Pharma News

The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce. This action follows inspections conducted by the FDA and Texas Department of State Health Services (DSHS) earlier this year where serious sanitation issues were observed, including several samples confirming the presence of Listeria and pathogenic Listeria monocytogenes (L. monocytogenes).

U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

Researchers have found that Dulaglutide, a commonly used drug for Type 2 diabetes, can be effective against cardiovascular and kidney diseases too. A clinical trial that followed more than 9,900 persons in 24 countries found that the drug reduced cardiovascular events and kidney problems in middle-aged and older people.

InvaGen Pharmaceuticals, Inc. a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency. Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, safe and effective medicines to patients. At the same time, EMA recognises the importance of guaranteeing the independence of the medicine assessment which takes place at a later stage.

The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Tuberculosis infection results in approximately nine million new cases worldwide every year. TB - causing bacterium can remain dormant in human body for a long time, even for several decades before it becomes infectious. The bacterium remains ensconced within a type of white blood cells called macrophages, when it is in its latent form.

Diabetes - increase in blood glucose levels - is an emerging health problem especially in developing countries. According to the World Health Organisation, India had 69 million diabetic individuals in 2015 and the number is projected to go up to 98 million by 2030. The problem is more serious for Asians as their genetic makeup puts them at a greater risk of diabetes at a younger age than their European counterparts.

Packaging is no longer a reference to a box or a carton, but rather to a coordinated system of preparing goods for safe, cost-effective, and efficient movement throughout the whole supply chain that eventually leads to maximizing consumer value, sales, and hence profits. The ever-evolving global pharmaceutical packaging industry holds a market size of around $95 - $97 billion. This market is expected to witness a notable growth with a healthy CAGR of 6% to 7% in the coming years, owing to the increased R&D, new innovations in packaging materials, growth in generic market & rise in the trend of contract packaging. The brand matters and the companies need to protect it. They have worked hard to build the customers trust and loyalty. This industry is in a constant battle against counterfeiting & is thriving hard towards its Brand Protection.