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Brief View of the Latest Healthcare Industry_Issue6

Mar - Apr, 2015


New compound may lead to development of cheaper anti-cancer drugs

A new compound developed at the University of Toronto Scarborough could play an important role in developing cheaper anti-cancer drugs. Professor Bernie Kraatz, chair of the Department of Physical and Environmental Sciences at U of T Scarborough, has developed a new compound that can be used to monitor the biochemical processes involved with a group of enzymes called protein kinases. The prevailing form of monitoring kinase activity involves the use of radioactive isotopes, which is costly because the isotopes are expensive to use and have a short shelf life. They are also difficult to work with because of the regulations associated with their handling and disposal.


Synthetic biology breakthrough leads to cheaper statin production

University of Manchester researchers, together with industrial partner DSM, have developed a single-step fermentative method for the production of leading cholesterol-lowering drug, pravastatin, which will facilitate industrial-scale statin drug production. In a study published in Proceedings of the National Academy of Sciences, the researchers have devised a single-step fermentative method for the industrial production of the active drug pravastatin that previously involved a costly dual-step fermentation and biotransformation process.


FDA approves first biosimilar product Zarxio

The U.S Food and Drug Administration have approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:-patients with cancer receiving myelosuppressive chemotherapy;-patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;-patients with cancer undergoing bone marrow transplantation;-patients undergoing autologous peripheral blood progenitor cell collection and therapy; and-patients with severe chronic neutropenia.


Alcohol disrupts body’s sleep regulator

Around 20% of adult Americans use alcohol-known to be a powerful sleep inducer to help them fall asleep. However, new research shows that while alcohol may bring on sleepiness, it can disrupt sleep and, over time, cause insomnia by interfering with the body’s system for regulating sleep.


FDA involved in case after approving psych meds that cause boys to grow breasts

It’s not often the FDA gets sued for anything, but a powerful Philadelphia legal firm that handles whistleblower and class action cases throughout the nation, Sheller, P.C., has petitioned the Federal Court to demand the FDA follow through with black box warnings for Johnson & Johnson’s drug Risperdal or remove its pediatric approval. The FDA had ignored Sheller’s requests to allow the legal firm to release documents held by drug company Johnson & Johnson and its subsidiary Janssen that would prove the necessity of withdrawing the FDA’s 2006 approval of Risperdal for pediatric prescriptions or at least demand black box warnings. By November 2014, the FDA simply denied all legal actions from Sheller and dismissed their motions to proceed toward a black box warning or remove the drug’s pediatric prescription classification. So, Sheller has filed a suit which would insist that a federal judge issue an injunction to the FDA for either issuing a black box warning or removing the drugs from pediatric use. The law under which Sheller is suing the FDA is the Administrative Procedures Act (APA). According to “The APA serves to police improper agency behavior, protect public safety, and secure proper entitlements. The APA governs all three main agency functions: rulemakings, adjudications, and licensing."


Remsima (infliximab) accepted for restricted use in NHS Scotland by the Scottish Medicines Consortium

Patients in Scotland suffering from inflammatory conditions including rheumatoid arthritis (RA), Crohn’s Disease (CD), ulcerative colitis (UC), and psoriasis will now have access to a new wave of biological medicines. Remsima (infliximab) is a new biosimilar medicine which has the potential to bring significant savings to the NHS without compromising patient care. Patient access follows a review of Remsima by the SMC, which has accepted Remsima for restricted use in line with SMC and Health Improvement Scotland (HIS) advice for the originator medicine Remicade (infliximab), in RA, UC (adults and pediatric), CD (adults and pediatric), psoriasis and psoriatic arthritis.


New test uses human stem cells to identify dangerous side effects of drugs

Scientists at Imperial College London have developed a test that uses combinations of cells from a single donor’s blood to predict whether a new drug will cause a severe immune reaction in humans. The test could avert disasters like the 2006 trial of the drug TGN1412, which led to six healthy young men being admitted to intensive care with multiple organ failure. The volunteers receiving TGN1412 experienced a catastrophic inflammatory reaction called a cytokine storm.


