AstraZeneca's hopes of beefing up its heart drug Brilinta with a new indication took a major hit today after it released data showing the pill did not help stroke patients any better than a drug first discovered in the 19th century.
Corvus Pharmaceuticals has priced its IPO at just $15 per share--the lowest range it could offer--as 2016 continues to produce a mixed bag of results for biotechs going public.
New York biotech Syntimmune has hit its targets in preclinical testing and been given a nice $10 million gift for its efforts. The small autoimmune disease specialist achieved preclinical proof of concept and its preclinical safety testing targets, triggering a second $10 million tranche of the company's $26 million Series A financing.
Genentech and Johnson & Johnson are joining hands on another checkpoint combo program, matching Darzalex (daratumumab) and the PD-L1 drug atezolizumab for an unidentified solid tumor as well as multiple myeloma, where Darzalex is already approved for use.
German firm Evotec has spun off its first drug unit as it looks to start a new era in its business strategy.
Analysts at Zion Research say the worldwide CRO market will nearly double from 2014 to the end of the decade given the rise of new deals and the need for biopharma firms to take greater risks in their R&D.;
Biopharmas are interested in incorporating wearables that offer continuous patient monitoring into clinical trials of their drug candidates. But it's still early in terms of understanding of how these sorts of data can be used--and what regulators will make of them.
Analysts remain skeptical of Amgen's new osteoporosis treatment romosozumab as the Big Biotech releases new data ahead of a potential filing in the next year.
The China Food and Drug Administration has issued more than 20 guidance documents on medical device regulation over the last two years as it tightens its oversight of the device industry in the fast-growing market. The chief concern and area of uncertainty revolves around the country's clinical trial regime, especially for devices that are not on an "exempt list." Adding to the confusion, some devices on the list may still require a clinical trial, while others not on the list could get registered and approved without a trial.
BioMarin says it hit the primary endpoint in its pivotal Phase III study of pegvaliase, another one of its rare disease drugs bound for a filing date with regulators later in the year. But the study also flubbed a key secondary endpoint for cognitive improvements, raising doubts about the drug's future and driving down its shares by more than 4%.