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Pharmaceutical
Shares of Swedish drugmaker Camurus shot up 23% to 638.50 kronor yesterday on news of that it has entered a collaboration and license agreement with Eli Lilly, granting the US pharma major exclusive, worldwide rights to the research, development, manufacture, and commercialization of long-acting incretin products for cardiometabolic health based on Camurus’ FluidCrystal technology. 6 June 2025
Biosimilars
At its May meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for three biosimilar medicines: 23 May 2025
Biotechnology
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. 12 May 2025
Biotechnology
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. 9 May 2025
Pharmaceutical
Opella today becomes an independent global leader in consumer healthcare, marking a pivotal step in French pharma major Sanofi's strategy. 30 April 2025
Biotechnology
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. 31 March 2025
Pharmaceutical
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. 29 March 2025
Pharmaceutical
Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025
Pharmaceutical
Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025
Biosimilars
Japanese drugmaker Kyowa Kirin and Swiss generics and biosimilars giant Sandoz have won approval for the partial change of their rituximab biosimilar for the treatment of refractory nephrotic syndrome (frequently relapsing or steroid-dependent). 7 March 2025
Biotechnology
Swiss pharma giant Roche has announced the launch of the Roche Genentech Innovation Center Boston, USA, at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning. 7 March 2025
Biotechnology
US cell and gene therapy specialist Mustang Bio has announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts, and concurrent divestment of certain fixed assets including furniture and equipment to an AbbVie unit for $1.0 million. 3 March 2025
Biotechnology
US health officials are reportedly reexamining a $590 million agreement awarded to Moderna for the development of its bird flu vaccine, according to sources cited by Bloomberg. The review is part of a broader government effort to scrutinize spending on mRNA-based vaccines, the technology behind Moderna’s COVID-19 shot. 28 February 2025
Pharmaceutical
Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025
Pharmaceutical
Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025
Biotechnology
Further to the announcement on January 2, 2025 on the potential combination of UK-listed Poolbeg Pharma and Austria’s HOOKIPA Pharma, the board of Poolbeg announced that it was informed yesterday that HOOKIPA has terminated discussions on the proposed combination of the two companies. 21 February 2025
Biotechnology
Reacting to press reports, Germany’s Merck KGaA has confirmed it is in advanced discussions with SpringWorks Therapeutics with the aim of acquiring the US biotechnology company. 11 February 2025
Biotechnology
Kite, a Gilead Sciences company, will share four posters that add to the growing body of evidence to support the clinical use of its chimeric antigen receptor (CAR) T-cell therapy portfolio, at the 7th European CAR T-cell Meeting, 6-8 February 2025, Strasbourg, France. 8 February 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Philadelphia-based biotech Vivodyne has raised $40 million in series A funding to advance its fully robotic, AI-powered platform that tests drug candidates on lab-grown human tissues. 30 May 2025
Pharmaceutical
Swiss pharma giant Roche today announced new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. 30 May 2025
Biotechnology
Shares in US biotech Intellia Therapeutics slid by a quarter on Thursday following a safety update from its late-stage trial of a CRISPR-based treatment for a rare heart disease. 30 May 2025
Biotechnology
US biotech Regeneron and French drugmaker Sanofi are reviewing next steps for their experimental COPD therapy itepekimab following contrasting outcomes from two Phase III studies. The companies plan to discuss the results with regulatory agencies before determining the future of the interleukin (IL)-33 inhibitor. 30 May 2025
Biotechnology
Vima Therapeutics, a Cambridge, USA-based clinical-stage biotechnology company focused on oral therapies for movement disorders, has launched with a $60 million Series A financing. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
Pharmaceutical
Clinigen has entered a new phase of collaboration with Japanese drugmaker Shionogi, signing a licensing agreement for cefiderocol that sets the stage for potential market entry in Australia and New Zealand. 29 May 2025
Biotechnology
US biotech iTeos Therapeutics is preparing to wind down its operations and halt clinical work, as it looks to sell off assets and return value to investors following a major blow to its lead immunotherapy program. 29 May 2025
Pharmaceutical
Health and Human Services Secretary Robert F Kennedy Jr has said he may prohibit researchers at government institutions from submitting their work to major medical journals, raising fresh tensions between the federal agency and the broader scientific community. 29 May 2025
Biotechnology
US biotech Moderna has reported encouraging early-stage results from a trial of its experimental vaccine for avian influenza, just as a significant federal funding agreement was unexpectedly withdrawn. 29 May 2025
Pharmaceutical
US biotech Hillstar Bio has appointed Maude Tessier as chief operating officer and Shiva Krupa as vice president of program management, reinforcing its leadership bench ahead of a planned clinical entry for its lead autoimmune program in 2026. 29 May 2025
Pharmaceutical
Spero Therapeutics is making headlines as its stock experienced a remarkable 244% surge to $2.35 yesterday, on news of positive clinical trial results. 29 May 2025
Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Biotechnology
Sino-American biotech BeiGene has now effected its previously announced transition, becoming BeOne Medicines and redomiciling to Switzerland, marking a significant milestone in the company’s evolution. 29 May 2025
Pharmaceutical
Artificial Intelligence (AI) has rapidly evolved from a promising technology to a core enabler of innovation in the pharmaceutical industry. Today, AI is estimated to generate between $350 billion and $410 billion in annual value for pharmaceutical companies. 29 May 2025
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