Drug Application Articles & Analysis

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical ...

By Acta Group

On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature ...

By Bergeson & Campbell, P.C.

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical ...

By Bergeson & Campbell, P.C.

Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its updated New Drug Application (NDA) for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder. The CRL is a result of continued quality related deficiencies at Braeburn’s US ...

By Camurus AB

PHILADELPHIA, May 10, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by 90 days for the Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, the two components of AT-GAA. The revised PDUFA action dates for miglustat and ...

By Amicus Therapeutics, Inc.

Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castrationresistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. ...

By Advanced Accelerator Applications SA

Duaklir® NDA for treatment of chronic obstructive pulmonary disease (COPD) Tudorza® sNDA for inclusion of COPD exacerbation reduction and cardiovascular safety data in label Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug ...

By Circassia Group PLC

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vialsto market a generic equivalent of Brovana®Inhalation Solution, 15 mcg/2 ml of Sunovion Pharmaceuticals Inc. (Sunovion). ...

By Lupin Limited

Oxford, UK – 29 March 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Tudorza®’s supplemental New Drug Application (sNDA) for the inclusion of unique new clinical data in the product’s ...

By Circassia Group PLC

Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to label – – Tudorza® is the only product in its class with these data in the label Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US ...

By Circassia Group PLC

Symberix and licensor, University of North Carolina at Chapel Hill, received a Notice of Allowance from the U.S. Patent and Trademark Office for a pharmaceutical patent application related to using non-antibiotic, small molecules to address side effects from chemotherapeutic drugs. The patent application is titled “Selective Beta-Glucuronidase Inhibitors as a Treatment for Side Effects of ...

By Symberix, Inc.

CARLSBAD, Calif., March 7, 2023 /PRNewswire/ -- Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The application has been given ...

By Heart Failure Society of America, Inc. (HFSA)

Antengene is proud to announce that the oral presentation for ATG-031 (anti-CD24 monoclonal antibody) presented at the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022) was selected for the SITC top 100 abstracts. ATG-031 is a first-in-class, humanized anti-CD24 antibody. ATG-031 potently binds to CD24-postive tumor cells. ATG-031 blocks the interaction between CD24 and ...

By Antengene Corporation Limited

Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801. This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central ...

By Botanix Pharmaceuticals

Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces that the United States Food and Drug Administration (FDA) has confirmed it has completed its validation for completeness, and accepted for filing and review, the previously submitted Duaklir® New Drug Application ...

By Circassia Group PLC

Notitia Biotechnologies Company has developed a ground-breaking live biotherapeutic product (LBP) for patients with early-stage and end-stage diabetic kidney disease (DKD) patients. The drug, NBT-BM306, combines the purified Foundation Guild bacteria and the tailored microbiome nutrition to support their growth in one convenient format. Notitia is preparing the Investigational New Drug (IND) ...

By Notitia Biotechnologies

NEW YORK, NY – January 3, 2021 – Woolsey Pharmaceuticals, a repurposed therapeutics development company announced that the European Medicines Agency’s Committee for Orphan Medicinal Product has issued a positive opinion on the orphan drug application for the Company’s investigational drug, BRAVYL® (oral fasudil), for the treatment of Amyotrophic Lateral Sclerosis ...

By Woolsey Pharmaceuticals, Inc.

Oxford, UK – 8 May 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the full publication of the Tudorza® phase IV ASCENT study in the prestigious Journal of the American Medical Association*. The ASCENT study was conducted in patients with ...

By Circassia Group PLC

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the New Drug ...

By Polarean Imaging plc.

SOMERVILLE, Mass., April 19, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced plans to reduce its workforce by approximately 20%. This ...

By Finch Therapeutics Group, Inc.