Oncology
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Biotechnology
Despite being presenting with briefing documents expressing some concerns about efficacy and safety, the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 11 to 2 in favor of Polivy (polatuzumab vedotin-piiq) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). 10 March 2023
Biotechnology
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC). 10 March 2023
Pharmaceutical
Privately-held Swiss drugmaker Ferring was responsible for two out of the eight biological medicines approved by the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research in 2022. 9 March 2023
Biotechnology
Staff at the US Food and Drug Administration (FDA) have prepared a report on the use of Roche’s Polivy (polatuzumab vedotin) alongside Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated large B-cell lymphoma. 9 March 2023
Biotechnology
UK pharma major AstraZeneca this morning released new Phase III data on two of its oncology drugs, showing positive results in lung cancer survival. 9 March 2023
Biotechnology
UK biotech Redx Pharma added to its woes, announcing that top-line results of its Phase II program were not sufficient enough to support the development of its RXC004 treatment as a monotherapy. 8 March 2023
Biotechnology
Japanese biotech Carna Biosciences has terminated a licensing deal with its Chinese partner BioNova Pharmaceuticals and regained all China rights of the asset AS1763, a BTK inhibitor treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell non-Hodgkin lymphoma (B-cell NHL). 8 March 2023
Biotechnology
An analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pre-treated patients. 7 March 2023
Biotechnology
US clinical-stage cancer biotech Volastra Therapeutics, which is focused on exploiting chromosomal instability (CIN), today announced completion of the in-licensing of Amgen’s sovilnesib (AMG650), an oral, first-in-class small molecule inhibitor of KIF18A. 7 March 2023
Pharmaceutical
Shorla Oncology, a privately-held, female founded US-Ireland pharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. 7 March 2023
Biosimilars
The Russian drugmaker R-Pharm is accelerating its expansion in the domestic market this year with the planned investments of 4 billion roubles ($100 million) in the building a new production facility in St Petersburg and the establishment of a large-scale production in the capital city of Moscow. 7 March 2023
Biotechnology
Shares of UK cell therapy specialist Adaptimmune Therapeutics and Cambridge, USA-based TCR² Therapeutics moved in opposite directions this morning, as they announced plans to merge. 6 March 2023
Pharmaceutical
UK-based drug developer ImmuPharma has signed an initial collaboration agreement on the company's peptide technology, with Orano. 6 March 2023
Pharmaceutical
Australian radiopharmaceuticals developer Radiopharm Theranostics (ASX: RAD) announced that through its wholly-owned US subsidiary, it has entered into a binding agreement to acquire Pharma15 Corporation,. 6 March 2023
Pharmaceutical
New clinical research news last week included USA-based Blueprint Medicines on Monday releasing promising data on its Ayvakit in the treatment of indolent systemic mastocytosis. On Friday, US drug developer Exelixis announced that a Phase III trial of its Cabometyx in kidney cancer failed. On the regulatory front, Germany’s Bayer gained expanded approval for its oncology drug Nubeqa in Japan for the indication of metastatic prostate cancer, and last Wednesday the US Food and Drug Administration (FDA) granted approval for Reata Pharmaceuticals’ Skyclarys (omaveloxolone) as a treatment for Friedreich’s ataxia. Also of note, there were media reports that Pfizer had stepped in where fellow US pharma giant Merck & Co had failed, entering early-stage talks to acquire US biotech firm Seagen. 5 March 2023
Pharmaceutical
Exelixis has announced the failure of the Phase III CONTACT-03 study of Cabometyx (cabozantinib), in kidney cancer. 3 March 2023
Pharmaceutical
The global cancer vaccines market is expected to garner a market value of $9 billion in 2023 and is expected to accumulate a market value of $24.22 billion by registering a compound annual growth rate (CAGR) of 12% in the forecast period 2023 to 2033. 3 March 2023
Generics
Taiwan generics drugmaker Lotus Pharmaceuticals has received approval in Vietnam for its cancer drug vinorelbine soft gel in two varieties - 20mg and 80mg- to compete with the branded version Navelbine, originated by French drugmaker Pierre Fabre. 3 March 2023
Biotechnology
USA-based Ambrx Biopharma and partner NovoCodex Biopharmaceuticals have announced an update on ACE-Breast-02, a Phase III breast cancer trial. 2 March 2023
Pharmaceutical
Markets were not hugely worried by predictions for a tough 2023 for Merck KGaA, with the German company’s share price only marginally down late Thursday. 2 March 2023
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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