Industry News

18 February 2025

MED-EL USA gets FDA approval for cochlear implant

MED-EL USA announced that the U.S. Food and Drug Administration approved the new SONNET 3 audio processor for MED-EL cochlear implants. SONNET 3 is the companys lightest and smallest behind-the-ear audio processor and features integrated wireless direct streaming capabilities.

15 February 2025

Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer

Pfizer Inc announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA talazoparib, an oral poly ADP-ribose polymerase inhibitor, in combination with XTANDI enzalutamide, an androgen receptor pathway inhibitor ARPI, demonstrating a statistically significant and clinically meaningful improvement in overall survival OS compared to placebo plus XTANDI in patients with metastatic castration-resistant prostate cancer mCRPC, with or without homologous recombination repair HRR gene mutations.

21 January 2025

Glenmark Pharma USA launches Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules

Glenmark Pharmaceuticals Inc., USA announces the launch1 of Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules. Glenmark’s Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules is bioequivalent and therapeutically equivalent to the reference listed drug, Vitamin K1 Injectable Emulsion USP, 10 mg/mL of Hospira, Inc., ANDA 087955.

8 January 2025

Sentynl Therapeutics announces USFDA Acceptance and Priority Review of NDA for CUTX-101

Sentynl Therapeutics, Inc. a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd and Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration has accepted for filing and Priority review Sentynls New Drug Application for CUTX-101

8 January 2025

Zydus agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR

Zydus Lifesciences Ltd. a global innovation driven healthcare company announced that it has entered into an agreement with CVS Caremark®, a CVS Health® (NYSE: CVS) company to add ZituvioTM , ZituvimetTM and ZituvimetTM XR (Sitagliptin | Sitagliptin and Metformin Hydrochloride) tablets to its template formulary.

CVS Caremark will add Zydus’ ZituvioTM and combination products to its template formulary starting January 1, 2025.

1 January 2025

Lupin acquires Huminsulin from Lilly to Enhance Diabetes Portfolio

Global pharma major Lupin Limited announced the acquisition of Huminsulin® in India from Eli Lilly and Company to further enhance its diabetes portfolio. Lupin has been marketing the Huminsulin range of products comprising of Insulin Human, including Huminsulin R, Huminsulin NPH, Huminsulin 50/50, and Huminsulin 30/70, through existing Distribution and Promotion Agreements with Lilly, India.

27 December 2024

Akums signs agreement of Rs. 1760 crore to supply pharmaceuticals in Europe

Akums Drugs and Pharmaceuticals has entered into an agreement with one of Leading Global Pharma Company for Manufacture and Supply of selected pharmaceutical formulations in the European Market. Akums group will manufacture and supply Oral Liquid Formulation to be marketed in multiple European countries.

19 December 2024

SPARC announces Signing of Binding Letter of Intent with UCSF and Tiller Therapeutics for Pre-clinical Oncology Asset and Associated Intellectual Property

Sun Pharma Advanced Research Company Ltd announced the signing of a binding Letter of Intent with the University of California, San Francisco, through the office of OTMA, and Tiller Therapeutics Inc. to license SPARC’s rights in the joint intellectual property held between SPARC and UCSF for pre-clinical oncology asset along with associated IP. The LOI outlines the key terms of license and rights for development and commercialization by Tiller.

13 December 2024

IBRANCE® in combination with Standard-of-Care therapies extends survival by over 15 months

Pfizer Inc. and Alliance Foundation Trials, LLC announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE palbociclib to current standard-of-care first-line maintenance therapy following induction chemotherapy resulted in statistically significant and clinically meaningful improvement in progression-free survival by investigator assessment in patients with hormone receptor-positive

12 December 2024

Cipla receives approval for distribution and marketing of inhaled insulin in India

Cipla Limited announced that it has obtained regulatory approval from Central Drugs Standard Control Organisation for the exclusive distribution and marketing of Afrezza insulin human Inhalation Powder in India. Afrezza, a product created and manufactured by MannKind Corporation

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MED-EL USA gets FDA approval for cochlear implant

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