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
Novel biologics must demonstrate improvements in efficacy, safety and cost-benefit compared with currently listed agents for a given disease to be included on both national and institutional formularies in Argentina, Brazil and Mexico. 23 December 2013
The US Food and Drug Administration has approved a revised US Prescribing Information and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib), from Ariad Pharmaceuticals (Nasdaq: ARIA), that allows immediate resumption of its marketing and commercial distribution in the USA. 22 December 2013
Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; December 16-19), there were positive opinions for four investigational drugs issued on Friday. 22 December 2013
US biopharma company Onconova Therapeutics says it has discontinued the Phase III ONTRAC study of intravenous (IV) rigosertib plus gemcitabine in front-line metastatic pancreatic cancer. 20 December 2013
German drugs and chemicals major Bayer has officially announced its intention to acquire Norwegian pharmaceutical company Algeta, its partner on prostate cancer drug Xofigo (radium Ra 223 dichloride), to further strengthen its oncology portfolio. 19 December 2013
Merck Serono, the biotech division of German life sciences group Merck KGaA, has signed an accord with the Spanish National Cancer Research Center (CNIO) in Madrid in the area of cancer drug development. 19 December 2013
French pharmaceutical company Ipsen has announced the appointment of Dominique Brard as Executive Vice President in charge of Human Resources of the Ipsen group in place of Etienne de Blois. 19 December 2013
US pharma giant Merck & Co says it has initiated a clinical trial to evaluate the combination of the company’s investigational anti-PD-1 immunotherapy, MK-3475, and UK-based GlaxoSmithKline’s orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma. 18 December 2013
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major Roche’s Zelboraf (vemurafenib), in the treatment of adults with a certain type of advanced melanoma, and has concluded that, despite this dossier containing additional and more recent data, it did not provide any new findings. T 18 December 2013
US pharma behemoth Pfizer says it has settled its long-standing litigation against a US subsidiary of Israeli generics giant Teva Pharmaceutical Industries relating to the patent covering the use of erectile dysfunction drug Viagra (sildenafil), which expires in April 2020 (including pediatric exclusivity). 18 December 2013
South Korean oncologists are significantly less familiar with biosimilars than oncologists surveyed in Europe. This finding is despite the fact that South Korea has had an approval pathway for biosimilars since 2009 and the world’s first biosimilar monoclonal antibody, Celltrion’s Remsima (infliximab), was launched in South Korea. 16 December 2013
There was yet another setback for US biotech firm AVEO Oncology on Friday), when the company announced that its Phase II study with colorectal cancer (CRC) drug candidate tivozanib is unlikely to meet the primary endpoint in the intent-to-treat patient population. The news sent the stock down 9% to $1.71 by close of trading. 14 December 2013
The I-SPY 2 trial, an innovative, multidrug, Phase II breast cancer study, has yielded positive results with the first drug to complete testing in the trial, US drugmaker AbbVie’s veliparib (ABT-888), a new class of investigational medicines called PARP inhibitors, which target an enzyme cancer relies on to grow. 14 December 2013
The market value for monoclonal antibodies in colorectal cancer treatment will experience a moderate increase from $3.7 billion in 2012 to $5.2 billion by 2019, at a compound annual growth rate of 5%, according to a new report from business intelligence provider GBI Research. 14 December 2013
From 2012 to 2017, the colorectal cancer therapy market in China will grow at an annual rate of 9%, from $360 million in 2012 and reaching around $575 million in 2017, according to a new report from health care advisory firm Decision Resources. 13 December 2013
A study of 4,000 women found that anastrozole, Anglo-Swedish drug major AstraZeneca’s now off-patent breast cancer treatment Arimidex, is a new option to help prevent the disease, and can reduce the risk of breast cancer by 53% over five years when used as a preventative therapy in postmenopausal women who are at high risk of the disease. 13 December 2013
From 2013 to 2018, the non-small-cell lung cancer (NSCLC) market in Argentina, Brazil and Mexico will increase at an annual rate of 6%, reaching $495 million in 2018, according to a new report from health care advisory firm Decision Resources. 12 December 2013
The release of much anticipated new data by US biotech firm CytRx Corp on its investigation drug aldoxorubicin saw the company’s shares leap 65% to $3.95 in pre-market trading yesterday. 12 December 2013
Metabolism specialist Agios Pharmaceuticals has announced an extension of one additional year to the period of exclusivity for their strategic cancer metabolism collaboration with Celgene Corp, with regard to the original accord that involved an initial payment of $130 million to Agios and an equity investment in the firm. 12 December 2013