Drug Filing

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.
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).
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.
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)
11 Nov 2019
Regulation
Drug Filing
AbbVie submits sNDA to FDA for IMBRUVICA, Rituximab combo for CLL

By PBR Staff Writer

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
08 Nov 2019
Regulation
Drug Filing
Johnson & Johnson seeks EMA approval for Ebola vaccine regimen

By PBR Staff Writer

Johnson & Johnson announced that Janssen Pharmaceutical Companies is seeking approval from the European Medicines Agency (EMA) for an investigational Ebola vaccine regimen.
31 Oct 2019
Regulation
Drug Filing
Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA

By PBR Staff Writer

Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment.
25 Oct 2019
Regulation
Drug Filing
Spectrum Pharmaceuticals announces submission to FDA of updated BLA for ROLONTIS

By PBR Staff Writer

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, announced today that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).

Drug Discovery

Research & Development

Parvus and Resilience expand partnership to develop IBD drug candidate

Ring Therapeutics signs partnerships to advance R&D in biomedical sciences

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

Scholar Rock submits application of SMA therapy to FDA

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

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

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

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Drug Filing

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

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

US FDA accepts regulatory submission for Selumetinib

AbbVie submits sNDA to FDA for IMBRUVICA, Rituximab combo for CLL

Johnson & Johnson seeks EMA approval for Ebola vaccine regimen

Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA

Spectrum Pharmaceuticals announces submission to FDA of updated BLA for ROLONTIS

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

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