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Yearly Archives: 2020

USFDA Approves First Generic of Daraprim

Feb 28, 2020: The U.S. FDA  has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by...

USFDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for the treatment of HER2-positive breast cancer

Feb 25, 2020: USFDA has accepts Roche’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,...

Sanofi to create new industry-leading European company to provide active pharmaceutical ingredients

Feb 24, 2020: Sanofi plans to produce a major leading European company dedicated to the production and marketing to the third parties of active...

AstraZeneca divests global rights to Movantik (naloxegol)

Feb 25, 2020: AstraZeneca has decided to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill). Movantik...

Y-mAbs Announces Positive Pre-Biologics License Application Meeting with FDA for Omburtamab

Feb. 26, 2020: Therapeutics announced that it has completed a positive Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S.FDA regarding a potential pathway for...

NIH clinical trial of remdesivir to treat coronavirus disease 2019 (COVID-19) begins

Feb 25, 2020: A randomized, controlled clinical trial to evaluate the safety and effectiveness of the investigational antiviral remdesivir in hospitalized adults diagnosed with...

Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Feb 24, 2020: Novartis announced that both the USFDA and EMA have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application...

Novartis receives EC Approval for Beovu®(brolucizumab), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020: Novartis announced the European Commission has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the...

US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

Feb. 18, 2020: Retrotope announced that the U.S.FDA Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug...

MediciNova Receives Notice of Allowance from the Japan Patent Office for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH...

Feb. 17, 2020: MediciNova announced that it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-001...

Arctoris announces a formal partnership with Molecule to tackle the innovation crisis in the drug discovery and development

Feb 10, 2020: Arctoris Ltd has announced a formal partnership with Molecule to address the ongoing crisis of innovation faced by drug discovery and development across industry and  academia alike. “Arctoris helps researchers and biotechnology entrepreneurs to design and conduct advanced cellbased, molecular biology, and biochemical assays remotely through its fully automated drug discovery platform. Together with Molecule's collaborative IP ownership network, which enables drug development stakeholders to collaborate and share ownership of the IP they work to develop, Arctoris and Molecule are positioned to take crucial steps to make drug discovery and production quicker, cheaper, less risk-prone and more competitive at all levels. "Drug discovery researchers worldwide face enormous challenges posed by a wide-ranging lack of reproducibility and the limited ease of use of standardised, structured,...

Lupin received approval from U.S. FDA and launches Moxifloxacin Ophthalmic Solution USP 0.5%

Feb 14, 2020: Pharma major Lupin Limited announced the launch of Moxifloxacin Ophthalmic Solution USP, 0.5%, having received an approval from the U.S. FDA earlier....
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