FDA approves two-in-one blood pressure drug
EAST HANOVER, N.J. The Food and Drug Administration has approved a blood pressure pill that combines two drugs in one.
Novartis announced Tuesday that the FDA had approved Tekturna HCT (aliskiren and hydrochlorothiazide), which combines the existing treatment Tekturna with hydrochlorothiazide, a widely used diuretic.
The approval was based on a 2,700-patient clinical trial indicating that the combination of the two drugs reduced blood pressure more than either drug alone.
High blood pressure, also known as hypertension, affects nearly 74 million adults in the United States and is a major risk factor for cardiovascular disease.
Letter urges Waxman to push for provisions in H.R. 1427 for biosimilars regulatory pathway
WASHINGTON In a letter Friday, a group of organizations urged a Congressman to push for provisions contained in a bill he introduced that would create a regulatory pathway for biosimilars if a House committee calls for a pathway as part of healthcare reform legislation.
The Generic Pharmaceutical Association, AARP, the Pharmaceutical Care Management Association, labor unions and other groups asked Rep. Henry Waxman, D-Calif., to try and insert provisions from his Promoting Innovation and Life Saving Medicines Act in health reform legislation, if the legislation includes a pathway for biosimilars.
Waxman’s bill, introduced on March 11, would grant biotech drugs five years of market exclusivity, much like the Hatch-Waxman Act he co-sponsored in 1984, which created an approval pathway for generic pharmaceutical drugs.
Nevertheless, the bill has garnered only 14 co-sponsors, compared to 137 for the Pathway for Biosimilars Act, a competing bill introduced days after Waxman’s by Rep. Anna Eshoo, D-Calif., which would allow 12 to 14 years of exclusivity. Earlier this month, the Senate Health, Education, Labor and Pensions Committee voted to amend the healthcare reform bill to allow 12 years of exclusivity for biotech drugs.
Oramed announces mid-stage trial results for Type 1 diabetes treatment
JERUSALEM A company that develops alternative drug delivery systems said it achieved positive results in a mid-stage clinical trial of an orally administered insulin for treating Type 1 diabetes.
Oramed Pharmaceuticals said the phase 2a trial of its insulin capsules, ORMD-0801, showed the capsules was well-tolerated and produced no serious harmful side effects.
“These results demonstrate that Oramed’s oral insulin capsule had a good safety profile and was effective on patients with Type 1 diabetes when taken prior to a meal,” Oramed chief scientific officer Miriam Kidron said in a statement.
The company said it is conducting a phase 2b trial in South Africa, evaluating the insulin’s effects on patients with Type 2 diabetes.