HONG KONG – Samsung Bioepis Co. Ltd.'s biosimilar Renflexis (infliximab-abda) will be the first product of the conglomerate's biologics arm to be marketed in the U.S. and only the second infliximab biosimilar in the market after Pfizer Inc.'s Inflectra. Samsung Bioepis gained FDA approval late Friday for its BLA for Renflexis (formerly SB2), a biosimilar candidate referencing Remicade (infliximab, Janssen Biotech Inc.). Read More

Polyphor Ltd., of Allschwil, Switzerland, presented data for its OMPTA (outer membrane protein targeting antibiotics) platform, showing a 91 percent clinical cure rate and 9 percent mortality rate in 12 patients treated with lead OMPTA murepavadin, with multiple doses of the drug demonstrating acceptable tolerability. Read More

Alder Biopharmaceuticals Inc., of Bothell, Wash., presented data for eptinezumab (formerly ALD-403), which is in phase III development for the prevention of migraine, showing that the drug was designed to be delivered intravenously and target soluble CGRP ligand with high selectivity and affinity as characterized by a rapid on-rate and very slow off-rate. Read More

Vyome Biosciences Pvt Ltd., of New Delhi, India, said it completed enrollment in its proof-of-concept study of VB-1953, a topically administered gel, for patients with moderate to severe acne. Data are expected later this year. Read More

BOSTON – At the presidential plenary session of the 2017 annual meeting of the American Academy of Neurology, Ronald Petersen freely admitted that "I'm biased." Read More

AMSTERDAM – New data on Albireo Pharma Inc.'s A-4250, an ileal bile acid transport inhibitor, has shown its capacity to reduce high levels of serum bile acids (sBA), which are often associated with severe itching, or pruritus, and liver damage in children with the rare cholestatic liver disease progressive familial intrahepatic cholestasis (PFIC). Read More

AMSTERDAM – Bristol-Myers Squibb Co.'s lead nonalcoholic steatohepatitis (NASH) candidate, BMS-986036, significantly reduced liver fat vs. placebo, meeting the primary endpoint of a phase II trial, the company reported during the International Liver Conference. Read More

AMSTERDAM – NGM Biopharmaceuticals Inc., true to its fascination with the long-lasting effects of gastric bypass surgery and what President Jeff Jonker called the procedure's "fundamental rewiring" of metabolism, honed in on the liver de-fatting feats of its lead candidate, NGM282, during a presentation at the International Liver Conference. Read More

The docket for the FDA's most recent efforts to address the off-label question drew dozens of comments, many of which were at least modestly supportive of the changes in the agency's stance. However, two trade associations opined that the FDA is too pessimistic about the impact of a less stringent standard for off-label communication on the incentives to study those off-label uses. Read More

The FDA is issuing draft guidance to aid government public health and emergency response stakeholders in testing to extend the shelf life of doxycycline tablets and capsules kept in strategic stockpiles in the event of an anthrax emergency. Read More

Galapagos NV, of Mechelen, Belgium, said it closed its underwritten public offering of 4.3 million American depositary shares (ADSs), which included the full exercise of the underwriters' option to purchase additional ADSs, at $90 each, for gross proceeds of $395.2 million. Read More

Hitgen Ltd., of Chengdu, China, said it inked a collaborative agreement with the Scripps Research Institute (TSRI) and its affiliate, the California Institute for Biomedical Research (Calibr), to focus on oncology, regenerative medicine and virology. Hitgen will utilize its technology platform to identify new small-molecule leads for therapeutic targets identified by the collaboration. TSRI and Calibr will provide target materials and expertise to prosecute drug targets of interest. Read More

Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., said data from a phase Ia/Ib study of ARC-AAT, an earlier generation of the company's RNAI candidate for the treatment of liver disease associated with alpha-1 antitrypsin (AAT) deficiency, can achieve "deep durable and dose-dependent reductions" of AAT, with the highest dose studied in healthy volunteers achieving near full suppression of the liver production of the AAT protein. Read More