Pacira Pharmaceuticals Announces Favorable Resolution With U.S. Food and Drug Administration, Which Reaffirms the Broad Indication for EXPAREL®

-- Terms Include Labeling Changes to Reinforce that the Use of EXPAREL is not Limited to Pivotal Trial Surgical Models, and Formal FDA Rescission of 2014 Warning Letter –

-- Conference Call Today at 8:30 am EST –

PARSIPPANY, N.J., Dec. 15, 2015 -- Pacira Pharmaceuticals, Inc. (PCRX) today announced that it has achieved an amicable resolution with the United States in its lawsuit filed on September 8, 2015, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015)(LAK).  The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia. 

TherapeuticsMD Announces Positive Top-Line Results from its Phase 3 Rejoice Trial in Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) Treated with 25 mcg, 10 mcg or 4 mcg of TX-004HR

Conference Call Scheduled for Today at 4:45 p.m. ET to Discuss Results

BOCA RATON, Fla.-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced positive top-line results from its pivotal Phase 3 Rejoice Trial of TX-004HR, an investigational, applicator-free vaginal estradiol softgel, for the treatment of moderate to severe dyspareunia (vaginal pain during sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. VVA is a chronic condition affecting nearly half of postmenopausal women in the United States that can significantly impair their quality of life.

Oramed Signs up to $50 Million Licensing and Investment Agreements for Oral Insulin Capsule in China

Receiving up to $38,000,000 + royalties for licensing deal and $12,000,000 for equity investment at $10.39 per share

JERUSALEM, Nov. 30, 2015 -- Oramed Pharmaceuticals Inc. (ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. ("HTIT") for exclusive rights to market Oramed's oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

SciClone Reports Third Quarter 2015 Financial Results

Overall Performance Continues to Outpace China Pharmaceuticals Market Growth Rate;
Non-GAAP EPS Guidance for 2015 Revised Upward

FOSTER CITY, Calif., Nov. 9, 2015 -- SciClone Pharmaceuticals, Inc. (SCLN) today reported financial results for the quarter ended September 30, 2015.

• Revenues: In the third quarter of 2015, SciClone reported revenues of $42.9 million, compared to $34.3 million for the same period in 2014. 
• GAAP Diluted EPS: In the third quarter of 2015, SciClone reported a GAAP diluted earnings per share of $0.23, compared to $0.15 for the same period in 2014.
• Non-GAAP Diluted EPS: In the third quarter of 2015, SciClone reported non-GAAP diluted earnings per share of $0.26, compared to $0.17 for the same period in 2014.

  Published: 10 November 2015

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