MedImmune announces strong future plans
GAITHERSBURG, Md. Biotechnology company MedImmune has said that it expects to have at least three new drug candidates in trials by 2010 and to have an average of six new drug applications for submission per year, according to the baltimoresun.com.
This new outlook represents an acceleration of earlier plans by the company. The company was acquired earlier this year by AstraZeneca to help bolster its product pipeline.
“We have brought AstraZeneca’s two pre-existing biologics locations and 300 more people under the MedImmune umbrella to address unmet therapeutic needs within the central nervous, gastrointestinal and cardiovascular systems, in addition to our historical focus on the areas of infectious disease, inflammatory disease and cancer,” said MedImmune chief executive David Mott. “As a result, our biologics pipeline now has more than doubled in size to contain 100 research projects and more than a dozen clinical product candidates.”
MedImmune plans on filing an application for FluMist, its nasal spray influenza vaccine with the European Agency for the Evaluation of Medicinal Products in 2008.
Amgen discussing Aranesp label changes
THOUSAND OAKS, Calif.
Biotechnology company Amgen stated late Thursday that it is discussing potential safety updates for its anemia drugs with the Food and Drug Administration.
The drugs are part of a class of drugs called erythropoiesis stimulating agents, or ESAs, used to treat anemia in chemotherapy and kidney-failure patients. They include Aranesp and Epogen, made by Amgen, and Johnson & Johnson’s Procrit.
The FDA’s Oncologic Drugs Advisory Committee will meet during the first quarter as part of its ongoing review for ESA therapies, the company said.
Earlier this year, the FDA issued requirements for stronger warnings on the drugs and asked for additional studies. The FDA issued a black box warning on the drugs, the most critical warning a drug can carry.
Amgen currently is conducting studies to further determine the possible safety risks when patients use their pharmaceuticals.
Additional safety label changes will likely be based on data from a breast cancer patient study and follow-up data from a cervical cancer patient study, Amgen said.
Shares of Amgen fell $2.05, or 3.7 percent, to $53.10 in premarket trading.
Vemics enters agreement to use eRx Network
NANUET, N.Y. Vemics and eRx Network have announced an agreement under which eRx will use Vemics’ iMedicor online, HIPPA compliant Electronic Health Record transport network, which will carry refill requests electronically rather than by fax or phone.
“The proposed solution will eliminate manual processes and reduce costs for eRx Network pharmacy clients,” said Tom Dorsett, president of healthcare solutions for Vemics. “In addition, it will eliminate multiple manual processes for the physician office and take them a step closer to adoption of more profitable e-prescribing technology.”
“This relationship will move physicians quicker to electronic prescribing and help the pharmacy by eliminating the need to data-enter refill responses,” said Murray Lyle, president and chief operating officer of eRx Network. “There is significant room for growth and expansion as this partnership evolves.” eRx Network currently has more than 200,000 active physician subscribers utilizing the network for carrying e-prescribing transactions and prescription refill requests.
The iMedicor portal, which went live on Oct. 10, is the health industry’s first free, HIPAA-compliant online personal health data exchange and secure messaging portal for physician collaboration, community and referrals. The portal’s proprietary HIPAA-compliant technology and ability to enable health providers to exchange medical record data, documentation and images are what distinguishes it from the chat-room-style portals for doctors currently in existence.