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BRIEF—GSK’s Blenrep combo approved by UK MHRA

18 April 2025

BRIEF—Opthea decides to discontinue wet AMD trials

Following the negative results of the COAST Phase III trial announced on 24 March, Australia-based Opthea announced has updated on its clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and accelerated top-line results from its second Phase III trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD. 31 March 2025

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—Kyowa Kirin and Sandoz permitted partial change of rituximab biosimilar

Japanese drugmaker Kyowa Kirin and Swiss generics and biosimilars giant Sandoz have won approval for the partial change of their rituximab biosimilar for the treatment of refractory nephrotic syndrome (frequently relapsing or steroid-dependent). 7 March 2025

BRIEF—Roche Genentech Innovation Center Boston launched

Swiss pharma giant Roche has announced the launch of the Roche Genentech Innovation Center Boston, USA, at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning. 7 March 2025

BRIEF—Mustang Bio sells assets; focuses on MB-109, MB-108 and MB-101

US cell and gene therapy specialist Mustang Bio has announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts, and concurrent divestment of certain fixed assets including furniture and equipment to an AbbVie unit for $1.0 million. 3 March 2025

BRIEF—Uncertainty over $590 million Moderna bird flu contract

US health officials are reportedly reexamining a $590 million agreement awarded to Moderna for the development of its bird flu vaccine, according to sources cited by Bloomberg. The review is part of a broader government effort to scrutinize spending on mRNA-based vaccines, the technology behind Moderna’s COVID-19 shot. 28 February 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—Proposed combination of Poolbeg with HOOKIPA called off

Further to the announcement on January 2, 2025 on the potential combination of UK-listed Poolbeg Pharma and Austria’s HOOKIPA Pharma, the board of Poolbeg announced that it was informed yesterday that HOOKIPA has terminated discussions on the proposed combination of the two companies. 21 February 2025

BRIEF—Merck KGaA confirms talks with US biotech SpringWorks

Reacting to press reports, Germany’s Merck KGaA has confirmed it is in advanced discussions with SpringWorks Therapeutics with the aim of acquiring the US biotechnology company. 11 February 2025

BRIEF—Kite shares new data on CAR T cell therapy

Kite, a Gilead Sciences company, will share four posters that add to the growing body of evidence to support the clinical use of its chimeric antigen receptor (CAR) T-cell therapy portfolio, at the 7th European CAR T-cell Meeting, 6-8 February 2025, Strasbourg, France. 8 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—EC calls for update on regulatory review of lecanemab

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union. 3 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

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Imbria raises $57.5 million; appoints CEO

US clinical-stage biotech Imbria Pharmaceuticals, which is focused on cardiometabolic diseases with high unmet need, says it has closed a $57.5 million Seres B financing. 10 April 2025

Latigo’s $150 million fundraise shows potential gains from pain as early-stage non-opioid pipeline grows

Pain is good. Or finding non-opioid ways to manage it is good, if Latigo Biotherapeutics’ $150 million March fundraise is anything to go by. 10 April 2025

ImmunityBio raises $75 million in direct offering

US biotech ImmunityBio has secured $75 million through a direct offering with a single institutional investor, according to a statement released Tuesday. 10 April 2025

NICE backing for J&J’s Balversa

The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025

Tempest to explore alternatives to advance promising pipeline

California-based clinical-stage biotech Tempest Therapeutics has announced that the company plans to explore a full range of strategic alternatives to advance its promising clinical stage programs and maximize stockholder value. 10 April 2025

Menarini Biotech partners with ERBC on clinical trials

Menarini Biotech, a group company of Italy’s Menarini, has entered into a strategic collaboration with ERBC, a leading pre-clinical contract research organization (CRO), aimed at streamlining and speeding up the transition of biopharmaceuticals from the research stage to First-In-Human (FIH) clinical trials. 10 April 2025

Lilly-backed Solu stacked and ready for the clinic

Solu Therapeutics, a US biotech developing therapies to eliminate disease-driving cells in cancer, immunology and other therapeutic areas, has announced the successful completion of a $41 million Series A financing. 10 April 2025

Axsome’s AXS-05 challenges current standard of care for Alzheimer’s agitation

At the recent American Academy of Neurology (AAN) 2025 annual meeting, Axsome Therapeutics presented promising data for AXS-05 (bupropion + dextromethorphan) in treating agitation associated with Alzheimer’s disease (AD). 10 April 2025

UK analysis reveals strengths and gaps in clinical trial landscape

The first comprehensive analysis of clinical trials in the UK has found the country remains a global leader in medical research but highlights the need for broader disease focus and better trial representation. 10 April 2025

Novo Nordisk goes big with obesity and diabetes production in Brazil

Danish pharma major Novo Nordisk has announced an investment of $1.1 billion to expand its production facility in Brazil’s Montes Claros, northern Minas Gerais, with the aim of increasing production capacity for injectable treatments for people with obesity, diabetes and other serious chronic diseases. 10 April 2025

Telitacicept shows strong Phase III results in myasthenia gravis trial

Chinese biotech RemeGen has reported positive late-stage clinical trial data for its dual-target fusion protein telitacicept in patients with generalized myasthenia gravis, offering a potential new treatment option for the rare autoimmune disorder. 10 April 2025

ICER releases obesity medicines white paper

US health technology assessor the Institute for Clinical and Economic Review (CER), in collaboration with researchers from Brown University, has published a new white paper that provides clear policy and market solutions to help manage affordable and equitable access to GLP-1 obesity medications. 10 April 2025

Expected budget savings on ustekinumab biosimilars in Europe

South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025

Russian patients call on state to expand public procurements of certain vital drugs

The All-Russian Union of Patients (VSP) has called on Russia’s Deputy Prime Minister, Tatyana Golikova, to expand the list of drugs that are the subject of public procurements in the country in order to avoid a shortage of certain categories of drugs in the domestic market, The Pharma Letter’s local correspondent reports.. 10 April 2025

Big pharma drug licensing from China hits record high

Licensing agreements for Chinese drug candidates hit a record high in 2024, with large pharma in-licensing 28% of innovator drugs from Chinese biopharma companies. 9 April 2025

Russian pharma market grew 10% to 2.85 trillion roubles in 2024

The Russian pharmaceutical market grew by 10% in value terms to 2.85 trillion roubles ($85 billion) in 2024, which was mainly due to the growth of it commercial segment, where the growth of sales was equivalent to 13.8%. 9 April 2025

ValoTx lures J&J exec to be its CEO

Privately-held Finland-based Valo Therapeutics (ValoTx), an immunotherapy company developing novel, adaptable treatments for cancer, today announced the appointment of Marcella Origgi as its chief executive (CEO) of its Helsinki headquarters and Naples, Italy, subsidiary. 9 April 2025

AbbVie wins EC nod for new Rinvoq indication

The European Commission (EC) has granted marketing authorization to Rinvoq (upadacitinib; 15mg, once daily), from US pharma major AbbVie , for the treatment of giant cell arteritis (GCA) in adult patients. 9 April 2025

Buntanetap shows early potential for Parkinson’s-related dementia

US biotech Annovis Bio has reported encouraging findings for its experimental therapy buntanetap in a subgroup of patients with early-stage Parkinson’s disease and mild dementia. 9 April 2025

FDA removes REMS requirement from Idorsia’s Tryvio label

Swiss biopharma Idorsia has received approval from the US Food and Drug Administration for an updated label on its hypertension drug Tryvio (aprocitentan), removing the previous Risk Evaluation and Mitigation Strategy requirement. 9 April 2025

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