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Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

BioTime, Inc. today announced a $4 million equity financing by its subsidiary, Embryome Sciences, Inc. Concurrent with the financing, Embryome Sciences will be renamed ReCyte Therapeutics, Inc. and will develop therapeutic products for cardiovascular and blood diseases. The new equity financing is being led by a $2.5 million investment by private investors and a $1.5 million investment from BioTime that valued ReCyte Therapeutics at a post money valuation of $60 million on a fully diluted basis.

4 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

30 Dec 2010

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva® for patients with Non-Small Cell Lung Cancer (NSCLC).

30 Dec 2010

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

ZIOPHARM Oncology, Inc., announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.

29 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 Dec 2010

International reference standards for use of bone turnover markers in clinical studies recommended

An expert working group of the International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has released a new position paper which reviews the evidence of bone turnover markers (BTMs) in fracture risk prediction and monitoring of osteoporosis therapy. More importantly, it identifies research priorities and recommends that specific markers be used as reference analytes for BTMs in clinical and observational studies.

28 Dec 2010

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

Repros Therapeutics Inc. today announced it has completed two animal model studies of the use of Proellex® in a vaginally administered formulation that demonstrated effects on progesterone sensitive tissues equivalent to the highest oral dose formerly in development by the Company.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

Biglycan protein offers potential therapy for muscular dystrophy

A novel potential therapy based on a natural human protein significantly slows muscle damage and improves function in mice who have the same genetic mutation as boys with the most common form of muscular dystrophy, according to a paper published online Dec. 27 in the Proceedings of the National Academy of Sciences.

28 Dec 2010

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

24 Dec 2010

Alimera receives FDA CRL for ILUVIEN NDA

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

24 Dec 2010

MigreLief releases safe, proven effective supplement for children with migraines

MigreLief, the first name in migraine prevention, releases a safe and proven effective supplement for children of all ages: Children's MigreLief.

24 Dec 2010

Efficacy News and Research

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

FDA approves Endo's FORTESTA Gel for low testosterone

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

International reference standards for use of bone turnover markers in clinical studies recommended

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Biglycan protein offers potential therapy for muscular dystrophy

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Alimera receives FDA CRL for ILUVIEN NDA

MigreLief releases safe, proven effective supplement for children with migraines

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