Today Stories

Cycle Pharmaceuticals has completed its acquisition of Applied Therapeutics, a clinical-stage biopharmaceutical company focused on rare disease treatments. The deal follows a definitive agreement reached late last year under which Cycle launched a tender offer to buy all outstanding Applied shares at a fixed cash price per share along with a contingent value right that may provide additional future payments if certain regulatory or commercial milestones are met. Applied’s portfolio includes drug candidates such as govorestat, being developed for rare metabolic and neurological conditions. The acquisition strengthens Cycle’s position in the rare disease space and adds new development assets to its pipeline. Prior to closing, Cycle extended its tender offer several times to secure enough sha…

Researchers at Case Western Reserve University School of Medicine have uncovered a hidden biological interaction that may help change the way Parkinson’s disease is treated. A team led by scientists including Xin Qi found that a toxic protein involved in Parkinson’s attaches to a vital enzyme and disrupts the cell’s energy supply, accelerating nerve cell damage in the brain. This insight goes beyond symptom relief and gets closer to understanding the core mechanisms of the disease itself. Building on this discovery, the researchers have developed a novel compound called CS2. In experimental models including human brain tissue, patient-derived neurons and mice, CS2 acts like a decoy. It blocks the harmful interaction, helping restore energy function in cells and reducing inflammation. Early…

Stanford Medicine scientists have uncovered a promising way to reverse cartilage loss in aging knees and prevent arthritis after injury by targeting a protein linked to aging. In research recently published and shared by Stanford, blocking a protein known to rise with age helped restore healthy knee cartilage in older mice and reduced arthritis development after injuries similar to common ligament tears. Treated mice regained thicker, functional cartilage and showed improved joint movement compared with untreated animals. Early tests on human knee cartilage samples from joint replacement surgeries also demonstrated signs of new cartilage formation when exposed to the treatment, offering hope for future therapies that could regenerate worn-out tissue without surgery. This approach works by…

Evestia Clinical has announced the acquisition of ICRC-Weyer GmbH, a well-established contract research organisation and scientific consultancy based in Berlin. This move strengthens Evestia Clinical’s full-service clinical research capabilities by bringing specialist expertise in biostatistics, data management and medical writing into its global offering. The deal also reinforces the company’s presence in Germany and across Europe, providing biotech innovators with more integrated support throughout clinical development. ICRC-Weyer will continue to operate under its own brand with existing services and teams remaining intact. Leadership from ICRC-Weyer, including Managing Director Johann Daniel Weyer, will join the Evestia Clinical leadership team. The acquisition builds on Evestia Clinic…

South Korean contract manufacturer ST Pharm has sealed a supply contract worth $56 million to provide active pharmaceutical ingredients (APIs) for an oligonucleotide therapeutic developed by an unnamed US biotech company. The deal covers manufacture of oligonucleotide raw materials for a prospective treatment targeting severe hypertriglyceridemia and represents roughly 30 percent of ST Pharm’s 2024 revenue, underscoring its expanding footprint in the global API market. The supply agreement runs from late January through December of this year, and the value jump has also boosted ST Pharm’s order backlog by around 30 percent. The company has responded to growing demand for oligonucleotide therapies by ramping up capacity, including opening a second dedicated manufacturing facility last year…

Otsuka Pharmaceutical, in partnership with Ionis Pharmaceuticals, has secured European Commission approval for Dawnzera (donidalorsen) in the European Union as a preventative treatment for hereditary angioedema (HAE) in adults and adolescents aged 12 and older. This decision comes after a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, which reviewed data demonstrating that Dawnzera can significantly reduce the frequency of debilitating HAE attacks. The medication is designed to be self-administered by patients via pre-filled injection pens at multi-week intervals, offering convenience alongside clinical benefit. Trials showed substantial reductions in attack rates versus placebo, supporting its use as a routine prophylactic therapy. Th…

DeepHow has introduced PharmaCloud, a cloud-based platform designed specifically for pharmaceutical and medical device manufacturers to improve training, execution, and verification on the factory floor. PharmaCloud provides a GMP-compliant environment that helps teams standardize procedures across sites so operators follow approved methods with greater consistency and fewer errors than traditional training. The platform unifies training content, guided step-by-step execution, and AI-powered verification to ensure critical process steps are completed correctly and according to validated procedures. PharmaCloud also tracks changes and training records so teams always work with current, approved instructions and maintain full audit trails. By bringing visual guidance and AI feedback into dai…

