The USA's research-based drug and biotechnology companies are working on nearly 1,000 life-changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the US Food and Drug Administration or are in human clinical trials. 20 October 2009
US biotechnology major Amgen has received a Food and Drug Administration 'Complete Response' letter for its Biologic License Application for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis, requesting additional information needed to complete the review of applications for product approval. 20 October 2009
Miami, USA-based Opko Health has agreed to acquire from drug major Schering-Plough assets relating to a neurokinin-1 receptor antagonist program, marking Opko's latest step away from the RNAi drugs space. The companies did not disclose the terms of the agreement. 16 October 2009
OXiGENE and fellow drug developer VaxGen have entered into a definitive merger agreement following which OXiGENE will acquire VaxGen in exchange for common stock of OXiGENE. On closing of the transaction, VaxGen will become a wholly-owned subsidiary of OXiGENE, and VaxGen stockholders will become stockholders of OXiGENE. The deal is valued at around $22 million. 16 October 2009
UK drug giant GlaxoSmithKline has told the European Medicines Agency (EMEA) that it is withdrawing its application for a centralized marketing authorization for Zunrisa (casopitant mesilate), 50mg and 150mg film coated tablets, in what it described as 'a difficult decision.' Zunrisa was expected to be used in the prevention of post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting. 14 October 2009
USA-based Phyton Biotech, an affiliate of Phyton Inc, has purchased the assets of Natural Pharmaceuticals, a US manufacturer of oncology drug active pharmaceutical ingredients (APIs). 13 October 2009
California, USA-based Proteolix has agreed to a takeover bid from Onyx Pharmaceuticals, valuing the firm at a potential $851 million based on upfront and milestone payments. Proteolix' lead compound is carfilzomib, a proteasome inhibitor currently in multiple clinical trials, including an advanced Phase IIb studies for patients with relapsed and refractory multiple myeloma. 12 October 2009
Cancer treatments are on track to become the biggest driver of specialty pharmacy spending as its contribution to overall drug spending hit 5%for the first time in the first half of 2009, according to USA-based Medco Health Solutions. 12 October 2009
California, USA-based Spectrum Pharmaceuticals says that it received a Complete Response letter from the Food and Drug Administration regarding its supplemental New Drug Application for Fusilev (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer. 12 October 2009
French drugmaker Ipsen and the UK's Spirogen have entered into a new agreement superseding their 2003 contractual relationship regarding the DNA minor groove binder SJG-136 (now known as SG2000). The new agreement between the parties will allow Spirogen to continue and lead the clinical development of this first-in-class anticancer agent. 8 October 2009
The US Food and Drug Administration's Oncologic Drugs Advisory Committee has come up with positive recommendations on two cancer drugs, UK drug giant GlaxoSmithKline's Votrient (pazopanib) and a new indications for US major Schering-Plough's Pegintron (pegylated interferon alfa-2b). 6 October 2009
US Washington State-based Seattle Genetics says its share price plunge, almost 20% at $10.71 in pre-market trading, after announcing that it has discontinued the SeaGen MARINER clinical trial based on a determination that it would be unlikely to meet its primary endpoint of superior complete response rate in the dacetuzumab combination arm as compared to the placebo combination cohort. 6 October 2009
Scientists have discovered why a group of cancer drugs are so effective in treating the disease. Although they have been used for many years to treat certain tumors, researchers did not know how they worked until now. 6 October 2009
Vancouver, Canada-headquartered QLT Inc says that it has completed the sale of all of the shares of its wholly-owned US subsidiary, QLT USA Inc, to TOLMAR Holding, for up to an aggregate $230 million. QLT USA's principal operating asset is the Eligard (leuprolide) line of products for the treatment of prostate cancer, which is currently manufactured by TOLMAR. 2 October 2009
Belgium's Ablynx says that it will receive milestone payments totalling 3 million euros ($4.4 million) from independent German drug major Boehringer Ingelheim triggered as part of its strategic alliance for the development and commercialisation of Nanobodies This is the second time Ablynx receives milestone payments from Boehringer Ingelheim since the initiation of the strategic alliance between the companies, and the second in two days as the Belgium firm received a $4 million payment from Wyeth the previous day. 2 October 2009
Speaking at the Labour Party conference in Brighton, the UK's Prime Minister, Gordon Brown, re-affirmed his support to ensure Britain remains a base for pioneering research, and innovation development and manufacturing, and promised that in future cancer patients would be diagnosed with a week. 2 October 2009
The Prix Galien USA committee celebrated members of the science and biotechnology industries for the development and discovery of drugs and technologies that improve the human condition. Novartis Oncology, Amgen, GlaxoSmithKline and Veridex were honored with the 2009 Prix Galien USA, considered the industry's highest accolade for pharmaceutical R&D, for treatments that could change the course of health care worldwide. 2 October 2009
Confirming its ambitious expansion plans, French drug major Sanofi-Aventis has signed a binding agreement for the acquisition of French firm Fovea Pharmaceuticals, valuing the business at some 370 million euros ($542 million) and entered into a licensing deal with the USA's Merrimack Pharmaceuticals to gain rights to a monoclonal antibody, in a deal that could cost it up to $530 million. 1 October 2009
The AIM-quoted Chinese pharmaceutical manufacturer Taihua has disclosed initial details of plans for high-margin European sales of the active pharmaceutical ingredient of anti-cancer drug paclitaxel. The drug is widely used in the treatment of lung, breast and ovarian cancers, and Taihua already sells the APIs to manufacturers for Russian and South American markets. 30 September 2009
UK-based drugs giant GlaxoSmithKline says that it has 'made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting.' Regulatory applications were filed in a number of countries worldwide and GSK is currently communicating with those authorities and all study investigators. 29 September 2009
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