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Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 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
The demand for foreign drugs designed for cancer treatment in Russia remains stable, despite the ever-growing number of generics in the local market, according to recent statements by some leading Russian pharma analysts and local media, reports The Pharma Letter’s local correspondent. 22 December 2020
Biosimilars
China-based Henlius, the biotech arm of Fosun Pharma’s, is likely to have a busy year ahead. 22 December 2020
Biotechnology
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. 21 December 2020
Pharmaceutical
Swiss firm Myovant Sciences has won US approval for Orgovyx (relugolix), for the treatment of adults with advanced prostate cancer. 21 December 2020
Pharmaceutical
There was good and bad news from the US regulator on Friday for UK pharma major AstraZeneca. 21 December 2020
Biotechnology
Janux Therapeutics has announced a strategic collaboration with Merck & Co valued at more than $1 billion to develop novel T cell engager (TRACTr) immunotherapies for the treatment of cancer. 18 December 2020
Pharmaceutical
UK pharma major GlaxoSmithKline has entered into a license agreement to gain exclusive worldwide development and commercial rights to Surface Oncology’s pre-clinical program SRF813, a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. 18 December 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has published its final recommendations on two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 17 December 2020
Pharmaceutical
Privately-held US drug developer Oncoceutics says it has out-licensed the rights to the company’s lead compound, ONC201, for Greater China to China Resources Sanjiu Medical & Pharmaceutical (CR Sanjiu). 17 December 2020
Biotechnology
News of a merger deal for Israel-headquartered pre-clinical biopharma firm Anchiano Therapeutics sent the firm’s shares up as much as 183% early yesterday, and still up 87% at $2.8 by close of trading. 16 December 2020
Biotechnology
Californian investment group Westlake Village BioPartners has launched two new funds totaling $500 million, with the goal of promoting promising firms with innovative technologies. 15 December 2020
Biotechnology
Japanese firms Ono Pharmaceutical and Chordia Therapeutics have agreed a licensing deal on CTX-177, the latter company’s MALT1 inhibitor and its related compounds. 15 December 2020
Biotechnology
ADC Therapeutics and Hillhouse Capital-backed Overland Pharmaceuticals have jointly formed a new company. 14 December 2020
Pharmaceutical
COVID-19, regulatory news and M&A activity featured last week, with Amgen gaining Breakthrough Therapy designation for sotorasib (AMG 510), its candidate for lung cancer patients with KRAS G12C mutations. Pfizer and BioNTech received a positive vote for their COVID-19 vaccine candidate BNT162b2 from a US Food and Drug Administration advisory panel, followed the next day with an emergency use authorization from the FDA. Johnson & Johnson’s Janssen unit filed for European Medicines Agency approval of its PP6M, a new formulation of paliperidone palmitate for schizophrenia. Also of significance was Gilead Sciences’ announcement of its fifth M&A deal this year, with an agreement to acquire Germany’s MYR GmbH for $1.39 billion. Also, Boehringer Ingelheim announced a $1.4 billion acquisition of Swiss immune-oncology company NBE Therapeutics. 13 December 2020
Pharmaceutical
The European Medicines Agency’s human medicines committee (CHMP) has recommended eight novel medicines for approval at its December 2020 meeting, as well as two biosimilars. 11 December 2020
Biotechnology
Shares in French biotech Innate Pharma dropped 20% on Friday morning, after the firm announced it was handing back US and EU commercialization rights for Lumoxiti (moxetumomab pasudotox-tdfk). 11 December 2020
Biotechnology
Takeda’s Alunbrig (brigatinib) has been recommended for use on the National Health Service (NHS) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor. 10 December 2020
Pharmaceutical
COVID-19 will continue to be a defining issue for pharma and biotech companies in 2021, but overall, the sector will start the year from a position of strength, according to the Evaluate Vantage 2021 Preview, published today. 10 December 2020
Biotechnology
The US Food and Drug Administration granted a coveted Breakthrough Therapy designation for US biotech giant Amgen’s investigational KRASG12C inhibitor, sotorasib (AMG 510). 9 December 2020
Pharmaceutical
Swiss pharma giant Novartis has presented detailed results on its investigational STAMP inhibitor asciminib’s comparison with Pfizer’s (NYSE: PFE) Bosulif (bosutinib) at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). 8 December 2020
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