Regulation

Moderna receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against Covid-19 in US

Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.

FDA grants priority review to KEYTRUDA for treatment of esophageal and gastroesophageal junction cancer

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ).

GSK gets FDA nod for Benlysta to treat adult patients with active lupus nephritis

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) to treat adult patients with active lupus nephritis (LN) who are securing standard therapy.

Xentria announces FDA orphan drug designation for XTMAB-16 in sarcoidosis

Xentria, a biopharmaceutical company focused on developing novel biologics and biosimilars to address unmet clinical needs, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its intravenous TNF-α inhibitor, XTMAB-16, for the treatment of sarcoidosis.

Acceleron gets EC orphan designation for sotatercept to treat PAH

Acceleron Pharma has secured orphan designation from the European Commission (EC) for its sotatercept to treat patients with pulmonary arterial hypertension (PAH).

Novartis gets EC nod for Leqvio to treat hypercholesterolemia or mixed dyslipidemia

Novartis has secured approval from the European Commission (EC) for its Leqvio (inclisiran) to treat adults with hypercholesterolemia or mixed dyslipidemia.

Merck gets positive CHMP opinion for Keytruda as first-line treatment for dMMR colorectal cancer

Merck (known as MSD outside the US and Canada) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

Pfizer and BioNTech celebrate historic first authorisation in US of vaccine to prevent Covid-19

Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

European CHMP adopts positive opinion for Dynavax’s HEPLISAV-B vaccine for Hepatitis B

Dynavax Technologies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.