Sanofi has secured European Union approval for Teizeild (teplizumab), a new disease-modifying therapy for people aged eight years and older with stage 2 type 1 diabetes. This decision by the European Commission follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and makes Teizeild the first treatment in the EU shown to delay the onset of stage 3 clinical type 1 diabetes. The approval is based on positive results from the TN-10 phase II study, where Teizeild significantly extended the time patients remained in the presymptomatic stage compared with placebo, effectively slowing progression of the autoimmune attack on insulin-producing cells. Sanofi says the drug offers patients and families a chance to postpone the need for insulin t…

QPS Holdings, LLC, an award-winning contract research organisation focused on clinical trials and bioanalysis, has implemented the Oracle Argus Safety Database to elevate its pharmacovigilance capabilities. This industry-leading safety case management system will support QPS in capturing, managing and reporting adverse event data across clinical trials with greater efficiency and compliance. By adopting Argus, QPS aims to improve patient safety oversight, strengthen regulatory compliance and streamline safety reporting workflows for sponsors. The move reflects QPS’s commitment to operational excellence and advanced technology integration as drug development becomes increasingly complex and data-intensive. Oracle Argus is widely recognised as a comprehensive pharmacovigilance solution that…

OpenAI has unveiled ChatGPT Health, a new feature within its popular AI chatbot that lets users bring their medical information and wellness data into a dedicated health-focused space. The tool creates a separate environment inside ChatGPT where people can connect electronic health records and data from wellness apps such as Apple Health, MyFitnessPal, Function and others. This enables the AI to provide responses that are grounded in an individual’s own lab results, fitness patterns or appointment history rather than generic wellness guidance. Health conversations are isolated from regular chats and protected with purpose-built encryption and privacy controls, and OpenAI says they are not used to train its core models. OpenAI stressed that ChatGPT Health is designed to help users understan…

AbbVie is stepping up its commitment to the United States with a major investment pledge tied to a broad agreement with the US government. The Chicago-based biopharmaceutical company has agreed to invest a total of $100 billion in research, development and manufacturing projects across the country over the next decade. This pledge comes as part of a three year deal with the administration that also involves lowering certain Medicaid drug prices and securing exemptions from tariffs and future pricing mandates. The investment is set to support expanded US-based R&D efforts, boost manufacturing capacity and enhance direct-to-patient drug availability through government channels. The move follows a trend among large pharma firms to strengthen domestic operations amid changing trade and pri…

Pretzel Therapeutics is gaining attention in biotech circles as it continues advancing its mission to transform treatments for diseases linked to mitochondrial dysfunction. The company’s lead therapy candidate, PX578, is now in Phase 1 clinical development targeting mitochondrial DNA depletion syndromes and potentially broader conditions where energy production in cells falters. Pretzel’s approach focuses on harnessing cellular energetics to restore mitochondrial function and impede disease progression across neurological, metabolic, rare and muscle-related conditions. Recent clinical progress follows groundbreaking research published in Nature demonstrating novel small molecule activators that can restore mutant mitochondrial DNA polymerase activity, underlining the scientific potential…

Domain Therapeutics has officially changed its name to Kainova Therapeutics, marking a new chapter for the clinical-stage biopharmaceutical company. The rebrand reflects the firm’s expanding global focus and progress in developing therapies that target G Protein-Coupled Receptors, a key class of drug targets in immuno-oncology and inflammation. The new name combines the sense of a decisive moment with innovation and renewal, underscoring the company’s ambition to transform patient outcomes through scientific excellence and an integrated approach to drug discovery and development. Kainova continues to advance a robust pipeline of differentiated therapies designed to address unmet medical needs. Its clinical programs include candidates such as a Treg-depleting anti-CCR8 antibody in Phase I/I…

Merck (known as MSD outside of the United States and Canada) is set to finalise its purchase of Cidara Therapeutics, a move that adds a promising late-stage antiviral to its portfolio and strengthens its infectious disease pipeline. The deal values Cidara at approximately $9.2 billion in cash, with Merck agreeing to pay $221.50 per share to acquire all outstanding Cidara stock. Approval from both company boards has already been secured, and the transaction is expected to close in the first quarter of 2026 after satisfying regulatory and customary closing conditions. Cidara’s lead asset, CD388, is a long-acting, strain-agnostic antiviral currently in Phase 3 development for the prevention of influenza in people at higher risk of complications. Supported by encouraging Phase 2b results and…

