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Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today welcomed the decision from the UK’s National Institute for Health and Care Excellence (NICE) recommending the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant (ASCT) is suitable. 22 December 2021
Pharmaceutical
On Friday, the European Medicines Agency’s human medicines committee (CHMP) announced recommendations of novel medicines for approval at its December 2021 meeting. 18 December 2021
Biotechnology
AstraZeneca has exercised its first license option for an Invir.IO oncolytic virus (OV) developed from its ongoing OV collaboration with Transgene, the biotech that designs and develops virus-based immunotherapeutics against cancer. 15 December 2021
Biotechnology
Swiss clinical-stage biotech Molecular Partners has entered into a collaboration with pharma giant Novartis n the form of a license agreement to develop, manufacture and commercialize DARPin-conjugated radioligand therapies (DARPin-RLTs). 15 December 2021
Biotechnology
Germany-based Immatics, a company focused on the discovery and development of T cell-redirecting cancer immunotherapies, has entered into a license, development and commercialization agreement with US pharma major Bristol Myers Squibb. 14 December 2021
Biotechnology
Shares of Foghorn Therapeutics were up nearly 43% at $17.18 (having risen as high as $18.15) by mid-morning, after the US biotech revealed a lucrative research collaboration with Eli Lilly’s Loxo Oncology unit for the use of its proprietary Gene Traffic Control platform. 13 December 2021
Biotechnology
US pharma major Bristol Myers Squibb has announced the first disclosure of results from a prespecified interim analysis of the pivotal TRANSFORM study at the American Society of Hematology (ASH) Annual Meeting. 13 December 2021
Biotechnology
Updated results from the ASCEND Phase III trial showed that Calquence (acalabrutinib) maintained a statistically-significant progression-free survival (PFS) benefit at three years compared to investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults, said the drug’s developer, Anglo-Swedish pharma major AstraZeneca 13 December 2021
Pharmaceutical
Real world evidence (RWE) continues to grow as a promising frontier in evidence generation to support positive health outcomes. It can be useful in evaluating unmet healthcare needs, real world standard of care, and patient-reported outcomes, as well as developing realistic trial designs and budget impact models. 13 December 2021
Biotechnology
US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary has received Conditional Marketing Authorization (CMA) approval from the European Commission for Rybrevant (amivantamab) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy. 11 December 2021
Pharmaceutical
Virtually every drugmaker with a presence in hematology is preparing for their end-of-year attempt to impress physicians and investors with the best of their freshest data at the American Society of Hematology (ASH) Annual Meeting and Exposition. 10 December 2021
Biotechnology
China-based Avistone Pharmaceuticals has received a strategic investment of more than $200 million led by Vivo Capital with participation from Bain Capital and Primavera Capital. 9 December 2021
Biosimilars
Hungary's largest drugmaker Gedeon Richter has reached a deal with London-listed drugmaker Hikma Pharmaceuticals, out-licensing biosimilar denosumab for commercialization in the USA. 9 December 2021
Pharmaceutical
Danish firm Novo Nordisk announced pharma's biggest M&A deal in November with its $3.3 billion planned buy of Dicerna Pharmaceuticals. 8 December 2021
Biotechnology
Czech immuno-oncology (I-O) specialist SOTIO Biotech, part of the investment company PPF Group, has entered into a clinical trial collaboration and supply agreement with Merck & Co, the US pharma giant known as MSD outside North America. 8 December 2021
Biotechnology
New data from the TROPIONPanTumor01 trial of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC), being developed by Daiichi Sankyo and AstraZeneca, continue to show encouraging durable tumor response and disease control in patients with metastatic triple negative breast cancer (TNBC) with disease progression following standard treatment. 8 December 2021
Biotechnology
Deal hungry Recursion Pharmaceuticals signed a second deal this week, entering into a collaboration with Swiss giant Roche and its Genentech subsidiary, to more rapidly identify novel targets and advance medicines in key areas of neuroscience as well as in an oncology indication. 7 December 2021
Biotechnology
US biotech Bolt Biotherapeutics lost more than half of its stock market value on Monday. 7 December 2021
Pharmaceutical
The updated Chinese national drug reimbursement list, released on December 3 by the National Healthcare security Administration (NHSA), showed clearly that China wants more affordable rare disease drugs and innovative cancer drugs, reports The Pharma Letter’s local correspondent. 6 December 2021
Biotechnology
UK clinical-stage biotech Redx Pharm edged up 5% to 62.80 pence this morning, as it announced a partnership with Caris Life Sciences, a molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare. 6 December 2021
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
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