Regulation

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.

Canada approves Pfizer and BioNTech’s BNT162b2 vaccine for Covid-19

Canada has approved Pfizer and BioNTech’s mRNA vaccine BNT162b2 for the prevention of Covid-19.

Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC

Amgen has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its sotorasib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.

Neurogene announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy

Neurogene, a company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, announces that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to its adeno-associated virus vector (AAV) with engineered transgene encoding the human AGA gene for patients diagnosed with aspartylglucosaminuria.

Roche gets FDA approval of Gavreto in advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

UK regulator grants EUA status for Pfizer and BioNTech’s Covid-19 mRNA vaccine

Pfizer and BioNTech have secured temporary emergency use authorisation (EUA) from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for their Covid-19 mRNA vaccine called BNT162b2.

Zymeworks gets FDA breakthrough therapy status for HER2-targeted bispecific antibody zanidatamab in patients with BTC

Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC).

Moderna seeks FDA EUA for Covid-19 vaccine candidate

Moderna announced that it is seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 mRNA vaccine candidate.

EC approves Vertex’s Symkevi plus Kalydeco to treat CF in children aged 6-11 years

Vertex Pharmaceuticals has secured approval from the European Commission (EC) for Symkevi (tezacaftor/ivacaftor) plus Kalydeco (ivacaftor) for the treatment of elder children with cystic fibrosis (CF) aged between six and 11 years.