Approvals

21 May 2020
- Regulation
- Approvals
LYNPARZA approved in US for HRR gene-mutated metastatic castration-resistant prostate cancer

By PBR Staff Writer

AstraZeneca and Merck announced that LYNPARZA (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
20 May 2020
Regulation
Approvals
Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular atrophy

By PBR Staff Writer

Novartis company AveXis has secured conditional approval from the European Commission (EC) for its Zolgensma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA).
19 May 2020
Regulation
Approvals
FDA approves Genentech’s Tecentriq as first-line monotherapy for certain people with metastatic NSCLC

By PBR Staff Writer

Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
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).
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
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

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

No data found

Approvals

LYNPARZA approved in US for HRR gene-mutated metastatic castration-resistant prostate cancer

Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular atrophy

FDA approves Genentech’s Tecentriq as first-line monotherapy for certain people with metastatic NSCLC

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

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

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