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
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Mosaic Therapeutics, a UK-based oncology therapeutics company dedicated to resolving cancer’s complexity to power new combination therapies for patients, has announced the appointment of Barry Davies as chief scientific officer. 7 October 2024
Breast and Lung Cancer patients in Australia will have affordable access to life-changing medicines that normally cost up to A$80,000 ($61,162) for treatment from today, Minister for Health Sussan Ley has announced. 1 July 2015
Montreal, Canada-based Telesta Therapeutics has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for MCNA. 30 June 2015
Clinical-stage oncology company Prescient Therapeutics has notified the US Food and Drug Administration of the transfer of the Investigational New Drug (IND) for its novel drug candidate PTX-200 in a Phase Ib/II trial for metastatic ovarian cancer. 30 June 2015
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the investigational PD-1 (programmed death-1) immune checkpoint inhibitor, Opdivo (nivolumab), from US Pharma major Bristol-Myers Squibb. 30 June 2015
US biotech major Celgene Corp has entered into a collaboration with fellow-USA-based and Juno Therapeutics for the development and commercialization of immunotherapies. 30 June 2015
Several complaints that manufactures in India are selling life saving anticancer drugs at exorbitant prices has got the drug regulator to pressurize the National Pharmaceutical Pricing Authority (NPPA) to include anticancer drugs under the Drug Price Control Order (DPCO), reports The Pharma Letter’s India correspondent. 29 June 2015
The Australian government will invest A$57 million ($43.6 million) to list breakthrough melanoma drug Keytruda (pembrolizumab), from US pharma giant Merck & Co, on the Pharmaceutical Benefits Scheme (PBS). 29 June 2015
Privately-owned British company Immunocore and US drug major Eli Lilly have entered into an immunotherapy-based trial collaboration for Immunocore’s IMCgp100 in combination with Lilly’s galunisertib and merestinib in melanoma. 29 June 2015
Privately held Dutch biotech firm Amarna Therapeutics has entered into a cooperation with the Austrian Center for Biomarker Research in Medicine (CBmed), for the development of immunotherapies. 29 June 2015
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorization for Swiss pharma giant Novartis’ Odomzo (sonidegib), intended for the treatment of adults with locally advanced basal cell carcinoma (BCC). 28 June 2015
The European Medicines Agency’s Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Swiss pharma giant Novartis’ Farydak (panobinostat) for the treatment of multiple myeloma. 26 June 2015
Eli Lilly has announced that it had received a positive UK court ruling on the patent for its blockbuster cancer drug Alimta (pemetrexed disodium). 26 June 2015
The New Drug Application for MM-398 (irinotecan liposome injection), also known as "nal-IRI," has been accepted for review by the US Food and Drug Administration (FDA), according to the NDA’s sponsor, Merrimack Pharmaceuticals. 25 June 2015
Belgian biotech company Celyad, formerly Cardio3, has completed a US IPO and EU placing to raise $100.1 million gross which will fund a clinical trial program for a novel natural killer CAR cancer therapy, NKG2D. 25 June 2015
The breast cancer treatment market is forecast to increase in value from $9.2 billion in 2013 to more than $13.1 billion by 2020, representing a compound annual growth rate (CAGR) of 5.1%. 25 June 2015
Australian biotech firm Benitec Biopharma has launched a new exploratory cellular therapy program including exosome-based delivery utilizing the company's proprietary ddRNAi technology. 24 June 2015
Data presented at the recent American Society of Clinical Oncology (ASCO) Annual Meeting 2015 by US pharma major Bristol-Myers Squibb suggests that its Opdivo (nivolumab)/Yervoy (ipilimumab) combination of immunotherapies to treat metastatic melanoma will shape the therapeutic landscape once it is approved, says an analyst. 23 June 2015
The full therapeutic value of a cancer therapy is typically realized long after the drug's initial Food and Drug Administration approval, according to a report from Boston Healthcare. 23 June 2015
The American Society of Clinical Oncology (ASCO) has proposed a new framework designed to help clinicians and patients gauge the viability of different cancer treatments by taking into account clinical benefits as well as cost. 23 June 2015
USA-based oncology specialist Kite Pharma and clinical-stage biotech firm bluebird bio have entered into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor (TCR) product candidates 22 June 2015