Regulation

21 Nov 2019
- Regulation
- Marketing Authorisation
EC approves two new regimens of Merck’s KEYTRUDA for metastatic or unresectable recurrent HNSCC

By PBR Staff Writer

Merck, known as MSD outside the US and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1).
21 Nov 2019
Regulation
Approvals
Alnylam announces approval of GIVLAARI by US FDA

By PBR Staff Writer

Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced today that the US Food and Drug Administration (FDA) approved GIVLAARI (givosiran) injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP).
20 Nov 2019
Regulation
Drug Filing
Newron’s sarizotan secures FDA rare paediatric status in Rett syndrome

By PBR Staff Writer

Newron Pharmaceuticals has secured rare paediatric disease designation for sarizotan from the US Food and Drug Administration (FDA) for the treatment of Rett syndrome.
20 Nov 2019
Regulation
Approvals
Janssen gets EC approval for Darzalex combination regimen to treat multiple myeloma

By PBR Staff Writer

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorisation from the European Commission (EC) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).
19 Nov 2019
Regulation
Approvals
FDA approves Pfizer’s biosimilar, ABRILADA (adalimumab-afzb) for multiple inflammatory conditions

By PBR Staff Writer

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
18 Nov 2019
Regulation
Approvals
Novartis’ Adakveo approved by FDA to reduce VOCs in sickle cell disease

By PBR Staff Writer

Novartis has secured approval for Adakveo (crizanlizumab) from the US Food and Drug Administration (FDA) for its use in sickle cell disease patients.
18 Nov 2019
Regulation
Approvals
Qtrilmet approved in EU to treat type-2 diabetes

By PBR Staff Writer

AstraZeneca announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).
15 Nov 2019
Regulation
Drug Filing
US FDA accepts regulatory submission for Selumetinib

By PBR Staff Writer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs)
15 Nov 2019
Regulation
Approvals
Shionogi gets FDA approval for cUTI drug Fetroja

By PBR Staff Writer

Shionogi has secured approval from the US Food and Drug Administration (FDA) for its Fetroja (cefiderocol) to treat complicated urinary tract infections (cUTI) in adult patients with limited or no alternative treatment.
13 Nov 2019
Regulation
Approvals
X4 Pharmaceuticals receives breakthrough therapy designation from FDA for Mavorixafor to treat WHIM Syndrome

By PBR Staff Writer

X4 Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for mavorixafor (X4P-001) for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene.

Drug Discovery

Research & Development

WellSpan and Johns Hopkins renew partnership for advanced cancer care access

SandboxAQ introduces AQPotency for virtual drug screening

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

EC approves two new regimens of Merck’s KEYTRUDA for metastatic or unresectable recurrent HNSCC

Alnylam announces approval of GIVLAARI by US FDA

Newron’s sarizotan secures FDA rare paediatric status in Rett syndrome

Janssen gets EC approval for Darzalex combination regimen to treat multiple myeloma

FDA approves Pfizer’s biosimilar, ABRILADA (adalimumab-afzb) for multiple inflammatory conditions

Novartis’ Adakveo approved by FDA to reduce VOCs in sickle cell disease

Qtrilmet approved in EU to treat type-2 diabetes

US FDA accepts regulatory submission for Selumetinib

Shionogi gets FDA approval for cUTI drug Fetroja

X4 Pharmaceuticals receives breakthrough therapy designation from FDA for Mavorixafor to treat WHIM Syndrome

Pharmaceutical Business review is using cookies

Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found