As part of its proposed Physician Fee Schedule revisions for next year, the U.S. Centers for Medicare & Medicaid Services (CMS) plans to implement an expansion of the 2010 Physician Payment Sunshine Act, which was rolled into the Affordable Care Act. Passed last year as part of a sweeping bill addressing the opioid epidemic, the expansion requires drug companies to report payments made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives, as well as to doctors. The payment categories that have to be reported also would be expanded to include debt forgiveness, long-term loans of covered devices or medical supplies, and acquisitions of companies in which a covered recipient has an ownership interest. (See BioWorld, Aug. 1, 2013.) Read More
Oncolytics Biotech Inc., of San Diego and Calgary, Alberta, said it closed its underwritten public offering, selling 4.61 million common shares and warrants to purchase up to 4.61 million common shares, at 81 cents per share and warrant, for gross proceeds of approximately $3.7 million. Each warrant entitles the holder to purchase one common share, for a period of five years, at an exercise price of 90 cents each. It expects to use the net proceeds for research and development activities and working capital purposes. Read More
Novo Nordisk A/S, of Bagsværd, Denmark, said a securities lawsuit has been filed in Denmark against the company by a number of shareholders who are claiming DKK11.785 billion (US$1.75 billion) based on their trading and holding of shares in Novo Nordisk during the period of Feb. 3, 2015, to Feb. 2, 2017. It alleges that the company made misleading statements and did not make appropriate disclosures regarding its sales of insulin products in the U.S. Read More
RIYADH, Saudi Arabia – Saudi Arabia, a country best known as one of the largest oil producers in the world, is looking to develop a stronger domestic biotech and pharmaceutical industry, partly to diversify its economy and partly to address its domestic health care needs. Read More
A little more than a year into starting enrollment, a massive U.S. biomedical research effort led by the NIH has signed up almost one-quarter of the 1 million people it aims to study. The program, now known as "All of Us," is slated to provide health and genetic data on a massive scale. Read More
HONG KONG – South Korean biotech venture Crystal Genomics Inc., based in Seongnam City, Gyeonggi-do, said it signed a memorandum of understanding for a strategic partnership with Bellevue Asset Management AG, a global asset manager headquartered in Küsnacht, Switzerland. Read More
Monopar Therapeutics Inc., another company looking to attack the bane of many cancer patients – severe oral mucositis (SOM) – has filed for a $40.2 million IPO that will help advance into phase III its mucobuccal tablet of the adrenergic alpha2 agonist clonidine, branded Validive. Read More
Following a priority review at the FDA, Abbvie Inc.'s oral rheumatoid arthritis (RA) drug, upadacitinib, has won U.S. approval at the agency, taking the first step into a market that analysts predict could eventually lead to peak annual sales of as much as $2.2 billion by 2023. Read More
What began a year and a half ago as a takeover of Impact Biomedicines Inc. ended Friday with FDA approval for the wholly owned Celgene Corp. subsidiary's rare bone marrow disorders drug, Inrebic (fedratinib). Read More
Investigators at Stanford University have created a panel of isogenic iPSC-derived neurons with various mutations of amyloid precursor protein (APP) and presenilin (PSEN), and used it to demonstrate that accumulation of APP beta C-terminal fragments (beta-CTFs), but not of amyloid beta, correlated with endosomal dysfunction and could be improved by inhibiting beta-secretase (BACE-1). Genetic evidence clearly implicates APP misprocessing in Alzheimer's disease (AD), and amyloid beta plaques are the disease's major anatomical calling card, which has led to a focus on therapeutic targeting of the latter. However, that therapeutic targeting has failed multiple times, and the evidence linking amyloid beta to AD is weaker than that for APP. Recently, endosomal dysfunction has been proposed as "another plausible underlying pathological mechanism," leading the authors to investigate the causes of endosomal dysfunction in their cell lines. They showed that endosomal dysfunction, which leads to deficits in intracellular transport, was correlated with changes in beta-CTF but not amyloid beta. Read More
