Regulation

30 Apr 2020
- Regulation
- Approvals
FDA approves Zejula in platinum-responsive advanced ovarian cancer regardless of biomarker status

By PBR Staff Writer

GlaxoSmithKline announced the US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
29 Apr 2020
Regulation
Approvals
FDA approves additional dosage of KEYTRUDA across all adult indications

By PBR Staff Writer

Merck said that the US Food and Drug Administration (FDA) has given its approval for the use of its cancer drug KEYTRUDA (pembrolizumab) at an additional dosage of 400mg every six weeks (Q6W) across all indications in adult patients.
28 Apr 2020
Regulation
Approvals
Takeda gets FDA breakthrough therapy status for mobocertinib to treat certain type of lung cancer

By PBR Staff Writer

Takeda Pharmaceutical has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational drug mobocertinib (TAK-788) to treat patients with metastatic non-small cell lung cancer (NSCLC).
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
27 Apr 2020
Regulation
Approvals
Sanofi gets FDA nod for MenQuadfi meningococcal vaccine

By PBR Staff Writer

French drugmaker Sanofi has secured approval from the US Food and Drug Administration (FDA) for its MenQuadfi meningococcal vaccine.
23 Apr 2020
Regulation
Akili announces ENDEAVOR Digital Attention Treatment is available for children with ADHD under FDA’s COVID-19 enforcement discretion guidance

By PBR Staff Writer

Akili today announced that ENDEAVOR (AKL-T01) is now available for use by children with attention deficit hyperactivity disorder (ADHD) and their families.
23 Apr 2020
Regulation
Approvals
Novartis gets FDA RMAT designation for Kymriah in follicular lymphoma

By PBR Staff Writer

Novartis has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel) for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).
22 Apr 2020
Regulation
Approvals
Nexus Pharmaceuticals announces approval of Emerphed injection

By PBR Staff Writer

Nexus Pharmaceuticals announced that has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial. With no need for compounding, diluting, or mixing, Emerphed saves valuable staff time while also reducing the potential for preparation error and waste.
22 Apr 2020
Regulation
Approvals
Boehringer Ingelheim gets EC approval for nintedanib to treat SSc-ILD

By PBR Staff Writer

Boehringer Ingelheim has secured approval from the European Commission (EC) for its nintedanib to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adult patients.
20 Apr 2020
Regulation
Approvals
FDA approves Incyte’s Pemazyre as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma

By PBR Staff Writer

Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre™ (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

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

Regulation

FDA approves Zejula in platinum-responsive advanced ovarian cancer regardless of biomarker status

FDA approves additional dosage of KEYTRUDA across all adult indications

Takeda gets FDA breakthrough therapy status for mobocertinib to treat certain type of lung cancer

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

Sanofi gets FDA nod for MenQuadfi meningococcal vaccine

Akili announces ENDEAVOR Digital Attention Treatment is available for children with ADHD under FDA’s COVID-19 enforcement discretion guidance

Novartis gets FDA RMAT designation for Kymriah in follicular lymphoma

Nexus Pharmaceuticals announces approval of Emerphed injection

Boehringer Ingelheim gets EC approval for nintedanib to treat SSc-ILD

FDA approves Incyte’s Pemazyre as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found