Array BioPharma (ARRY) announced that it has submitted two new drug applications (NDAs) to FDA, seeking approval for the combination of binimetinib and encorafenib to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
Основные фондовые индексы Азиатско-Тихоокеанского региона торгуются в красной зоне, из-за фиксации прибыли, поскольку инвесторы опасаются покупать рискованные активы перед заседанием ФРС США на следующей неделе. Многие ожидают, что центробанк повысит процентную ставку в ходе заседания 14-15 марта. Широчайший Индекс MSCI по акциям Азиатско-Тихоокеанского региона за пределами Японии снизился на 0,1% в начале торгов Акции на торгах материкового Китая торгуются около нулевой черты, чему, в некоторой степени способствовали слабые данные по торговому балансу Китая. Как стало известно торговый баланс снизился на CNY -60,4 млрд . Экономисты ожидали рост показателя внешней торговли до CNY 172.5 млрд. В январе профицит торгового баланса составил CNY 354.4 млрд. Экспорт из Китая в национальной валюте увеличился на + 4,2%, что ниже прогноза экономистов + 14,6% и предыдущего значения + 15,9%. Импорт в Китай в январе увеличился на + 44,7%, после роста до 25,2%. Экономисты ожидали увеличение импорта до + 23,1%. В Японии индекс Nikkei 225 снизился, так как иена укрепилась по отношению к доллару США. Комментарии Дональда Трампа также оказал давление на японские фармацевтические компании. Акции Takeda Pharmaceutical Co Ltd подешевели на 1,0%, Ono Pharmaceutical Co Ltd - на 1,4%, и Eisai Co Ltd - на 1,4%. С другой стороны, акции Nintendo Co Ltd выросли на 2,6% до почти двухмесячного максимума. NIKKEI 19230,00 -114,15 -0,59% HSI 23800.00 118,93 0,50% ASX 200 5751,40 -9,9 -0,17% SHANGHAI 3243,75 1,34 0,04% Информационно-аналитический отдел TeleTradeИсточник: FxTeam
Amgen Inc. (AMGN) announced that the FDA has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Bristol-Myers Squibb Company (BMY) along with partner Ono Pharmaceutical Company, Ltd. announced that both the companies have signed a global patent license agreement with Merck & Co., Inc. (MRK) to settle all litigation related to Keytruda.
Amgen Inc. (AMGN) announced that data from three phase III studies on its pipeline candidate, Parsabiv (etelcalcetide), were published in the Journal of the American Medical Association (JAMA).
Ligand Pharmaceuticals announced that it has entered into a worldwide license agreement with Ono Pharmaceutical under which Ono will use its OmniAb platform for the discovery of fully human mono- and bispecific antibodies.
Bristol-Myers Squibb Company (BMY) announced that the FDA has cleared Opdivo for the treatment of patients with advanced renal cell carcinoma.
Receptos, Inc. (RCPT) reported a loss of $1.29 per share in the first quarter of 2015, much wider than the Zacks Consensus Estimate of a loss of $1.19 and the year-ago loss of $1.01 per share.
Dako, an Agilent Technologies (A) subsidiary, recently entered into a strategic partnership with ONO PHARMACEUTICAL CO., LTD to develop a potential diagnostic test to be used specifically with Opdivo for treating non-small cell lung cancer (NSCLC).
Despite advances in medicine, the process of discovering new pharmaceuticals remains expensive and is often inefficient. A recent study conducted by the Computational and Structural Biotechnology Journal has concluded that the healthcare industry faces increasingly demanding challenges in delivering more cost-effective services exclusively focused on research and development. The German company Evotec AG (EVTG.DE) may have some answers. Evotec provides drug discovery services and alliances to the pharmaceutical and biotechnology industry. Its sole mission is to build a partnered product pipeline based on high quality drug discovery and science and technology through efficient collaborations. Evotec has had significant drug discovery innovations in its 20-year history. According to Alpha Deal Group’s recent buy-side intelligence report, Evotec has generated 100 lead series, 30 pre-clinical candidates and 20 clinical compounds. It recently introduced a rich Phase 3-1 product pipeline, which includes first in class targets. The company has profitably been growing its business, driven by milestones and a strong cash position. Core competencies Alpha Deal Group’s recent intelligence brief asserts that Evotec has a significant value proposition within the areas of neuroscience, pain, metabolic diseases, oncology and inflammation. According to CEO Werner Lanthaler, Evotec’s focus is on curing the disease, rather than its symptoms. In the past 14 years, the company has evolved with an approximate increase in costs to $3 from $1 billion. It has also divested non-core assets. Additional core competencies include innovation in academia, target ID/validation, hit identification, lead optimization, pre-clinical phases I-III, approval and market. Evotec AG has two operating segments – EVT Execute and EVT Innovate. EVT Execute provides a cost-effective drug discovery research and development outsourcing platform. EVT Execute is an expert in providing high quality services with the help of Western strategic outsourcing partners. It is run by industrial logic and under the leadership of Evotec professionals. EVT Innovate