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Pharma/fine chemicals roundup—16 April
10:08 AM MDT | April 16, 2013 | By DEEPTI RAMESH
FDA’s self-identification process for 2014 begins in May
The US FDA says that the generic drug facility self-identification reporting period for fiscal-year 2014 will begin on 1 May 2013 and close on 1 June 2013. Generic drug facilities, certain sites, and organizations identified in a generic-drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually, the agency says.
GDUFA became effective on 1 October 2012. The worldwide generic drug industry will pay FDA a total of about $1.5 billion over 5 years in return for faster and more predictable reviews of generic-drug applications, according to the terms of GDUFA. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, FDA says. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to FDA’s generic-drugs program. GDUFA will also significantly improve global supply-chain transparency by requiring owners of facilities producing generic-drug products and active pharmaceutical ingredients, as well as certain other sites and organizations that support the manufacture or approval of these products, to electronically self-identify with FDA and update that information annually, FDA says.
Annual self-identification is required for two purposes: it is necessary to determine the universe of facilities required to pay user fees and self-identification is a central component of an effort to promote global supply-chain transparency. The information provided through self-identification enables quick, accurate, and reliable surveillance of generic drugs and facilitates inspections and compliance, FDA says.
Thermo Fisher to acquire Life Technologies for $13.6 billion
Thermo Fisher Scientific (Waltham, MA) and biotechnology company Life Technologies (Carlsbad, CA) say they have signed a definitive agreement under which Thermo Fisher will acquire Life Technologies for about $13.6 billion, plus the assumption of net debt at close. The transaction was approved by both companies’ boards of directors. Life Technologies provides innovative products and services to customers conducting scientific research and genetic analysis, as well as those in applied markets, such as forensics and food safety testing, and had sales of $3.8 billion in 2012.
Bachem and Axon sign API deal
Biochemicals company Bachem (Bubendorf, Switzerland) says it has entered into a collaboration with biotech company Axon Neuroscience (Bratislava, Slovakia), under which Bachem will manufacture Axon’s investigational active pharmaceutical ingredient (API) and supply it as a finished dosage form under Bachem’s Clinalfa brand. Axon’s product targeting Alzheimer’s disease consists of a peptide-protein conjugate and will enter phase one clinical trials in Europe. Bachem was chosen because of the “wide range of services they provide spanning peptide API production to conjugates and fill finish activities,” says Roman Sivak, CEO of Axon.
Barentz takes stake in lanolin distributor NK Chemicals
Barentz Group (Hoofddorp, Netherlands) has acquired an undisclosed equity stake in NK Chemicals (NKC; Wakefield, UK) with the aim of strengthening the activities of each company in the United States and Europe, Barentz has announced. NKC is a distributor of lanolin and lanolin derivatives for the personal-care and pharmaceutical industries. The integration of NKC into the Barentz structure will improve the availability of NKC products across Europe, the Mideast, and Africa. Barentz distributes ingredients and materials for the human and animal nutrition, pharmaceutical, personal-care, and chemical industries. It generated sales of €850 million ($1.11 billion) in 2012.
Beyond IHS Chemical Week:
Swiss pharma firms and government reach drug pricing deal
Aiming to improve drug affordability and access, the Swiss government and the pharmaceutical industry have struck a short-term deal, whereby drugmakers will withdraw price-related law suits in return for a faster drug-approval process, according to the Swiss Broadcasting Corp.’s International Service.
US API imports for clinical trials now require effective IND
US officials' new take on import rules may mean active pharmaceutical ingredients destined for trials will only be allowed into the country if they are listed in an effective investigational new drug (IND) application.