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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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Russia losing its positions in global drug export market

Russia is losing its positions in the global drug export market due to difficulties in settlements with foreign partners, caused by sanctions imposed against the country, The Pharma Letter’s local correspondent reports. 10 October 2023

New calls from Russian patient organizations on vital drugs shortages

The situation with the availability of modern, original drugs continues to deteriorate in Russia, which is mainly due to ever-tightening sanctions against the country and its growing isolation in the international arena, reports The Pharma Letter’s local correspondent. 9 October 2023

FDA issues CRL on Alnylam's Onpattro sNDA

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to Alnylam Pharmaceuticals’ supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis 9 October 2023

Paxlovid and Lagevrio cut deaths and hospitalization in Omicron patients

New Cleveland Clinic-led research shows that the COVID-19 antivirals Paxlovid (nirmatrelvir) and Lagevrio (molnupiravir)—from Pfizer and Merck & Co, respectively - reduce risk of hospitalization and death in high-risk patients with mild disease, even with Omicron subvariants. 9 October 2023

Zhifei to co-promote GSK's shingles vaccine in China

Shares of Chinese high-tech biological enterprise Chongqing Zhifei Biological Products leapt 20% to 58.40 renminbi, on the news that it will to co-promote UK pharma major GSK's shingles vaccine, Shingrix. 9 October 2023

Don't damage UK reputation as life sciences leader, industry says

More than 20 industry leaders from companies supplying the UK’s National Health Service (NHS) with essential medicines warn that plans to change the Statutory Scheme for branded medicines are unworkable. 9 October 2023

Globally known professor and dermatologist joins LEO Pharma

Privately-held Danish dermatology specialist LEO Pharma has named Professor Alexander Egeberg, a globally recognized dermatologist and top key opinion leader as the company’s new vice president, head of global medical affairs. 9 October 2023

$61 million series A raise for new oral Alzheimer's therapies

British biotech firm AstronauTx has raised around $61 million in a series A financing led by Switzerland’s Novartis Venture Fund. 9 October 2023

Australia adds GSK's Shingrix to National Immunization Program

The Australian business of British drugmaker GSK has secured a positive listing decision from authorities for its shingles vaccine. 9 October 2023

Clinical trials: two arms are better than one, says IQWiG

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has responded critically to a reflection paper by the European Medicines Agency (EMA) on the approval of new drugs based on single-arm studies. 9 October 2023

With enhancements and continued patient focus, expedited regulatory pathways still delivering, EMA official says

Leading regulatory bodies around the world have various pathways in place to speed up the approval process for promising medicines that offer a solution to unmet medical needs. 6 October 2023

Patient organizations have become more important in the USA

New research from the IQVIA Institute for Human Data Science shows the significant role that patient organizations play in the US healthcare system. 6 October 2023

FDA accepts Sun Pharma's NDA for alopecia candidate

Leading Indian drugmaker Sun Pharmaceutical Industries today revealed that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. 6 October 2023

The Pharma Letter M&A roundup - September 2023

Pharma's biggest companies were inactive during September's M&A market. 6 October 2023

EMA issues revised transparency rules for the EU clinical trials information system

The European Medicines Agency (EMA) today revealed it has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). 6 October 2023

Regulatory submissions for crinecerfont on the way after Phase III win

Californian biotech Neurocrine Biosciences has announced positive top-line data from the Phase III CAHTALYST study of crinecerfont. 6 October 2023

Shorla to advance pipeline thanks to $35 million Series B financing

Privately-held Irish-American cancer specialist Shorla Oncology has raised $35 million in Series B funding. 6 October 2023

MNCs wary of pouring big investments in China while actively seeking local partnerships

Caught up in the geopolitical tension between China and the West, western pharma multi-national corporations (MNCs) are increasingly cautious about investing in China. 5 October 2023

FDA vote bodes well for US WorldMeds

Wednesday was a good day for US WorldMeds as the US Food and Drug Administration (FDA) moved a step closer to a potential approval of its New Drug Application (NDA) for eflornithine (DFMO). 5 October 2023

NICE recommends Jardiance for chronic heart failure

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has backed the use of Jardiance (empagliflozin) for a new indication. 5 October 2023

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