PSI CRO has broadened its footprint in Canada by opening a new office in the Toronto area and naming an experienced industry leader to guide its operations there. The office, located in Mississauga, Ontario, builds on the company’s established Canadian presence and commitment to clinical research excellence. PSI CRO has been active in Canada for over a decade, supporting complex clinical trials with a focus on dependable delivery and strong relationships with research sites. As part of this expansion, David Allen, MBA, has been appointed as Country Manager for Canada. Allen brings more than 30 years of experience in clinical research from both sponsor and CRO environments. In his new role, he will lead efforts to enhance the company’s operational capabilities in the local market and ensure…

Samsung Biologics has agreed to acquire GlaxoSmithKline’s Human Genome Sciences and its two pharmaceutical manufacturing facilities in Rockville, Maryland for about 280 million US dollars. This move marks Samsung Biologics’ first major production footprint in the United States and reflects a strategic push into US biomanufacturing amid rising demand for biologics. The site includes 60,000 liters of drug substance capacity and can handle both clinical and commercial production. Samsung Biologics said it plans further investments to increase capacity and upgrade technologies to better support supply chains for critical biologic medicines for patients. The Korean contract development and manufacturing organisation intends to retain more than 500 employees at the site after the deal closes.…

Swedish biopharmaceutical company Sobi has agreed to acquire late-stage biotechnology firm Arthrosi Therapeutics in a deal valued at up to $1.5 billion. Under the agreement, Sobi will pay $950 million in cash upfront with up to an additional $550 million contingent on clinical and regulatory milestones. The move is designed to strengthen Sobi’s presence in inflammatory and specialty care by adding Arthrosi’s leading gout treatment candidate, an investigational once-daily oral URAT1 inhibitor called pozdeutinurad. Pozdeutinurad is currently being evaluated in two fully recruited global Phase 3 trials for the management of progressive and tophaceous gout, with key data expected in 2026. If successful, the therapy could offer a new option for patients whose symptoms persist despite first-line…

GlaxoSmithKline announced that the US Food and Drug Administration has approved its twice-annual asthma therapy Exdensur, offering a new option for patients aged 12 and older with severe eosinophilic asthma inadequately controlled by standard treatment. Exdensur, known by its active ingredient depemokimab, is designed as an add-on maintenance treatment that can be administered just twice a year, potentially improving convenience and adherence for patients living with persistent symptoms. The decision follows positive clinical evidence showing significant reductions in asthma exacerbations and hospital visits when added to existing therapies, underscoring its potential impact on this patient population. GSK expects Exdensur to complement current biologics and become an important part of its…

Sanofi is advancing its innovation strategy through a series of strategic investments aimed at enhancing its pipeline in immune and oncology areas. The French global pharma leader has made a strategic equity investment in InduPro Therapeutics, supporting a collaboration to develop a novel bispecific PD-1 agonist for autoimmune and inflammatory disorders. The deal gives Sanofi funding support and rights to negotiate further on the program as it moves toward clinical development.  In another move, Sanofi invested around €300 million in Orano Med, gaining a significant minority stake in the radioligand therapy developer focused on lead-212 based treatments for hard-to-treat rare cancers and gastroenteropancreatic neuroendocrine tumors. This investment strengthens Sanofi’s presence in innovati…

Mirum Pharmaceuticals has signed a definitive agreement to acquire Bluejay Therapeutics, a private biotech firm specialising in viral and liver diseases. The transaction brings into Mirum’s portfolio worldwide rights to brelovitug (BJT-778) — a fully human monoclonal antibody being developed for chronic Hepatitis D virus infection (HDV), the most severe form of viral hepatitis, currently without approved therapies.  Under the terms of the deal, Mirum will pay US$250 million in cash and US$370 million in stock upfront. Bluejay’s shareholders may receive an additional up to US$200 million in sales-based milestones, bringing total deal value to as much as US$820 million. The acquisition adds a potentially transformative late-stage asset to Mirum’s rare-disease pipeline and leverages Bluejay’…