Pharma News

Sun Pharmaceutical Industries Sales / Income from operations at Rs. 7,657 crores, growth of 16% over same quarter last year. India sales at Rs. 2,235 crores, growth of 7%. It reported financials for the third quarter & nine month ending December 31st, 2018.

In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients.

The U.S. Food and Drug Administration  permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.

The first large-scale clinical trial to study liver transplantation between people with HIV has begun at clinical centers across the United States. The HOPE in Action Multicenter Liver Study will determine the safety of this practice by evaluating liver recipients for potential transplant-related and HIV-related complications following surgery. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and follows the 2018 launch of a similar study evaluating kidney transplantation between people with HIV.

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.