Biologics News

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• In August 2024, AstraZeneca’s Imfinzi (durvalumab), an immunotherapy in combination with chemotherapy was approved in the United States for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
• In June 2024, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck), a type of immunotherapy that can be used with carboplatin and paclitaxel. This combination is followed by a regimen of single-agent pembrolizumab, specifically targeting adult patients suffering from primary advanced or recurrent endometrial carcinoma.

• April 2024: Nestle India and Dr Reddy’s Laboratories Ltd entered a definitive agreement to form a joint venture to bring innovative nutraceutical brands to consumers in India and other agreed territories. Dr Reddy’s has licensed brands such as Rebalanz, Celevida, Antoxid, Kidrich-D3, and Becozinc in the nutrition and OTC (over-the-counter) segments.
• March 2024: Emcure Pharmaceuticals launched its new over-the-counter (OTC) product, Galact, and entered the OTC market.

• February 2024: Nivasorexant (ACT-539313), the first selective orexin-1 receptor antagonist (SO1RA), was investigated during clinical trials.
• May 2022: Idorsia Ltd received marketing authorization from the European Commission for QUVIVIQ, which was indicated for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.
• January 2022: Idorsia received approval from the US Food and Drug Administration for QUVIVIQ 25 and 50 mg for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

• November 2023: The United States Food and Drug Administration approved fast-track designation for Alladapt Immunotherapeutics’ IgE-mediated multi-food oral immunotherapy, ADP101, based on Phase I/II data.
• November 2023: Aimmune Therapeutics Inc. received approval for PALFORZIA from the US Food and Drug Administration to treat allergic reactions like anaphylaxis that may occur with accidental exposure to peanuts.

• In September 2023, Biogen Inc. received approval from the US Food and Drug Administration (FDA) for TOFIDENCE (tocilizumab-bavi) intravenous formulation. TOFIDENCE marks the pioneering approval of the tocilizumab biosimilar in the United States, signaling a significant advancement in treatment options for specified medical conditions.
• In June 2022, Aeglea BioTherapuetics announced that it had failed to secure a biologics license application (BLA) from the FDA after administrators issued a refusal to file for the company's biologic pegzilarginase.
• In February 2022, Janssen Pharmaceutical Companies of Johnson & Johnson received the United States Food and Drug Administration (FDA) approval for CARVYKTI (ciltacabtagene autoleucel; cilia-cel). This biologic medicine treats adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

• October 2023: Panacea Biotec launched Paclitaxel protein-bound particles for injectable suspension (albumin-bound), which is indicated for the treatment of metastatic breast cancer, non-small cell lung cancer, and adenocarcinoma of the pancreas in the Canadian market through its strategic partner, Apotex Inc. of Canada.
• March 2023: Natco Pharma introduced a generic version of the cancer drug Pomalidomide Capsules in Canada. It is the first generic alternative to Celgene Corporation’s Pomalyst brand in the country, approved by Health Canada. Pomalidomide is used in combination with Dexamethasone and Bortezomib for the treatment of multiple myeloma in adults.

• May 2024: Dr. Reddy's Laboratories introduced a generic medication, Doxycycline Capsules (40 mg), to the US market. This medication is designed to combat a broad spectrum of bacterial infections. Notably, the product serves as a therapeutic generic alternative to the USFDA-approved Oracea capsules (40 mg).
• January 2024: SinoT received approval for its generic drug Posaconazole delayed-release tablets from Health Canada. Posaconazole is a member of the group of triazole antifungals, which is used to prevent certain kinds of fungal or yeast infections.

• April 2023: Aurobindo Pharma approved the transfer of two API units (Unit V and XVII) to its wholly-owned subsidiary Apitoria Pharma Private Limited.
• January 2023: Novartis sold its active pharmaceutical ingredient (API) manufacturing facility in Ringaskiddy, Ireland, to Sterling Pharma Solutions. Under the terms of the agreement, Novartis continues to manufacture several APIs for cardiovascular, immunology, and oncology medicines at Ringaskiddy.

• January 2023: Elicio Therapeutics engineers lymph node-targeted adjuvants and vaccines for an array of aggressive cancers and infectious diseases and entered into a definitive merger agreement with Angion Biomedica Corp to focus on advancing Elicio's proprietary lymph node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.
• November 2022: Hubro Therapeutics AS acquired GM-CSF vaccine adjuvant from Targovax ASA in an asset purchase agreement for a cash payment of NOK10 million. Hubro continues the development of GM-CSF as an adjuvant for use with its pipeline of novel cancer vaccines.

• July 2023: Gilead Sciences, Inc. received approval from the European Commission (EC) for Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
• July 2023: BeiGene and DualityBio entered a partnership agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors.