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USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
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In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
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AstraZeneca China Announces Leadership Changes and New Biopharmaceutical Unit
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AstraZeneca (AZ, NASDAQ: AZN)’s China unit is set to undergo significant organizational changes, including the establishment of a new business department and three C-suite appointments, as reported by local media. Chen Kangwei, currently the General Manager of AstraZeneca’s China oncology division, will relocate to Singapore for family reasons, taking on…
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Cytokinetics Attracts Big Pharma Interest Amid Aficamten’s Phase III Success
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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AstraZeneca Secures Exclusive Rights to Omniose’s Enzyme Platform for Bacterial Vaccine Development
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AstraZeneca (AZ; NASDAQ: AZN) has secured an exclusive licensing agreement with biotechnology firm Omniose for up to three years, gaining access to Omniose’s enzyme-based bioconjugation platform. This platform will be utilized for the development of vaccines targeting bacterial pathogens, including those that are multidrug-resistant. Omniose’s proprietary enzyme technology enables the…
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AstraZeneca and Sanofi’s RSV Prevention Drug Beyfortus Approved by China’s NMPA
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AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
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Allorion Therapeutics Strikes Deal with AstraZeneca for EGFR L858R Inhibitor Development and Commercialization
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Allorion Therapeutics, a China-based biopharmaceutical company, has announced an exclusive option and global licensing agreement with AstraZeneca (AZ, NASDAQ: AZN) to develop and commercialize a novel allosteric inhibitor targeting the L858R mutation of the epidermal growth factor receptor (EGFR). The drug is intended for the treatment of advanced EGFR mutant…
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AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
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AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for its ligand-conjugated antisense oligonucleotide (LICA) Wainua (eplontersen) as a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN/ATTRv-PN) in adults. Developed in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS),…
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AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
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Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies Inc., (NASDAQ: GRCL), a China-based developer of chimeric antigen receptor (CAR) T cell therapies. This marks the first major merger and acquisition (M&A) deal by a foreign company targeting one of China’s newest generation biotechs.…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Gilead Acquires Pre-Clinical IL-18BP Targeting Antibody Candidate from Compugen in $848 Million Deal
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Gilead (NASDAQ: GILD) has licensed a potential first-in-class IL-18 binding protein (IL-18BP) targeting antibody candidate from cancer immunotherapy developer Compugen (NASDAQ: CGEN), which is currently in the pre-clinical stage. Gilead will assume development responsibilities from Phase II onwards and will pay USD 60 million upfront, with up to USD 788…
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Sanofi Expands Oncology Portfolio with NK Cell Engager In-License from Innate Pharma
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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GSK’s CCO Calls China a Hotbed for Innovative Molecules and Licensing Deals
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In an interview with the Financial Times, Luke Miels, Chief Commercial Officer of UK-based GlaxoSmithKline (GSK; NYSE: GSK), highlighted China as a key source of innovative molecules for licensing agreements. Miels attributes this trend to China’s robust chemistry capabilities and the willingness of local companies to out-license their rights: “You…
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AstraZeneca Acquires Icosavax to Boost Infectious Disease Pipeline with VLP Vaccine Technology
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced the acquisition of US vaccines specialist Icosavax (NASDAQ: ICVX), including its protein virus-like particle (VLP) platform. AstraZeneca will pay approximately USD 800 million upfront for all outstanding shares, plus about USD 300 million in milestone payments. The acquisition is set to…
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Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis…
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MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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AbelZeta and AstraZeneca Team Up for Co-Development of GPC3-Targeted CAR-T Therapy
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AbelZeta Pharma Inc., a Sino-U.S. biotech firm based in Rockville, Maryland, and Shanghai, has announced a co-development agreement with AstraZeneca (AZ, NASDAQ: AZN) for its C-CAR031 chimeric antigen receptor (CAR) T cell therapy. C-CAR031 is an autologous, armored CAR-T therapy specifically targeting GPC3, currently under development for hepatocellular carcinoma (HCC).…
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AstraZeneca Halts Late-Stage Trials for Lokelma in Hyperkalemia Due to Timing and Event Rate Issues
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, has announced the termination of two late-stage trials for its commercial-stage potassium binder, Lokelma (sodium zirconium cyclosilicate), in hyperkalemia (HK) across the cardiorenal spectrum. The company has clarified that the decision is not due to safety concerns and does not affect…
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Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
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Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
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AstraZeneca to Open R&D Center in Hong Kong, Focusing on Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has concluded a roughly 12-month discussion period with local authorities and is proceeding to establish a research and development (R&D) center in Hong Kong, marking a significant step as it becomes the first leading global Big Pharma to do so in the city.…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
