PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs.
If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device.
With the next big wave of biologic patent expirations soon to wash over the U.S. market, companies developing biosimilars are optimistic about the future. “We’re at a place where we’re seeing really strong uptake of biosimilars, which has resulted in cost savings,” Chad Pettit, executive director of marketing for Amgen Inc.’s biosimilars unit, told BioWorld.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications.
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation.
DUBLIN – Canakinumab, an interleukin-1 beta (IL-1beta) inhibitor, has joined a growing list of immunomodulatory therapies that have failed to demonstrate efficacy in COVID-19. Novartis AG said that an interim analysis showed the drug did not meet the primary endpoint of clinical response.
It didn’t take long for a U.S. district judge to grant Gilead Sciences Inc.’s request for a temporary restraining order to stop two interconnected health care networks in Florida from defrauding the company’s Advancing Access Medication Assistance Program that provides free HIV pre-exposure prophylaxis drugs to eligible, uninsured people.
HONG KONG – Haihe Pharmaceutical Co. Ltd. has outsourced the China rights to its non-opioid analgesics candidates, RMX-1001 and RMX-1002, to 3D Biomedicine Science & Technology Co. Ltd. in the latest collaboration between the two companies.
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.