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ORMP Talks It Out, CLDX On High, MRK Settles Suit, UTHR Gets Another Chance


Oramed Pharmaceuticals Inc. (ORMP) announced Thursday that it now has a clear path to move forward with its Investigational New Drug Application for oral insulin, thanks to FDA's guidance. The company has been asked to perform a sub study in a controlled in-patient setting for up to a one-week period before it begins the clinical trial.

ORMP closed Thursday's trading at $8.90, down 3.68.

Celldex Therapeutics Inc. (CLDX) touched a new 52-week high of $8.41 on Thursday before closing at $8.19 after the company announced that phase I study results of CDX-301 (recombinant human Flt3L; rhuFlt3L) in healthy volunteers strongly support the initiation of a pilot study in hematopoietic stem cell transplantation later this year.

La Jolla Pharmaceutical Co. (LJPC) has received additional notice of allowance for patent covering its lead product candidate, GCS-100. The company noted that the newly issued patent expands its protection of modified pectin solutions.

LJPC closed Thursday's trading 1.96% higher at $0.08.

Merck & Co. Inc. (MRK) on Thursday announced it has resolved the securities class-action lawsuits related to the delay in announcing the trial results of its cholesterol drug Vytorin. The trial, dubbed ENHANCE, was completed in 2006, but the results were revealed only in 2008.

Under the proposed agreement, Merck will pay $215 million to resolve the securities class action against all the Merck defendants and $473 million to resolve the securities class action against all of the Schering-Plough defendants.

Merck noted that it has recorded a pre-tax and after-tax charge of $493 million as a result of which its previously reported Q4 and full-year 2012 GAAP EPS results are reduced.

Bristol-Myers Squibb Co. (BMY) Thursday announced that Ann Powell Judge will be taking charge as senior vice president, Human Resources, in March. Prior to joining Bristol-Myers Squibb, Judge was chief human resources officer at Shire Pharmaceuticals.

DARA BioSciences Inc. (DARA) has regained compliance with NASDAQ's minimum bid price rule.

The stock closed Thursday's trading at $1.15, up 10.59.

Santarus Inc. (SNTS) on Thursday launched UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis in the U.S. The drug, developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A, was approved by FDA on January 14, 2013.

Upon first commercial sale of UCERIS, $7 million is payable to Cosmo in cash or Santarus common stock, at Cosmo's option.

United Therapeutics Corp.'s (UTHR) resubmitted new drug application for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension has been accepted by the FDA as a complete, class 1 response. The FDA's decision is now set for March 31, 2013.

UTHR closed Thursday's trading 4.26% higher at $56.10.

by RTTNews Staff Writer

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