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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
US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that 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). 2 June 2025
Biotechnology
The Alliance for Clinical Trials in Oncology has announced results from ATOMIC, a Phase III trial evaluating standard chemotherapy alone or combined with Roche’s Tecentriq (atezolizumab) in patients who have surgically resected stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). 2 June 2025
Pharmaceutical
US biotech Regeneron Pharmaceutical today announced a strategic in-licensing agreement with China’s Hansoh Pharmaceuticals for exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase III testing. 2 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has entered into an agreement for the global co-development and co-commercialization of German biotech BioNTech’s (Nasdaq: BNTX) investigational bispecific antibody BNT327 across numerous solid tumor types. 2 June 2025
Biotechnology
Netherlands-based biotech VectorY Therapeutics, which is developing treatments for neurodegenerative diseases, today announced the appointment of Jessica Atkinson as Chief Business Officer (CBO). 2 June 2025
Biotechnology
With ASCO 2025 drawing toward its close in Chicago, Amsterdam-based biotech Avidicure is entering the spotlight with its first public data on a new class of cancer immunotherapies. The company’s lead program, AVC-S-101, is designed to target TROP2 in non-small cell lung cancer (NSCLC) and other solid tumors. 2 June 2025
Biotechnology
US biotech Regeneron Pharmaceuticals has announced detailed analyses from the Phase III C-POST trial, which evaluated PD-1 inhibitor Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. 2 June 2025
Biotechnology
AstraZeneca has reported positive findings from its Phase III MATTERHORN trial, spotlighting the potential of its immunotherapy Imfinzi (durvalumab) to significantly delay disease progression in patients with early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. 2 June 2025
Pharmaceutical
Arcus Biosciences is setting the stage for a high-stakes Phase III showdown in kidney cancer, after early results showed that nearly half of patients treated with its experimental therapy had a confirmed response. 2 June 2025
Biotechnology
French pharma major Sanofi today revealed an agreement to acquire, and Blueprint Medicines, a US company, specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-driven diseases. Blueprint’s shares soared 26.80% to $101.35 in pre-market activity today. 2 June 2025
Biosimilars
Swiss generic and biosimilar medicines company Sandoz today announced that Wyost (denosumab) and Jubbonti (denosumab) are available to patients in the USA starting today. 2 June 2025
Pharmaceutical
US drugmaker Protagonist Therapeutics and Japan’s Takeda Pharma announced detailed results from the Phase III, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints. 2 June 2025
Pharmaceutical
Arvinas and Pfizer today announced detailed results from the Phase III VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. 2 June 2025
Pharmaceutical
US pharma giant Pfizer on Saturday announced statistically-significant and clinically-meaningful survival results from the Phase III BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. 2 June 2025
Pharmaceutical
The development of new drugs is more expensive than ever. Last year, it cost an average of over $2.23 billion to develop one new drug. 2 June 2025
Pharmaceutical
Treating greater numbers of Danish patients with rare diseases requires a more open and shared dialogue about handling uncertainty around the effects of the medicines used. 2 June 2025
Biosimilars
In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs." 2 June 2025
Pharmaceutical
Privately-held German drugmaker Grünenthal has acquired commercial rights to erectile dysfunction drug Cialis (tadalafil) in Mexico, Brazil and Colombia from US pharma major Eli Lilly. 2 June 2025
Biotechnology
Daiichi Sankyo and AstraZeneca have released detailed Phase III results that could help position their HER2-targeting drug Enhertu (trastuzumab deruxtecan) as the second-line standard of care for advanced gastric cancer. 2 June 2025
Pharmaceutical
Swiss biotech iOnctura has appointed Steven Sciuto as chief financial officer and Michelle Tsai as chief operating officer, marking a leadership shift as the company moves deeper into Phase II trials for its lead cancer candidate, roginolisib (IOA-244). 2 June 2025
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