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Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

The National Cancer Institute has awarded Albert Einstein College of Medicine of Yeshiva University $4.1 million to test the microbicide Carraguard- against the human papillomavirus, which causes cervical cancer. The research will evaluate the efficacy of Carraguard- - a clear gel made from the seaweed derivative carrageenan - in preventing new HPV infections in women.

26 Jul 2010

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

XenoPort, Inc. announced today that it has discovered a novel prodrug that has the potential to improve significantly the blood concentration of acamprosate compared with the currently approved formulation of acamprosate. Preclinical data on this new product candidate will be presented tomorrow at the National Fragile X Foundation's 12th International Fragile X Conference in Detroit, Michigan.

23 Jul 2010

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Emisphere Technologies, Inc. today announced that Novartis Pharma AG and its license partner Nordic Bioscience a/s have reported the following in connection with their Phase III Study 2302 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.

23 Jul 2010

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Unigene Laboratories, Inc. announced today that Novartis and its license partner Nordic Bioscience have decided to continue the companies' two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee. Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented SecraPep® E. coli manufacturing technology.

23 Jul 2010

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Inhibitex, Inc. today announced that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue to completion without modification.

23 Jul 2010

Human Genome Sciences second-quarter revenues increase to $38.8 million

Human Genome Sciences, Inc. today announced financial results for the quarter ended June 30, 2010, and provided highlights of recent key developments.

23 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Baxter second-quarter global sales increase 2% to $3.2 billion

Baxter International Inc. today announced its financial results for the second quarter of 2010, reporting earnings in line with the company's previously issued guidance of $0.90 to $0.93 per diluted share.

From Baxter International Inc. 22 Jul 2010

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

22 Jul 2010

Repros granted IRB approval to commence low dose Proellex study

Repros Therapeutics Inc. today announced it has received IRB approval to commence the low dose Proellex® study. The contract for clinical services was previously awarded to ICON. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion. The study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg being the first dose tested. In previous studies a 12.5 mg dose was well tolerated and yielded statistically significant efficacy signals for both uterine fibroids and endometriosis.

22 Jul 2010

Euthymics Bioscience completes $24 million Series A financing

Euthymics Bioscience, Inc., a clinical-stage company developing next-generation antidepressants, today announced the completion of a Series A financing -- led by Novartis Venture Funds and Venture Investors - for a total investment commitment of $24 million in milestone-conditioned tranches. Hambrecht & Quist Capital Management, LLC, GBS Venture Partners and the State of Wisconsin Investment Board also participated in the financing.

22 Jul 2010

Predator-released chemicals function as warning signals for egg-laying mosquitoes

A scientific breakthrough might assist in the fight against mosquitoes. New research carried out at the University of Haifa in collaboration with researchers from other universities has chemically identified, for the first time, compounds released by mosquitoes' natural aquatic predators that function as warning signals for egg laying mosquitoes. Introducing these natural chemicals into mosquito breeding sites will cause the mosquitoes to sense risk of predation to their progeny and avoid laying their eggs there.

22 Jul 2010

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.

22 Jul 2010

Elan total revenue increases 10% to $579.4 million for first half of 2010

Elan Corporation, plc today reported its second quarter and first half 2010 financial results.

22 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010

Efficacy News and Research

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Human Genome Sciences second-quarter revenues increase to $38.8 million

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Baxter second-quarter global sales increase 2% to $3.2 billion

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Repros granted IRB approval to commence low dose Proellex study

Euthymics Bioscience completes $24 million Series A financing

Predator-released chemicals function as warning signals for egg-laying mosquitoes

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Elan total revenue increases 10% to $579.4 million for first half of 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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