Pharma News

U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile.

Empowering meaningful digital health innovation for over a billion lives throughout India is the theme of the 2019 HITLAB Innovators Summit: India. The one-day event, sponsored by ANSYS, Praava Health, and Tech Care for All, will be held on February 16 at IIT Delhi, an Institute of Eminence. It brings together leaders and practitioners in life sciences, technology, academia, public health, medicine, investment, and design to leverage digital solutions and bring meaningful change to populations.

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The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.

On the illicit drugs front, worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs.

National Eye Institute scientists led a collaborative study and zeroed in on genes associated with age-related macular degeneration (AMD), a leading cause of vision loss and blindness among people age 65 and older. These findings provide a more expanded and in-depth picture of the genetic contributions to AMD, and they present new pathways for treatment development. The study was published Feb. 11 in Nature Genetics.

With five countries in Western Africa reporting outbreaks of Lassa fever, the World Health Organization (WHO) has scaled up its efforts to support the region’s response to the disease.

The World Health Organization and health partners are appealing for US$ 43.5 million to provide life-saving interventions for 388 000 people inside Libya affected by ongoing conflict.

The fourth Conference of AYUSH/Health Ministers of States/UTs was inaugurated by the Minister of State for AYUSH (Independent Charge) Shri Shripad Yesso Naik in New Delhi today. The day long conference was organized by the Ministry of AYUSH to provide an opportunity to States/UT to interact with each other for the development of AYUSH sector. The conference was attended by AYUSH/Health Ministers/Secretaries and officials from 29 States/UTs; senior officials of AYUSH Ministry and representatives of AYUSH organizations.

Hyperglycemia, or increased glucose, is common in patients with acute ischemic stroke and is associated with worse outcomes compared to normal glucose levels. Doctors all over the world have debated whether intensive glucose management, which requires the use of IV insulin to bring blood sugar levels down to 80-130 mg/dL, or standard glucose control using insulin shots, which aims to get glucose below 180 mg/dL, lead to better outcomes after stroke. Primary results from the Stroke Hyperglycemia Insulin Network Effort (SHINE) study, a large, multisite clinical study provide a clear answer to that question.

In a high powered meeting with senior officers of the Health Ministry, Ms Preeti Sudan, Secretary (HFW) reviewed the state of preparedness and action taken to deal with H1N1 influenza cases, here today. Additional Secretary (Health) Shri Sanjeeva Kumar, DCGI Dr S Reddy, Directors and Senior Officials from NCDC and representatives from EMR were also present in the meeting.