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Stock Market & Financial Investment News

News Breaks
January 9, 2014
08:31 EDTZGNX, MNKMallinckrodt, Zogenix to end co-promotion agreement
Mallinckrodt (MNK) announced a mutually-agreed upon end of the company’s co-promotion agreement with Zogenix (ZGNX). The co-promotion agreement covered SUMAVEL DosePro, a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches. Mallinckrodt’s promotion of SUMAVEL DosePro will end January 31. Mallinckrodt and Zogenix entered into the co-promotion agreement June 7, 2012. Under terms of the agreement, Mallinckrodt’s U.S. sales force sold SUMAVEL DosePro to its customer base of prescribers. Zogenix continued to record all product revenues and Mallinckrodt was compensated based on a percentage of net sales from prescriptions generated by Mallinckrodt. The original agreement was to have run through June 30, 2014.
News For MNK;ZGNX From The Last 14 Days
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November 25, 2014
06:29 EDTMNKMallinckrodt says Questcor received subpoena from FTC in June
Mallinckrodt (MNK) disclosed in its quarterly regulatory filing that on June 11, Questcor received a subpoena and Civil Investigative Demand from the Federal Trade Commission seeking documentary materials and information regarding the FTC’s investigation into whether Questcor’s acquisition of certain rights to develop, market, manufacture, distribute, sell and commercialize Synacthen Depot from Novartis (NVS) violates the antitrust laws.
November 20, 2014
14:26 EDTZGNXZogenix slips after FDA approves new extended-release opioid analgesic
Shares of Zogenix, the maker of Zohydro ER, are lower in afternoon trading after the FDA approved Hysingla ER, another extended-release opioid analgesic. WHAT'S NEW: Earlier, the Food and Drug Administration announced it has approved Hysingla ER, which is an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry. Hysingla ER is manufactured by Purdue Pharma. WHAT'S NOTABLE: Janet Woodcock, the director of the Center for Drug Evaluation and Research, stated in a post to the "FDA Voice" blog, that the approval of Hysingla ER marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. In her blog post, Woodcock stated: "While Hysingla ER has the same active ingredient, hydrocodone, as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two." Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not, Woodcock noted. The CDER director also stated that the FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER. PRICE ACTION: In afternoon trading, shares of Zogenix slipped 1.7% to $1.18.
November 19, 2014
09:16 EDTMNKOn The Fly: Pre-market Movers
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07:01 EDTMNKMallinckrodt reports Q4 adjusted EPS $1.68, consensus $1.41
Reports Q4 revenue $789.3M, consensus $757.86M.
November 18, 2014
15:21 EDTMNKNotable companies reporting before tomorrow's open
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November 14, 2014
17:27 EDTMNKPaulson & Co. gives quarterly update on stakes
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09:51 EDTMNKMallinckrodt management to meet with Oppenheimer
Meeting to be held in Europe on November 20 hosted by Oppenheimer.
November 13, 2014
10:44 EDTMNKMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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08:20 EDTMNKMallinckrodt could be down $6-$8 on FDA reclassification, says UBS
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06:11 EDTMNKMallinckrodt responds to FDA expected reclassification of methylphenidate ER
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release, or ER, tablets, USP may not be therapeutically equivalent to the category reference drug Concerta. As a result, the agency indicated that it has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB to BX. The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014. Although the Draft Guidance has an open comment period through January 5, 2015, the agency nevertheless confirmed that this change would be reflected on November 13, 2014 in the on-line Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Mallinckrodt strongly believes its methylphenidate ER products are safe and effective when used in accordance with the approved labels. Mark Trudeau, president and CEO of Mallinckrodt stated, “We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients." Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug to the company’s methylphenidate ER products.

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