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Pharmaceutical
Privately-held Austrian firm pharmaand (pharma&) has announced the presentation of new data from the randomized, Phase III company-sponsored ATHENA trial. 18 March 2024
Biotechnology
Pre-clinical contract research organization Selvita has expanded its services portfolio and entered the field of biologic drug discovery and development. 18 March 2024
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Japanese drugmaker Chugai Pharmaceuticals has filed regulatory applications with the Ministry of Health, Labor and Welfare (MHLW) for the anti-CD20xCD3 bispecific antibody mosunetuzumab for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior systemic therapies. 18 March 2024
Pharmaceutical
Eris Lifesciences has announced the acquisition of fellow Indian company Biocon Biologics’ India branded formulation business for a consideration of rupees 1,242 crore (~$149 million). 16 March 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Japanese drugmaker Daiichi Sankyo’s (quizartinib) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukemia (AML). 11 March 2024
Biotechnology
Belgian drugmaker UCB and South Korean contract development and manufacturing organization Samsung Biologics have signed a new drug substance manufacturing deal worth 382 billion Korean won ($288 million). 8 March 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today (March 7) approved US drugmaker Marinus Pharmaceuticals’ Ztalmy (ganaxolone) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD). 7 March 2024
Biotechnology
California’s BridgeBio Pharma is launching an underwritten public offering, with common stock available at $29 per share. 6 March 2024
Pharmaceutical
US pharma company CymaBay Therapeutics today announced that the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC), has been validated and will be reviewed by the European Medicines Agency (EMA). 4 March 2024
Pharmaceutical
Serum Institute of India (SII) aims to significantly boost supply of its human papillomavirus (HPV) vaccine as it gears up to provide its jabs to the government at cheaper rates for an immunization campaign this year against the cancer-causing virus, according to a Reuters report. 4 March 2024
Biotechnology
The UK’s Cell and Gene Therapy Catapult (CGT Catapult) has announced that its Braintree Manufacturing Innovation Centre has received a license from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables it to accelerate large-scale manufacturing of advanced therapy medicinal products (ATMPs). 1 March 2024
Pharmaceutical
Viking Therapeutics’ shares surged more than 80% pre-market on Monday, after it announced positive top-line results from the company's Phase II clinical trial of VK2735 as an obesity treatment. 27 February 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in a sixth potential indication. 23 February 2024
Pharmaceutical
Japanese drugmaker Daiichi Sankyo said on Friday that it would invest about 1 billion euros ($1.07 billion) to expand a manufacturing site near Munich, Germany, to boost its work on precision cancer drugs, according to media reports. 20 February 2024
Pharmaceutical
Japanese drugmaker Sosei Group Corporation (Sosei Heptares) today announced that its Board of Directors resolved to change the corporate names of the company and its subsidiaries and the location of the head office of the company. 16 February 2024
Biotechnology
US biotech major Gilead Sciences has opened a new research site in the UK. 14 February 2024
Biotechnology
The US Food and Drug Administration has provided a draft guidance document, consisting of recommendations to help drugmakers decide on best practice in respect of data monitoring. 13 February 2024
Pharmaceutical
The European Commission (EC) has published a report providing an overview of the enforcement of European Union antitrust and merger rules by the EC and EU national competition authorities in the pharmaceutical sector between 2018 and 2022. 12 February 2024
Pharmaceutical
February 9, 2024
Sylentis, a wholly owned subsidiary of Spain’s PharmaMar, (has obtained the results of the Phase III SYL10111_V (tivanisiran) clinical trial for the treatment of dry-eye associated with Sjögren’s syndrome. 11 February 2024
Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Biotechnology
Australian clinical-stage biotech Neurizon Therapeutics, which is advancing innovative treatments for neurodegenerative diseases, has significantly strengthened its executive management team with three key appointments. 18 April 2025
Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
Wall Street watched in awe as Eli Lilly made rampant gains in early trading Thursday. 17 April 2025
Biotechnology
Swiss pharma major Novartis has discontinued development of its experimental treatment QUC398 for knee osteoarthritis, ending hopes for a new therapy in the anti-ADAMTS-5 class. 17 April 2025
Pharmaceutical
Florida biopharma Ligand Pharmaceuticals subsidiary Pelthos Therapeutics is to merge with Channel Therapeutics, a developer of non-opioid pain treatments. 17 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biotechnology
Germany’s Evotec has unveiled a new strategy, and provided 2025 guidance—bolstered by strong results from the fourth-quarter of 2024. 17 April 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical announced that results from the Phase III clinical trial (NIHONBASHI study) of anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo (faricimab) intravitreal injection 120mg/mL, for angioid streaks associated with neovascularization were presented at the 129th Annual Meeting of the Japanese Ophthalmological Society on April 17. 17 April 2025
Pharmaceutical
Switzerland-based Addex Therapeutics, a biopharma developing a portfolio of novel small molecule allosteric modulators for neurological disorders, has announced an update on its Phase II asset, ADX71149. 17 April 2025
Biotechnology
US gene therapy company bluebird bio announced that after three weeks of engagement, including a timeline extension, Ayrmid Pharma has not submitted a binding proposal to acquire bluebird and has not obtained necessary financing. 17 April 2025
Pharmaceutical
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). 17 April 2025
Pharmaceutical
US biotech Wayfinder Biosciences has entered a research collaboration with Japanese drugmaker Daiichi Sankyo to develop small molecule therapies targeting RNA in neurodegenerative diseases. 16 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biotechnology
US biotech Myeloid Therapeutics has restructured its operations to concentrate on two cancer programs already in the clinic, a move that has resulted in staff reductions and an uncertain future for its early-stage research work. 16 April 2025
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