Pharmaceutical
Thousands of workers dismissed from the US Department of Health and Human Services this week may soon be reinstated, after health secretary Robert F Kennedy Jr admitted that a significant share of the job cuts were made in error. 7 April 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 7 April 2025
Pharmaceutical
A planned autumn review of the UK’s 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) will be brought forward to report back in June, it has been announced. 4 April 2025
Recent news
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries revealed it has launched fexuprazan tablets 40mg in India under the brand name Fexuclue, which is a novel potassiumcompetitive acid blocker (PCAB) that is approved as a new treatment for adults with erosive esophagitis of all grades. 8 April 2025
Biotechnology
Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer. 8 April 2025
Pharmaceutical
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
Pharmaceutical
At the recent AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Disease (PD), Cerevance announced that solengepras, a first-in-class G-protein coupled receptor 6 (GPR6) antagonist in development for early PD, failed to meet its primary endpoint in the Phase II ASCEND trial as a monotherapy. 8 April 2025
Pharmaceutical
US biotech company Vertex Pharmaceuticals has received European Commission approval to extend the use of its cystic fibrosis therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with ivacaftor. 8 April 2025
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Recent News
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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Pharmaceutical
The Chinese government is contemplating a new drug reimbursement category called category C to make commercial insurance companies a major payer. If the new category is introduced, it is expected to significantly accelerate China’s innovation, said speakers at the BIOCHINA event held in Suzhou. 26 March 2025
Generics
Russian drug manufacturers are eliminating global players from the domestic insulin market, as their sales are steadily growing, The Pharma Letter’s local correspondent reports. 26 March 2025
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
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
China-based biotech DualityBio has named Hua Mu as its global chief medical officer, as the company prepares to ramp up its international clinical development efforts and advance toward key capital market milestones. Mu, who trained as a physician in China and earned a doctorate at the University of California, Berkeley, brings decades of experience from roles in multinational pharmaceutical companies, biotech firms, and investment groups. He has overseen multiple drug programs from early-stage development through to commercialization. 7 April 2025
Biotechnology
Italy-based Angelini Ventures, the corporate venture arm of Angelini Industries, has named Regina Hodits as managing director as it looks to scale its biotech investment activities across Europe and North America. The firm said the appointment signals a major step in strengthening its international footprint and its presence in cutting-edge areas such as therapeutic development and biotech-driven artificial intelligence. 7 April 2025
Pharmaceutical
Swedish biotech OncoZenge (Nasdaq: ONCOZ) has expanded its regulatory team as it prepares for a Phase III trial of BupiZenge (bupivacaine), a non-opioid treatment for oral pain caused by cancer therapies. The company has brought in Christina Junvik through a partnership with PharmaRelations. Ms Junvik will coordinate regulatory strategy and documentation and take part in oversight of the Phase III trial. 4 April 2025
Pharmaceutical
US neuroscience-focused biopharma Neurocrine Biosciences (Nasdaq: NBIX) today announced the appointment of Sanjay Keswani to the company's executive management team as chief medical officer (CMO) effective June 2, 2025. 4 April 2025
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