Hemispherx submits answers to 14 FDA questions regarding approval of Ampligen
PHILADELPHIA Hemispherx Biopharma, which develops new drug entities for treatment of seriously debilitating disorders, announced Wednesday that it has formally submitted to the Food and Drug Administration detailed responses to all of the 14 questions posed by the FDA concerning the company’s application for Ampligen, an experimental therapeutic to treat chronic fatigue syndrome, according to reports.
On Dec. 15, Hemispherx received the questions from the FDA, at which point the application was deemed by the FDA as “not sufficiently complete” to permit substantive review. The questions spanned a range of clinical and preclinical topics.
Ampligen represents an entirely new class of RNA-based drug therapies. The company’s prompt response to the questions posed by the FDA was made possible by the broad-based team of clinical and scientific experts assembled during 2007, with experience in successful global development of NDAs for new molecular entities, Hemispherx reported.
House investigates possibly misleading Lipitor advertisement
WASHINGTON Democrats in the House of Representatives are investigating as to whether or not consumers are being misled by advertisements for Lipitor featuring Dr. Robert Jarvik, the inventor of the artificial heart, the Associated Press reported.
Michigan Reps. John Dingell and Bart Stupak sent a letter to the drug’s manufacturer Pfizer on Monday, questioning the credibility of Jarvik, whom they believe is not certified to practice or prescribe medicine because he might not have taken the necessary tests or performed an internship.
Pfizer spokesman Chris Loder said Jarvik’s presence in the advertisements is meant to educate consumers on the importance heart health. “Dr. Jarvik is a respected health care professional and heart expert who knows how imperative it is for patients to do everything they can to keep their heart working well,” Loder said in a statement.
The representatives have requested that Pfizer turn over all of its information concerning Jarvik including its contract with him and any information about his professional qualifications.
Lipitor is the most prescribed drug in the U.S., with sales of $13.6 billion in 2006.
King ends five-year Skelaxin patent suit against CorePharma
BRISTOL, Tenn. & MIDDLESEX, N.J. King Pharmaceuticals has ended is patent lawsuit with CorePharma regarding its muscle relaxant drug Skelaxin and has signed an agreement with CorePharma related to the drug, according to Forbes.
On Jan. 2, the two companies signed an agreement under which, CorePharma will gain certain exclusive rights to Skelaxin 800 mg to market a generic version, called metaxalone and have also gained a non-exclusive license to produce and market a 400 mg version of the drug. This license will come into effect on Jan. 1, 2012.
Back in 2003, CorePharma was one of several biopharmaceutical companies to file with the Food and Drug Administration seeking permission to produce a generic. King countered by suing CorePharma and later Eon Labs and Mutual Pharmaceuticals, who also sought permission to produce a generic.
As of now, CorePharma is the only company that King Pharmaceuticals has an agreement with concerning Skelaxin. The drug is estimated to account for about $400 million in sales in 2008, according to Morgan Stanley.