News

At 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.

GlaxoSmithKline 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.

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA for the first time brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. According to a press statement, the workshop was designed to enable EMA and attendees to review regulatory and scientific challenges in developing medicines for eye disorders.

GlaxoSmithKline (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.

On 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.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011.

In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take the following steps to prevent and reduce drug shortages

On 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.

The European Commission has launched an antitrust investigation to examine whether contracts between Johnson & Johnson (J&J) and Novartis were designed to delay the market entry of generic versions of Fentanyl in the Netherlands. Fentanyl, developed by J&J, is a strong painkiller for chronic pain.

Merck, 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.

Last 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 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.

The European Commission (EC) has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines, while maintaining a strict ban on direct-to-consumer advertising.

In 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.

After announcing the official appointment of Guido Rasi as new executive director, the EMA management board also endorsed the implementation plan for the agency?s ?Road map to 2015? in a press statement released Oct. 7, 2011.

Servier 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 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.

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

The 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.

FDA 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.

The 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.

Last 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 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.

The 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 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.

The 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.

The 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.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.