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Biotechnology
Today Everest Medicines announced the approval of its New Drug Application (NDA) for Trodelvy (sacituzumab govitecan) from China’s National Medical Products Administration (NMPA) to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. 10 June 2022
Biotechnology
Swiss cancer giant Roche has secured the first and only European approval for a checkpoint blocker in a subset of people with early-stage non-small cell lung cancer (NSCLC). 9 June 2022
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The European Medicines Agency (EMA) has adopted a list of critical medicines for dealing with the COVID-19 pandemic. 8 June 2022
Biotechnology
Kimmtrak (tebentafusp-tebn), a T-cell receptor (TCR) therapy developed by Immunocore, has been approved in the UK, Australia and Canada. 8 June 2022
Biotechnology
China’s CanSino Biologics and US pharma giant Pfizer announced on June 4 that they had terminated a 10-year partnership signed in 2020. 6 June 2022
Biotechnology
On Saturday, Bristol Myers Squibb announced that it has withdrawn a supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. 4 June 2022
Pharmaceutical
French born now Australian citizen Pascal Soriot, chief executive of UK pharma major AstraZeneca, today received a British knighthood for services to UK life sciences and leadership in the global response to the COVID pandemic in the Queen’s Birthday Honours 2022. 2 June 2022
Biotechnology
Due to safety concerns, the US Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). 2 June 2022
Generics
Chinese drugmaker Hengrui has received approval from the National Medical Products Administration (NMPA) for its generic version of Santen's Diquas (diquafosol) to treat dry eye. 31 May 2022
Pharmaceutical
ViiV Healthcare has picked up Japanese approval for its Vocabria (cabotegravir)-based combo. 31 May 2022
Pharmaceutical
The US Food and Drug Administration has informed French pharma major Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design. 30 May 2022
Biotechnology
California, USA-based Catalyst Biosciences has signed a definitive asset purchase and sale agreement with Vertex Pharmaceuticals, under which Vertex has acquired Catalyst’s portfolio of protease medicines that regulate complement, including CB 2782-PEG, for $60 million in cash. 27 May 2022
Pharmaceutical
UK pharma major GlaxoSmithKline (GSK) today announced that China’s National Medical Products Administration (NMPA) has approved a two-dose vaccine schedule for Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, in girls aged between nine to 14 years for the prevention of cervical cancer, cervical intraepithelial neoplasia and adenocarcinoma in situ causally related to oncogenic Human Papillomavirus (HPV) types 16 and 18. 27 May 2022
Biotechnology
The CD19 targeted CAR-T therapy Yescarta (axicabtagene ciloleucel) was added in the Shanghai local government-backed commercial health insurance scheme Hu Hui Bao. 25 May 2022
Pharmaceutical
Japanese drug major Astellas Pharma has confirmed the US District Court for the District of Delaware ruling that all asserted claims of the 8,106,183; 8, 524,883; and RE47301 patents for Lexiscan (regadenoson injection) 0.4mg/mL are not infringed. 24 May 2022
Pharmaceutical
At the annual meeting of the American Society of Clinical Oncology (ASCO 22), data on 18 new and approved products will be offered by British firm AstraZeneca. 23 May 2022
Biotechnology
In Europe, AstraZeneca's COVID-19 vaccine, Vaxzevria, has been granted approval as a third dose booster in adults, including for those who had mRNA-based jabs initially. 23 May 2022
Pharmaceutical
China-based Kelun Pharmaceutical saw its shares jump as much as 6.7% after it revealed it has granted overseas development rights of an investigational cancer drug to a unit of US pharma giant Merck & Co that could potentially earn it over $1.4 billion, according to media reports. 18 May 2022
Biotechnology
Jiangsu Hengrui Pharmaceuticals – one of the largest pharma companies in China – today announced it is launching Luzsana Biotechnology. 18 May 2022
Biotechnology
Finnish drug delivery firm DelSiTech has joined forces with a precision medicine firm based in China, Anticancer Bioscience, to develop silica-based therapies in oncology. 18 May 2022
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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The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
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