Celgene releases positive data from Revlimid study
BOUDRY, Switzerland Celgene International has released data from a new clinical study regarding its Revlimid drug, which is used to treat the growth of cancerous myeloma cells within the bone marrow. The drug is usually taken with the steroid drug dexamethasone.
The data was taken from a Phase III trial evaluating newly diagnosed multiple myeloma patients taking the drug with low-dose dexamethasone compared to the drug with a standard high-dose dexamethasone.
The 87 percent survival rate with Revlimid and low-dose dexametheasone at two years showed an advantage compared to the two-year survival rate of 75 percent for patients who received Revlimid and high-dose dexamethasone. Increased overall survival was seen in patients receiving Revlimid and low-dose dexamethasone regardless of age, however patients under the age of 65 showed a two year survival probability of 91 percent compared to 85 percent using high-dose dexamethasone at two years.
In patients who continued on treatment past six months, the 99 percent survival rate showed an advantage compared to a survival rate of 97 percent for patients who received Revlimid and high-dose dexamethasone at one year.
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.