Drug Filing

18 May 2020
- Regulation
- Drug Filing
Can-Fite announces pre-IND submission to US FDA for Piclidenoson in treatment of Covid-19 infected patients with moderate-to-severe symptoms

By PBR Staff Writer

Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms.
15 May 2020
Drug Filing
InPro 7100 Series

By victoria.smith

The InPro 7100 (i) series is designed for the Chemical, Pharmaceutical, Food & Beverage and Pulp & Paper industries. The PEEK shaft material offers high resistivity against aggressive liquids and is particularly suitable for processes with frequent CIP/SIP cycles.
08 May 2020
Regulation
Drug Filing
Daiichi Sankyo submits sNDA for trastuzumab deruxtecan in Japan for HER2 positive metastatic gastric cancer

By PBR Staff Writer

Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer.
05 May 2020
Regulation
Drug Filing
Acceleron receives PRIME designation from EMA for Sotatercept in pulmonary arterial hypertension

By PBR Staff Writer

Acceleron Pharma said that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
04 May 2020
Regulation
Drug Filing
FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adults in remission with AML

By PBR Staff Writer

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486 for the maintenance treatment of adults in remission with acute myeloid leukemia (AML)
27 Apr 2020
Regulation
Drug Filing
Janssen announces submission of two applications to US FDA seeking approval of SIMPONI ARIA to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

By PBR Staff Writer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate
09 Apr 2020
Regulation
Drug Filing
Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension

By PBR Staff Writer

Acceleron Pharma announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
08 Apr 2020
Regulation
Drug Filing
Alnylam seeks FDA approval for lumasiran in primary hyperoxaluria type 1

By PBR Staff Writer

Alnylam Pharmaceuticals has filed an application with the US Food and Drug Administration (FDA) seeking the latter’s approval for lumasiran for the treatment of primary hyperoxaluria type 1 (PH1).
08 Apr 2020
Regulation
Drug Filing
Beam Therapeutics licenses SIRION Biotech’s LentiBOOST Technology for its CAR-T pipeline

By PBR Staff Writer

SIRION Biotech announced that Beam Therapeutics licensed rights to use SIRION Biotech’s LentiBOOST for use in their CAR-T cell products.
01 Apr 2020
Regulation
Drug Filing
Bristol Myers Squibb and bluebird bio submit BLA for Idecabtagene Vicleucel to FDA

By PBR Staff Writer

Bristol Myers Squibb and bluebird bio submitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adults with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

Drug Discovery

Research & Development

FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL

AGC Biologics to expand cell line development with ATUM partnership

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

Drug Filing

Can-Fite announces pre-IND submission to US FDA for Piclidenoson in treatment of Covid-19 infected patients with moderate-to-severe symptoms

InPro 7100 Series

Daiichi Sankyo submits sNDA for trastuzumab deruxtecan in Japan for HER2 positive metastatic gastric cancer

Acceleron receives PRIME designation from EMA for Sotatercept in pulmonary arterial hypertension

FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adults in remission with AML

Janssen announces submission of two applications to US FDA seeking approval of SIMPONI ARIA to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension

Alnylam seeks FDA approval for lumasiran in primary hyperoxaluria type 1

Beam Therapeutics licenses SIRION Biotech’s LentiBOOST Technology for its CAR-T pipeline

Bristol Myers Squibb and bluebird bio submit BLA for Idecabtagene Vicleucel to FDA

Pharmaceutical Business review is using cookies

Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found