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Biotechnology
London-listed Irish company Poolbeg Pharma, an infectious disease specialist, has signed an option agreement to license MelioVac, a pre-clinical vaccine candidate for melioidosis. 6 December 2021
Biotechnology
The US Food and Drug Administration has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants 4 December 2021
Biotechnology
Czech immuno-oncology specialist SOTIO Biotech, part of the investment company PPF Group, says it has raised up to 280 million euros ($317 million). 2 December 2021
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) has approved a new site to manufacture Vaxzevria (previously COVID-19 Vaccine AstraZeneca) finished product. 1 December 2021
Pharmaceutical
Chinese drugmaker Hengrui is about to file a new drug application (NDA) in China for approval of the ophthalmic treatment SHR8058 (perfluorohexyloctane), an eye drop for lowering intraocular pressure (IOP) developed by the German biotech Novaliq, which in 2019 sold its China rights to Hengrui. 1 December 2021
Pharmaceutical
UK pharma major GlaxoSmithKline today announced that Dr Phil Dormitzer will join the company as global head of vaccines R&D on December 3, 2021. 30 November 2021
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a draft guidance for drugmakers relating to the use of real-world evidence (RWE). 30 November 2021
Biotechnology
UK-headquartered pharma services and products company Clinigen Group has signed an exclusive agreement with Japan’s Nippon Shinyaku to implement a managed access program (MAP) for Viltepso (viltolarsen) for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy. 29 November 2021
Biotechnology
In Greece, a joint venture (JV) between USA-based cell and gene therapy firm Orgenesis and Greek regenerative medicine company Theracell Advanced Biotechnology has been designated a “Priority Investment of Strategic National Importance.” 29 November 2021
Biotechnology
BioConnection, an independent Contract Development Manufacturing Organization (CDMO) based in Oss, The Netherlands, today announced that Nykode Therapeutics, the Norwegian vaccines and novel immunotherapies company formerly known as Vaccibody, has selected BioConnection for the aseptic drug product manufacturing of its lead vaccine candidate. 29 November 2021
Biotechnology
Germany’s BioNTech has said it is testing Comirnaty, the COVID-19 vaccine it developed with Pfizer that is one of the most-widely used in the western world, against the new variant of the coronavirus that has emerged in several southern African counties, according to a company statement. 26 November 2021
Pharmaceutical
Earlier this month, Novartis agreed to sell 53.3 million (around 33%) bearer shares of fellow Swiss pharma giant Roche in a bilateral transaction to Roche for a total consideration of $20.7 billion. 26 November 2021
Pharmaceutical
Danish diabetes care giant Novo Nordisk says it has received the results from the Volume Based Procurement (VBP) tender for insulin in China. 26 November 2021
Biotechnology
Japanese drugmaker Chugai, which is majority-owned by Swiss giant Roche, says that it obtained approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibody Herceptin (trastuzumab) injection 60 and 150 for the additional indication of advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection. 25 November 2021
Pharmaceutical
UK pharma major AstraZeneca will today formally unveil The Discovery Centre (DISC) in Cambridge, UK – a state-of-the-art research and development (R&D) facility designed to the world’s highest environmental standards and accommodating over 2,200 research scientists. 23 November 2021
Biotechnology
US pharma giant Merck & Co says that the US Food and Drug Administration has approved Keytruda (pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 18 November 2021
Biotechnology
Japanese pharma major Takeda Pharmaceutical has taken the next step in its collaboration with San Franciscan neuroscience company Denali Therapeutics, exercising an option on a progranulin replacement therapy, DNL593. 17 November 2021
Pharmaceutical
In the week that the company has announced that it will start selling its Vaxzevria COVID-19 vaccine for profit in the world’s wealthier countries, AstraZeneca has stressed that poorer nations have been receiving their share. 16 November 2021
Biotechnology
Los Angeles-based biotech Acelyrin has completed a $250 million series B financing round led by AyurMaya, an affiliated fund of Matrix Capital Management. 16 November 2021
Biosimilars
India’s Biocon Biologics has launched a new outreach initiative in diabetes, together with Asia’s largest research and professional organization for the therapy area, the Research Society for the Study of Diabetes in India (RSSDI). 15 November 2021
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Biotechnology
US biotech Paragon Therapeutics yesterday revealed that biotech industry veteran Susanna High has been appointed as chief executive (CEO). In this newly-created role, Ms High will lead the team’s continued efforts to propel the development of a pipeline of transformative therapies and accelerate their potential impact. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
California-based venture capital firm Versant Ventures yesterday announced the launch of Pep2Tango Therapeutics, a start-up focused on innovative, next-generation weight loss therapies. Proceeds from the significant, undisclosed round will support development of the company’s novel unimolecular tetra-receptor agonist peptides to treat obesity and related conditions. 22 November 2024
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
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