FDA grants orphan drug status to arGentis for sclerosis drug
MEMPHIS, Tenn. arGentis Pharmaceuticals has received orphan drug designation for its systemic sclerosis drug ARG201 from the Food and Drug Administration.
The drug treats the disease, which attacks the body’s own type 1 collagen causing fibrosis of the skin, lungs and other organs. As the disease progresses, patients suffer increasing difficulties with digestion, breathing, joint pain and often develop pulmonary hypertension.
The designation from the FDA gives the company seven years of marketing exclusivity for the drug upon approval. It also gives arGentis the opportunity to apply for grant funding from the government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA’s application user fee.
IVoice announces patent on new product for easy medicine consumption
MATAWAN, N.J. iVoice has created a new product that will organize the way that patients consume pills. According to published reports, the invention is a medicine container that has speaking instructions.
iVoice has filed a patent application with the U.S. Patent and Trademark Office under the title, “Methodology for Wirelessly Loading Speaking Medicine Containers, with an internal clock.”
The new iVoice product contains an internal clock, which starts when a patient activates the audio playback that, with recurring use, creates a message that displays how many pills the patient should have left, and if that “predetermined amount” is not in the container, a warning is displayed for the patient to contact a doctor or pharmacist. Other features include a medicine container starting table count, required consumption data and self-programming.
FTC files complaint over Cephalon’s attempt at protection of Provigil market
WASHINGTON Cephalon is facing a lawsuit filed by antitrust enforcers regarding its Narcolepsy medicine, Provigil.
Provigil is Cephalon’s best-selling drug, and according to the Wall Street Journal, the civil complaint filed by the Federal Trade Commission stated that Cephalon was illegally delaying the sale of the drug by four rivals that were slated to produce and market the generic version of the drug. The sales of Provigil are a recorded $800 million per year.
According to the Wall Street Journal report, companies including Teva Pharmaceuticals, Ranbaxy Pharmaceuticals, Barr Pharmaceuticals, and Mylan Pharmaceuticals, were given a combined $200 million to push off the genetic version of their drug from market entry until 2012.
Cephalon denies any wrongdoing. “The transactions we reached met the letter and spirit of the law in every way,” Frank Baldino, Cephalon’s chief executive, said, “and we will litigate this matter, and we will prevail.”