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Biotechnology
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 2024
Biotechnology
US clinical stage biotech Kronos Bio saw its shares edge up 2.3% to $1.32 this morning, on news of further restructuring. 8 March 2024
Biotechnology
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. 8 March 2024
Pharmaceutical
Germany’s Merck KGaA will hope to draw a line under a challenging year as it predicts a return to growth in 2024—albeit when adjusted for currency headwinds. 7 March 2024
Pharmaceutical
French drugmaker Ipsen has secured a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE). 7 March 2024
Biotechnology
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 7 March 2024
Biotechnology
In a filing with the US Securities and Exchange Commission (SEC), Boundless Bio has revealed its intention for an initial public offering (IPO). 7 March 2024
Biotechnology
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
Biotechnology
UK pharma major GSK today announced positive headline results from an interim analysis of the DREAMM-8 Phase III head-to-head trial evaluating Blenrep (belantamab mafodotin). 7 March 2024
Biotechnology
US antiviral drug specialist Gilead Sciences has entered into a research collaboration, option and license agreement with Dutch biotech Merus to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. 6 March 2024
Pharmaceutical
Melbourne-based Telix has entered into an agreement to acquire the Canadian radioisotope production technology firm ARTMS. 6 March 2024
Biosimilars
Sandoz has announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. 6 March 2024
Biotechnology
Marking a fourth deal this year, Japanese drugmaker Ono Pharmaceutical today announced that it has entered into a license agreement with pre-clinical stage Korean biotechnology NEX-I for NXI-101. 6 March 2024
Biotechnology
A pair of big pharma companies have become the latest drugmakers to take aim at the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 5 March 2024
Biotechnology
UK health technology assessor the National Institute for for Health and Care Excellence (NICE) today issued a final draft guidance recommending UK pharma major GSK’s Jemperli (dostarlimab) for a new indication. 5 March 2024
Pharmaceutical
Announcing its financial results for 2023, diversified German drugmaker said it would delay a plan to break up the group for at least a couple of years. 5 March 2024
Biotechnology
C4 Therapeutics saw its shares closed down 2.8% at $10.68 yesterday, despite announcing a license deal with Germany’s Merck KGaA. 5 March 2024
article
The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADCs), replacing the February 2022 draft guidance. 5 March 2024
Biotechnology
California-based Gritstone bio, a biotech company aiming to develop the world’s most potent vaccines, has announced an approximately 40% reduction of its workforce. 4 March 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
Pharmaceutical
Swiss cancer giant Novartis has entered into an exclusive worldwide licensing and collaboration deal with Ratio Therapeutics, aiming to develop a next-generation radiotherapeutic. 19 November 2024
Biotechnology
Chinese biotech Keymed Biosciences has entered an exclusive licensing agreement with Platina Medicines for its bispecific antibody candidate, CM336. 18 November 2024
Pharmaceutical
In yet another sign of the mounting interest in radiopharmaceuticals, Tongrui Biopharma, a Chinese innovator in this area, has announced the completion of a $100 million series A+ financing round. 18 November 2024
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