Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
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- Category: AstraZeneca
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
Pfizer to supply Global Fund up to 6 million PAXLOVID™ treatment courses for low-and-middle-income countries
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to Global Fund as part of its COVID-19 Response Mechanism (C19RM). The C19RM has been the primary channel for providing grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment and critical elements of health systems strengthening.
WHO grants prequalification to GSK's Mosquirix - the first and only approved malaria vaccine
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) announced that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK's groundbreaking malaria vaccine. This is the first prequalification for a malaria vaccine and is an important step in rolling out the vaccine in countries with moderate to high P. falciparum malaria transmission.
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in European Union
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- Category: Business
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.
Novartis invests in early technical development capabilities for next-generation biotherapeutics
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- Category: Novartis
Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria,
FDA grants Breakthrough Therapy Designation to Pfizer's Group B Streptococcus vaccine candidate
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.
Xenpozyme™ (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations)
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- Category: Sanofi
The U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.
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