FDA, EMA approve Bayer’s sterile fill facility
BERKELEY, Calif. The Food and Drug Administration and the European Medicines Agency have given license approval to Bayer HealthCare for a new sterile filling facility on its Berkeley, Calif., campus, the company said Monday.
Bayer said the licenses from the FDA and EMEA will allow it to support the supply of its Kogenate line of products in the United States and European Union.
“These regulatory approvals for the Berkeley SFF represent a significant milestone for us and come at an opportune time given the continued expansion of the Kogenate product line in existing and new markets around the world,” Bayer HealthCare senior vice president and global head of product supply biotech Joerg Heidrich said. “We we look toward the future and the promise of true therapeutic advancements reflective of our strong product pipeline, it is crucial that our biotech facilities, infrastructure and processes are in line with the bold vision we have as an organization for developing therapeutic solutions for disease areas where there are still high unmet medical needs.”
Rheumatoid arthritis drugs don’t affect cancer risk, researchers find
CHICAGO Spanish researchers have found that drugs for rheumatoid arthritis called TNF blockers don’t appear to increase the risk of cancer, the researchers announced Saturday.
The drugs block a protein called the tumor necrosis factor, which is part of the immune system and is linked to arthritic inflammation. Some studies have shown that they increase the risk of cancer because they suppress the immune system, but the researchers did not find a statistical difference between the two groups of patients studied.
The research included one group of 4,500 people who took TNF blockers between 2001 and 2007, and another that included data from between 1999 and 2005 from almost 800 people who did not take the drugs.
FDA approves Barr extended-cycle oral contraceptive
MONTVALE, N.J. The Food and Drug Administration has approved a Barr Pharmaceuticals subsidiary’s application for a new oral contraceptive, Barr said Monday.
The FDA approved Duramed Pharmaceuticals’ drug LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethynyl estradiol tablets).
Barr said the drug is the first lower-dose, extended-cycle oral contraceptive. Under the extended-cycle regimen, women take combination tablets containing 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol for 84 consecutive days, followed by tablets containing 0.01 mg of ethinyl estradiol for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.
“As a leader in women’s health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers,” Duramed chief executive officer Fred Wilkinson said.