The Medicines Co.'s ongoing quest to narrow its focus, free up cash and reduce burn in the face of multiple challenges headlined its third quarter earnings announcement. By year's end, the Parsippany, N.J.-based company said that it expects to announce a transaction to sell its infectious disease business, to slash its workforce to fewer than 60 staff, and to start all trials in the LDL-C lowering program for inclisiran, a protein convertase subtilisin/kexin type 9 (PCSK9) candidate it expects to file with the FDA by the end of 2019.
Sweden's Wilson Therapeutics AB said that the first patient in a single pivotal trial of its copper-protein-binding agent for the rare copper-excess condition, Wilson disease, is expected to be enrolled in early 2018. Data from the study is anticipated to follow in the second half of 2019.
Astellas Pharma Inc.’s U.S.-based regenerative medicine center has agreed to pay Seattle-based Universal Cells Inc. up to $124 million for global rights to use its Universal Donor Cell technology in a new cell therapy for an undisclosed indication.
Janssen Pharmaceuticals Inc. is enlisting privately held RNA therapy specialist Arcturus Therapeutics Inc. to help it develop and commercialize new nucleic acid-based drugs for hepatitis B virus (HBV) and possibly other infectious and respiratory diseases. Only a broad outline of the deal's financials was disclosed. Nonetheless, excitement about the tie-up indirectly moved the market, lifting shares of Alcobra Ltd. (NASDAQ:ADHD) by 18.9 percent to $1.51 on Thursday, ahead of a proposed merger with Arcturus.
SAN FRANCISCO – Following uncertainty, suspense and surprise in the heady political dramas around health care – outside of drug pricing controversies – predicting what else would unfold has been a perilous business. Nonetheless, policy mavens looking ahead to 2018 at the BIO Investor Forum gave it a go on Wednesday.
SAN FRANCISCO – Bispecific antibodies, expected as a class to carve out a multibillion-dollar niche in the decade ahead, continue to face multiple challenges between now and then. However, with significant clinical investment, the approach is gaining momentum, company executives said at the BIO Investor Forum in San Francisco on Monday.
Just weeks after the close of a flush third quarter for biotech fundraising, three more drug developers – Apellis Pharmaceuticals Inc., Inflarx NV and Genprex Inc. – are making the leap into the public market with IPOs, all on Nasdaq.
After a brief and uncontentious advisory committee meeting, FDA approval for the Aerie Pharmaceuticals Inc. glaucoma drug Rhopressa (netarsudil) appears likely, setting the stage for the arrival of a new class of medicine to be used in addressing one of the leading risk factors for vision loss associated with the condition, elevated intraocular pressure (IOP).
The NIH and 11 big biopharma companies have agreed to contribute $215 million to fund a new five-year effort to facilitate systematic and uniform clinical testing of biomarkers to understanding mechanisms of response and resistance to cancer immunotherapy.
Aerie Pharmaceuticals Inc.'s claims about the efficacy of its triple-acting glaucoma drug, Rhopressa (netarsudil), earned uncomplicated support from FDA briefing docs published ahead of the agency's Friday Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) meeting, sending company shares (NASDAQ:AERI) climbing 16.2 percent to $64.30 on Wednesday as the company took another substantive step toward an anticipated Feb. 28 approval or earlier.
