Swiss pharma giant Novartis will spotlight key data across its oncology portfolio, including Kisqali (ribociclib), Scemblix (asciminib) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which was recently approved for use prior to chemotherapy, at the upcoming 2025 ASCO Annual Meeting. 15 May 2025
Privately-held Remedy Plan Therapeutics, a US pharma company developing novel, hyperbolic NAMPT inhibitors, has raised more than $18 million in an oversubscribed insider financing round. 13 May 2025
Genmab posted a 19% rise in revenue to $715 million for the first quarter of 2025, driven by higher royalties and increasing sales of its lymphoma therapy Epkinly (epcoritamab). Earnings before interest and taxes rose to $188 million, up from $116 million a year earlier. 9 May 2025
Sino American biotech BeiGene, a global oncology company that will change its name to BeOne Medicines, today announced financial results and corporate updates from the first quarter 2025. 7 May 2025
Sweden’s Mendus, a clinical-stage drug developer, has announced the appointment of Dr Tariq Mughal as chief medical officer, effective today, May 5. 5 May 2025
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late Friday announced it has granted a conditional marketing authorization for the Aucatzyl (obecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 28 April 2025
Chinese biotech LTZ Therapeutics has closed an oversubscribed series A+ financing round, raising $40 million to support its push into early-stage clinical development. 25 April 2025
Swiss pharma giant Roche today reported that it achieved sales growth of 6% (7% in francs) to 15.4 billion francs ($18.8 billion) for the first three months of 2025. That topped projections for $18.34 billion, according to FactSet. 24 April 2025
Bristol Myers Squibb beat Wall Street expectations in the first quarter of 2025, sending shares higher in early trading Thursday, as the company raised its full-year forecast on the back of favorable foreign exchange and solid performance from its newer medicines. 24 April 2025
French pharma major Sanofi delivered a set of first-quarter financial results that seemed to satisfy markets Thursday, as its share price remained unchanged near close. 24 April 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Hympavzi (marstacimab) to prevent or reduce bleeding in patients 12 years of age and older weighing at least 35kg with hemophilia A and B. 22 April 2025
UK pharm major GSK has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in the pharmaceutical industry, the trade group’s Prescription Medicines Code of Practice Authority (PMCPA) has revealed. 16 April 2025
Johnson & Johnson has announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients given Darzalex (daratumumab)-subcutaneous (SC) therapy alongside bortezomib, lenalidomide and dexamethasone (VRd). 11 April 2025
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
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
The European Commission (EC) has approved an indication extension of Darzalex (daratumumab) subcutaneous (SC) formulation in the frontline setting. 7 April 2025
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024
Russia plans to create conditions for a significant increase of domestic production of anti-Rhesus immunoglobulin drugs after a sharp decrease of their imports to the local market this year, reports The Pharma Letter’s local correspondent. 22 August 2024
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for linvoseltamab.. 21 August 2024
US oncology focused biotech Syros Pharmaceuticals announced that it will discontinue enrollment in the SELECT-AML-1 Phase II clinical trial. 14 August 2024
CRISPR genome-editing biopharma company Caribou Biosciences has announced the appointment of Tina Albertson as chief medical officer (CMO). 13 August 2024
Octapharma announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar (prothrombin complex concentrate, human-lans) have been published by the American peer-reviewed journal JAMA Network Open. 13 August 2024
US pharma giant Merck & Co is to buy CN201, an investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases, from privately-held Chinese biotech Curon Biopharmaceutical. 9 August 2024
Citius Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 9 August 2024
Finland-based Faron Pharmaceuticals, a biopharma reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has announced that its chief executive Markku Jalkanen is to retire. 7 August 2024
The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). 6 August 2024
Shanghai-based Antengene (SEHK: 6996) has announced that the Malaysian medicines regulator has approved Xpovio (selinexor) for the treatment of multiple myeloma. 6 August 2024
Actinium Pharmaceuticals’ shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate. 6 August 2024
California’s BioMarin Pharmaceutical (Nasdaq: BMRN) has announced a strategic pivot for its Roctavian (valoctocogene roxaparvovec-rvox) business, focusing on the USA, Germany, and Italy. 6 August 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final draft guidance (FDG) recommending Brukinsa for MZL. 1 August 2024
The US Food and Drug Administration (FDA) has approved a new indication for Darzalex Faspro, (daratumumab and hyaluronidase-fih) from US healthcare giant Johnson & Johnson. 31 July 2024