Pharma News

Bristol Myers Squibb announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. Findings of the open-label switch period showed that early seropositive RA patients treated with Orencia demonstrated substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab. In seropositive patients switching from adalimumab to Orencia, the efficacy responses generally increased over the open-label period to week 48. These results are featured in a poster presentation at the European E-Congress of Rheumatology (EULAR) 2020.

The fight against Chikungunya disease has got a major boost with CEPI, the global Coalition for Epidemic Preparedness Innovations, and its Indian arm Ind-CEPI, announcing a new partnering agreement with a consortium comprising Hyderabad-based Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to promote the development of a vaccine against the disease.

Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies announced a clinical strategy to treat patients with moderate to severe COVID-19 who require hospitalization. ATR-002, an oral small molecule, has been proven in preclinical trials to block viral propagation of SARS-CoV-2 and to have an immunomodulatory effect leading to a decreased cytokine and chemokine release. This dual benefit makes the MEK-inhibitor ATR-002 particularly relevant for the treatment of COVID-19.

Roche announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.

The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network. EMA, together with EU Member States and the European Commission, has published a PDF iconplan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic.

Sun Pharmaceutical Industries Ltd and includes its subsidiaries and/or associate companies) has announced that it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in Covid-19 patients. Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC).

Eminence Business Media  organized the Pharma GMP, GCP & Quality Management Webinar on  May 14th-15th, 2020.

Patients with a vascular condition called abdominal aortic aneurysm did not benefit from taking the common antibiotic doxycycline for two years to shrink the aneurysm when compared to those who took a placebo, according to a Vanderbilt University Medical Center (VUMC) study published in the Journal of the American Medical Association (JAMA).