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Here, EPR’s Hannah Balfour examines the trends that look set to shape clinical research in 2022, with comment from Aman Khera, VP and Global Head of Regulatory Strategy at Worldwide Clinical Trials.
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
A new clinical study by Pfizer Inc. and BioNTech SE, and Phase II study by Moderna, are seeking to evaluate the immunogenicity and safety of Omicron-based vaccines and boosters.
Katalin Karikó, Robert Langer and Drew Weissman win BBVA Foundation Frontiers of Knowledge Award in Biology and Biomedicine for driving the advance of messenger RNA (mRNA) therapeutics.
Based on the latest data, and Omicron's current dominance in the US, the FDA has announced two monoclonal antibody treatments are not authorised for use in any US states, territories and jurisdictions at this time.
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
US researchers have been granted $930,000 to develop a freeze drying technique for mRNA-based COVID-19 vaccines.
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
Phase II trial data suggests ensovibep (MP0420) significantly reduces SARS-CoV-2 viral load and reduces hospitalisation and death due to COVID-19.
Survey finds British adults expect pharma to continue to work together to advance both COVID-19 treatments and innovations for other diseases.
New collaboration between Pfizer and BioNTech will develop an mRNA vaccine to combat shingles (herpes zoster virus).
