Pharma News

With millions of Americans misusing and abusing opioids and more than 40 people dying every day from overdoses involving prescription opioids, it’s clear that we need to do everything we can, including working with stakeholders, to get ahead of this crisis.
Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids. And too many prescriptions are written for longer durations of use than are appropriate for the medical need being addressed.

Onconova Therapeutics, Inc. a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS),  announced that its commercial partner, Pint Pharma GmbH, will assist in expanding access to clinical trials studying rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of MDS, to several selected sites across South America. Pint Pharma is a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market and has successfully participated in clinical trials for hematological cancers.

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In a strategic move, Cadila Healthcare Limited (CHL), a leading global healthcare provider announced that it will be acquiring 51% stake in Dehradun-based Windlas Healthcare Private Limited (WHPL).

Novartis announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor

When the good and bad bacteria in our mouth become imbalanced, the bad bacteria form a biofilm (aka plaque), which can cause cavities, and if left untreated over time, can lead to cardiovascular and other inflammatory diseases like diabetes and bacterial pneumonia.

U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).

As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.

Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses.

U.S. Food and Drug Administration approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs. Prime objective of the scheme is to develop the culture of documenting adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media. The Standing Finance Committee (SFC) chaired by Secretary (AYUSH) approved the scheme on 1st November, 2017 and thereafter it was rolled out for implementation in the country near the end of financial year 2017-18.

Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.