The 2015 BIO Investor Forum opens this morning at the Parc 55 San Francisco – a new venue that boasts “breathtaking views of Union Square, Twin Peaks and the Bay from every room and suite,” according to the Biotechnology Industry Organization (BIO).
Before the curtains even close on the 2015 American Society of Clinical Oncology annual meeting, attention is turning to the American Diabetes Association's (ADA) 75th Scientific Sessions, which begin Friday in Boston. Abstract titles suggest presentations will address not only the raft of current drug development efforts and large cardiovascular outcome trials (CVOT) that have weighed on biopharmas in the diabetes space but also some of the emerging technologies to treat the disease.
A funny thing happened while analysts and investors were debating implications of the two-month gap in advisory committee meetings between Duchenne muscular dystrophy (DMD) candidates from Biomarin Pharmaceutical Inc. and Sarepta Therapeutics Inc. PTC Therapeutics Inc., whose DMD candidate, Translarna (ataluren), already has conditional approval in the EU, reported data from its phase III ACT DMD trial suggesting treatment with Translarna can alter the course of DMD disease progression.
Galera Therapeutics Inc. completed a $37 million series B designed to propel its pipeline of selective dismutase mimetics and move lead candidate, GC4419, into a randomized, double-blind phase IIb trial aimed to prevent oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy.
In an ambitious scheme to develop a pipeline of drug therapies targeting hearing loss, Third Rock Ventures backed Decibel Therapeutics with a $52 million series A to advance "disruptive discoveries in the physiology of the ear," as characterized by Third Rock partner Kevin Starr, who serves as Decibel's chairman and interim CEO.
Acceding to the recommendation of an independent data monitoring committee (DMC), Eli Lilly and Co. said it was terminating the phase III ACCELERATE study of evacetrapib (formerly LY2484595) in high-risk atherosclerotic cardiovascular disease (CVD) for lack of efficacy, bringing the program to an abrupt end.
Just four years out of the starting blocks, the race to approval for its first oral drug seems more a sprint for Marathon Pharmaceuticals LLC than the longer event that inspired its name.
Not done with the old, but in with the new. That seemed the drumbeat for Vertex Pharmaceuticals Inc., which looked to squeeze out every bit of commercial opportunity for its cystic fibrosis (CF) drug, Kalydeco (ivacaftor), even as it introduced the next generation of CF candidates.
Under-the-radar biosimilars partners Formycon AG and Bioeq GmbH gained altitude by disclosing that they initiated a pivotal phase III trial of FYB201, a biosimilar of ranibizumab (Lucentis, Genentech Inc.), in patients with neovascular age-related macular degeneration (wet AMD).
Theraclone Sciences Inc. and the University of Texas MD Anderson Cancer Center broadened an informal immuno-oncology (IO) relationship in a big way, jointly launching Oncoresponse Inc. to discover and advance therapeutic antibodies against targets identified during the treatment of cancer patients receiving the IO regimens.
