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Biotechnology
Shares in China-headquartered company Adagene were up by 4% during Wednesday morning’s trading in New York. 2 March 2022
Pharmaceutical
Crinetics Pharmaceuticals, a USA-based clinical-stage developer of novel therapeutics for rare endocrine diseases and endocrine-related tumors, has teamed up with Sanwa Kagaku Kenkyusho to exclusively develop and commercialize in Japan. 2 March 2022
Generics
Taiwanese generics and biosimilar drugmaker Lotus Pharmaceutical has received approval for its abbreviated new drug application (ANDA) in the Philippines for its generic versions of Bristol Myers Squibb’s Revlimid (lenalidomide) and AstraZeneca’s lung cancer drug Iressa (gefitinib). 2 March 2022
Pharmaceutical
The US medicines regulator has issued three final guidances to drugmakers regarding cancer clinical trials, reflecting a broader push from the administration to improve healthcare outcomes in oncology. 2 March 2022
Pharmaceutical
German pharma and crop sciences major Bayer shared successful fourth-quarter and full-year 2021 financial results on Tuesday. 1 March 2022
Pharmaceutical
Germany’s Heidelberg Pharma has gained a potentially significant route into the Chinese market via a blockbuster licensing deal. 1 March 2022
Biotechnology
US precision therapy company Blueprint Medicines’ shares dipped more than 2% to $61.62 early today, after it announced a strategic collaboration with Proteovant Therapeutics to advance novel targeted protein degrader therapies to address important areas of medical need. 28 February 2022
Biosimilars
Biocon subsidiary Biocon Biologics has agreed to buy the biosimilars unit of Viatris for $3.3 billion. 28 February 2022
Biotechnology
Among significant news last week, US biotech Synairgen’s COVID-19 therapy SNG001 missed endpoints in a Phase III study of hospitalized patients. BioNTech announced a deal with fellow German company Medigene for the discovery of cancer immunotherapeutics. Sanofi and GlaxoSmithKline have now developed Phase III clinical trial data that prepares then for regulatory filings for their investigational COVID-19 vaccine. US biotech Moderna released financial results last Thursday that were very much focussed on the performance of its COVID-19 vaccine Spikevax. Also, Amicus Therapeutics announced that its planned SPAC deal with ARYA Sciences has been terminated. 27 February 2022
Pharmaceutical
Following its February meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for six novel new medicines, as well as two biosimilars. 25 February 2022
Biotechnology
GlobalData has taken a look at the acute myeloid leukemia (AML) treatment landscape in China. 25 February 2022
Biotechnology
UK pharma major GlaxoSmithKline has today welcomed a decision by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to issue a Final Appraisal Determination (FAD) recommending the use of Zejula (niraparib) on the National Health Service (NHS). 24 February 2022
Biotechnology
The World Health Organization (WHO), the Republic of Korea and the WHO Academy have established a global biomanufacturing training hub that will serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments. 24 February 2022
Pharmaceutical
US cancer therapies specialist Karyopharm Therapeutics saw its shares drop as much as 31% Tuesday, on the news that its chief medical officer was stepping down, even though it also announced two prominent research appointments. 23 February 2022
Biotechnology
German biotech BioNTech, which has earned billions of dollars through its COIVD-19 vaccine development with Pfizer (NYSE: PFE), is looking to expand its business into new areas. 22 February 2022
Biotechnology
US T-cell immunotherapy company Atara Biotherapeutics closed 4% lower after Friday’s trading. 21 February 2022
Biotechnology
Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically-significant and clinically-meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy. 21 February 2022
Biotechnology
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
Biotechnology
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
Biotechnology
German life sciences and pharma company Merck KGaA late on Friday revealed that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 19 February 2022
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
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
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
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
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
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
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