Approvals

18 Dec 2020
- Regulation
- Approvals
Moderna receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against Covid-19 in US

By PBR Staff Writer

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.
18 Dec 2020
Regulation
Approvals
GSK gets FDA nod for Benlysta to treat adult patients with active lupus nephritis

By PBR Staff Writer

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.
16 Dec 2020
Regulation
Approvals
Xentria announces FDA orphan drug designation for XTMAB-16 in sarcoidosis

By PBR Staff Writer

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.
15 Dec 2020
Regulation
Approvals
Acceleron gets EC orphan designation for sotatercept to treat PAH

By PBR Staff Writer

Acceleron Pharma has secured orphan designation from the European Commission (EC) for its sotatercept to treat patients with pulmonary arterial hypertension (PAH).
14 Dec 2020
Regulation
Approvals
Novartis gets EC nod for Leqvio to treat hypercholesterolemia or mixed dyslipidemia

By PBR Staff Writer

Novartis has secured approval from the European Commission (EC) for its Leqvio (inclisiran) to treat adults with hypercholesterolemia or mixed dyslipidemia.
14 Dec 2020
Regulation
Approvals
Pfizer and BioNTech celebrate historic first authorisation in US of vaccine to prevent Covid-19

By PBR Staff Writer

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.
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).

Drug Discovery

Research & Development

J&J announces Tecvayli-Darzalex combo approval from FDA for multiple myeloma

Liberate Bio gains licences for myeloid-specific CAR design patents

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

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

Suppliers

No data found

Approvals

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

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

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

Acceleron gets EC orphan designation for sotatercept to treat PAH

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

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

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

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found