Regulation

30 Oct 2020
- Regulation
- Marketing Authorisation
EC approves Zejula as first-line monotherapy maintenance treatment in advanced ovarian cancer

By PBR Staff Writer

GlaxoSmithKline (GSK) announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.
29 Oct 2020
Regulation
Drug Filing
ENHERTU gets FDA priority review in HER2-positive metastatic gastric cancer

By PBR Staff Writer

AstraZeneca and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
28 Oct 2020
Regulation
Drug Filing
FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib

By PBR Staff Writer

Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older.
28 Oct 2020
Regulation
Approvals
Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease

By PBR Staff Writer

Kala Pharmaceuticals, a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the US Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
26 Oct 2020
Regulation
Drug Filing
Novartis’ iptacopan gets EMA’s orphan drug designation in IgAN

By PBR Staff Writer

Novartis has secured orphan drug designation from the European Medicines Agency (EMA) for its oral, small molecule iptacopan (LNP023) in IgA nephropathy (IgAN).
23 Oct 2020
Regulation
Approvals
US FDA approves Gilead’s antiviral drug Veklury for treatment of Covid-19

By PBR Staff Writer

The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for the treatment of Covid-19 in patients needing hospitalisation.
22 Oct 2020
Regulation
Approvals
Novartis gets FDA orphan drug status for branaplam to treat Huntington’s disease

By PBR Staff Writer

Novartis has secured orphan drug designation from the US Food and Drug Administration (FDA) for its branaplam (LMI070) to treat Huntington’s disease (HD).
21 Oct 2020
Regulation
Drug Filing
TAGRISSO granted FDA priority review in early-stage EGFR-mutated lung cancer

By PBR Staff Writer

AstraZeneca’s TAGRISSO (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
21 Oct 2020
Regulation
Approvals
Xeris Pharmaceuticals granted fast track designation by FDA for novel concentrated diazepam formulation for injection

By PBR Staff Writer

Xeris Pharmaceuticals, a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced it was granted fast track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.
21 Oct 2020
Regulation
Approvals
Astellas Pharma gets FDA fast track status for ASP036 to treat primary mitochondrial myopathies

By PBR Staff Writer

Astellas Pharma has secured fast track status from the US Food and Drug Administration (FDA) to develop ASP0367/MA-0211 (ASP0367) as a potential treatment for primary mitochondrial myopathies (PMM).

Drug Discovery

Research & Development

Formycon and Zydus sign exclusive agreement for FYB206 supply

Inductive Bio gains $21m ARPA-H funds for drug prediction models

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

EC approves Zejula as first-line monotherapy maintenance treatment in advanced ovarian cancer

ENHERTU gets FDA priority review in HER2-positive metastatic gastric cancer

FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib

Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease

Novartis’ iptacopan gets EMA’s orphan drug designation in IgAN

US FDA approves Gilead’s antiviral drug Veklury for treatment of Covid-19

Novartis gets FDA orphan drug status for branaplam to treat Huntington’s disease

TAGRISSO granted FDA priority review in early-stage EGFR-mutated lung cancer

Xeris Pharmaceuticals granted fast track designation by FDA for novel concentrated diazepam formulation for injection

Astellas Pharma gets FDA fast track status for ASP036 to treat primary mitochondrial myopathies

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found