Pharma & Healthcare – The latest on Sun Pharma shares, Valeant Settlement, and more.
Shares of Sun Pharmaceutical Industries Ltd(
SUN.NS) fell as much as 2.1 percent after Bloomberg News reported the drug maker had received queries from the U.S. Food and Drug Administration over quality control at a U.S. subsidiary.
Sun received two so-called Form 483s, issued when the U.S. regulator has queries, for its Detroit-based Caraco Pharmaceutical Laboratories Ltd following inspections in January and May this year, Bloomberg reported on Monday, citing a Freedom of Information Act request… [
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NEW YORK (AP) — Valeant Pharmaceuticals will pay Anacor Pharmaceuticals $142.5 million in a settlement, the companies said Monday.
The payment will be made by Nov. 8, and it will resolve all disputes between Anacor and Valeant. That includes legal proceedings involving Medicis Pharma, which Valeant acquired in December.
Anacor says that Dow Pharmaceutical Services, which is now part of Valeant, breached a contract related to Anacor’s work on Jublia. The drug is a treatment for onychomycosis, a fungal infection of the nail and nail bed. On Oct. 18 an arbitrator awarded Anacor $100 million in damages and ordered Valeant to pay costs and attorney’s fees as well. Anacor, of Palo Alto, Calif., said it believed it had other claims against Valeant as well… [
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“Despite some high-profile commitments from some of the industry’s largest innovators, R&D for some of the world’s most deadly neglected diseases remains underfunded and unimpressive, according to a study, a state of affairs that has barely improved over the last three decades.”
So starts an article by Damian Garde of FierceBiotech. Garde is referring to a recent paper in “The Lancet” entitled:
“The drug and vaccine landscape for neglected diseases (2000 -11): a systematic assessment.” Neglected diseases are defined as diseases that affect people in low-income countries and are the leading cause of mortality, chronic disability and poverty. They include malaria, tuberculosis, diarrheal diseases, and tropical diseases. The Lancet paper made the following points… [
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NEW DELHI: Drug maker Sun Pharmaceutical today said it has addressed the US health regulator’s concerns about manufacturing lapses at its US-based Caraco Pharmaceutical Laboratories. United States Food and Drug Administration had conducted inspections in January and May this year and had noticed the lapses.
When asked about the nature of lapses and the corrective measures the company has taken a Sun Pharmaceutical spokesperson said they were “minor observations”.
“The company has responded to these a long time back,” the spokesperson said without elaborating. Earlier in the August 2012, Sun Pharmaceutical Industries had said American health regulator had approved resumption of manufacturing operations at Caraco for two drugs after inspections of facilities… [
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Tags: FDA, Legal News, USFDA