Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
Drug offerings expand under Merck Helps programs
WHITEHOUSE STATION, N.J. Merck is expanding its patient assistance program, the drug maker said Wednesday.
Merck announced an expansion of the number of drugs it offers under its Merck Helps programs, including the Merck Patient Assistant program, the Merck Vaccine Patient Assistance program, the ACT program for cancer and hepatitis C drugs, and the SUPPORT program for HIV and AIDS drugs. The program provides medicines and vaccines free of charge to eligible patients, primarily the uninsured, who make up to 400% of the federal poverty level and can’t afford Merck drugs without assistance.
“Merck has historically recognized the critical need for people to have access to the prescription medicines and vaccines they require, even if they lose their insurance,” Merck EVP and chief medical officer Michael Rosenblatt said. “Our patient assistance programs now provide access to even more medicines for chronic conditions like asthma, diabetes and high blood pressure, allowing us to reach more people in need.”
Merck also said that its philanthropic arm, the Merck Company Foundation, made a grant to NeedyMeds, a nonprofit group that helps people who can’t afford medicines or healthcare costs by making information about assistance programs available. NeedyMeds plans to use the grant to translate its website into Spanish.
FDA approves multiple sclerosis drug Gilenya
SILVER SPRING, Md. The Food and Drug Administration has approved a drug for reducing relapses in patients with multiple sclerosis.
The FDA announced Wednesday the approval of Swiss drug maker Novartis’ Gilenia (fingolimod) capsules, saying it was the first oral drug that can slow the progression of disability in patients with MS and offered an alternative to injected drugs.
Around 400,000 people in the United States and 2.1 million worldwide have MS, according to the National Multiple Sclerosis Society.