22 May 2025 US clinical-stage biotech Vigil Neuroscience saw its share price skyrocket more than 240% to $7.89 pre-market, on the news that French pharma major Sanofi had made a takeover bid for the company.
USA-based nonprofit CureDuchenne has announced the appointment of Brenda Wong as its new chief medical advisor (CMA), effective January 5, 2026. 22 May 2025
South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025
The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025
Chinese drugmaker Jiangsu Hengrui Pharmaceuticals priced its Hong Kong stock offering at the top of the marketed range to raise HK$9.9 billion ($1.3 billion). 22 May 2025
US clinical-stage biotech Vigil Neuroscience saw its share price skyrocket more than 240% to $7.89 pre-market, on the news that French pharma major Sanofi had made a takeover bid for the company. 22 May 2025
USA-based UroGen Pharma, a biotech developing and commercializing innovative solutions that treat urothelial and specialty cancers, closed 45% lower Wednesday. 22 May 2025
UK pharma major AstraZeneca is set to present data from more than 80 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Spanning across 20 approved and investigational medicines, the presentations include two plenary sessions and a special late-breaking abstract. 22 May 2025
Swiss biosimilars specialist Sandoz has launched what it says is the first autoinjector presentation of a biosimilar to Stelara (ustekinumab) in Europe, bolstering its presence in the region’s rapidly expanding immunology market. 22 May 2025
Privately-held US genome-scale drug discovery company Orionis Biosciences has announced a second multi-year collaboration with Genentech, a subsidiary of Roche , to discover small-molecule monovalent glue medicines for novel and challenging targets in oncology. 22 May 2025
Merck KGaA plans to move its investigational lupus drug enpatoran into late-stage development, after new Phase II data showed clinically meaningful improvement in skin manifestations of the disease among treated patients. 22 May 2025
The share of generics in the Russian pharmaceutical market is steadily growing despite the efforts of the local state to create conditions for the production of original drugs, The Pharma Letter’s local correspondent reports. 22 May 2025
The US Food and Drug Administration (FDA) is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science. 22 May 2025
Anglo-Swedish pharma major AstraZeneca reports that it will have a historic presence at this year’s American Society of Cancer Oncology (ASCO) meeting across its expansive cancer portfolio. 21 May 2025
US biotech Moderna today announced that in consultation with the US Food and Drug Administration (FDA), the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. 21 May 2025
The Dementia Discovery Fund (DDF) - managed by healthcare fund manager SV Health Investors - has announced the final closing of its second fund, DDF-2, with $269 million in commitments. 21 May 2025
Earlier this month, the US Department of Health and Human Services (HHS) said it would require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 21 May 2025
Pharmasyntez, one of Russia’s leading drugmakers, plans a significant expansion of its portfolio of innovative drugs in the short-term, according to recent statements, made by representatives of the company, reports The Pharma Letter’s local correspondent. 21 May 2025
Swiss reproductive and women’s health medicines specialist ReproNovo today announced the successful closing of a $65 million Series A financing round, which will be used to advance its pipeline of multiple Phase II programs. 21 May 2025
Danish diabetes and obesity giant Novo Nordisk today announced headline results from REDEFINE 2, a Phase III trial in the global REDEFINE program. 10 March 2025
Finnish drugmaker Orion Corporation has announced that it is establishing a new research and development (R&D) center in Cambridge, UK, during 2025 to accelerate its global growth strategy and the development of innovative medicines. 10 March 2025
Shares of German biotech BioNTech dipped 2.5% to $105.86 today, after it reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress. 10 March 2025
Thought leaders from pharma are among the authors of a column tackling one of society’s toughest questions - what we should do to solve society’s obesity epidemic. 10 March 2025
Indian drug major Sun Pharmaceutical Industries has entered an agreement with Checkpoint Therapeutics to acquire the US immunotherapy and targeted oncology company, with the news sending the latter’s shares rocketing more than 65% to $4.06 this morning. 10 March 2025
The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Encelto (revakinagene taroretcel-lwey; NT-501) for the treatment of macular telangiectasia type 2 (MacTel), submitted by privately-held US biotech Neurotech Pharmaceuticals. 10 March 2025
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Belgian biotech Agomab Therapeutics has reported positive interim results from its Phase IIa STENOVA trial of AGMB-129, an oral gut-restricted small molecule ALK5 inhibitor in development for fibrostenosing Crohn’s disease. The analysis includes data from 44 patients who completed 12 weeks of treatment, with the study meeting both its primary and secondary endpoints. 10 March 2025
Novartis has reported new data showing that its investigational BTK inhibitor, remibrutinib, significantly improves sleep quality for patients with chronic spontaneous urticaria (CSU). The findings, from the Phase III REMIX-1 and REMIX-2 trials, were presented at the American Academy of Dermatology annual meeting in Orlando. 10 March 2025
Positive results from the ADEPT Phase II/III study indicate that Dupixent (dupilumab) may be effective in treating moderate-to-severe bullous pemphigoid (BP). The findings were presented at the 2025 American Academy of Dermatology Annual Meeting. 10 March 2025
US biotech Amgen and Japanese partner Kyowa Kirin announced new results from the ongoing ROCKET Phase III clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). 10 March 2025
Valo Therapeutics says it has successfully secured a financing round of 19 million euros ($20.6 million), part of which was raised in Europe and part in Australia, to clinically develop its innovative immune therapy for cancer. 10 March 2025
The Bulgarian Association of Research-Based Pharmaceutical Manufacturers, ARPharM, says it is following the discussion of the National Health Insurance Fund (NHIF) budget for 2025 with attention and concern. 10 March 2025
Last week’s significant research news included positive new Phase III data on Tezspire in nasal polyps from Amgen and AstraZeneca. US pharma major AbbVie became the latest entrant to the weight management sector, striking a deal with Gubra for its obesity candidate GUB14295. On the M&A front, Ireland-headquartered Jazz Pharmaceuticals announced it is acquiring Chimerix for around $935 million to expand its oncology portfolio. USA-based scPharmaceuticals gained US Food and Administration (FDA) approval for its supplemental new drug application (sNDA) for Furoscix in chronic kidney disease (CKD). 9 March 2025
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Following swiftly after US regulatory clearance for the same indication for Odactra tablet brand, Danish allergy expert ALK Abello its Acarizax announced that Health Canada has approved tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. 8 March 2025
Nona Biosciences has introduced Hu-mAtrIx, an AI-assisted drug discovery platform designed to accelerate the identification and development of antibody-based therapies. 7 March 2025
Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting. 7 March 2025
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025