Generic drug maker American Pharmaceutical Partners (APP, Schaumburg, IL) reported
late last week that FDA's ANDA-approval inspection of a raw material
supplier uncovered issues that would delay the approval of its
ceftriaxone (injection, USP). The delay does not affect any currently
marketed products, APP said.
MAP Pharmaceuticals (Montainview, CA) and Elan Corporation
have agreed to amend their previous 2004 agreement to apply Elan's
proprietary "NanoCrystal" technology to defined inhalation therapies.
MAP has been collaborating with Elan to develop a nebulized form of
budesonide for the treatment of asthma. The agreement provides
additional rights to MAP for the use of NanoCrystal technology for the
treatment of multiple respiratory diseases.
Marion Weinreb & Associates, Inc. (Kansas City, MO) and ProPharma Group, Inc.
(San Francisco, CA) have announced a strategic alliance to offer
comprehensive compliance services to pharmaceutical, medical device,
and biotech companies.
CSSC (Morristown, NJ) opened
a new office in Cambridge, Massachusetts, boosting its US property to
three offices and a strategic partnership in Europe.
Hospira, Inc. has completed
its acquisition of Physiometrix, Inc., a Massachusetts-based developer
of noninvasive medical devices. Hospira announced plans to acquire
Physiometrix in June for approximately $23 million in cash.
The proposed acquisition of Transkaryotic Therapies, Inc.
(Wayne, PA) by Shire
Pharmaceuticals (Basingstoke, UK) was approved by Shire’s
shareholders on July 27, 2005. The acquisition is now expected to
completed later today, July 28.
Bionutrics, Inc.,
(Phoenix, AZ) has entered into an agreement to purchase Kirk
Pharmaceuticals and its affiliate, Andapharm. Under the terms of the
agreement, Bionutrics will purchase Kirk for $12 million and will gain,
among other things, a designated manufacturing site for Bionutric's
prospective ANDA and 505(b)(2) drug applications. (continued to People)