Regulation

11 Dec 2020
- Regulation
- Drug Filing
European CHMP adopts positive opinion for Dynavax’s HEPLISAV-B vaccine for Hepatitis B

By PBR Staff Writer

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.
10 Dec 2020
Regulation
Approvals
Canada approves Pfizer and BioNTech’s BNT162b2 vaccine for Covid-19

By PBR Staff Writer

Canada has approved Pfizer and BioNTech’s mRNA vaccine BNT162b2 for the prevention of Covid-19.
09 Dec 2020
Regulation
Approvals
Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC

By PBR Staff Writer

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.
04 Dec 2020
Regulation
Approvals
Neurogene announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy

By PBR Staff Writer

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.
03 Dec 2020
Regulation
Approvals
Roche gets FDA approval of Gavreto in advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

By PBR Staff Writer

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).
03 Dec 2020
Regulation
Approvals
UK regulator grants EUA status for Pfizer and BioNTech’s Covid-19 mRNA vaccine

By PBR Staff Writer

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.
01 Dec 2020
Regulation
Approvals
Zymeworks gets FDA breakthrough therapy status for HER2-targeted bispecific antibody zanidatamab in patients with BTC

By PBR Staff Writer

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).
01 Dec 2020
Regulation
Drug Filing
Moderna seeks FDA EUA for Covid-19 vaccine candidate

By PBR Staff Writer

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.
30 Nov 2020
Regulation
Approvals
EC approves Vertex’s Symkevi plus Kalydeco to treat CF in children aged 6-11 years

By PBR Staff Writer

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.
27 Nov 2020
Regulation
Drug Filing
EMA validates application for Tepotinib for treatment of advanced NSCLC with METex14 skipping alterations

By PBR Staff Writer

Merck announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

Drug Discovery

Research & Development

Transcripta Bio, Mayo Clinic join force on ALS therapies

Pfizer partners with Enodia Therapeutics in $500m drug deal

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

Suppliers

No data found

Regulation

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

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

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

Neurogene announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy

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

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

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

Moderna seeks FDA EUA for Covid-19 vaccine candidate

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

EMA validates application for Tepotinib for treatment of advanced NSCLC with METex14 skipping alterations

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found