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
German pharma and chemicals firm Merck KGaA says it is increasingly counting on partnerships with Israeli biotech companies, as demonstrated by its cooperation with Metabomed and ChanBio, both of which have today joined the Merck Serono Israel Bioincubator. 26 November 2013
In response to recent media commentary, the board of directors of Norway’s Algeta this morning confirmed that it has received a preliminary acquisition proposal from German pharma and chemical major Bayer. 26 November 2013
US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. 26 November 2013
USA-based Progenics Pharmaceuticals says it is resuming a Phase IIb clinical study of safety and efficacy of a novel targeted radiotherapy, Azedra, in patients suffering from pheochromocytomas. Existing options for these rare endocrine tumors that form in the adrenal glands can fail to result in effective disease treatment, the company noted. 25 November 2013
While metabolic drugs account for one-quarter of drugs recently filed for approval or approved, oncology continues to be the most active therapeutic area for Phase II and III R&D, according to a new report for health care advisory firm Decision Resources. 25 November 2013
Japanese drug major Eisai (TYO: 4523) will become the Marketing Authorization Holder for the antineoplastic agent Gliadel in Japan from December 2, having acquired this right from developer Nobelpharma. 25 November 2013
There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22), first Japanese clearance for its ophthalmic drug Eylea (aflibercept) and, later in the day, a new indication in the USA for cancer drug Nexavar (sorafenib). 23 November 2013
The European Medicines Agency’s Committee for Medicinal Products for Human Use has made a number of recommendations to help minimize the risk of blood clots obstructing arteries or veins in patients taking the leukemia medicine Iclusig (ponatinib). 23 November 2013
At its late November meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a series of recommendation, including positive opinions for the approval of five new drugs. 22 November 2013
Two of the world’s pharma giants, USA-based Pfizer and the UK’s GlaxoSmithKline have joined forces to study a novel combination therapy in patients with melanoma. 22 November 2013
The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 22 November 2013
US biotech firm Clovis Oncology says it has acquired EOS (Ethical Oncology Science), a privately-held Italian biopharmaceutical company developing a novel targeted therapy to treat cancer. 21 November 2013
Cadila Pharmaceuticals, one of India’s largest privately-held pharmaceuticals company, has launched for the first time in the world, Mycidac-C, an affordable, unique and innovative drug for the treatment of lung cancer. 21 November 2013
Zelboraf (vemurafenib), an already marketed cancer drug from Swiss pharma major Roche (ROG: SIX), has been show to extend life in patients whose skin cancer has spread to the brain. 21 November 2013
The prostate cancer treatment market is forecast to increase from $4.1 billion in 2012 to $8 billion by 2019, according to business intelligence provider GBI Research. 21 November 2013
UK-based biotech company Immunocore has appointed Jonathan Knowles as the new executive chairman of the board of directors with immediate effect. 20 November 2013
Starting next year, supplemental and private health insurance companies in Brazil will be required to cover the costs of oral administered medicines for the treatment of cancer patients at home, reports Juliane Carvalho, writing on the Brazil Pharma News. 20 November 2013
Swiss drug major Roche says that Kadcyla (ado-trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer. 20 November 2013
USA-based Amgen has presented positive interim overall survival results from a pivotal Phase III trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). 20 November 2013
Advances in cancer therapy are expected in the next years, thanks in particular to treatment using antibody-drug conjugates and multi-kinase inhibitors. 19 November 2013