News

Brussels (May 30)-The European Federation of Pharmaceutical Industries and Associations (EFPIA) called for the pan-European and industry-wide adoption of 2-D barcode technology to combat the increase in counterfeit drugs in Europe.

Merck, Amgen, Lonza, Vical, more

Kvistgard, Denmark (June 4)-Bavarian Nordic received a $1.6-billion contract from the US Department of Health and Human Services to manufacture and deliver 20 million doses of its smallpox vaccine "Imvamune."

AstraZeneca, Barr Pharmaceuticals, Jubilant Organosys, Roche, more

Thousand Oaks, CA (June 4)-Amgen agreed to acquire Ilypsa (Santa Clara, CA), a private company that develops nonabsorbed drugs for renal disorders, for $420 million.

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).

Rockville, MD (June 4)-Americans may soon have access to more information about the risks and benefits of the prescription and over-the-counter drugs they take. The US Food and Drug Administration is establishing an advisory committee to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Look ahead to keep from falling behind.

Global corporate citizenship can go a long way.

Perhaps Congress can help FDA meet its multiple oversight demands.

Signature authentication technology has evolved to become a stong tool for improving confidence in verification.

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's (New York, NY, www.ey.com) annual analysis of the biotechnology industry. Its report, "Beyond Borders 2007," was issued at the Biotechnology Industry Organization's (BIO, www.bio.org) annual conference and exhibition, which was held in Boston May 6–9.

Cambridge, MA (May 30)-Genzyme agreed to buy its US partner Bioenvision (New York) in an all-cash transaction worth $345 million.

Rockville, MD (May 25)-The US Food and Drug Administration issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc., citing deviations from current good manufacturing practices.

Acambis, FDA, Biogen, Ranbaxy, more

Rockville, MD (May 25)-The US Food and Drug Administration issued a statement announcing its intention to take action against companies that market unapproved timed-release drug products that contain the expectorant guaifenesin.

AAI, AstraZeneca, Biovail, West, more

Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey.

Mumbai, India (May 21)-Sun Pharmaceutical Industries and its subsidiaries signed definitive agreements to acquire Taro Pharmaceutical Industries, a generics manufacturer with subsidiaries and manufacturing operations in the United States, Canada, and Israel.

Aptuit, Actavis, BASF, Bristol-Myers Squibb, more

Basel, Switzerland (May 11)-Roche opened a new biotechnology production center in Basel today, just two years after beginning construction. The facility will manufacture "Avastin," a cancer drug that inhibits the formation of new tumor blood vessels.

Rockville, MD (May)-The US Food and Drug Administration issued a draft guidance, "Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information."

Darmstadt, Germany (May 13)-Mylan Laboratories Inc. and Merck KGaA have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics, the company?s generics business.

Washington, DC (May 3)-The Biotechnology Industry Organization published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity.

London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's annual analysis of the biotechnology industry.

Rockville, MD (May 1)-The US Food and Drug Administration issued a report, "Critical Path Opportunities for Generic Drugs," to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.

Dublin, OH (May 3)-In preparation for California?s new pedigree legislation, Cardinal Health plans to integrate radio frequency identification (RFID) technology into the operations at its pharmaceutical distribution center in Sacramento by fall 2007.

Althea, AstraZeneca, Bosch, more