Pharma News

Since the biosimilar pathway was established in 2010, there’s been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance. Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition.

Eighty-six percent of individuals who entered HIV care soon after diagnosis maintained viral suppression after 48 weeks during a clinical trial conducted at four National Institutes of Health-funded Centers for AIDS Research (CFARs) across the United States. Participants in the clinical trial, called iENGAGE, achieved viral suppression in an average of just 63 days. The findings were presented in a poster at the Conference on Retroviruses and Opportunistic Infections(link is external) (CROI 2019) in Seattle.

Among people with HIV in Latin America, those diagnosed with tuberculosis (TB) at an initial clinic visit were about twice as likely to die within 10 years as people not initially diagnosed with TB, according to findings from a large observational study.

New HIV infections declined by 30 percent in southern African communities where health workers conducted house-to-house voluntary HIV testing, referred people who tested positive to begin HIV treatment according to local guidelines, and offered other proven HIV prevention measures to those who tested negative. Local guidelines evolved during the study from offering HIV treatment based on immune health to offering immediate treatment for all.

New findings from a large, randomized clinical trial that compared two infection control techniques are already being incorporated into practice within the network of U.S. community hospitals where the trial took place.

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus.

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisationin the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.

The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for the treatment of the familial chylomicronaemia syndrome (FCS).

U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

Cancer is one of the leading causes of adult illness and death due to chronic non-communicable diseases in India.   India is witnessing a steady rise in cancer incidence.  The number of incident-cases has risen from 8 lakh in 2004 to an estimated 15 lakh (annually) by 2018.  Even with nearly two third of patients eventually dying of this disease, an estimated 22.5 lakh patients are currently living with cancer in India.