AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) in combination with Faslodex (fullvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations.

Virocell Biologics has announced that it can now manufacture and export viral vectors from Great Ormand Street Hospital’s (GOSH) state-of-the-art manufacturing facility, the Zayed Centre for Research, for use in clinical trials.

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Welcome to the December 2023 issue of Pharmafocus!

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GSK has announced that the CHMP of the EMA has given a positive recommendation to the company’s momelotinib for patients with myelofibrosis.

Novo Nordisk has announced plans to invest over 42bn Danish kroner to expand its existing manufacturing facilities in Kalundbord, Denmark, for production of the company’s current and future product portfolio within serious chronic diseases.

Bit.bio has announced its cell therapy pipeline as well as having shared its lead cell therapy candidate, preparing to enter clinical development in 2025.

Autifony Therapeutics has announced that it has entered an exclusive global licensing agreement with Jazz Pharmaceuticals for up to $770.5m, with the intention of discovering and developing drug candidates to target two different ion channel targets associated with neurological disorders.

GSK has announced that in 2024 it intends to start phase 3 trials of a low carbon version of its metered-dose inhaler ventolin (salbutamol) using a next-generation propellant.

AstraZeneca has announced positive results from the EMERALD-1 phase 3 trial for Imfinzi (durvalumab) in combination with transarterial chemoembolisation and bevacizumab for the treatment of patients with hepatocellular carcinoma eligible for embolisation.

Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/ml injection for intravenous use at the 16th annual clinical trials on Alzheimer’s disease conference in Boston, US on 24-27 October 2023.

Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its nivolumab injection (ba1104) in china.

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Merck, known as MSD outside of the US, has announced that the FDA has approved Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic her2-negative gastric or gastroesophageal junction adenocarcinoma.

Bristol Myers Squibb has announced that the FDA has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer.

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Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination use with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia that is flt3-itd positive.

Eli Lilly has announced that the FDA has approved Zepbound (tirzepatide) injection for chronic weight management, indicated for patients who are obese or overweight and have weight-related medical problems such as hypertension, dyslipidaemia, type 2 diabetes mellitus, obstructive sleep apnoea or cardiovascular disease.

Johnson & Johnson Medtech has announced plans to submit the Ottava robotic surgical system to the FDA for an investigational device exemption application in the second half of 2024.

AstraZeneca has announced a collaboration and investment agreement with Cellectis for the development of next-generation cell and gene therapeutics in areas such as oncology, immunology and rare diseases.

Evotec and Dewpoint Therapeutics have announced a strategic R&D collaboration for the advancement of Dewpoint’s oncolo y pipeline programmes of condensate-modifying therapeutics to investigational new drug applications through the use of Evotec’s fully integrated data-driven platform.

Halozyme Therapeutics has announced a global collaboration and non-exclusive licence with Acumen Pharmaceuticals, providing Acumen with access to Halozyme’s ENHANZE drug delivery technology.

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Roche has announced that it has entered into a definitive agreement to acquire Telavant Holdings, a Roivant company, owned by Roivant sciences and Pfizer.

Astellas Pharma and Propella Therapeutics have announced that they have entered a merger agreement in which Astellas will acquire Propella for approximately $175m.

Prange Group and Adragos Pharma have announced the signing of definitive agreements with Fresenius Kabi for their acquisition of its leading sterile pharmaceutical production site in Halden, Norway.

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Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials

Steve Brownett-Gale, marketing lead at Origin, considers how to combat counterfeiting in the pharma industry

Monika Lamba Saini, Greg Lever and Ashley Polhemus from IQVIA and Q2 Solutions explore digital health technologies and their use in clinical trials

Oxolife has announced that it has appointed globally renowned fertility experts to its scientific advisory board.

NanoSyrinx has announced the appointment of Anthony Johnson MD to its board as non-executive director.

Enhanc3D Genomics has announced the appointment of Hazel Jones as chief operating officer.

IO Biotech has announced the appointment of Helen Collins MD to its board of directors.

Betsy Goodfellow from Pharmafocus looks back at 2023 and reviews some of the biggest pharma news of the year

Read on for five key facts about AMR.

Get in touch @pharmafocus

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