Dyax to be bought by Shire in up-to-$6.5B deal | FDA awards breakthrough designation to Merck's colorectal cancer drug | FDA to expedite review of psychosis drug from Acadia
November 3, 2015
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Dyax to be bought by Shire in up-to-$6.5B deal
Shire will acquire Dyax in a deal worth as much as $6.5 billion, giving it access to Dyax's investigational hereditary angioedema drug, DX-2930. Under the terms of the agreement, Dyax will get an initial payment of $5.9 billion and an additional $646 million contingent on approval of the drug, which is expected to reach the market in 2018. The Wall Street Journal (tiered subscription model) (11/2)
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Health Care & Policy
FDA awards breakthrough designation to Merck's colorectal cancer drug
Merck's Keytruda, or pembrolizumab, has received breakthrough therapy status from the FDA for the treatment of microsatellite instability-high metastatic colorectal cancer. The designation was backed by midstage trial data showing the drug yielded a 62% objective response rate in mismatch repair-deficient metastatic CRC patients, compared with 0% for those with MMR-proficient tumors. OncLive (11/2)
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FDA to expedite review of psychosis drug from Acadia
Acadia Pharmaceuticals' new drug application for Nuplazid, or pimavanserin, as a treatment for Parkinson's disease-associated psychosis has received priority review status from the FDA. A decision from the agency is expected by May 1. Seeking Alpha (free registration) (11/2)
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EMA grants orphan status to Stemline's rare blood cancer drug
Stemline Therapeutics' SL-401, a treatment that targets interleukin-3 receptor, has secured orphan drug status from the European Medicines Agency for use in patients with blastic plasmacytoid dendritic cell neoplasm, a rare form of myeloid leukemia. The drug holds orphan drug designation in the US for the same indication and orphan status in the US and Europe for acute myeloid leukemia. Seeking Alpha (free registration) (11/2)
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Leukemia drug from Celgene granted label expansion in EU
Celgene obtained approval from the European Commission for the expanded use of Vidaza, an azacitidine injectable, for the treatment of acute myeloid leukemia patients at least 65 years old who are ineligible to receive hematopoietic stem cell transplants and patients whose myeloblasts are greater than 30%. The approval was granted based on clinical trial data that showed patients who took the drug had longer overall survival and higher one-year survival rates compared with those who received conventional treatment regimens. European Pharmaceutical Review (U.K.) (10/30), Seeking Alpha (free registration) (10/30)
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Insurance industry, not medicines, drives health care spending
The pharmaceutical industry spends about $2.6 billion to secure approval for each new prescription drug, but medications are not the main driving force behind health care spending, writes Christopher Molineaux, president and CEO of Pennsylvania BIO. The insurance industry's cost-sharing structures distort prescription drug costs, and restricted access to drugs creates adherence issues, he writes. The biopharmaceutical industry is doing its part to develop innovative treatments, but the US wastes billions of dollars each year on medical complications that could be avoided if patients took their medications as they were prescribed, writes Molineaux. The Patriot-News (Harrisburg, Pa.) (11/2)
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Company & Financial News
IPO could bring in $97.75M for Wave Life Sciences
Plans for an initial public offering of 5 million shares, with the goal of raising as much as $97.75 million, have been filed by Wave Life Sciences. The firm is focused on the development of nucleic acid therapeutics against genetic defects. In addition to working capital and general corporate functions, the firm will use the proceeds to support pipeline development and fund clinical trials. 24/7 Wall St. (11/2)
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Global Developments
India's Cipla sells holding in Chinese biosimilar company
India-based Cipla has divested its 25% stake in biosimilar developer Biomab Holding to the majority owners of the Chinese firm for $25 million. Cipla plans to focus its biosimilars business under its Cipla BioTec unit. Business Standard (India) (10/29)
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Food & Agriculture
Ghana court rules in favor of biotech cereals
An interim injunction suit filed by the advocacy group Food Sovereignty Ghana that aimed to stop the country's Ministry of Food and Agriculture, National Biosafety Committee and the attorney general from marketing biotech rice and cowpeas was dismissed by the Accra Fast Track High Court in Ghana. The presiding judge said ruling in favor of the group would damage Ghana and that residents will not be affected by the commercialization of biotech products in the country. GhanaWeb (10/30)
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Industrial & Environmental
Renewable fuel leaders should band together
It's important that renewable fuel producers work together in the effort to promote renewables, writes Biomass Magazine Managing Editor Anna Simet. "[R]enewable fuel makers of all kinds need to band together, instead of bash each other, to get where we need to go," Simet writes, echoing the sentiments of Green Plains Renewable Energy President and CEO Todd Becker, who gave the keynote speech at the National Advanced Biofuels Conference. BiomassMagazine.com (10/30)
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