forms a bridge between academia and pharmacy. VT Innovate has a systematic, unbiased and comprehensive pipeline with two main initiatives: Target X and Cure X. It works in the fields of oncology, diabetes and complications of diabetes, neurology, anti-effectives and pain and inflammation. EVT Innovate works in five major fields to provide complete infrastructure and discovery solutions. Furthermore, EVT Innovate works in the direction of driving product candidates to expand pharmaceutical pipeline strategies without financial risk. Drug Discovery Outsourcing Thus far in 2014, Evotec has reported strong profitable growth with a potential increase of $26 million in total revenue. In 2014, revenue was $14.8 billion. With an expected growth pace of 10% per annum, it is expected to reach $21.3 billion in 2017. Evotec Share Market Source: Reuters.com Estimates vs Earnings of Evotec AG Source: Reuters.com Market picture Current market capitalization is 405.61 million euros, with 131.69 million shares outstanding. EVT Execute cash is used for investing in long-term upsides of EVT Innovate. The condensed H1 segments of 2014 shows a positive EBITDA adjustment of Euro 5.5 million in EVT Execute despite a low milestone contribution. Evotec has several significant long-term discovery alliances with well-established industry players such as Bayer, Boehringer Ingelheim, the CHDI Foundation, Genentech, Janssen Pharmaceuticals, MedImmune/AstraZeneca and Ono Pharmaceuticals. Moreover, the company has many existing partnerships and product candidates available in both clinical and pre-clinical development. Under these partnerships, Evotec has collaborated with Boehringer Ingelheim, MedImmune and Andromeda (Teva) in the field of diabetes. Furthermore, these partnerships extend with Janssen Pharmaceuticals in the field of depression along with Roche to assist in the area of Alzheimer’s disease. Benefits of R&D outsourcing The company outsources research and development in a new way. The outsourced R&D of Evotec offers other companies research based on speed, creativity, new technological advancements and cost effectiveness. This outsourcing idea has proved to be a success, increasing R&D spend, industry consolidation, biotech in-licensing or acquisition, R&D reorganization, capital efficient outsourcing and innovation alliances. Recently, Evotec had also joined a trio of research projects that focused on multiple sclerosis. Growth and key milestones Evotec focuses on quality-driven services and innovative alliances. Some major key innovations were executed in the year 2014. For EVT Execute, the company has planned an expansion of drug discovery alliances. These would be accompanied by new long-term deals with big and medium-sized pharma and biotech players along with at least one new integrated technology or disease alliance. EVT Innovate will focus on expanding a network of top-class academic alliances in the year 2014. Concluding our call with the company, Lanthaler stated that Evotech anticipates a strong clinical pipeline development effort with significant partnerships throughout 2015. Alpha Deal Group currently views Evotec as an actionable high alpha opportunity. Receive stories like this to your inbox as they are published. Subscribe here and follow us @Alpha_Now on Twitter or check out the Thomson Reuters Eikon blog. If you are looking to access Thomson Reuters data or analytics, register for a free trial.
Progenics Pharmaceuticals (PGNX -2.4%) settles its arbitration with Ono Pharmaceutical Company over Ono's rights to subcutaneous Relistor in Japan and its development and commercialization of the drug. Both parties exchanged mutual releases and Ono agreed to pay Progenics $7.25M within 20 business days after receiving the necessary documentation. Post your comment!
According to Reuters, the FDA may clear Merck's (NYSE:MRK) anti-PD-1 Ab pembrolizumab for the treatment of patients with melanoma who are not responding to Yervoy (ipilimumab) (NYSE:BMY) in the next several weeks, significantly earlier that its October 28 PDUFA date. If approved, it will be the first PD-1 inhibitor cleared for sale in the U.S.The first PD-1 inhibitor cleared anywhere in the world was BMY's nivolumab which was approved in Japan last month. Ono Pharmaceutical owns the commercial rights to the product in that country and will market the product under brand name Opdivo.Analysts forecast the size of the worldwide PD-1 inhibitor market to be more than $30B by 2025. Post your comment!
Bristol-Myers Squibb (BMY +0.8%) and Ono Pharmaceutical Co. enter into a strategic collaboration agreement to jointly develop and commercialize immunotherapies for Japan, South Korea and Taiwan. The agreement includes the development of Ono's Opdivo (nivolumab) and BMY's Yervoy (ipilimumab) across a broad range of tumor types.The companies will jointly pursue the development of monotherapies and combination regimens based on Opdivo. Development costs and commercial profits will be shared equally when Opdivo is used in combination with any BMY compound. If BMY products alone are being developed then BMY will fund the majority of the cost. If Opdivo is being developed as a monotherapy then Ono will fund most of the cost. Post your comment!