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BRIEF—Peter Marks resigns as CBER chief under pressure

The Center for Biologics Evaluation and Research (CBER), part of the US Food and Drug Administration, saw its top vaccine official pushed out of the post on Friday, according to people familiar with the matter, according to a Wall Street report. 29 March 2025

BRIEF—Eisai to divest warfarin rights in Japan to Sawai

28 March 2025

BRIEF—Novo Nordisk ABPI membership restored

Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025

BRIEF—Isoprotrace launched in Germany

Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025

BRIEF—RFK Jr fears spreading—and there’s no vaccine

Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025

BRIEF—Zevra sells Miplyffa-linked PRV for $150 million

Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025

BRIEF—RFK Jr nomination to head HHS clears first hurdle

US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025

BRIEF—AstraZeneca ditches £450 million UK investment

UK pharma major AstraZeneca has scrapped its plans to invest £450 million in expanding ($559 million) to expand its vaccine plant in Speke, Liverpool, blaming a reduction in government support. 1 February 2025

BRIEF—Evaxion raises $10.8 million in public offering

Evaxion Biotech has priced a public offering, seeking to raise $10.8 million before expenses, with closing anticipated tomorrow. 30 January 2025

BRIEF—hVIVO acquires two German clinical research units

hVIVO, a fast-growing early-stage German contract research organization (CRO) has acquired two clinical research units from Clinical Research Services (CRS), in Mannheim and Kiel, Germany, for a total of 10 million euros ($10.5 million). 29 January 2025

BRIEF—Hopes of hepatitis D breakthrough with Bluejay’s brelovitug

Privately-held US biopharma Bluejay Therapeutics has announced that its lead product candidate brelovitug—also known as BJT-778—has received US Food and Drug Administration Breakthrough Therapy designation for the treatment of chronic hepatitis D. 22 January 2025

BRIEF—MHRA backs Idorsia’s hypertension drug Jeraygo

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jeraygo (aprocitentan) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension). 17 January 2025

BRIEF—FDA CDER director Patrizia Cavazzoni resigns

The US Food and Drugs Administration (FDA) has confirmed that Center for Drug Evaluation and Research (CDER) director, Patrizia Cavazzoni, has announced her resignation ahead of Donald Trump’s inauguration on January 20, according to media reports. 11 January 2025

BRIEF—Prefilled syringe presentation of Shingrix accepted for review by FDA

The US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). 10 January 2025

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

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Anglo-Indian licensing agreement for meningitis-B vaccine

In a significant stride towards addressing the challenge of meningococcal-B disease, Serum Institute of India (SII) and the University of Oxford, UK, have formalized a technology license agreement negotiated by Oxford University Innovation. 16 April 2024

New appointment at Chiesi USA

Italian family-owned drugmaker Chiesi Farmaceutici has appointed Richard Smith as vice president and business unit leader of the US AIR at Chiesi USA. 16 April 2024

Bulgarian court ruling prompts calls for reimbursement rethink

Bulgaria’s Supreme Administrative Court has cancelled the mechanism guaranteeing the predictability and sustainability of the National Health Insurance Fund (NHIF) budget for drugs for 2021. 15 April 2024

Lilly loses lawsuit on Mounjaro compounding

A US judge has dismissed a legal claim from pharma major Eli Lilly alleging that an online pharmacy illegally sold an unauthorized compounded version of the company's dual GIP and GLP-1 receptor agonist tirzepatide. 15 April 2024

Nxera partners with Handok for Pivlaz distribution

Japanese drugmaker Nxera Pharma has entered into an exclusive supply and distribution agreement with Handok to commercialize Pivlaz (clazosentan sodium) 150mg in South Korea. 15 April 2024

First ever 10-year outlook on chronic kidney disease highlights growing global health crisis

A new modelling analysis by UK pharma major AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a staggering rise of up to 59.3% in advanced-stage. 15 April 2024

State guarantee for financing medical expenses in Denmark

How the regions should handle the rising costs of medicine was a central theme at the Danish Regions' summit last week, where it was agreed to work for the re-introduction of a state guarantee scheme to finance medicine subsidies 15 April 2024

Basilea's Zevtera will play unique yet critical role in MRSAB, says analyst

As the first drug to reach the US market for the treatment of Staphylococcus aureus bacteremia (SAB) in over 15 years, Swiss drugmaker Basilea Pharmaceutica's (SIX: BSLN) Zevtera (ceftobiprole medocaril), will play a unique and critical role in the future management of this serious, and commonly fatal infection. 12 April 2024

Flawed assessments of a medicine’s value jeopardize patient access, says PhRMA

Under the US Biden administration’s Inflation Reduction Act (IRA), government bureaucrats will unilaterally decide how much a treatment selected for price setting is worth. 12 April 2024

No evidence that GLP-1 drugs cause suicidal thoughts, says EMA panel

Available evidence does not support a link between GLP-1 receptor agonists with suicidal and self-injurious thoughts and actions. 12 April 2024

Nectero Medical raises $96 million in series D financing

USA-based Nectero Medical has raised $96 million in a Series D financing round led by Norwest Venture Partners, with significant investments also from Boston Scientific, BioStar Capital and others. 12 April 2024

NICE backs Aquipta for migraine prevention in adults

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending Aquipta (atogepant). 11 April 2024

Kinselby hailed a new treatment paradigm in CTCL

Data from the RESMAIN study of Kinselby (resminostat) have been presented at the 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA. 11 April 2024

European lawmakers approve far-reaching new pharma law

The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024

A surprising finding: GLP-1s role in PCOS

Affecting one in 19 women, polycystic ovary syndrome (PCOS) remains understudied, with no dedicated treatments. Surprisingly, new diabetes and weight loss drugs may help. 10 April 2024

$130 million private fundraise for oncology start-up Acrivon

A private share placement is set to land Massachusetts, USA-based Acrivon Therapeutics with an additional $130 million to fund its oncology research. 10 April 2024

Serum Institute of India eager to step into Sanofi's shoes with IPV upscale

Keen to take French pharm major Sanofi head-on, the Serum Institute of India (SII) is to scale up supplies to fulfil India's entire annual demand for injectable inactivated poliomyelitis vaccines (IPV). 10 April 2024

Ginkgo Bioworks expands collaboration with Novo Nordisk

Cell programming specialist Ginkgo Bioworks today announced the expansion of its strategic partnership with Denmark’s Novo Nordisk under a framework agreement that initially is contemplated to run over five years. 10 April 2024

Teijin Pharma grants exclusive license to Bioprojet

Japan-based Teijin Group’s healthcare business, Teijin Pharma, has entered into an exclusive global licensing agreement with French drugmaker Bioprojet Pharma. 10 April 2024

Essential Pharma expands portfolio with Renaissance Pharma acquisition

British specialty medicines firm Essential Pharma has announced the completion of the acquisition of the entire issued share capital of fellow UK-based Renaissance Pharma. 10 April 2024

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