Pharmaceutical
US Department of Health and Human Services (HHS) Secretary Robert F Kennedy Jr (RFK Jr) has spoken in defence of his proposed HHS budget for fiscal year 2026 to the Senate Health, Education, Labor, and Pensions (HELP) Committee. 15 May 2025
Biotechnology
Belgian biotech Galapagos is pausing its high-profile plan to break into two separate businesses, just five months after unveiling the ambitious strategy. The company also confirmed a sudden change in leadership, with Henry Gosebruch stepping in as chief executive effective immediately. 14 May 2025
Pharmaceutical
US pharma stocks regained ground Monday after Donald Trump signed an executive order aiming to slash prescription drug prices, a move that initially rattled investors but left many analysts unconvinced about its impact. 13 May 2025
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Pharmaceutical
US biopharma Biohaven has been told by the US Food and Drug Administration (FDA) that the agency is extending the PDUFA date for the company’s troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months. 16 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Incyte’s Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). 16 May 2025
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec for the treatment of advanced retinitis pigmentosa. 16 May 2025
Pharmaceutical
Chinese AI drug developer METiS Pharmaceuticals is preparing for a Hong Kong initial public offering that could raise up to $200 million, highlighting the ongoing surge of investment in artificial intelligence-powered drug discovery - even as many companies in the sector remain unprofitable. 16 May 2025
Biotechnology
Irish contract research organization ICON has retained its position as the most active CRO worldwide in the first quarter of 2025, according to a new analysis by GlobalData. 16 May 2025
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Biotechnology
12 May 2025 The Indian subsidiary of UK pharma major AstraZeneca has announced a Central Drugs Standard Control Organization (CDSCO) approval to import for sale and distribution of trastuzumab deruxtecan concentrate for solution for infusion 100mg for an additional indication, according to a Healthcare Radius report.
Biotechnology
9 May 2025 Sweden’s immune-oncology firm Alligator Bioscience today announced the successful completion of the manufacture of the first GMP drug product batch of its lead asset mitazalimab using a new improved commercial-scale manufacturing process.
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16 July 2025 18 July 2025 Kuala Lumpur, Malaysia, Malaysia International Trade & Exhibition Centre (MITEC)
2 July 2025 5 July 2025 Barcelona, Spain, Centre de Convencions Internacional de Barcelona (CCIB)
24 June 2025 25 June 2025 Boston, MA, Boston Convention & Exhibition Center (BCEC
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Pharmaceutical
As the US government, under President Donald Trump, is on the verge of announcing significant new tariffs on pharmaceutical imports, Indian drug-maker stocks continue to take a hammering on the bourses. 8 May 2025
Pharmaceutical
The Russian government will consider registering next-in-class drugs based on data from the second phase of clinical trials (CT) as well as will implement other measures in order to avoid a shortage of drugs in domestic market this year, The Pharma Letter’s local correspondent reports. 7 May 2025
Pharmaceutical
The pharmaceutical industry in Latin America is currently facing several challenges in terms of containment of chronic non-communicable diseases, impacted by the lack of adherence to treatments and the delay in access to innovations in diagnosis, treatment, control and follow-up. 2 May 2025
Pharmaceutical
April marks Sarcoidosis Awareness Month - a timely opportunity to highlight recent advances in the treatment of this rare condition. 2 May 2025
Pharmaceutical
Shortly after Robert F Kennedy Jr was sworn in as Secretary of Health and Human Services (HHS), US President Donald Trump issued an executive order establishing the Make America Healthy Again Commission.
One of its goals was to investigate the use of obesity medications in children - framing such use as a potential threat to adolescent health. Secretary Kennedy, who chairs the commission, has made it his mandate to reverse the increasing rates of childhood obesity in America, stating that spending more on quality food would solve the obesity crisis overnight.1 1 May 2025
Pharmaceutical
The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca (LSE: AZN) to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter’s local correspondent reports. 1 May 2025
Pharmaceutical
The Russian pharmaceutical market grew up to 814 billion roubles ($10 billion) in the first quarter of 2025, 11% higher compared to the same period in 2024, according to latest data, provided by experts of the Russian research agency in the field of pharmaceutics DSM-Group and some local media reports, reports The Pharma Letter’s local correspondent. 30 April 2025
One to Watch Companies
One to watch
Privately-held GAIA is focused on the development of evidence-based, safe and accessible AI-powered digital therapeutics (DTx) that help patients restore and maintain their mental and physical health.
One to watch
Exsilio Therapeutics is developing genomic medicines that can be delivered in lipid nanoparticles to durably and safely treat a broad range of diseases, including genetic diseases, cancer, and autoimmune conditions.
One to watch
Aphaia Pharma is a clinical-stage biopharmaceutical company with headquarters in Switzerland, Canada and Puerto Rico.
One to watch
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
Boardroom
Pharmaceutical
USA-based Inozyme Pharma, a biopharma developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, has a new chief medical officer (CMO). 15 May 2025
Biotechnology
San Diego, USA-based biotech Capricor Therapeutics (Nasdaq; CAPR) yesterday announced the appointment of Dr Michael Binks as chief medical officer, effective immediately. 14 May 2025
Biotechnology
Compugen, an Israeli cancer immunotherapy company that calls itself a pioneer in computational target discovery, has announced key leadership transitions to take effect in September 2025 following the firm’s annual general meeting. 13 May 2025
Biotechnology
Swedish biotech Hansa Biopharma (Nasdaq Stockholm: HNSA) has appointed Maria Törnsén as chief operating officer and president US, strengthening its commercial leadership ahead of key milestones for its kidney transplant drug Idefirix (imlifidase). Ms Törnsén previously held senior commercial roles at Calliditas Therapeutics, Sarepta Therapeutics (Nasdaq: SRPT), Sanofi (Euronext: SAN) and Shire, and oversaw US commercial operations during Calliditas’ acquisition by Asahi Kasei in 2024. Her track record includes launching multiple products and leading a $1.6 billion franchise. 13 May 2025
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