A New York federal judge has frozen the assets of several individuals and entities for their alleged role in distributing counterfeit versions of Gilead Science’s (Nasdaq:GILD) HIV medications. Presiding over the U.S. District Court for the Eastern District of New York, Judge Ann M. Donnelly also denied the defendants’ motion to dismiss the case for…
Johnson & Johnson names proposed consumer health spinoff ‘Kenvue’
Johnson & Johnson (NYSE:JNJ) has announced that it will name its consumer health division ‘Kenvue.’ Earlier this year, GSK (NYSE:GSK) made a similar move by naming its consumer healthcare segment ‘Haleon.’ That moniker fuses the old English word ‘hale’ with the name ‘Leon.’ The first word means ‘healthy’ while the second refers to ‘strength.’ Haleon…
Pfizer and Moderna seek FDA nod for omicron-adapted COVID boosters in children
Pfizer/BioNTech (NYSE:/PFE, Nasdaq BNTX) and Moderna (Nasdaq:MRNA) have both won emergency use authorizations in the U.S. for bivalent vaccine boosters based on BA.4/BA.5. Pfizer is aiming to win authorization to use its updated COVID-19 vaccine in children aged 5 through 11 years. Moderna has requested that FDA greenlight the use of its omicron booster in…
Actylis launches with focus on raw materials and performance ingredients for life sciences and specialty chemicals
The conglomerate Actylis made its debut today. The new brand integrates specialty ingredient maker Aceto with 10 specialty ingredient manufacturing and sourcing companies. The Port Washington, New York–based company will serve customers in various industries, including pharmaceutical and biopharmaceutical companies. It will also offer materials to companies specializing in nutrition, cosmetics, agriculture and specialty chemicals markets.…
U.S. government earmarks $1.6 billion to battle opioid crisis and overdose epidemic
The U.S. Department of Health and Human Services (HHS) has awarded more than $1.6 billion as a part of an initiative to battle the drug overdose epidemic. SAMHSA’s State Opioid Response (SOR), Tribal Opioid Response (TOR) grant programs and Health Resources and Services Administration (HRSA)’s rural communities opioid response programs will lead the new initiative.…
Lonza bolsters HPAPI multipurpose suite for payload linkers in Switzerland
Contract development and manufacturing organization Lonza has completed the expansion of its highly potent API (HPAPI) multipurpose suite in Visp, Switzerland. The expansion gives Lonza additional development and manufacturing capacity for antibody-drug conjugates (ADC) payloads. The site includes a range of equipment for manufacturing payload linkers. Divided into cleavable and non-cleavable types, linkers are a vital…
Pfizer to provide up to 6 million Paxlovid courses to developing countries
Pfizer (NYSE:PFE) has reached an agreement to supply as many as six million courses of its oral COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) to the Global Fund, which seeks to help more than 100 low-to-middle income countries fight diseases such as COVID-19, HIV, tuberculosis and malaria. Pfizer notes that the agreement with the Global Fund is…
FDA updates ad comm meeting date for sabizabulin in hospitalized COVID-19 patients
The oncology biopharma Veru (Nasdaq: VERU) has announced that the FDA has moved the date for its Pulmonary-Allergy Drugs Advisory Committee to discuss the potential emergency use authorization (EUA) of sabizabulin for hospitalized COVID-19 patients. The meeting is now slated for November 9, 2022. It was originally scheduled for October 6, 2022. VERU shares skidded…
EU approves AstraZeneca’s Evusheld COVID-19 antibody cocktail
AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union. Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg…
U.S. Adderall shortages could resolve in the coming weeks
Generic versions of the Takeda’s (NYSE:TAK) ADHD drug Adderall (amphetamine and dextroamphetamine) continue to be in short supply as demand for it has surged. Both instant-release and extended-release versions of mixed amphetamine salts have been affected by the shortages. A central supplier of the drug in the U.S., Teva (NYSE:TEVA), says labor shortages related to packaging…