Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
US biotech firm Cell Therapeutics has received positive news from the UK’s drugs watchdog for use of its lymphoma drug Pixuvri (pixantrone) on the National Health Service. 27 February 2014
All children and young people with cancer should have the opportunity to take part in relevant clinical trials to increase knowledge about the disease and improve survival rates. This is one of a number of recommendations by the UK’s National Institute for Health and Care Excellence (NICE) to improve standards of care for children, teenagers and young adults with the disease. 27 February 2014
US pharma giant Merck & Co has told partner Ariad Pharmaceutical that it is terminating its license agreement for the global development and commercialization of ridaforolimus (proposed trade name Taltorvic), the latter’s mTOR inhibitor, in oncology. 26 February 2014
The way is now clear for Germany’s Bayer to acquire Norwegian pharmaceutical company Algeta, under a deal announced late last year (The Pharma Letter December 19, 2013). 26 February 2014
US drug major Bristol-Myers Squibb today expressed its disappointment that the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued draft guidance which effectively denies access to Yervoy (ipilimumab) for National Health Service patients with previously-untreated advanced (unresectable or metastatic) melanoma, not involved in clinical trials. 25 February 2014
In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products in November 2013, the German Institute for Quality and Efficiency in Health Care has determined an added benefit for USA-based Medivation and Japanese partner Astellas Pharma’s Xtandi (enzalutamide) over the appropriate comparator therapy specified by the Federal Joint Committee. 24 February 2014
US biotech firm Onconova Therapeutics saw its shares plunge 37% to $8.70 in pre-market trading yesterday morning, after it released disappointing clinical data with its lead investigational drug rigosertib late on Wednesday. 21 February 2014
Swiss drug major Roche’s blockbuster cancer drug Avastin (bevacizumab) can extend the lives of women with advanced cervical cancer compared to chemotherapy alone, according to new data published in the New England Journal of Medicine. 20 February 2014
Genentech, the biotechnology subsidiary of Swiss drug major Roche, has made notable gains as the top oncology franchise among oncologists over the past year, as evidenced by significantly higher scores across all key performance drivers, especially research and development and developing beneficial products. 20 February 2014
US pharma major Eli Lilly has revealed that the REVEL trial showed that its ramucirumab improved survival in patients with non-small cell lung cancer, with the news pushing the firm’s shares up 3% to $57.00 in premarket trading. 19 February 2014
Swiss drug major Novartis says the pivotal trial of the investigational oral compound LDE225 (sonidegib) in advanced basal cell carcinoma met its primary endpoint of demonstrating an objective response rate among patients within six months of treatment. 19 February 2014
The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), examined whether German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) offers an added benefit over the appropriate comparator therapy. 19 February 2014
German drug development company Mologen has raised 15.7 million euros ($21.6 million) in order to fund a planned pivotal Phase III clinical trial of MGN1703 in metastatic colorectal cancer. 19 February 2014
Children with cancer are being denied potentially life-saving drugs because European Union rules are allowing companies to trial some drugs only in adults, leading cancer experts warn today. 18 February 2014
Allogeneic CAR T-cell therapies specialist Cellectis has signed a strategic collaboration agreement with France’s leading independent drugmaker Laboratoire Servier to develop and commercialize novel product candidates targeting leukemia and solid tumors. 18 February 2014
MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca, has entered into a three-year collaboration with the Clinical and Translational Science Institute at the University of California, San Francisco. 17 February 2014
UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody for the treatment of metastatic melanoma by the US Food and Drug Administration. 17 February 2014
X-Chem Inc, a privately held US biotechnology company focused on applying its innovative drug discovery capabilities to the generation of novel small molecule therapeutic is licensing an early-stage drug discovery program directed against an epigenetic drug target to Germany’s Bayer. 17 February 2014
Swiss drug major Novartis said this morning that it is broadening its cancer immunotherapy research program with the acquisition of privately-held US biotech firm CoStim Pharmaceuticals, which is focused on harnessing the immune system to eliminate immune-blocking signals from cancer. 17 February 2014