Regulation

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.
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.
07 May 2020
Regulation
Approvals
Novartis gets FDA nod for Tabrecta to treat metastatic NSCLC with METex14

By PBR Staff Writer

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Tabrecta (capmatinib) to treat adult patients metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping (METex14).
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)
04 May 2020
Regulation
Approvals
FDA grants EUA to Gilead’s antiviral remdesivir for Covid-19 treatment

By PBR Staff Writer

The US Food and Drug Administration (FDA) has given its emergency use authorisation (EUA) for Gilead Sciences' investigational antiviral remdesivir for the treatment of Covid-19.

Drug Discovery

Research & Development

REGENXBIO receives FDA response for RGX-121 application

Takeda and Iambic announce $1.7bn deal to advance small molecule programmes

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

Regulation

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

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

Novartis gets FDA nod for Tabrecta to treat metastatic NSCLC with METex14

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

FDA grants EUA to Gilead’s antiviral remdesivir for Covid-19 treatment

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found