Regulation

28 Nov 2019
- Regulation
- Drug Filing
Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

By PBR Staff Writer

Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a medical dermatology company, announced that its New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is July 13, 2020.
28 Nov 2019
Regulation
Drug Filing
Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention of pregnancy

By PBR Staff Writer

Evofem Biosciences, Inc., a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Amphora, a Multipurpose Vaginal pH Regulator (MVP-R), for the prevention of pregnancy.
28 Nov 2019
Regulation
Drug Filing
FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma

By PBR Staff Writer

The US Food and Drug Administration (FDA) has accepted Incyte’s new drug application (NDA) for the priority review of its pemigatinib to treat patients with cholangiocarcinoma.
27 Nov 2019
Regulation
Approvals
FDA approves Oxbryta (Voxelotor), the first medicine specifically targeting the root cause of sickle cell disease

By PBR Staff Writer

Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older.
26 Nov 2019
Regulation
Approvals
Celltrion Healthcare gets EC approval for its subcutaneous formulation of biosimilar infliximab, Remsima

By PBR Staff Writer

Celltrion Healthcare has secured approval from the European Commission (EC) for its Remsima SC (CT-P13 SC), a subcutaneous formulation of biosimilar infliximab, Remsima, to treat patients with rheumatoid arthritis (RA).
25 Nov 2019
Regulation
Drug Filing
FDA grants breakthrough therapy designation to Usona Institute’s psilocybin for major depressive disorder

By PBR Staff Writer

Usona Institute has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for psilocybin in the treatment of major depressive disorder (MDD).
25 Nov 2019
Regulation
Approvals
SOLIRIS receives approval in Japan for the prevention of relapse in patients with neuromyelitis optica spectrum disorder

By PBR Staff Writer

Alexion Pharmaceuticals announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the extension of the current marketing authorization of SOLIRIS (eculizumab) to include the prevention of relapse in patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.
22 Nov 2019
Regulation
Approvals
FDA approves AstraZeneca’s Calquence to treat lymphocytic cancers

By PBR Staff Writer

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Calquence (acalabrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
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).

Drug Discovery

Research & Development

Apotex and Grünenthal sign deal for Nebido Canadian distribution

PrimeGen US and DT Cloud Star sign $1.5bn merger agreement

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

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Regulation

Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention of pregnancy

FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma

FDA approves Oxbryta (Voxelotor), the first medicine specifically targeting the root cause of sickle cell disease

Celltrion Healthcare gets EC approval for its subcutaneous formulation of biosimilar infliximab, Remsima

FDA grants breakthrough therapy designation to Usona Institute’s psilocybin for major depressive disorder

SOLIRIS receives approval in Japan for the prevention of relapse in patients with neuromyelitis optica spectrum disorder

FDA approves AstraZeneca’s Calquence to treat lymphocytic cancers

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

Alnylam announces approval of GIVLAARI by US FDA

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

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