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Biotechnology
The US Food and Drug Administration (FDA) has approved Lazcluze (lazertinib) in combination with Rybrevant (amivantamab-vmjw), from Janssen Biotech, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). 20 August 2024
Biotechnology
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Padcev (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer. 20 August 2024
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 20 August 2024
Biotechnology
Kineta today revealed that enrollment has resumed for the company’s ongoing VISTA-101 Phase I/II clinical trial, effective immediately. 19 August 2024
Biotechnology
Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE: AZN) have announced regulatory advancements for Enhertu (trastuzumab deruxtecan), in the treatment of certain people with brease cancer. 19 August 2024
Pharmaceutical
Texan firm Moleculin Biotech (Nasdaq: MBRX) has announced a public offering, raising approximately $5.5 million with stock priced at $2.23 per share. 16 August 2024
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has announced that the US medicines regulator will consider vimseltinib under the Priority Review scheme. 16 August 2024
Biotechnology
Adding to a string of recent news for its cancer drug, UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) has gained yet another indication approval. 16 August 2024
Biotechnology
US biotech Incyte has announced positive top-line results from the pivotal Phase III inMIND trial evaluating the efficacy and safety of Monjuvi (tafasitamab). 16 August 2024
Pharmaceutical
Californian biotech Apollomics (Nasdaq: APLM) has announced promising preliminary results from its Phase II SPARTA trial. 15 August 2024
Pharmaceutical
US President Joe Biden has announced an additional $150 million in funding as part of the ongoing Cancer Moonshot initiative. 15 August 2024
Biotechnology
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review by the US Food and Drug Administration (FDA). 15 August 2024
Pharmaceutical
Shares of American dermatology company Verrica Pharmaceuticals had a roller-coaster start to the day after announcing what it called positive trial results. 14 August 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma's (TYO: 4503) targeted cancer treatment, Vyloy (zolbetuximab). 14 August 2024
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published its final guidance recommending Accord Healthcare’s Orgovyx (relugolix) for the treatment of hormone-sensitive prostate cancer, recognizing the treatment as cost-effective in England. 14 August 2024
Biotechnology
US oncology focused biotech Syros Pharmaceuticals announced that it will discontinue enrollment in the SELECT-AML-1 Phase II clinical trial. 14 August 2024
Generics
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Pharmaceutical
The shortage of drugs in Russia is deepening, and is currently being observed in almost 70 regions throughout the country and forcing the local state to consider ways to resume stable supplies to local market, reports The Pharma Letter’s local correspondent. 13 August 2024
Biotechnology
CRISPR genome-editing biopharma company Caribou Biosciences has announced the appointment of Tina Albertson as chief medical officer (CMO). 13 August 2024
Biotechnology
Daiichi Sankyo’s shares rose 5.5% to 5,758 yen this morning, after it announced a third approval in China for Enhertu (trastuzumab deruxtecan). 13 August 2024
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
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
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