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- Read more about US FDA issues final guidance for selection of appropriate Package Type terms for labeling injectable medical products
US FDA has issued the final guidance for Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers1 for Human Use.
- Read more about ISPE GAMP RDI Guide: Data Integrity – Key Concepts Released
ISPE announced the release of their latest Guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts. This publication provides detailed practical guidance to support data integrity within a regulated organization.
- Read more about New global commitment to primary health care for all at Astana conference
Countries around the world today agreed to the Declaration of Astana, vowing to strengthen their primary health care systems as an essential step toward achieving universal health coverage.

The Declaration of Astana reaffirms the historic 1978 Declaration of Alma-Ata, the first time world leaders committed to primary health care.

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- Read more about FDA approves new drug to treat influenza
U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
- Read more about NIH selects first scholars in pioneering program to enhance diversity within in-house research program
Thirteen researchers have been selected for the inaugural class of the National Institutes of Health’s Distinguished Scholars Program (DSP). The NIH-wide pilot program is designed to build diversity within the NIH Intramural Research Program, comprised of NIH scientists, by facilitating hiring and career progression of tenure-track investigators who have demonstrated a commitment to promoting diversity and inclusion in the biomedical research workforce.
- Read more about FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status.
- Read more about FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.
- Read more about FDA Approved Valiant Navion(TM) Thoracic Stent Graft System
U.S. Food and Drug Administration (FDA) approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).
- Read more about FDA efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it’s critical that we continue to tackle this human tragedy from all fronts – including, and importantly, looking at new ways to increase the availability of naloxone.
- Read more about NITI Aayog launch Guidelines for Public Private Partnership for Non Communicable Diseases
NITI Aayog launched the Guidelines and Model Concessionaire Agreement, MCA for Public Private Partnership, PPP for Non Communicable Diseases. The documents have been designed to supplement efforts for provision of prevention and treatment services of non-communicable diseases related to Cardiac Sciences, Oncology, and Pulmonary Sciences at the district hospitals especially in tier 2 & 3 cities.