Posts Tagged: "Food and Drug Administration"

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one for Allergan, which saw its overall revenues increase by 48 percent when compared to 2015’s first quarter; revenue for Allergan’s branded pharmaceutical divisions grew by 71 percent year-over-year. The company’s infectious disease division was not its most profitable and yet it saw the greatest amount of growth compared to the previous year. Teflaro entered the Allergan portfolio thanks to a series of acquisitions in the biopharma realm over the past few years. The pediatric anti-infective was first developed by Forest Laboratories, formerly of New York City, which was acquired by Actavis in February 2014 for a combination of cash and equity which reached a reported $25 billion.

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated that a mere one in eight (11.8%) of all drugs that enter clinical trials are ultimately approved by the U.S. Food and Drug Administration. The drug development gamble appears to be getting riskier. A report released on May 25th by the Biotechnology Innovation Organization (BIO), the biotechnology industry’s national trade group, finds that fewer than one in ten (9.6%) of drugs that enter clinical trials will gain approval by the U.S. Food and Drug Administration.

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.

The 2016 inductee class for the National Inventors Hall of Fame includes two microbiologists whose contributions to the field of food safety have helped to keep many foodborne pathogens, especially Salmonella, in check: John H. Silliker and Welton I. Taylor. These two scientists worked together to develop more effective monitoring techniques for food products in response to the growing concerns in the mid-20th century regarding Salmonella outbreaks, especially those which hit children the hardest. With the anniversaries for important patents issued to both of these food safety engineers having passed in early March, we thought we’d visit their scientific contributions from in our Evolution of Technology series here on IPWatchdog.

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food and Drug Administration (FDA). The bill would have allowed anyone in compliance with FDA requirements “to manufacture, distribute, or sell an approved medicine.” The bill says it would have continued to spur innovation by establishing a fund for medical innovation prizes. It would have required the Board of Trustees for the newly created Fund to award prize payments of unspecified amounts for medical innovations relating to a drug, biological product, or manufacturing process. In order to be an eligible award recipient one would have to be the first person to receive market clearance or be the holder of an issued patent.

Twitter’s popularity has not only benefited the legitimate side of the pharmaceutical industry. A study released in December, supported by both the Global Health Policy Institute and the Alliance for Safe Online Pharmacies, found an empirical link between all Twitter content and content aimed at the illicit drug sales. A survey of two week’s worth of posts shared on Twitter, involving the analysis of more than two million tweets, turned up 45,000 tweets which encouraged drug abuse. The survey found that more than three-quarters of tweets both pertaining to the non-medical use of prescription medications and including a hyperlink to a sales affiliate related to the anti-anxiety drug Valium.

It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. Bouyed by success in earlier rounds of FDA testing, Aimmune Therapeutics, Inc. (NADSAQ: AIMT) announced earlier today that it has enrolled the first patient in the pivotal Phase 3 PALISADE trial of its lead product candidate, AR101 for the treatment of peanut allergy. Previously, the Food and Drug Administration (FDA) has granted AR101 Breakthrough Therapy Designation status, and in September 2014 the FDA gave AR101 fast track designation even before Phase 2 clinical data was available.

The Internet of Things has been lauded as a potential boon for crop production, including pest control. Automated IoT pest control systems have been developed by Spensa of West Lafayette, IN. Its Z-Trap unit is specifically designed for apple orchards to detect the levels of codling moths, one of the more common North American pests for apple trees. Z-Traps can be monitored remotely from a computer, Android or iPhone. This technology is also being developed to detect for Oriental fruit flies and obliquebanded leafrollers. Pest monitoring systems like this enable farmers to more effectively apply pesticides and hopefully reduce the amount of pesticide used on plants.

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with headquarters in New York City and Switzerland. Shortly after acquiring Daraprim, Turing CEO Martin Shkreli raised its price by more than 5,000 percent, from $13.50 per pill up to $750 per pill for a medication that’s not usually prescribed by itself; it’s typically part of a larger regimen for AIDS and cancer patients. As the result of public outcry, Shkreli announced several days ago that the price would drop from $750 a pill to some unspecified level. He pointed out that at $13.50 a pill the drug was not profitable to sell. Still, the damage has been done to an industry everyone loves to hate because drug prices in the U.S. are perceived to be outrageously high already.

Hybrigenics (ALHYG), a French bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to inecalcitol for the treatment of acute myeloid leukemia (AML) in the United States. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation allows the company receiving the designation to leverage a wide range of financial and regulatory benefits, including government and institutional grants, and waiver of FDA user fees for the potential submission of a New Drug Application.