DUBLIN – Nightstar Therapeutics plc is the latest contender to join the gene therapy tango, as Biogen Inc. stepped up with a $25.50 per-share bid that values the company at $877 million, or $800 million minus transaction expenses and anticipated cash at closing. Read More
Questions about the relevant efficacy, chemistry and production of Evoke Pharma Inc.'s diabetic gastroparesis candidate, Gimoti (metoclopramide), headlined a multidisciplinary review (DR) letter from the FDA, throwing into question whether a review of the drug will be completed by its April 1 PDUFA date. The company said it plans to respond to the deficiencies raised in the letter to allow time for potential FDA review prior to the PDUFA date. Nonetheless, investors sent company shares (NASDAQ:EVOK) down 57.2 percent to $1.30 on Monday. Read More
CEO Jan Møller Mikkelsen said Ascendis Pharma A/S is "still analyzing a lot of the data" from its phase III trial with its Transcon human growth hormone (hGH), a weekly therapy that beat daily growth hormone in the experiment called Height, but researchers are able to affirm that the better-than-expected outcome was "driven by the molecule itself, not by a difference in adherence between the two arms" of the study. Read More
With legislation intended to reduce the U.S. drug spend already stacking up in Congress, a few think tanks came together to propose a few of their own remedies. Read More
HONG KONG – Hangzhou-based Chinese oncology drugmaker Betta Pharmaceuticals Co. Ltd. said Chinese regulators have given a green light for the company to conduct clinical trials for its novel compound, BPI-17509. Developed in-house, the oral small molecule is designed to selectively target fibroblast growth factor receptor (FGFR) 1, 2 and 3 to treat intrahepatic cholangiocarcinoma, bladder cancer and lung squamous cell carcinoma, among other FGFR-relevant solid tumors. Read More
SAN DIEGO – Advice for startups from pharma executives and venture capitalists abounded at the Biocom Global Life Science Partnering Conference last week. Read More
The U.S. Supreme Court Monday agreed to hear arguments in Iancu v. Nantkwest over what costs an unsuccessful patent applicant has to cover when it asks a federal district court to review the Patent and Trademark Office's (PTO) denial of a patent. Read More
Oasmia Pharmaceutical AB, of Uppsala, Sweden, said it issued 22.94 million shares at SEK7.19 each to a limited group of investors for gross proceeds of approximately SEK165 million (US$17.6 million). The net proceeds are intended to be used to strengthen the working capital and finance ongoing operations. Read More
Clinigen Group plc, of Burton-upon-Trent, U.K., and Eiger BioPharmaceuticals Inc., of Palo Alto, Calif., are launching a worldwide managed access program for Eiger's lonafarnib, an inhibitor of farnesyltransferase for patients with progeria and progeroid laminopathies. Eiger plans to file an NDA for the drug this year. Read More
