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Biotechnology
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
Biotechnology
Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022
Biotechnology
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
Biotechnology
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
Pharmaceutical
UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022
Biotechnology
US biotech major Gilead Sciences’ shares were up 4% at $65.48 in early trading today, as it announced statistically-significant and clinically-meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. 15 August 2022
Biotechnology
Swiss pharma giant Novartis has announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab, an inhibitor of interleukin-1beta did not meet its primary endpoint of disease-free survival versus placebo. 15 August 2022
Biotechnology
Investments in research and development continue to pay dividends for British drugmaker AstraZeneca, with the firm’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) passing an important test in breast cancer. 15 August 2022
Biotechnology
An arbitrator issued a decision on Friday in a dispute between Japan’s Daiichi Sankyo and the USA’s Seagen, denying all claims made by Seagen. 14 August 2022
Biotechnology
AstraZeneca and Daiichi Sankyo’s drug Enhertu (trastuzumab deruxtecan) has become the first HER2-directed therapy to be approved in the USA for patients with previously-treated HER2-mutant metastatic non-small cell lung cancer. 12 August 2022
Pharmaceutical
Privately held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, yesterday announced that the US Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. 12 August 2022
Biotechnology
PsiOxus, a clinical-stage biotechnology company developing a novel platform technology for the targeted delivery of therapeutic transgenes to solid tumors, has announced the appointment of its new chief executive, Howard Davis. 12 August 2022
Biotechnology
German biopharma company Affimed Therapeutics closed Thursday’s New York trading 9% lower. 12 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has granted regular approval to Swiss pharma giant Novartis’ Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. 12 August 2022
Biosimilars
Russian drugmaker Biocad is eyeing becoming the largest supplier of oncology drugs for state needs, achieving this by producing analogues of some popular drugs for the treatment of cancer. 11 August 2022
Biotechnology
The US Food and Drug Administration is not ready to let French microbiome specialist MaaT Pharma continue work on its acute graft-versus-host disease (aGvHD) candidate. 11 August 2022
Biotechnology
California, USA-based Appia Bio, a pre-clinical-stage biotechnology company today announced that Jason Damiano has been appointed as its chief scientific officer. 10 August 2022
Biotechnology
Late-breaking post-hoc exploratory results from the POSEIDON Phase III trial suggest a trend for improved overall survival (OS) with a limited course of five cycles of tremelimumab added to AstraZeneca’s Imfinzi (durvalumab) plus platinum chemotherapy, in the first-line treatment of patients with STK11, KEAP1 or KRAS-mutated Stage IV (metastatic) non-small cell lung cancer (mNSCLC). 9 August 2022
Biotechnology
Chinese biotech BeiGene has announced that the global Phase III RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). 9 August 2022
Biotechnology
US clinical-stage biotech Mersana Therapeutics saw its shares trading up 14.1% at $5.99 pre-market this morning, after it announced a global collaboration that provides UK pharma major GSK with an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2. 9 August 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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