Sirona Biochem Corp., of Vancouver, British Columbia, received approval from the TSX Venture Exchange to extend the exercise date of its warrants that were issued on March 6, 2014, from March 6, 2017 to Nov. 30, 2017.
Enteris Biopharma Inc., of Boonton, N.J., said the first woman has been dosed in its phase IIa trial to evaluate Ovarest, an oral formulation of leuprolide, which binds to the gonadotropin releasing hormone receptor, for the treatment of endometriosis.
Boehringer Ingelheim GmbH (BI) has started a phase IIa trial in nonalcoholic steatohepatitis (NASH) seeking insight on four different doses of BI-1467335, an anti-inflammatory drug it acquired from Sydney-based Pharmaxis Ltd. The kick-off triggered an €18 million (US$21.3 million) milestone payment for Pharmaxis. A €10 million (US$11.8 million) milestone tied to the launch of another phase II study in a second soon-to-be disclosed indication is expected later this year.
Shares of Genmab A/S (CPH:GEN) shot up 11 percent Thursday after the company reported that the phase III ALCYONE study of daratumumab (Darzalex) met the primary endpoint of improving progression-free survival (PFS) as front-line treatment for newly diagnosed multiple myeloma (MM) patients.
Cowen and Co. analyst Eric Schmidt summed up the consensus of analysts on the phase III failure of Ultragenyx Pharmaceutical Inc. candidate aceneuramic acid extended release (Ace-ER) in patients with GNE myopathy (GNEM) as "disappointing, but not surprising." A win would have been a stunner, given tepid phase II findings and the company's withdrawal of a marketing authorization application (MAA) for the candidate in the fourth quarter of 2016.
Krystal Biotech Inc., a company developing gene therapies for rare skin disorders, has filed to raise up to $34.5 million in an IPO. Its two preclinical programs, KB-103 for dystrophic epidermolysis bullosa (DEB) and KB-104 for Netherton syndrome, employ an engineered viral vector based on herpes simplex virus 1 and skin-optimized gene transfer.
Intra-Cellular Therapies Inc. vice president Kimberly Vanover told BioWorld that the company "should have everything we need" to file an NDA for lumateperone, also known as ITI-007, in the middle of next year, and the company's shares (NASDAQ:ITCI) closed Wednesday at $14.39, up $3.12, or 27.7 percent, on word that the FDA found adequate the company's responses to a request for more information regarding toxicology experiments in dogs.
The holdup on an interoperable, electronic, serialized, track-and-trace system that will have a global reach for prescription drugs sold in the U.S. market is much more basic than supply and demand. It's a matter of settling on a vision of what that system should look like in the face of ever-evolving technology.
HONG KONG – China's drug authority is upscaling the Marketing Authorization Holder (MAH) mechanism pilot, which is seen as a boon for drug innovation in the country. The CFDA released another notice regarding the pilot MAH mechanism in the country which clarified details on the responsibilities of the authorization holders and license transferring.
A new confidentiality commitment signed by the European Commission, the EMA and the FDA allows the U.S. agency to share nonpublic and commercially confidential information with EU regulators.
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