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
The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance not recommending German drug major Bayer’s Xofigo (radium-223 dichloride) for treating adults with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases. 24 March 2014
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for US pharma giant Merck & Co and partner Endocyte’s Vynfinit (vintafolide) for the treatment of women with a subtype of platinum-resistant ovarian cancer for which there is limited approved treatment option. 21 March 2014
Over half a million cases of prostate cancer will be diagnosed worldwide in 2014 leading to a demand for new treatments, according to research from Datamonitor Healthcare. 21 March 2014
There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially lifted the clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). 21 March 2014
In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US health care giant Johnson & Johnson subsidiary Janssen’s Velcade (bortezomib) as a treatment for some patients with newly-diagnosed multiple myeloma. 21 March 2014
There was another setback for UK pharma giant GlaxoSmithKline with its MAGE-A3 antigen specific cancer immunotherapeutic MAGE-A, the company announced this morning, and seeing its shares slip 1.13% to £16.36. 20 March 2014
Ten new medicines to treat a range of illnesses from rare forms of cancer to skin conditions will be listed on the Australian Pharmaceutical Benefits Scheme (PBS) from April 1, Health Minister Peter Dutton announced, noting that that improved access to these medicines would benefit many Australians and particularly families with sick children. 19 March 2014
In an interview with The Pharma Letter, CEO Michael Forer discusses ADC Therapeutics' developing pipeline and intentions to take multiple proprietary ADCs into clinical development. 19 March 2014
The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit of ipilimumab, US pharma major Bristol-Myers Squibb’s Yervoy, this time seeing the data as uncertain. 19 March 2014
Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application with the US Food and Drug Administration seeking approval of Xtandi (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer who have not received chemotherapy. 18 March 2014
The non-small cell lung cancer (NSCLC) therapeutics market value in the Asia-Pacific (APAC) region - Australia, China, India and Japan - is expected to increase moderately over the coming years, climbing from $1.8 billion in 2012 to $2.9 billion by 2019, at a compound annual growth rate (CAGR) of 6.3%. 18 March 2014
Japanese drugmaker Kyowa Hakko Kirin has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma and cutaneous T-cell lymphoma for Poteligeo (mogamulizumab injection) from Japan's Ministry of Health, Labor and Welfare. 18 March 2014
USA-based MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca, and the University of Cambridge in the UK have entered into a three-year oncology research collaboration to use using imaging technologies to measure key biologic changes within growing tumors. 18 March 2014
Shares of Five Prime Therapeutics leapt 15% to $21.48 in early trading, after the company said it has signed a collaboration deal with US pharma major Bristol-Myers Squibb worth up to $350 million. 17 March 2014
The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini spoke about pharma innovation in action at The Economist’s Pharma Summit in London on Thursday. 17 March 2014
UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new draft guidance recommending German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) as an option for treating locally-advanced or metastatic non-small-cell lung cancer (NSCLC) in people whose tumors test positive for the EGFR-TK mutation and have not received a EGFR-TK inhibitor. 17 March 2014
Leading independent biotech firm Amgen says that findings from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of injected tumors and also non-injected tumors that had metastasized to other parts of the body. 16 March 2014
Therapeutic antibody discoverer AnaptysBio announced a strategic immuno-oncology collaboration with fellow USA-based Tesaro, an oncology-focused biopharmaceutical company, which could lead to payments of more than $340 million to the former. 14 March 2014