Pharmaceutical
Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services. 2 April 2025
Pharmaceutical
Merck & Co -as announced the first presentation of full results from the Phase III ZENITH trial of Winrevair (sotatercept-csrk) compared to placebo in adults with pulmonary arterial hypertension World Health Organization functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy. 1 April 2025
Biotechnology
US pharma major Eli Lilly has unveiled new Phase II data showing that its RNA-based therapy lepodisiran produced significant and lasting reductions in levels of lipoprotein(a), a known genetic risk factor for cardiovascular disease. 31 March 2025
Recent news
Biotechnology
Sino-American biotech BeiGene today revealed it intends to discontinue its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. 3 April 2025
Biotechnology
Australian biotech major CSL Limited subsidiary CSL Behring today announced that it has successfully concluded negotiations in Germany with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) resulting in national reimbursement of Hemgenix (etranacogene dezaparvovec). 3 April 2025
Pharmaceutical
Colorado, USA-based Edgewise Therapeutics, a muscle disease-focused biopharma company, closed 23% lower after Wednesday’s trading. 3 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Generics
US generic manufacturer Padagis has received clearance to extend the shelf life of its over-the-counter naloxone nasal spray to 36 months, as the company looks to bolster value and accessibility in a crowded but critical public health market. 3 April 2025
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Biotechnology
31 March 2025 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.
Pharmaceutical
29 March 2025 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.
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Generics
Russia may face a new wave of drugs’ shortages, particularly those, which are used for the treatment of rare diseases, as sanctions continue to bite, reports The Pharma Letter’s local correspondent. 25 March 2025
Biotechnology
China's burgeoning biotech R&D capabilities are attracting increasing international attention, with non-Western countries actively seeking partnerships. At the BIOCHINA event in Suzhou on March 13, representatives from South Korean and Russian biotechs expressed strong interest in collaborating with Chinese counterparts. 21 March 2025
Pharmaceutical
Budget limitations and health crises are a constant in several countries in the Americas, impacting not only the population, but also the pharmaceutical industry which, in some cases, does not benefit from solid regulatory bases to promote research or regulate innovative medicines, given that there are many cumbersome procedures and financial instability. 18 March 2025
Generics
The Russian drugmaker Axelpharm will continue sales of its drug axitinib, which is used in kidney cancer therapy and is a generic of version of US pharma giant Pfizer’s (NYSE: PFE) Inlyta, reports The Pharma Letter’s local correspondent.
drug of the US Pfizer. 18 March 2025
Pharmaceutical
Precision medicine has advanced significantly over the past decade, driven by breakthroughs in chemical, hardware, software, and especially cloud computing technologies. 18 March 2025
Pharmaceutical
Hours after the swearing-in of the Secretary of Health and Human Services, Robert F Kennedy Jr (RFK), President Donald Trump issued an executive order establishing the Make America Healthy Again Commission (MAHA). 17 March 2025
Pharmaceutical
Sales of antidepressants in Russia during the period of January-February 2025 amounted to 2.8 billion roubles ($30 million) with a total of 3.2 million packages sold, which became a record figure for the country in the last five years, reports The Pharma Letter’s local correspondent. 17 March 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
Biotechnology
US biotech Inhibrx Biosciences (Nasdaq: INBX) has announced a leadership shake-up following the departure of co-founder Brendan Eckelman, who is leaving to establish a new privately-held biotech company. Mr Eckelman, who served as chief scientific officer since the company’s founding in 2010, will take on the role of chief executive at the new venture. 2 April 2025
Pharmaceutical
French drugmaker Sanofi (Euronext: SAN) has appointed Chris Corsico as its new global head of development, according to an internal company communication obtained by The Pharma Letter. The appointment will enable the vaccines major to strengthen its research and development leadership, following a months-long vacancy. 2 April 2025
Biotechnology
French biotech Transgene (EPA: TNG) has named Simone Steiner as its new chief technical officer, in a move aimed at advancing the development and production of its virus-based immunotherapies. Ms Steiner will play a central role in optimizing manufacturing for Transgene’s individualized cancer vaccines based on its myvac platform, and will also be involved in preparing a second clinical study expected to begin in the fourth quarter of 2025. 2 April 2025
Pharmaceutical
Privately-held German radiopharmaceutical company Isotope Technologies Munich (ITM) has announced the appointment of Celine Wilke as chief medical officer (CMO), taking over from interim CMO Heike Oberwittler. 1 April 2025
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