Regulation

27 May 2020
- Regulation
- Approvals
FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent NSCLC

By PBR Staff Writer

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
27 May 2020
Regulation
Approvals
FDA approves Dupixent as first biologic medicine for children aged six to 11 years with moderate-to-severe atopic dermatitis

By PBR Staff Writer

The US Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.
26 May 2020
Regulation
Approvals
US FDA approves Takeda’s ALUNBRIG for rare and serious form of lung cancer

By PBR Staff Writer

Takeda Pharmaceutical Company announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
26 May 2020
Regulation
Drug Filing
Novaremed seeks FDA nod for evaluating NRD135S.E1 for treatment of PDPN

By PBR Staff Writer

Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).
26 May 2020
Regulation
Approvals
Enhertu granted orphan drug designation in US for gastric cancer

By PBR Staff Writer

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.
22 May 2020
Regulation
Approvals
Sunovion gets FDA nod for Kynmobi to treat Parkinson’s disease off episodes

By PBR Staff Writer

Sunovion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Kynmobi (apomorphine hydrochloride) sublingual film (APL-130277) to treat Parkinson’s disease (PD) off episodes.
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
Drug Filing
Tolero Pharmaceuticals submits investigational new drug application for experimental PKM2 activator TP-1454

By PBR Staff Writer

Tolero Pharmaceuticals, a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454.
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.

Drug Discovery

Research & Development

Sanofi receives FDA approval for Tzield in paediatric diabetes

MSD teams up with Google Cloud on agentic AI transformation

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

FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent NSCLC

FDA approves Dupixent as first biologic medicine for children aged six to 11 years with moderate-to-severe atopic dermatitis

US FDA approves Takeda’s ALUNBRIG for rare and serious form of lung cancer

Novaremed seeks FDA nod for evaluating NRD135S.E1 for treatment of PDPN

Enhertu granted orphan drug designation in US for gastric cancer

Sunovion gets FDA nod for Kynmobi to treat Parkinson’s disease off episodes

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

Tolero Pharmaceuticals submits investigational new drug application for experimental PKM2 activator TP-1454

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

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found