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
UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance recommending approval of Japanese drug major Astellas Pharma’s Xtandi (enzalutamide) as an option for treating hormone relapsed metastatic prostate cancer in adults on the National Health Service. 28 January 2014
US cancer drug developer Celsion Corp (Nasdaq: CLSN) says that the latest overall survival data from its Phase III HEAT study of ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radio frequency ablation (RFA) in liver cancer supports its continued clinical development. 27 January 2014
Most American investors are familiar with large European drugmakers like Sanofi and Novartis but the mid-caps like France’s Ipsen don't get as much attention, writes Stephen Simpson, Kratisto Investing on the Seeking Alpha blog. 27 January 2014
UK pharma major GlaxoSmithKline announced that its Phase III study of the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with unresectable or metastatic melanoma met its primary endpoint of progression free survival. 27 January 2014
Germany’s Medigene this morning revealed that it has acquired 100% of the shares of the Munich-based company Trianta Immunotherapies GmbH (Trianta), a spin-off of the Helmholtz Zentrum Munchen. 27 January 2014
Slow-growing, or indolent, non-Hodgkin lymphomas are difficult to treat, with most patients relapsing repeatedly and the disease becoming increasingly resistant to therapy over time. However, a new drug candidate, idelalisib, from US antivirals major Gilead Sciences appears to offer hope for fighting the disease. 24 January 2014
Indian biotech firm Biocon has entered into an exclusive licensing agreement for US cancer drug developer Advaxis for co-development and commercialization of ADXS-HPV, a novel cancer immunotherapy for the treatment of human papillomavirus (HPV)-associated cervical cancer in women, for India and key emerging markets. 23 January 2014
The bladder cancer therapeutics market in the six major countries is forecast to climb from $239.3 million in 2012 to $297.5 million by 2017, at a compound annual growth rate (CAGR) of 4.5%, says a new report from research and consulting firm GlobalData. 22 January 2014
Australian biotech company Patrys (ASX: PAB) has published 10-year follow up data for its product PAT-SC1 showing that it is well-tolerated in gastric cancer patients and offers a significant survival benefit. 22 January 2014
French drugmaker Ipsen (Euronext: IPN) has announced new governance in the USA following its decision to set up its own oncology team to commercialize Somatuline Depot (lanreotide) in neuroendocrine tumors (NETs) in the USA. 22 January 2014
An innovative screening technology that tags compounds with unique strands of DNA will be used to assess up to a billion prototype drug molecules for anti-cancer activity in a collaboration between The Institute of Cancer Research in London, Cancer Research Technology (CRT) and Denmark-based privately owned drug discovery company Nuevolution A/S. 22 January 2014
French drug developer Hybrigenics says it has achieved first drug discovery milestone in connection with the ongoing research collaboration with independent French drugmaker Servier on ubiquitin-specific proteases (USPs) and their inhibitors. Hybrigenics has received 330,000 euros ($447,410) in recognition of this achievement. 21 January 2014
Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from Japan’s Ministry of Health, Labor and Welfare for their new drug application for Savene (dexrazoxane) injectable for the treatment of anthracycline extravasation. 21 January 2014
India-based biotech firm Biocon (BSE: 532523) has introduced Canmab, a biosimilar trastuzumab, for the treatment of HER2-positive metastatic breast cancer in India. 20 January 2014
Japan’s largest drugmaker Takeda Pharmaceutical has received approval from the country’s Ministry of Health, Labor and Welfare for Adcetris (brentuximab vedotin) for the treatment for patients with CD30 positive or refractory Hodgkin lymphoma (HL) or relapsed or refractory anaplastic large cell lymphoma (ALCL). 18 January 2014
US biotech firm Celgene’s breast cancer drug, Abraxane (nanoparticle albumin-bound paclitaxel), has been shown to extend overall survival (OS) for patients with metastatic pancreatic cancer when used in combination with current standard of care, gemcitabine, with some patients surviving longer than three years. 18 January 2014
Due to favorable market conditions in terms of US pricing structures and the anticipated approval of a number of late-stage pipeline drugs, the market value for monoclonal antibodies (MAbs) in gastric and esophageal cancer treatment is expected to double by 2019. 18 January 2014
French drugmaker Ipsen (Euronext: IPN) has announced that Somatuline Autogel/Somatuline Depot (lanreotide) has been shown to reduce the need for rescue medication in patients with carcinoid syndrome. 17 January 2014
South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar monoclonal antibody Herzuma (trastuzumab), Swiss drug major Roche’s blockbuster cancer drug Herceptin, from Korea’s Ministry of Food and Drug Safety. 16 January 2014
USA-based Illumina has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Amgen’s Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the USA and European Union. 16 January 2014