Mylan Clarifies Certain Inaccuracies by Third Parties Related to Lowered Acceptance Condition to Acquire Perrigo
ERTFORDSHIRE, England and PITTSBURGH, Aug. 21, 2015 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) today clarified certain inaccuracies by third parties related to Mylan having lowered the acceptance condition in its offer to acquire Perrigo Company plc (NYSE: PRGO; TASE) from not less than 80% of Perrigo ordinary shares to greater than 50% of Perrigo ordinary shares. read more
Alkermes Provides Update on FDA Review of ARISTADA™ for the Treatment of Schizophrenia
DUBLIN–(EON: Enhanced Online News)–Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has advised Alkermes that it will not be able to complete its review of the New Drug Application (NDA) for ARISTADA™ (aripiprazole lauroxil) for the treatment of schizophrenia by the Prescription Drug User Fee Act (PDUFA) action date of Aug. 22, 2015. The FDA indicated that this delay was expected to be brief, measured in terms of weeks, but could not confirm specific timing. The FDA also indicated that no additional data or information is required from Alkermes at this time. read more
MicroPort Orthopedics Launches Profemur Preserve Hip Stem
ARLINGTON, Tenn.–(EON: Enhanced Online News)–MicroPort Orthopedics Inc. (“MicroPort Orthopedics”) announced today the launch of the Profemur® Preserve® Hip Stem (“Profemur® Preserve®”), a short stem designed to support today’s growing market of bone and tissue preserving surgical techniques. “As physicians evaluate the landscape of short stems, Profemur® Preserve® is attractively positioned to capture market share,” said Patrick Gregory, Hip Product Manager for MicroPort Orthopedics. Short stems have grown in popularity as physicians give additional consideration to tissue-friendly approaches and ongoing care for a younger patient population. Shorter stems preserve bone, which facilitates future revisions through a wider range of treatment options. read more
NW Bio Confirms Phase III Trial of DCVax®-L for GBM Brain Cancer Is Ongoing
U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, confirmed today that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. read more
HedgePath Pharmaceuticals Launches Clinical Trial for its Proposed Cancer Treatment
TAMPA, Fla. and SAN DIEGO, Aug. 21, 2015 /PRNewswire/ — HedgePath Pharmaceuticals, Inc. (OTCQB: HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today enrollment has commenced in its Phase II(b) SCORING (SUBA-Cap Objective Response in Gorlin’s) clinical trial. HPPI will study the efficacy and safety of twice-daily dosing of SUBA-Itraconazole Oral Capsules as a potential therapy for basal cell carcinoma (BCC) in patients with basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin’s Syndrome.
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