News

In a speech at Carnegie Mellon University?s National Robotics Engineering Center last Friday, President Obama unveiled an Advanced Manufacturing Partnership (AMP) designed to reinvigorate the country?s manufacturing sector. The partnership between academics, business leaders, and science and technology agencies is intended to create jobs by helping US manufacturers reduce costs, improve quality, and accelerate product development.

The International Pharmaceutical Excipients Council (IPEC) Federation issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan. Two phthalates, di-ethyl hexyl phthlate (DEHP) and di-isononyl phthalate (DINP), which are commonly used as plasticizers for polyvinyl chloride (PVC)-based plastics, were found in certain adulterated products and subsequently recalled by Taiwan authorities. It is believed that the phthlates were added as a form of economically motivated adulteration as a low-cost replacement for palm oil.

GlaxoSmithKline (GSK) has entered into an agreement to purchase Shenzhen Neptunus' stake in a previously formed joint venture between the companies involved in the development and manufacture of influenza vaccines in China, Hong Kong, and Macau. GSK will pay Shenzhen Neptunus $39 million, after which GSK will be the sole owner of the joint venture company, Shenzhen GSK-Neptunus Biologicals (GSKNB).

Merck & Co. and the biobusiness of Hanwha Chemical, a Korean chemical manufacturer, have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel (etanercept), a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a draft guidance, titled "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release. The program, which was intended to educate healthcare providers about misleading drug promotions, debuted on May 11, 2010. Since that time, the agency has received 328 reports of potentially untruthful promotion. In contrast, FDA received an average of 104 reports per year before the initiative was launched.

Believing that transparency in the pricing of medicines is ?fundamental? to enabling patients and stakeholders to make proper decisions about equity and value for money in health systems, the European Public Health Alliance (EPHA) called for greater pricing transparency. EPHA also called for the formation of a public website that provides comparative information on medicines? procurement prices. EPHA?s calls are a response to the European Commission?s consultation on the possible revision of Directive 89/105/EEC, which concerns the transparency of the pricing and reimbursement of medicines in various member states.

A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a ?Dear Doctor? letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.

The FDA Center for Drug Evaluation and Research's Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with Pharmaceutical Technology by the agency press office. Specifically, the Office of Compliance will be elevated to a "Super Office." Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

This week, AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company?s Philadelphia Business Center in Wayne, Pennsylvania. The US Department of Labor (DOL) brought the lawsuit in May 2010, alleging that AstraZeneca had discriminated against female sales specialists by paying them salaries that were an average of $1700 less than those of their male counterparts.

An independent report released by the European Medicines Agency on May 31, 2011, highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines. The report was the conclusion to a one-year project conducted by Frederic Bouder, PhD, at the behest of EMA, aiming to provide detailed, evidence-based input by analyzing the expectations and attitudes of the agency?s stakeholders toward communication on medicines.

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan. In a company press release, Mylan Chairman and CEO Robert J. Coury states: ?This rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months.? Matrix Laboratories is a supplier of active pharmaceutical ingredients (APIs), and a producer of APIs used to make generic antiretroviral therapies for the treatment of HIV/AIDS. Mylan acquired 51.5% of Matrix?s shares in 2007, and the remainder of its shares in 2009.

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly, the decision-making body of the World Health Organization, passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues. The sessions were held in Geneva during the annual meeting of the World Health Assembly. More than 2700 delegates attended, including government health ministers, senior health officials, nongovernment organizations, civil-society groups, and observers.

Last week, FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010. Users can find inspection dates, the type of FDA-regulated products that the facilities produced, and the agency?s final inspectional classification, which reflects each firm?s compliance status.

The pharmaceutical industry has been called to action by a new report that highlights the health and cost repercussions of patient noncompliance. According to Capgemini?s report, Patient Adherence: The Next Frontier in Patient Care, patient adherence to medications for chronic conditions, such as HIV and Arthritis, averages at only 50%.

On Monday, Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo. The deal values Taiyo at approximately $1.3 billion.

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.

Amylin Pharmaceuticals has filed a lawsuit against Eli Lilly, alleging that Lilly is engaging in "anticompetitive activity" and "breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide." According to Amylin, Lilly is planning to jointly develop and commercialize a linagliptin product with Boehringer Ingelheim that will directly compete with Amylin?s exenatide products.

Janssen-Cilag International, part of Johnson & Johnson (J&J) is working with regulatory authorities in five countries to address the trace amounts of 2,4,6-tribromoanisole (TBA) that were identified in five batches of the HIV?AIDS medicine Prezista (darunavir). The countries affected include the United Kingdom, Ireland, Germany, Austria, and Canada.

On May 12, 2011, a bill was introduced in the US House of Representatives to launch a national strategy for the development of regenerative medicines.

In fiscal year (FY) 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to a Federal Trade Commission (FTC) staff report. The number of these ?pay-to-delay? deals rose from 19 in FY 2009 to 31 in FY 2010, an increase of more than 60%. FY 2010 agreements involved 22 branded pharmaceutical products with combined annual US sales of about $9.3 billion, according to the report.

This month, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).

The Office of the United States Trade Representative (USTR) issued a report, 2011 Special 301 Report, as part of its annual review of the global state of intellectual-property rights (IPR) protection and enforcement. The report was issued earlier this month and addresses IPR protection and enforcement, and specific initiatives by the United States, its trading partners, and international bodies, including measures relating to drug anticounterfeiting and market access to medicines.

The International Pharmaceutical Excipients Council (IPEC) is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients. The document is the second draft of the ?Excipact? set of standards, and the authors sent it to industry stakeholders for review.

The Pharmaceutical Research and Manufacturers of America (PhRMA) urged Congress to reauthorize two pieces of legislation relating to pediatric studies and exclusivity, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). PhRMA made the comments in testimony in a public meeting before the Institute of Medicines (IOM), the health arm of the National Academy of Sciences.

Israel-based Teva Pharmaceuticals Industries has sealed a deal to acquire Cephalon for $6.8 billion. In a press release issued on May 2, 2011, Teva explained that it will pay $81.50 cash per share in a transaction that is expected to be completed in the third quarter of 2011. The companies' combined portfolio will include more than 20 branded products and represent approximately $7 billion in sales.

On Apr. 29, 2011, a federal appeals court has lifted a ban on federal funding for embryonic stem cell (ESC) research. The move was celebrated by researchers hoping to use such cells for research, but it is likely that the decision will be appealed. Embryonic stem cells are pluripotent cells derived from embryonic tissue in a process that usually results in the destruction of the embryo. The ban on funding did not apply to stem cells derived from adult tissue.

FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer (DTC) promotion of prescription drug products, according to an announcement in the Apr. 28, 2011, Federal Register.