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
Shares of US cancer drug developer Advaxis leapt 22% to $4.38 in pre-market trading as the company revealed it has entered into an exclusive licensing agreement for the development and commercialization of ADXS-HPV with Global BioPharma, a Taiwan-based biotech company funded by a group of investors led by Taiwan Biotech. 9 December 2013
Israeli drug developer BioLineRx is entering a catalyst-rich phase over the next 12 months, which will see early clinical data from studies of two internal R&D projects, BL-8040 (for acute myeloid leukemia) and BL-8020 (for hepatitis C virus; HCV), say analysts at Edison Investment Research initiating coverage of the company. 9 December 2013
In an early benefit assessment under the Act on the German Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Xtandi (enzalutamide), from USA-based Medivation and Japanese drug major Astellas Pharma offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 9 December 2013
UK-based Oxford BioTherapeutics and Berlin-Chemie, a subsidiary of family-owned Italian drugmaker Menarini, have designated a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical development candidate under the companies’ strategic oncology collaboration. 9 December 2013
Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning that it has made a decision to approve a proposal to widen funded access to Swiss drug major Roche’s Tarceva (erlotinib). 9 December 2013
USA-based development-stage firm Puma Biotechnology saw its shares leap 42% to nearly $66 in morning trading Thursday (December 5) after earlier rising as high as $72.40, up 57%, following the announcement of positive top line results from the Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the neoadjuvant treatment of breast cancer (I-SPY 2 TRIAL). 6 December 2013
Australian blood products and vaccine maker CSL Ltd has entered into an agreement with Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson, that may one day lead to new treatments for hematological cancers and autoimmune diseases. 5 December 2013
US biotech firm Cell Therapeutics has concluded an agreement with the Germany’s National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) for Pixuvri (pixantrone). 4 December 2013
Swiss drug major Roche has linked up with Switzerland-based privately held biotech firm Molecular Partners AG to discover, develop and commercialize several proprietary therapeutics incorporating the latter’s DARPin biologics conjugated to toxic agents developed at Roche for the treatment of cancer. 4 December 2013
US biotech companies OncoMed Pharmaceuticals and Celgene have entered an agreement to jointly develop and commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4). 4 December 2013
US biotech company Celgene’s (Nasdaq: CELG) European subsidiary has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Abraxane (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. 29 November 2013
UK pharma giant GlaxoSmithKline says that the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending marketing authorization for a two-dose schedule in nine to14 year old girls for its cervical cancer vaccine, Cervarix. 28 November 2013
The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar (branded copy) of Aventis' (a Sanofi legacy company) Taxotere (docetaxel) chemotherapy drug, writes attorney Otto Licks on the International Law Office web site. 28 November 2013
Israel-based global generic giant Teva Pharmaceutical Industries has been granted orphan drug exclusivity by the US Food and Drug Administration for Treanda (bendamustine HCL, for injection) through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL). 28 November 2013
According to US oncologists surveyed in the third quarter of 2013 by BioTrends Research, a unit of Decision Resources, Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf (vemurafenib) is the patient share leader in the first-line BRAF-mutation positive setting. 27 November 2013
UK drug watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance that does not recommend US pharma giant Pfizer’s Bosulif (bosutinib) for previously treated chronic myeloid leukemia. 27 November 2013
The UK’s drugs watchdog the National Institute of Health and Care Excellence (NICE) is holding a third consultation on draft guidance for Alimta (pemetrexed) from US drug major Eli Lilly (NYSE: LLY). 27 November 2013
Privately-held South Korean firm SillaJen says it has executed a definitive merger agreement to acquire San Francisco, USA-based Jennerex, a clinical-stage biotechnology company globally recognized as the leader in the development of best-in-class targeted oncolytic immunotherapies for solid tumors. 27 November 2013
Japanese digital camera and medical equipment conglomerate Fujifilm revealed that it is to conduct clinical development of three anticancer agents with The University of Texas MD Anderson Cancer Center, one of the world's most distinguished facilities for cancer research and treatment. 26 November 2013
In China, a combination of government restrictions on reimbursement and regional variations in formulary coverage heavily influence the use of premium-priced targeted therapies in the breast cancer drug market. 26 November 2013