All
EMA Addresses Globalized Supply Chain Issues with Annex 16 Revisions
November 22nd 2011The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:
FDA Approves 35 Novel Medicines in Fiscal Year 2011
November 22nd 2011At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years. Other approvals included drugs to treat late-stage prostate cancer, thyroid cancer, metastatic breast cancer, and late-stage lung cancer.
GSK Announces $50-Million Innovation Fund in Canada
November 22nd 2011GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto on Nov. 10, 2011. The $50-million national fund will identify strategic investment opportunities in Canada?s life-sciences industry, including academic and health institutions, translational research centers, and start-up companies.
GlaxoSmithKline Agrees to $3-Billion Settlement with the US Government
November 15th 2011GlaxoSmithKline (GSK) has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. The settlement is still subject to negotiation, but GSK expects to pay around $3 billion, which is covered by existing legal provisions, according to a press statement. The final amount and terms of the settlement are expected to be finalized in 2012. GSK says that the payments will be funded through existing cash resources.
FDA Notifies Genentech of Violations at Avastin Plant
November 15th 2011On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company?s South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
FDA Establishes Two Centers for Regulatory Science
November 8th 2011On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.
Merck, Sharpe, and Dohme Announces New Investments in Singapore
November 1st 2011Merck, Sharpe, and Dohme (MSD) and Singapore?s Economic Development Board jointly announced plans for significant investments by MSD to improve its existing manufacturing facilities in Singapore, as well as for new manufacturing, marketing, and research activities.
FDA Awards NIPTE Multimillion-Dollar Research Grant
October 18th 2011Last week, FDA awarded a grant to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug development and manufacturing. The grant could be worth as much as $35 million over the next five years. Using the grant, NIPTE will conduct research in various areas, including methods for reducing time to market, enabling new performance attributes in drugs, improving small-batch production, and promoting continuous manufacturing.
AstraZeneca Plans $200-Million Manufacturing Plant in China
October 18th 2011AstraZeneca is investing $200 million in a new manufacturing site in China Medical City (CMC), Taizhou, Jiangsu province, China. The new site represents AstraZeneca?s largest investment in a single manufacturing facility globally.
FDA Outlines Strategy to Spur Biomedical Innovation
October 18th 2011In response to concerns about the sustainability of US drug-development efforts, FDA has released a report, titled Driving Biomedical Innovation: Initiatives to Improve Products for Patients. The report outlines several steps that FDA will take to spur biomedical innovation and ensure that such innovation can be quickly translated into safe and effective therapies. Input used to compile the report was obtained from a broad spectrum of stakeholders, including members of large pharmaceutical companies, small biotech companies, academic researchers, and patient advocacy groups.
Servier and Galapagos Form Cancer Collaboration
October 11th 2011Servier and the Belgium-based biotechnology company Galapagos are embarking on a multiyear strategic alliance to develop new cancer therapies. As a result of the alliance, Galapagos could receive milestone payments of more than EUR 250 million ($332 million).
FDA Proposes Enhancing Search Criteria for Inspections Database
October 11th 2011FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.
Private Equity Firms to Acquire PPD for $3.9 Billion
October 11th 2011The CRO Pharmaceutical Product Development (PPD) will be acquired by the Carlyle Group and Hellman and Friedman in a deal valued at approximately $3.9 billion. PPD shareholders will receive $33.25 per share in cash, and PPD will become a privately held company after completion of the transaction.
New FDA Guidance on User Fee Waivers, Reductions, and Refunds
October 4th 2011FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA?s policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.
EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers
October 4th 2011The latest meeting of EMA?s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.
FDA Publishes Guidance on Marketed Unapproved Drugs
October 4th 2011Last week, FDA published a guidance titled Marketed Unapproved Drugs?Compliance Policy Guide, which describes the agency?s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter (OTC) drug review. The document is a revision of the June 2006 guidance of the same name
FDA and Department of Health Address Drug Shortages
September 20th 2011FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.
European Commission Consults on Pharmacovigilance
September 20th 2011The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission?s 2010 amended pharmacovigilance legislation.
Novo Nordisk Launches Diabetes Program in India
September 20th 2011Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate. The aim of the program is to contribute to meeting the fourth UN Millennium Goal?to reduce child mortality?by breaking down the barriers that prevent children with Type I diabetes in developing countries from receiving proper care. The program is currently operating in six countries?Bangladesh, Cameroon, the Democratic Republic of the Congo (DRC), Guinea, Tanzania, and Uganda, and Novo Nordisk plans to launch the program in Kenya within the next few months.
ISPE to Publish Updated Sterile-Product Manufacturing Guide
September 20th 2011The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.
Funding to Drive Nanoscale Technology for Healthcare
September 20th 2011The UK?s Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council (EPSRC) to invest as mush as £9 million ($14.2 million) in grant funding with the aim of bringing proof-of-concept ideas to pilot technology demonstration for healthcare.