Portuguese antibody solutions company Fairjourney Biologics has signed a research and option agreement with Israeli technology transfer company BioRap Technologies at the Rappaport Institute and Hadasit Medical Research Services and Development to develop antibodies against heparanase. 1 April 2014
Otsuka Pharmaceutical has reached an agreement with the US subsidiary of fellow Japanese drugmaker Eisai
to acquire rights to the hematological cancer treatment Dacogen (decitabine) and to an enzyme inhibitor, E7727. Financial terms of the deal were not disclosed. 1 April 2014
US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled in the company's favor regarding the vitamin dosage regimen patent for its cancer drug Alimta (pemetrexed for injection). 1 April 2014
UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a variation to the Marketing Authorization for Votrient (pazopanib) related to the additional indication for the maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy. 31 March 2014
The UK’s specialty pharma firm Clinigen Group says it has acquired rights to Savene (dexrazoxane) from SpePharm AG, a majority owned affiliate of independent Dutch drugmaker Norgine. Financial terms of the acquisition are not being disclosed. 31 March 2014
Tiziana Pharma, a recently-established UK biotech company that has licensed technology for a potential breast cancer drug from Cardiff University, Wales, is set to stage a reverse takeover of Alexander David Investments, an AIM-listed shell company, and plans to change its name to Tiziana Life Sciences. 31 March 2014
Efficacy, more than any other factors, drives oncologists’ prescribing of targeted therapies for breast cancer and, according to the majority of oncologists surveyed by Decision Resources, the escalating overall cost of drug treatment for breast cancer has little or no impact on their treatment decisions. 28 March 2014
France’s Transgene, Hong Kong-based Lee’s Pharmaceutical and South Korea’s SillaJen have unveiled their late-stage clinical development plan for Pexa-Vec oncolytic immunotherapy. 27 March 2014
Swiss drug major Novartis has published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate of 58% and a median progression-free survival of seven months in adults with advanced anaplastic lymphoma kinase positive non-small cell lung cancer. 27 March 2014
UK pharma giant GlaxoSmithKline released a couple of news items yesterday, one slightly negative regarding a melanoma combination product filing in Europe and the other announcing approval of a new diabetes treatment. 27 March 2014
The European Commission has approved Cometriq (cabozantinib), a drug for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC), from Swedish Orphan Biovitrum and partner Exelixis. 25 March 2014
US pharma behemoth Pfizer says that PROFILE 1014, a Phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens. 25 March 2014
UK drugs watchdog the National Institute for Health and Care Excellence (NICE), today issued final guidance that does not recommend French pharma major Sanofi’s Zaltrap(aflibercept) treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin containing regimen, confirming an earlier negative draft guidance (The Pharma Letter June 21, 2013). 25 March 2014
Japanese drug major Astellas Pharma has obtained the marketing approval in Japan of its oral androgen receptor signaling inhibitor Xtandi (enzalutamide) for the treatment of patients with castration-resistant prostate cancer in Japan. 24 March 2014
The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar drugs domestically, writes Juliane Carvalho on Brazil Pharma News: www.brazilpharmanews.com 24 March 2014
Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved Forxiga (dapagliflozin in 5mg and 10mg tablets), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, as a once-daily oral treatment for type 2 diabetes. 24 March 2014
A new study indicates that a commonly used mood stabilizing drug may help prevent head and neck cancer. The study is published early on-line in CANCER, a peer-reviewed journal of the American Cancer Society. 24 March 2014
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
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