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BRIEF—FDA Breakthrough status for GSK’227 in osteosarcoma

UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy. 7 January 2025

BRIEF—Centauri given $1.25m to advance antimicrobials

UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024

BRIEF—Brookfield mulls $7.4 billion bid for Grifols

19 November 2024

$800 million investment planned at GSK Pennsylvania site

GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024

BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024

BRIEF—UMCG and SHINE receive $11 million grant for cancer study

University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024

BRIEF—Germany becomes first country to launch LEO Pharma’s Anzupgo

Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024

BRIEF—Sanofi in talks to sell 50% of Opella

French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024

BRIEF—ABPI reviews first six months of the 2024 Voluntary Scheme

The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024

BRIEF—Mitem Pharma acquires Desferal from Novartis

French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024

BRIEF—OeAW and Boeh-Ing Foundation establish new Institute for biomedical AI in Vienna

The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024

BRIEF—Novartis expands US radioligand therapy manufacturing

Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024

BRIEF—UCB divesting mature product portfolio in China

Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024

BRIEF—AstraZeneca denies relocation claims for UK vaccine site

The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024

BRIEF—Collategene sales rights deal terminated in Japan and the USA

Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024

BRIEF—AstraZeneca’s market cap now exceeds over £200 billion

UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024

BRIEF—Pfizer adds to Vyndaqel data with RWE

US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024

BRIEF—Shionogi’s NDA for cefiderocol accepted in China

Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024

BRIEF—Bayer seeks approval for novel hot flashes treatment

Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024

BRIEF—Grifols not to proceed with Andorra immunology research center

Spanish plasma-derived medicines company Grifols announced with the Andorran government the cancellation of the immunology research center planned for the parish of Ordino. 29 July 2024

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Bayer tanks as it stops OCEANIC-AF study early due to lack of efficacy

Bayer shares plunged to their lowest in a decade after the German pharma major said it would discontinue a late-stage trial for a blood-thinning drug for heart disease that had failed to demonstrate efficacy. 20 November 2023

AstraZeneca launches new company to focus on digital health

The UK’s largest drugmaker, AstraZeneca, has announced the launch of a new AI-focused digital health solutions company, to be called Evinova. 20 November 2023

Obesity evolution: illuminating the runways

Leerink Partners analysts have published a Leerink Healthcare Team report on GLP1s+ (ie, including new drug mechanisms) to potentially transform the healthcare industry. 20 November 2023

New $2.5 billion facility as Eli Lilly readies tirzepatide to take world by storm

Buoyed by its recent approval in obesity, Eli Lilly has announced a massive new investment in manufacturing capacity in Europe. 17 November 2023

Pharma is focusing on the heart of the problem

A feature analyzing how - and why - cardiology is of renewed interest to pharma. 17 November 2023

NICE recommendation for Jardiance in chronic kidney disease

The National Institute for Health and Care Excellence (NICE) has issued its Final Draft Guidance (FDG) recommending Jardiance (empagliflozin) as an option for the treatment of eligible adults with chronic kidney disease (CKD) in England and Wales. 17 November 2023

Green shoots of recovery in UK trials landscape

A worrying drop in the number of clinical trials launched in the UK could be coming to an end, early figures suggest. 17 November 2023

AMA presses insurers to include new obesity meds in coverage

GLP-1 agonists are transforming the way cardiometabolic disorders are treated, with new approvals in obesity opening the door to significant new treatment opportunities. 17 November 2023

Combination therapies: CMA prioritization statement

The UK’s Competition and Markets Authority (CMA) has clarified the circumstances under which it will not prioritize enforcement action against pharmaceutical companies when they implement a specific ‘negotiation framework’ to make more combination therapies available on the National Health Service (NHS). 17 November 2023

Graphite and LENZ merge to focus on presbyopia programs

Vision-focused biopharma LENZ Therapeutics and Graphite Bio have entered into a definitive merger agreement to combine the companies in an all-stock transaction. 16 November 2023

Astellas to acquire Propella Therapeutics

Japanese pharma major Astellas Pharma has entered into a merger agreement to acquire Propella Therapeutics. 16 November 2023

CorMedix gains FDA approval for DefenCath

Shares of US biopharma CorMedix rose as much as 18% ad closed up 6.4% at $3.33 yesterday, after it revealed that the US Food and Drug Administration (FDA) has approved its DefenCath (taurolidine and heparin). 16 November 2023

Pfizer to slash 500 UK jobs in cost-cutting drive

Some 500 jobs are to go at US pharma giant Pfizer’s UK site in Sandwich, Kent. 15 November 2023

Well-funded Theseus takes bold action for a fresh start

Markets have reacted warmly to a radical plan from Theseus Pharmaceuticals to cut costs and potentially put itself up for a sale or merger. 15 November 2023

German Merck plans for new US Healthcare headquarters

German life sciences and pharma company Merck KGaA, which operates its Healthcare business as EMD Serono in the USA and Canada, yesterday announced that it plans to move its US Healthcare headquarters, currently located in Rockland, Massachusetts, to Boston’s Seaport district. 15 November 2023

MHRA licenses cystic fibrosis drugs Kaftrio and Kalydeco for infants

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today extended the license of the cystic fibrosis medicines Kaftrio (ivacaftor, tezacaftor and elexacaftor) and Kalydeco (ivacaftor) for children aged two to five years old. 15 November 2023

ICER slaps price tag on sotatercept

The USA's Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept for pulmonary arterial hypertension (PAH). 14 November 2023

Ipsen and Genfit present full Phase III data on elafibranor at AASLD

Ipsen and fellow French drugmaker Genfit presented full results from the pivotal Phase III ELATIVE trial in a late-breaking oral session) at the American Association for the Study of Liver Diseases (AASLD) late yesterday. 14 November 2023

Basilea buys rights to fosmanogepix, a broad-spectrum antifungal

Swiss drugmaker Basilea Pharmaceutica has entered into an asset purchase agreement with Amplyx Pharmaceuticals to acquire the rights to fosmanogepix, a clinical-stage broad-spectrum antifungal candidate. 14 November 2023

Insulin sales in Russia hit a five-year low

Insulin sales in Russia have hit a five-year low, as local patients and government agencies have stopped buying the product for future use, reports The Pharma Letter’s local correspondent. 14 November 2023

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