Regulation

19 Oct 2020
- Regulation
- Approvals
Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

By PBR Staff Writer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
16 Oct 2020
$FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL$
Regulation
Approvals
FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

By PBR Staff Writer

Merck announced that the US Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
15 Oct 2020
Regulation
Drug Filing
Y-mAbs announces FDA clearance of IND for its Lutetium-177 labelled omburtamab antibody

By PBR Staff Writer

Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children.
15 Oct 2020
Regulation
Drug Filing
Moderna secures eligibility for submission of MAA of mRNA-1273 to EMA

By PBR Staff Writer

Moderna has announced that it has received written confirmation from the European Medicines Agency (EMA) that mRNA-1273, the Company’s vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure.
15 Oct 2020
Regulation
Approvals
Regeneron’s Inmazeb gets FDA approval for Ebola treatment

By PBR Staff Writer

Regeneron Pharmaceuticals’ antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) has been approved by the US Food and Drug Administration (FDA) for the treatment of Zaire ebolavirus (Ebola virus).
12 Oct 2020
Regulation
Drug Filing
Gannex received US IND approval for its NASH Drug Candidate ASC42

By PBR Staff Writer

Gannex Pharma, a wholly owned company of Ascletis Pharma announces that it received investigational new drug application (IND) approval from FDA for its drug candidate ASC42, to conduct clinical trials for non-alcoholic steatohepatitis (NASH) indication.
08 Oct 2020
Regulation
Drug Filing
ARCA gets FDA approval of IND for Covid-19 drug candidate AB201

By PBR Staff Writer

ARCA biopharma said that its investigational new drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalised with Covid-19 has been approved by the US Food and Drug Administration (FDA).
08 Oct 2020
Regulation
Approvals
Ocular Therapeutix announces topline phase 1 clinical trial results of OTX-CSI

By PBR Staff Writer

Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).
07 Oct 2020
Regulation
Drug Filing
FDA broadly supports Oragenics’ Pre-IND development programme for SARS-CoV-2 vaccine

By PBR Staff Writer

Oragenics, Inc. announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2.
07 Oct 2020
Regulation
Drug Filing
BioNTech, Pfizer initiate rolling submission to EMA for SARS-CoV-2 vaccine candidate

By PBR Staff Writer

Pfizer and BioNTech announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against Covid-19.

Drug Discovery

Research & Development

Parvus and Resilience expand partnership to develop IBD drug candidate

Ring Therapeutics signs partnerships to advance R&D in biomedical sciences

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

Scholar Rock submits application of SMA therapy to FDA

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

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

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Regulation

Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

Y-mAbs announces FDA clearance of IND for its Lutetium-177 labelled omburtamab antibody

Moderna secures eligibility for submission of MAA of mRNA-1273 to EMA

Regeneron’s Inmazeb gets FDA approval for Ebola treatment

Gannex received US IND approval for its NASH Drug Candidate ASC42

ARCA gets FDA approval of IND for Covid-19 drug candidate AB201

Ocular Therapeutix announces topline phase 1 clinical trial results of OTX-CSI

FDA broadly supports Oragenics’ Pre-IND development programme for SARS-CoV-2 vaccine

BioNTech, Pfizer initiate rolling submission to EMA for SARS-CoV-2 vaccine candidate

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

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