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Stock Market & Financial Investment News

News Breaks
April 30, 2014
09:03 EDTMNKMallinckrodt to present new data for Xartemis XR, Pennsaid 2%
Mallinckrodt will present new data for two of its recently approved pain medications – XARTEMIS XR Extended-Release Tablets and PENNSAID 2% – during the 33rd Annual Scientific Meeting of the American Pain Society to be held April 30 - May 3, 2014 in Tampa, Florida. XARTEMIS XR is an oral medication indicated for the management of acute pain severe enough to require opioid treatment in patients for whom alternative treatment options are ineffective, not tolerated or would otherwise be inadequate. It is the first and only oxycodone HCI/acetaminophen combination for acute pain with immediate- and extended-release analgesia, providing fast-acting and long-lasting pain relief with 12-hour dosing for patients. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for the treatment of the pain of osteoarthritis of the knee(s). The data to be presented on XARTEMIS XR evaluates pharmacokinetics in different populations, as well as pooled safety data from Phase III trials. The first presentation of pivotal efficacy and safety results for PENNSAID 2% in the treatment of pain for osteoarthritis of the knee will also be presented, as well as an assessment of pharmacokinetics and tolerability compared with the 1.5% PENNSAID formulation.
News For MNK 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 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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