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
The Scottish Medicines Consortium (SMC) revealed this morning (November 12) that it has accepted US drug behemoth Pfizer’s Inlyta (axitinib) for use within NHS Scotland for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. 12 November 2013
A novel drug which assists neurosurgeons to better visualize and remove malignant brain tumors has been approved by Australia’s Therapeutic Goods Administration (TGA). 11 November 2013
Spain's largest drugmaker Almirall (ALM: MC) has released third quarter 2013 financial results reporting net sales of 511.3 million euros. 11 November 2013
At its November 4-7 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed new information on the cancer drug Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union marketing authorization in July 2013. 9 November 2013
Geron Corp (Nasdaq: GERN) has boosted its share price with the results of a clinical trial into the safety and efficacy of imetelstat in patients with the blood cancer myelofibrosis. 8 November 2013
The Brazilian Ministry of Health is managing a series of product development partnerships and the selection processes of new partners in order to attract more investments from multinational companies in Brazil's national healthcare system, reports Juliane Carvalho of Brazil Pharma News. 8 November 2013
US drug major Bristol-Myers Squibb says it is “evolving its strategic focus in R&D to ensure continued leadership in delivering innovative medicines for patients with serious disease,” dropping new research in the areas of diabetes, hepatitis C and neuroscience. 8 November 2013
Swiss drug major Roche (ROG: SIX) has announced new data from the second stage of the CLL11 Phase III study which compared Gazyva (obinutuzumab), also known as GA101, to its already marketed MabThera/Rituxan (rituximab), both in combination with chlorambucil. 7 November 2013
UK-based biotech firm Immunocore has achieved its first milestone in its major research and licensing agreement with UK pharma major GlaxoSmithKline (LSE: GSK) for multiple novel targets. 7 November 2013
Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of written notification from the US Food and Drug Administration that its Phase I study of CUDC-427 has been placed on partial clinical hold following the report of death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. 7 November 2013
Australia’s Prima BioMed has entered into a binding term sheet granting Israeli firm Neopharm Group an exclusive license to market and sell CVac, a personalized immunocellular therapeutic under investigation for the treatment of epithelial ovarian cancer, in Israel and the Palestinian Authority. 6 November 2013
Australian biotech company Novogen (ASX: NRT) has announced a joint venture with Yale University in the USA dedicated to developing personalized approaches to chemotherapy to fight ovarian cancer. 6 November 2013
Swiss ADC Therapeutics, a portfolio company of Auven Therapeutics, and Five Prime Therapeutics (NASDAQ: FPRX) have agreed an exclusive license for human antibodies directed to an undisclosed target expressed on the surface of various types of cancers. 5 November 2013
US biotech firm ImmunoGen (Nasdaq: IMGN) will stop the IMGN901 Phase II small cell lung cancer study, following the recommendation of the trial's independent Data Monitoring Committee. 5 November 2013
UK pharma giant GlaxoSmithKline has revealed the results of a Phase III study of its HPV vaccine, Cervarix, which showed that two doses of the vaccine in girls aged nine to 14 years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25 year olds. 4 November 2013
US specialty drugmaker Sagent Pharmaceuticals has announced the launch of Carboplatin Injection, an antineoplastic agent, in four preservative-free vial presentations. 4 November 2013
Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa as first-line treatment to 70% of their non-small-cell lung cancer patients. 4 November 2013
The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL), making it the first to be approved as first-line therapy for this condition. 4 November 2013
US oncology focused biotech firm Ignyta has entered entry into a license agreement with Nerviano Medical Sciences that will grant Ignyta exclusive global development and marketing rights to RXDX-101, a tyrosine kinase inhibitor directed to the TrkA, ROS1 and ALK proteins. 3 November 2013