FDA to Hold Public Hearing on Online Drug Promotion
The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

Bayer Receives Warning Letter for Alleged Deviations
The US Food and Drug Administration sent Bayer Schering Pharma a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients.

EMEA Report Issues Urgent Call for New Antibiotics
A report from the European Medicines Agency highlights the lack of enough new antibiotics in the pharmaceutical industry's pipeline to fight multidrug-resistant bacteria.

Pharma Goes Back to Basics to Battle Recession
Many pharmaceutical companies in the United Kingdom are turning to basic business-skills training to help them emerge from the recession stronger than before.

AstraZeneca (London) and Nektar Therapeutics (San Carlos, CA) signed a license agreement for two drug development programs: NKTR-118, a late-stage investigational product designed for the treatment of opioid-induced constipation, and NKTR-119, which is intended to deliver products for the treatment of pain without constipation side effects. Both programs were developed by Nektar, using its proprietary small-molecule advanced polymer conjugate technology platform. Nektar will receive an upfront payment of $125 million for both NKTR-118 and NKTR-119; for the NKTR-118 program specifically, up to $235 million in regulatory milestones, up to $375 million in sales milestones, and double-digit royalty payments; and for NKTR-119, the company is eligible to receive development and sales milestone payments and double-digit royalties on sales.

Avid Bioservices (Tustin, CA), a contract manufacturer, and Boehringer Ingelheim (Ingelheim, Germany) entered into a production-alliance agreement that makes Avid an approved member of Boehringer Ingelheim’s global Production Alliance Network PAN Biologics. The Production Alliance Network program is set up to provide the partners’ customers with a broader range of contract services, according to an Avid press release.

Chiral Technologies (West Chester, PA), a provider of chiral chromatography columns, signed a sales agreement with LEACSA (Mexico City), distributor of separation systems. Under the agreement, LEACSA will serve as Chiral Technologies’ master sales distributor in Mexico.

Merck & Co. (Whitehouse Station, NJ) and the charity Wellcome Trust (London) formed Hilleman Laboratories, which will use a not-for-profit operating model to develop and deliver vaccines to low-income countries. Hilleman Laboratories will be based in India and will seek to develop vaccines in areas of unmet need, as well as to optimize vaccines to increase their impact when resources are limited. The CEO will be Altaf A. Lal, who spent 20 years working for the National Center for Infectious Diseases at the Centers for Disease Control and Prevention, and is currently Health Attache and Department of Health and Human Services Regional Representative for South Asia at the US embassy in New Delhi, India.

Wyeth Pharmaceuticals (Collegeville, PA), a division of Wyeth and Ambrx (La Jolla, CA), a biopharmaceutical company, formed an alliance to discover, develop, and commercialize protein-drug candidates for three undisclosed targets in multiple therapeutic areas. Ambrx anticipates earning an upfront payment, as well as preclinical, clinical, regulatory, and commercial milestone payments and royalties on sales.

The US Food and Drug Administration is awarding $2 million in grants for the development of pediatric medical devices, according to a Sept. 21, 2009, agency release. Sixteen companies applied for the grants, which will be administered by FDA’s Office of Orphan Products Development (OOPD). The grantees are: Dr. James Geiger and the Michigan Pediatric Device Consortium ($1 million), Dr. Pedro DelNido and the Pediatric Cardiovascular Device Consortium ($500,000), and Dr. Michael Harrison and the University of California at San Francisco Pediatric Device Consortium ($500,000). OOPD Director Timothy Cote said in the release that Congress provided the funds based on medical device legislation passed in 2007 to “help connect innovators and their ideas with experienced professionals who assist them through development.” The grants are meant to help “effectively meet the special and unique needs of our children.

FDA is extending the deadline to Sept. 30, 2010 for those wishing to participate in the Office of Biotechnology Product’s pilot program for the submission of chemistry, manufacturing, and controls (CMC) information. The pilot is modeled after the Office for New Drug Quality Assessment’s CMC Pilot Program focused on quality-by-design principles.

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American Pacific (Las Vegas, NV), a manufacturer of active pharmaceutical ingredients and intermediates, announced that John R. Gibson, chairman of the board of directors and CEO, will retire as CEO, effective December 31, 2009. He will be succeeded by Joseph Carleone, who currently serves as president and chief operating officer. Gibson will retain his role as chairman of the board.

BioMicro Systems (Salt Lake City, UT), a developer of biological research products based on its proprietary microfluidic and microarray technologies, appointed Rob Parry president and chief operating officer. Parry will be responsible for expanding sales of the MAUI Microarray Product Suite, as well as launching a new line of products for the cytogenetics market.

Eli Lilly and Company (Indianapolis, IN) promoted David Ricks, currently general manager of Lilly China, to president of Lilly USA, LLC. Ricks will succeed Enrique Conterno, who was named leader of Lilly's new Diabetes Business Unit as part of a company reorganization announced Sept. 14, 2009. Ricks will assume his new role beginning Nov. 1, 2009, and Eric Baclet, currently vice-president of marketing over global neuroscience brands, will succeed Ricks to lead Lilly China.

Elite Pharmaceuticals (Northvale, NJ) appointed Jerry I. Treppel as its CEO, and Ashok G. Nigalaye, as its chief scientific officer. Treppel has served on Elite's board of directors since October 2008 and has been chairman since November 2008. Nigalaye has served on the board since June 2009. 

Ryan Titmas was named vice-president of sales for Sartorius Mechatronics (Bohemia, NY). Titmas will be responsible for the following brands: Sartorius Lab, Industrial, and Process Weighing products including the Denver and Acculab brands.

Variation Biotechnologies (Cambridge, MA) appointed Jeff Baxter as CEO and as a member of the board of directors. Baxter replaces Francisco Diaz-Mitoma, a founder of the company who will remain a board member and will transition to chief scientific officer and president of the company’s Canadian operations. Baxter will be based at the company's new US headquarters in Cambridge, Massachusetts.