Pharma News

Acacia Pharma show Positive Pivotal Phase 3 Trial result of BAREMSIS

  • Posted on: 16 August 2016
  • By: Shalini.Sharma

Acacia Pharma show Positive Pivotal Phase 3 Trial result of BAREMSIS
Acacia Pharma Group plc, the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (“PONV”).


Drug response influence by Intestinal microbes

  • Posted on: 13 August 2016
  • By: PharmaTutor News

Intestinal flora has multiple influences on human health, but researchers have revealed that it is also likely to have an effect on the body's response to drugs. Recent research from Kumamoto University in Japan strongly suggests that changes in the intestinal flora, caused by antibacterial and antibiotic drugs or individual differences between people, may have an effect on a person's response to drugs including side effects. The research focused on the changes in proteins due to the condition of intestinal flora that affect the response to drugs in the liver and kidneys.


Proteins responsible for Zika's microcephaly discovered

  • Posted on: 13 August 2016
  • By: PharmaTutor News

USC researchers have tracked down two Zika proteins potentially responsible for thousands of microcephaly cases in Brazil and elsewhere -- taking one small step toward preventing Zika-infected mothers from birthing babies with abnormally small heads.


Coodination treatment require for TB & HIV

  • Posted on: 13 August 2016
  • By: PharmaTutor News

Tuberculosis (TB) is a leading killer of people with HIV, and providing therapy for both illnesses simultaneously saves lives - according to new guidelines on the treatment of drug-susceptible TB developed jointly by the American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC) and Infectious Diseases Society of America (IDSA). Treatment of TB in the presence of HIV infection is one of several special situations addressed in the new guidelines, published today in the journal Clinical Infectious Diseases.


Advaxis’s Phase 2 Head and Neck Cancer Study of AXAL Advances to Second Stage

  • Posted on: 12 August 2016
  • By: Shalini.Sharma

Advaxis, Inc. announced that its Phase 2 “window of opportunity” clinical study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC) met its stage 1 primary objective and is advancing into the second stage of the clinical study.


Mallinckrodt acquire Stratatech Corporation, regenerative medicine company

  • Posted on: 12 August 2016
  • By: Shalini.Sharma

Mallinckrodt plc, a leading global specialty pharmaceutical company, announced that it has entered into a merger agreement with Stratatech Corporation, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. Financial terms of the transaction were not disclosed.


SANUWAVE Health Submits de novo Petition for FDA Review and Classification of the dermaPACE System

  • Posted on: 12 August 2016
  • By: Shalini.Sharma

SANUWAVE Health, Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device. Through the course of two trials, 336 patients were randomized in double-blind, parallel group, sham controlled, multicenter, 24-week pivotal clinical trials that were designed to quantify the safety and effectiveness of the noninvasive procedures with the dermaPACE System (dermaPACE®).


Lilly gets DMC recommendation to continue MONARCH 2 phase 3 trial of abemaciclib without modification

  • Posted on: 11 August 2016
  • By: Shalini.Sharma

Eli Lilly and Company announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, phase 3 trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.


Proteostasis Therapeutics complete preclinical milestone in Astellas collaboration

  • Posted on: 11 August 2016
  • By: Shalini.Sharma

Proteostasis Therapeutics, Inc., a clinical stage biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing, announced that it has successfully completed a key preclinical milestone in its collaboration with Astellas Pharma Inc. (Astellas). The milestone, which triggered an undisclosed payment from Astellas, demonstrated that selective modulation of the Unfolded Protein Response (UPR) pathway in vitro is potentially an effective disease-modifying approach in the treatment of multiple diseases with few or no therapies currently available.


Pages