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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
Pharmaceutical
Germany’s Merck KGaA today announced the presentation of detailed positive results from Part 1 of the global Phase III MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics, in the treatment of patients with tenosynovial giant cell tumor (TGCT). 28 May 2025
Biotechnology
German drug developer InflaRx saw its US-traded shares plunge 55% to $0.82 in pre-market activity today, as it announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase III trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. 28 May 2025
Biotechnology
Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025
Pharmaceutical
US biotech GRIN Therapeutics has secured $140 million in Series D funding and signed a licensing deal with Italy's Angelini Pharma that could bring in more than $500 million in future payments tied to its lead investigational therapy, radiprodil. 28 May 2025
Biotechnology
In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025
Pharmaceutical
New York-based neurosciences company Gilgamesh Pharmaceuticals yesterday announced Phase IIa results for GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). 28 May 2025
Biotechnology
US biotech Lexeo Therapeutics has secured $80 million from a private placement, giving the company enough capital to push ahead with its cardiac gene therapy pipeline and fund operations into 2028. 28 May 2025
Biotechnology
US biotech royalty firm XOMA Royalty has expanded its interest in mezagitamab, an anti-CD38 monoclonal antibody in Phase III development, through a deal worth up to $30 million with Swedish antibody developer BioInvent International. 28 May 2025
Pharmaceutical
US pharma major Eli Lilly has announced a definitive agreement to acquire SiteOne Therapeutics, a private biotechnology company developing small molecule inhibitors of sodium channels to treat pain and other neuronal hyperexcitability disorders. 28 May 2025
Biotechnology
Lupus is a rare autoimmune disease characterized by chronic inflammation. It presents in four main forms: systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), drug-induced lupus, and neonatal lupus. 28 May 2025
Biotechnology
German biotech TQ Therapeutics today announced the acquisition of Juno Therapeutics GmbH, a cell therapy company, through a share purchase agreement. Financial terms of the agreement were not disclosed. 28 May 2025
Biotechnology
French biotech ImCheck Therapeutics is preparing to showcase encouraging interim results for its investigational monoclonal antibody ICT01 at the 2025 ASCO Annual Meeting, highlighting the compound’s potential to improve outcomes in acute myeloid leukemia (AML) patients not eligible for intensive chemotherapy. 27 May 2025
Biotechnology
Swedish biotech Hansa Biopharma is preparing to reduce its headcount by around one-fifth as part of a restructuring plan aimed at sharpening operational focus and reducing costs. 27 May 2025
Biotechnology
The market for antibody-drug conjugates (ADCs) in non-small cell lung cancer (NSCLC) is poised for significant growth, projected to surpass $3.9 billion by 2032 across the USA, Europe, and Japan, according to data and analytics group GlobalData. 27 May 2025
Biotechnology
US late-stage biotech Rocket Pharmaceuticals saw its shares plummet as much as 64% to $2.25 in pre-market activity today, after it announced an update related to a trial of RP-A501, its investigational gene therapy for Danon disease, which resulted in a patient death. 27 May 2025
Biotechnology
China’s biopharmaceutical sector experienced a notable increase in oncology drug licensing deals in 2024, particularly for monoclonal antibodies (MAbs) and antibody-drug conjugates (ADCs), with a combined deal value of $30 billion. 27 May 2025
Biotechnology
Biotech major Biogen and fellow Cambridge, USA-based City Therapeutics, today announced a strategic collaboration to develop select novel RNA interference (RNAi)-based therapies. 27 May 2025
Pharmaceutical
Leading healthcare solutions company Zuellig Pharma has announced that Mounjaro (tirzepatide), Eli Lilly’s blockbuster diabetes and obesity drug, will be launched in Thailand at the end of May 2025. 27 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
US biotech Syndeio Biosciences has launched with over $90 million in funding and a pipeline of synapse-targeting neurotherapies aimed at treating major depressive disorder, Alzheimer’s disease, and other central nervous system (CNS) conditions. 27 May 2025
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