicing four months off the review timeline for a therapy that is being hustled along at an accelerated rate.
Last spring a prominent analyst suggested that a successful late-stage study for Smith & Nephew's spray-on cell therapy for wound healing could be a catalyst to break up the company a la Abbott and Baxter. But today, the discussion of the much buzzed-about trigger event turned bitter after the company reported that the Phase III trial flopped.