Egalet a/s (Copenhagen, Denmark, www.egalet.com)signed a long-term manufacturing agreement with SP Medical A/S (Juelsminde,Denmark, www.sp-group.dk)by which SP Medical will manufacture clinical-grade quantities ofEgalet products for hypertension and pain management for Phase IIItesting using injection moulding. If the products gain regulatoryapproval, SP Medical will be responsible for commercial scale-up andmanufacture of both products. All manufacturing will take place in aGMP environment and is subject to approval by the Danish authoritiesand the US Food and Drug Administration.
MicroTest(Agawam, MA, www.microtestlabs.com)invested $7.50 million to expand its pharmaceutical andvirology testing services and fill-finish contract manufacturingcapabilities. The expansion includes constructing and equipping newpharmaceutical testing laboratories, a series of segregated virologytesting laboratories, and aseptic fill-finish manufacturing facilitiies.
Pending approval by the Romanian CompetitionCouncil, Ranbaxy Netherlands BV(Haryana, India, www.ranbaxyusa.com)will acquire generics company Terapia (Romania) for $324 million.
People
RNAi therapeutics maker Alnylam Pharmaceuticals, Inc.(Cambridge, MA, www.alnylam.com)appointed Saraswathy (Sara) Nochur,PhD, to the position of vice-president of regulatory affairs.Nochur has experience in regulatory affairs and overalldrug development. At Alnylam, she will lead the global regulatorystrategy for the company's development-stage programs, overseeregulatory operations, and serve as a member of the management team.
Vivian Liuwas named executive vice-president and chief operating officer of NexMed, Inc. (East Windsor, NJ, www.nexmed.com), adeveloper of transdermal products. Liu joined the company in 1994 andwill oversee NexMed's day-to-day operations in her new position.
PenwestPharmaceuticals Company (Danbury, CT. www.penw.com), adeveloper of drugdelivery technology, named JenniferL. Good to the position of chief executive officer and member ofthe Board of Directors. Good had been president and chief operatingofficer of Penwest since November 2005.
Deborah M. Autorwas selected as the director of the USFood and Drug Administration's (Rockville, MD,
www.fda.gov
) Center for Drug Evaluation and Research's Officeof Compliance. Autor joined the Office of Compliance in October2001 as a senior advisor and has been the associate director forcompliance policy since July 2002. StevenNiedelman, deputy associate commissioner for regulatoryoperations, announced his retirement from FDA. He will join Quintiles Consulting (ResearchTriangle Park, NC,
www.quintiles.com
)as executive vice-president.