Regulation

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.
18 May 2020
Regulation
Approvals
Deciphera gets FDA nod for Qinlock to treat fourth-line gastrointestinal stromal tumour

By PBR Staff Writer

Deciphera Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Qinlock (ripretinib) to treat fourth-line gastrointestinal stromal tumour (GIST).
15 May 2020
Regulation
Approvals
Neuraptive Therapeutics announces FDA has granted fast track designation to NTX-001 clinical development programme to treat peripheral nerve injuries

By PBR Staff Writer

Neuraptive Therapeutics, a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
15 May 2020
Regulation
Approvals
Takeda gets expanded EC approval for lymphoma drug Adcetris

By PBR Staff Writer

Takeda Pharmaceutical has secured expanded approval from the European Commission (EC) for its Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone) to treat adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), a subtype of peripheral T-cell lymphoma (PTCL).
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.
13 May 2020
Regulation
Approvals
Seattle Genetics gets approval of TUKYSA in Switzerland for metastatic HER2-positive breast cancer

By PBR Staff Writer

Seattle Genetics announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine (T–DM1).
12 May 2020
Regulation
Approvals
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA RMAT designation granted to CTX001 to treat severe hemoglobinopathies

By PBR Staff Writer

CRISPR Therapeutics and Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX001, an investigational, autologous, gene-edited hematopoietic stem cell therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
11 May 2020
Regulation
Marketing Authorisation
EC approves subcutaneous formulation of Entyvio as maintenance therapy in ulcerative colitis or Crohn’s disease

By PBR Staff Writer

Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
11 May 2020
Regulation
Approvals
Lilly receives US FDA approval for Retevmo

By PBR Staff Writer

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) approved Retevmo (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
11 May 2020
Regulation
Approvals
AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug

By PBR Staff Writer

AstraZeneca and Daiichi Sankyo have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Enhertu to treat patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Drug Discovery

Research & Development

Aarvik announces ADC option exercise by collaboration partner ArriVent

FDA grants priority review for Bavarian Nordic’s chikungunya vaccine BLA

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

FDA grants priority review for Bavarian Nordic’s chikungunya vaccine BLA

FDA accepts Exelixis’ cabozantinib sNDA for neuroendocrine tumours

Production & Sales

Manufacturing

Merck launches GMP-compliant cell culture media line in China

Rosemont acquires Pharma-Data to enhance global product development

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Regulation

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

Deciphera gets FDA nod for Qinlock to treat fourth-line gastrointestinal stromal tumour

Neuraptive Therapeutics announces FDA has granted fast track designation to NTX-001 clinical development programme to treat peripheral nerve injuries

Takeda gets expanded EC approval for lymphoma drug Adcetris

InPro 7100 Series

Seattle Genetics gets approval of TUKYSA in Switzerland for metastatic HER2-positive breast cancer

CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA RMAT designation granted to CTX001 to treat severe hemoglobinopathies

EC approves subcutaneous formulation of Entyvio as maintenance therapy in ulcerative colitis or Crohn’s disease

Lilly receives US FDA approval for Retevmo

AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found