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 AVEO Oncology and Japanese drug major Astellas Pharma are to end their worldwide collaboration and license agreement for the development and commercialization of their investigational cancer drug tivozanib. 14 February 2014
Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full approval of leukemia drug Synribo (omacetaxine mepesuccinate) for injection, to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. 14 February 2014
Privately-owned Pierre Fabre and Aurigene, a leading Indian biotech company, have entered into an agreement granting Pierre Fabre global worldwide rights excluding India to a new immune checkpoint modulator, AUNP-12. 13 February 2014
The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson & Johnson and Pharmacyclics' Imbruvica (ibrutinib) for chronic lymphocytic leukemia, a rare blood and bone marrow disease, patients who have received at least one previous therapy. 13 February 2014
Swiss drug major Roche’s Kadcyla (ado-trastuzumab emtansine or T-DM1) is now available for UK patients with advanced HER2-positive breast cancer, its third European launch, the company announced this morning. 13 February 2014
Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. 12 February 2014
US biotech firm Regeneron Pharmaceuticals reports that its blockbuster ophthalmic drug Eylea (aflibercept) sales in the fourth quarter of 2013 rose 46% to $401 million and were up 68% to $1.41 billion for the full year, beating the company’s own forecasts. The firm’s shares rose 2.3% to $311.00 in early trading this morning. 11 February 2014
US cancer drug developer Sorrento Therapeutics has obtained exclusive rights to Cynviloq (marketed as Genexol-PM in South Korea and other countries) in Australia, Canada and Mexico from Samyang Biopharmaceuticals, a South Korean corporation. 11 February 2014
Nanobiotix, a French nanomedicine company focused on cancer therapy, has announced today its development plan for the CE marking of NBTXR3, the first product from the NanoXray pipeline. 11 February 2014
Danish oncology drug development company Topotargetin (OMX: TOPO) has been the subject of an increased valuation ahead of an anticipated approval for Beleodaq (belinostat). 10 February 2014
Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan ), just as the companies were launching the world's first biosimilar version of Roche blockbuster breast cancer drug Herceptin (trastuzumab) in India (The Pharma Letter February 3), report the Economic Times and other media. 10 February 2014
Danish insulin giant Novo Nordisk has sold full development and commercialization rights to the anti-NKG2A antibody, a first-in-class immune checkpoint inhibitor ready for Phase II development in oncology to French drugmaker Innate Pharma. 7 February 2014
French drugmaker Ipsen has announced that the Phase III clinical trial evaluating Decapeptyl (triptorelin pamoate) in patients with prostate cancer has met its primary endpoints. 7 February 2014
A US federal court yesterday unsealed a whistleblower/false claims law suit brought against US biotech firm Celgene, according to law firm Grant & Eisenhofer, which represents a key whistleblower. 7 February 2014
‘Momentum’ is the word which best describes 2013, according to AstraZeneca’s chief executive Pascal Soriot who commented on the firm’s year-end results at a media briefing in London this morning. 6 February 2014
Servier, France’s largest privately‐held pharmaceutical company, has exercised its exclusive option to develop and commercialize MGD006, a DART‐based product candidate developed by US clinical-stage drug developer MacroGenics. 6 February 2014
Privately-held USA-based Kinex Pharmaceuticals and Taiwan’s PharmaEssentia say they have signed a new licensing agreement granting PharmaEssentia exclusive development and commercial rights to Oraxol (an oral form of paclitaxel) and Oratecan (an oral combination therapy of cytotoxic agents with HM30181A) in Taiwan and Singapore. 6 February 2014
US drugmaker AbbVie says it plans to invest $320 million to establish operations in Singapore for small molecule and biologics active drug substance manufacturing. 6 February 2014
Stomach and bowel cancer, two of the most common cancers worldwide, could be treated with a class of medicines that are currently used to treat a blood disorder, a Melbourne research team has discovered. 6 February 2014