New Rules Are Issued for Testing of Medical Devices

FDA has released a new guideline for testing procedures of reusable medical devices. It issued the new requirements in the wake of news that two people in a Los Angeles hospital had died from a deadly bacteria traced to medical scopes. The changes will apply to new devices that the FDA approves, not the ones on the market that have led to the infections. The FDA has said it received 75 reports from January 2013 to December 2014 of bacterial infections across the country believed to be linked to duodenoscopes. See the new guideline:


#BeCrueltyFree South Korea campaign welcomes cosmetics bill requiring mandatory use of alternatives, but loopholes must be closed

Humane Society International’s #BeCrueltyFree South Korean campaign joined Congresswoman Moon Jeong-Lim and officials on 11 March at the National Assembly to witness the launch of a Korean bill that marks an initial milestone towards ending animal testing of cosmetics in the country. The #BeCrueltyFree campaign has been working with the Congresswoman over the past two years, including discussions last week regarding bill language. Most recently, the campaigners also held a public event with TV star Sam Hammington and LUSH cosmetics to call for the bill to be an effective ban on cosmetics cruelty


Teva to Buy Auspex, an American Drug Developer, for $3.2 Billion

Teva Pharmaceutical had agreed to acquire Auspex Pharmaceuticals, a developer of drugs that treat people with movement disorders, for about $3.2 billion in cash. Teva will pay $101 a share for Auspex. Including debt, the deal is worth $3.5 billion, and the boards of both companies have approved it



More research needed on use of 'smart drugs' by healthy people

Researchers have called for the pharmaceutical industry, governments and medical organizations to work together to investigate the consequences of long-term use of cognitive-enhancing drugs by healthy individuals.


FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids

The U.S Food and Drug Administration has issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however, opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop, abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse. *


Amphetamine-like stimulant remains in dietary supplements 2 years after FDA discovery

The 2014 study from the Food and Drug Administration (FDA), published in the Journal of Pharmaceutical and Biomedical Analysis, revealed that nine of the tested 21 dietary supplements marketed for weight loss, improved cognitive function or enhanced athletic performance containing a plant extract called Acacia rigidula also contained beta-methylphenylethylamine (BMPEA). BMPEA is a synthetic compound closely related to amphetamine. Though the safety of the substance has not been tested in humans, studies in cats and dogs have shown it to increase blood pressure and heart rate conditions known to raise the risk of heart attack and stroke in humans. But despite the FDA’s findings, it seems the organization has taken no action to enforce the removal of BMPEA from dietary supplements or warn consumers about the potential risks. * J Pharm Biomed Anal. 2014 Jan; 88:457-66. doi: 10.1016/j.jpba.2013.09.12 Epub 2013 Oct 5.


Making food more 'porous' could reduce its salt content

Scientists from the University of Illinois have found that manipulating the porosity of food during manufacturing can affect its health benefits. Much of the salt that is added to food for flavoring is not released into our mouths, which means that a lot of salt content is wasted. The Illinois researchers wanted to see if they could release more salt during chewing. The implications of this would be no difference in terms of taste to the consumer, but food manufacturers would not have to add as much salt as before. They attempted to do this by targeting a certain fat-protein emulsion structure to increase the porosity of the food. When the porosity of the food was increased, the researchers found that the foods broke apart differently when chewed, which exposed more surface area and increased the saltiness.


3D printing may make individualized medicine more affordable

The market for mass beauty products in Western Europe had slowed in the early part of the year but was still growing moderately in North America as it posted a 14.1 percent rise in first-quarter sales according to L’Oréal. Looking forward, L’Oréal forecast sales growth in the first quarter would be below its average for the year due to an improvement in demand for mass market consumer beauty products later in the year.


FDA: Medtronic Must Stop Most Sales of Synchromed Drug Pumps

The Food and Drug Administration says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems. The FDA has filed a court order against Medtronic that says the medical device giant must halt most production and distribution of its Synchromed II drug pumps, which are implemented devices used to treat patients with cancer, chronic pain and severe muscle spasms. Medtronic will be legally required to hire an outside expert to help correct the problems. The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota between 2006 and 2013. FDA inspectors visited the plant five times over that period, the agency said in a Monday statement.


Mylan Rejects Teva's $40 Billion Takeover Offer

Mylan rejected a $40 billion takeover bid from an Israeli competitor, Teva. Mylan firmly and sharply rejected Teva’s bid to become the industry’s biggest generic drug company, deriding its unwanted suitor as a tangle of flawed corporate culture and mismanaged operations. Mylan will not begin negotiating unless a big surpasses $100 a share, while Teva is offering about $82 a share.


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