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.
On Apr. 27, 2011, the National Institutes of Health (NIH) announced the composition of a working group tasked with making recommendations about the training of the next generation of biomedical researchers. The group will be co-chaired by Dr. Shirley Tilghman, president of Princeton University, and Dr. Sally Rocky, NIH deputy director for extramural research. Ten other scientists, most of them from academia, will complete the group.
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.
Shanghai Pharmaceutical and Pfizer have signed a memorandum of understanding for the companies to jointly pursue potential business opportunities in China.
The IMS institute has released its report on the use of medicines in the United States during 2010. The report looks at consumer spending on prescription drugs, and presents data on how many prescriptions have been filled, in which therapeutic areas, and compares use of generics with branded drugs.
A Record Number of Therapies for Cancer Currently in Development
Merck Forms Joint Venture with Sun Pharmaceutical
FDA Publishes Guidance for Preventing Cross-Contamination
J&J Announces Settlement for Corrupt Practices
J&J Reorganizes Consumer Group
Pfizer's Capsugel Fetches $2.375 Billion
Nigeria Looks to Simple Packaging Controls and International Cooperation to Curb Counterfeit Drugs
sanofi Completes Genzyme Acquisition
AstraZeneca Agrees to $1.1-Billion Settlement to US and UK Tax Authorities
Biosimilars Market will be Worth $3.7 Billion by 2015
New Challenges for Use of Embryonic Stem Cells
Sanofi Issues Bonds to Fund Genzyme Acquisition
Merck Sells Contract Biopharmaceutical Business to Fujifilm
