BioPharm International Editors

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy?s Laboratories, according to Reuters. The import ban is a result of the company?s failure to correct the violations listed in a June 3, 2011, Warning Letter to the agency's satisfaction.

The European Medicines Agency (EMA) has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain. The directive comes into effect on July 21, 2011, and EMA will be working closely with its partners and the European Commission (EC) on implementation over the next 18 months. Member states will have to begin applying the measures beginning January 2013.

EMA has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation?s execution. The forum, held on June 17, 2011, was attended by a wide cross-section of participants from industry, patient, and consumer representatives, as well as those from the EMA and national authorities, and represented a clear effort to guarantee timely input from all stakeholders during the implementation process.

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.

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.

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.

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.

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.

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.

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.

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.

Warner Chilcott, a specialty pharmaceutical company with headquarters in Dublin, announced its plans to restructure in a press release on Apr. 18, 2011, which places 500 Western European jobs on the line. The decision came after a strategic review of operations following the loss of Actonel's patent exclusivity in late 2010. Accounting for approximately 70% of the company's Western European revenues, Actonel (risedronate sodium) is a monthly, oral medication for the prevention and treatment of ostioporosis.

FDA has released a list of its strategic priorities for the next five years to address new global challenges. The document, titled ?Strategic Priorities 2011?2015: Responding to the Public Health Challenges of the 21st Century?, provides a vision for FDA. This vision includes a new field of regulatory science that uses innovations in science and technology to ensure the safety and effectiveness of products, according to the document, which also includes proposals for meeting the needs of the world?s unique populations.

FDA Publishes Guidance for Preventing Cross-Contamination

J&J Reorganizes Consumer Group

Pfizer's Capsugel Fetches $2.375 Billion

Sanofi Issues Bonds to Fund Genzyme Acquisition

Rare Disease Day 2011 ? "Rare but Equal"

EMA Releases New Guidance on Stem Cell Products

Follow-on Biologics Grow in India

The US Food and Drug Administration has approved the vaccine Gardasil, manufactured by Merck and Co. Inc. (Whitehouse Station, NJ), for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26, according to an FDA press release.

At a press conference in Edina, Minnesota, on Dec. 30, 2010, US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an ?unprecedented? shortage of prescription drugs, especially for chemotherapy. ?Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no longer be available. That?s not right. There needs to be better coordination between the pharmaceutical industry, the FDA, and healthcare providers so patients don?t lose access to the medications they depend on,? said Klobuchar in a press release.

London-based drugmaker GlaxoSmithKline (GSK) and Immutep S.A. (Orsay, France) have signed a license agreement granting GSK exclusive worldwide rights to ImmuTune IMP731 and any other antibodies that deplete LAG-3 positive cells. IMP731 has demonstrated potency at low doses in preclinical models of T-cell mediated inflammation and could represent a new therapeutic approach to the treatment of autoimmune diseases.

US researchers say they have developed a vaccine that may someday help cocaine addicts kick their habits. The vaccine combines a segment of the common cold virus with a molecule similar to cocaine, according to a study published in the online edition of Molecular Therapy.

Amgen (Thousand Oaks, CA) and Xencor, Inc. (Monrovia, CA) will collaborate to develop XmAb5871, an Fc-engineered monoclonal antibody dually targeting CD19 and CD32b. XmAb5871 is currently in late-stage preclinical development for the treatment of autoimmune diseases.

Avila Therapeutics, Inc. (Waltham, MA) and France-based sanofi-aventis have signed a global alliance to discover targeted covalent drugs for the treatment of cancers. Under the alliance agreement, sanofi-aventis obtains a worldwide exclusive license to develop and commercialize the compounds resulting from the discovery collaboration.

Novavax, Inc. (Rockville, MD) has begun patient enrollment in a Phase 1 clinical trial to assess the safety, immunogenicity, and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim data from the trial will be available in the third quarter of 2011.

Merrion Pharmaceuticals, Plc (Dublin, Ireland), a product development company, has signed an oral drug delivery feasibility and option agreement with Rebel Pharmaceuticals, LLC (Thousand Oaks, CA) for two undisclosed compounds. Rebel will evaluate the ability of Merrion?s GIPET technology to enhance the compounds? clinical profiles and provide an improved product.

Baxter International Inc. (Deerfield, IL) and Takeda Pharmaceutical Company Limited (Osaka, Japan) have completed a development, license, and technology transfer agreement. Under the terms of the agreement, Takeda and Baxter will expand on their previously announced collaboration to bring Vero cell culture-based influenza vaccines to the Japanese market. Baxter will license its proprietary Vero cell-based influenza vaccine technology exclusively to Takeda for the Japanese market.