Shares of Soligenix Inc. (SNGX.OB) soared over 18% to $0.71 on Friday after the company won clearance from the FDA to initiate a program evaluating OrbeShield as a therapy for gastrointestinal acute radiation syndrome.
According to the company, the development program will include safety and efficacy evaluations conducted in appropriate preclinical models as well as a phase 1/2 pharmacokinetic/pharmacodynamic study of OrbeShield in healthy adolescents and young adults.
Regeneron Pharmaceuticals Inc. (REGN) recommends shareholders to reject an unsolicited "mini-tender" offer by TRC Capital Corp. which values the company's stock price at $161.25 per share.
TRC Capital has offered to purchase up to 1 million shares, or approximately 1.06%, of the outstanding Regeneron common stock. TRC's offer price represents about 4.46% discount to the closing price of Regeneron common stock on December 27, 2012, the last closing price prior to commencement of the offer, and a 10.77% discount to the closing price of Regeneron common stock on January 3, 2013.
Herbalife Ltd. (HLF) announced Friday that it has completed the acquisition of a manufacturing facility in Winston-Salem, North Carolina.
The company expects to invest over $100 million on machinery & technology, as well as a complete retro-fitting of the existing facility, over the next two years. Production in this facility is expected to begin as early as June 2014, and approximately 500 new jobs will be created by the time it reaches full operations, says the company.
Durata Therapeutics Inc.'s (DRTX) phase III study of Dalbavancin, dubbed DISCOVER 1, for the treatment of acute bacterial skin and skin structure infections has achieved clinical success at the end of treatment as well.
The preliminary top-line data from the DISCOVER 1 study reported last month showed that Dalbavancin achieved its primary endpoint of non-inferiority to Vancomycin at 48-72 hours after initiation of therapy.
Preliminary top-line results from another phase III study of Dalbavancin for acute bacterial skin and skin structure infections, dubbed DISCOVER 2, are anticipated this quarter.
The company expects to seek approval for Dalbavancin in the U.S. in mid-2013 and in the EU at the end of 2013.
ADVENTRX Pharmaceuticals Inc. (ANX) has appointed Brandi L. Roberts as Chief Financial Officer and Senior Vice President, effective January 2, 2013. She had served as the company's vice president, finance since March 2011. The company is all set to initiate a phase III study of ANX-188 for the treatment for sickle cell patients experiencing vaso-occlusive crisis.
Impax Laboratories Inc. (IPXL) has launched Oxymorphone Hydrochloride Extended-Release Tablets, through its generics division, Global Pharmaceuticals.
Oxymorphone Hydrochloride Extended-Release Tablet is therapeutically equivalent to the original formulation of Endo Pharmaceuticals and Penwest Pharmaceuticals (collectively known as Endo) OPANA ER.
The product is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
IGI Laboratories Inc. (IG), a New Jersey based generic topical pharmaceutical company, announced it filed two abbreviated new drug applications, or ANDAs, last year-end. The company expects to file six ANDAs in 2013.
Biogen Idec (BIIB) announced Friday that it recently submitted a Biologics License Application to the FDA for approval of recombinant factor IX Fc fusion protein for the treatment of hemophilia B. The regulatory submission was based on results from B-LONG, the largest registrational phase III clinical study in hemophilia B to date.
The company is also on track to file BLA for rFVIIIFc for use in patients with hemophilia A in the first half of this year.
On Jan.3, the company pulled the plug on its phase III study investigating Dexpramipexole in people with Amyotrophic Lateral Sclerosis as it failed to demonstrate efficacy in primary and key secondary endpoints.
by RTT Staff Writer
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