Novartis agreed to pay $678 million to settle allegations that it paid kickbacks to physicians through sham speaker fees to boost prescriptions of its diabetes and cardiovascular drugs. Separately, the company agreed to pay $51.25 million to resolve accusations that it violated the False Claims Act by funneling money through three charitable foundations to cover cost sharing for Medicare patients taking its drugs.
A federal appeals court ruled against Novartis in its patent case against Amgen over its rheumatoid arthritis drug Enbrel. The court rejected the argument of Novartis' Sandoz unit that two patents for Enbrel should be voided because they described concepts included in previous patents.
National Health Service England announced it has completed a deal with Vertex for its triple-drug combo Kaftrio, or tezacaftor, ivacaftor and elexacaftor, a treatment for cystic fibrosis, several days after the European Medicines Agency's Committee for Medicinal Products for Human Use backed its approval. The UK's CF patients will be some of the first patients in Europe to gain access to Kaftrio once the EMA grants formal approval of the drug.
US nonprofits are addressing high drug manufacturing costs and the reliance on Asia for active pharmaceutical ingredients. For example, the Medicines for All Institute developed a manufacturing process based on flow chemistry that can be used to make several medications, including lamivudine, a treatment for HIV/AIDS.
The COVID-19 pandemic has resulted in numerous changes and new guidelines from the FDA, and included in this article are some of the most recent guidance relevant to the pharmaceutical, biotechnology and biologic industries. The guidelines cover the conduct of clinical trials, regulatory compliance and development of COVID-19 investigational therapeutics.
Novavax has appointed Ben Machielse as executive vice president for chemistry, manufacturing and controls. The industry veteran previously worked with Vtesse and MedImmune, and will help Novavax advance its COVID-19 and flu vaccine candidates from clinical to commercial stage.
A GlobalData report that included 322 biopharma companies found almost 200 had stopped or delayed clinical trials due to the COVID-19 pandemic. Data showed 44.8% of the disrupted studies were in Phase II and 67.3% of the disruptions were linked to enrollment suspension.
Monoclonal antibodies derived from the blood of people who have recovered from COVID-19 attached to the SARS-CoV-2 spike protein and attached to 18 of the 21 ACE2 attachment sites in cells. One antibody reduced the amount of virus in transgenic mice by 32.8%, the other reduced it by 26%, and mice treated with either of the antibodies had less lung damage than mice that were not treated, researchers reported in Science.
Two doses of a SARS-CoV-2 vaccine given three weeks apart provoked production of neutralizing antibodies in hamsters and protected them from infection, while hamsters not given the vaccine had high levels of the virus in their lungs, trachea and various organs, says Ray Goodrich, director of the Infectious Disease Research Center at Colorado State University. The vaccine is based on inactivated virus and can be produced in a portable device used for purifying blood donations.