Headlines the world over have been dominated by the resilience of the Ukrainian military – but the country’s clinical research body said that amid the chaos of war, trials are carrying on despite the destruction of hospitals and civilian infrastructure. As revealed by BioWorld, big pharma sponsors are putting clinical studies on hold in Russia, Ukraine and Belarus as the war plays havoc with medical supplies and the normal functioning of society.
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
As it settles a patent dispute with Japan’s Chugai Pharmaceutical Co. for $775 million, the U.K.’s Astrazeneca plc is looking to bring intellectual property in-house by snapping up a new generation of talented scientists.
Biotechs that tackle the effects of aging are beginning to make headlines: in January Altos Labs Inc. launched with a reported investment from Jeff Bezos. With Bezos getting involved with San Francisco-based Altos, the immediate reaction was that anti-aging biotechs would be there for the benefit of billionaires searching for eternal life.
Not so, according to London U.K.-based Genflow Biosciences plc, which hopes to show that fighting aging is really about improving health as people age.
Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. As revealed by BioWorld last week, hundreds of clinical trials were being conducted in the two countries at the time Russian President Vladimir Putin gave orders to invade Ukraine on Feb. 20.
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial.
Novo Nordisk A/S, best known for its range of diabetes drugs and insulins, has said that growing its rare disease unit will be an important part of its business strategy this decade. Novo Nordisk has actually been operating in rare diseases for 40 years, starting in hemophilia and gradually growing its presence. But the Bagsværd, Denmark-based company has big plans for its rare diseases arm in the next few years, with a pipeline of drugs aimed at the busy hemophilia market and for rare endocrine disorders.
As the conflict in Ukraine intensifies following the Russian invasion, hundreds of clinical trials could be in jeopardy amid the chaos and destruction of war, with pharma giant Merck & Co. Inc. saying it is putting recruitment for dozens of studies on hold.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology.
Microbiotica Ltd. of Cambridge, U.K., has raised £50 million ($67 million) in series B funding as the company aims to test its microbiome-based technology in early cancer and ulcerative colitis trials. The funding was co-led by new investors Tencent and Flerie Invest, with British Patient Capital on board along with existing investors Cambridge Innovation Capital, IP Group and Seventure. With response rates to checkpoint inhibitors still very low, Microbiotica’s scientists think that the way to improve the immune system’s response to these drugs is by modifying the bacteria present in the gut.
