Pharma News

Unichem Laboratories to appeal the decision of European Commission

  • Posted on: 10 July 2014
  • By: PharmaTutor News

(10th July, 2014); On 9th July 2014, the European Commission (the EU’s top competition regulator) decided to impose a wholly unjustified fine on Niche /Unichem (jointly and severally) contending that it had acted in breach of EU Antitrust Rules. The European Commission reached this conclusion because its subsidiary, Niche Generics Ltd (Niche), agreed to settle financially crippling patent litigation with Laboratories Servier (Servier) at the beginning of 2005.

Celgene Reports Results from the Phase III POSTURE Study Evaluating Oral OTEZLA® in Ankylosing Spondylitis

  • Posted on: 10 July 2014
  • By: PharmaTutor News

(Business Wire India; 10th July, 2014); Celgene Corporation (NASDAQ:CELG) announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing.

Deliberations and recommendations made by the Apex Committee for supervising clinical trials

  • Posted on: 9 July 2014
  • By: PharmaTutor News

(9th July, 2014); The meeting of the apex committee held on 17-06-2014 under the chairmanship secretary  of health and family welfare for supervising clinical trials (CTs) on new chemical entities in the light of directions of the honorable supreme court of India dated 03.01.2013

Four new vaccines introduced by government to boost health & reduce mortality rates

  • Posted on: 3 July 2014
  • By: PharmaTutor News

(3rd July, 2014); Four new vaccines are introduced as part of India’s Universal Immunization Programme (UIP), announced by Shri Narendra Modi, Prime Minister of India. Vaccines against rotavirus, rubella and polio (injectable) will collectively expedite India’s progress on meeting the Millennium Development Goal 4 targets to reduce child mortality by two-thirds by the year 2015 and meet global polio eradication targets. In addition, an adult vaccine against Japanese encephalitis will be introduced in districts with high levels of the disease.

Type 2 Diabetes: Jardiance® (empagliflozin) as an add-on therapy significantly reduced blood glucose and body weight in two newly presented Phase III trials

(20th June, 2014); Boehringer Ingelheim and Eli Lilly and Company presented results of two Phase III clinical trials studying the efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in adults with Type 2 Diabetes (T2D) at the American Diabetes Association's 74th Scientific Sessions®. Results showed that empagliflozin in combination with certain other diabetes therapies reduced blood glucose, body weight and blood pressure.