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For all the hoopla about CRISPR (clustered regularly-interspaced short palindromic repeats), the revolutionary genome-editing technology has a dirty little secret: it’s a very messy business. Scientists basically whack the famed double helix with a molecular machete, often triggering the cell’s DNA repair machinery to make all sorts of unwanted changes to the genome beyond what they intended...On Wednesday, researchers unveiled in Nature a significant improvement — a new CRISPR system that can switch single letters of the genome cleanly and efficiently, in a way that they say could reliably repair many disease-causing mutations...Because of "the cell’s desperate attempts" to mend its genome..."what often passes as ‘genome editing’ would more appropriately be called ‘genome vandalism,’" as the cell inserts and deletes random bits of DNA where CRISPR cuts it...Because the new version of CRISPR avoids that mess, it "offers a huge step forward,"...

US ranks first in terms of how its domestic policies contribute to global biopharmaceutical innovation, according to a recent analysis...The report , released by the Information Technology and Innovation Foundation, a nonprofit, nonpartisan research and educational institute focusing on the intersection of technological innovation and public policy, includes findings that assess 56 countries making up nearly 90% of the world’s economy...relative to its share of the global economy (22%), the US contributes twice the share (44%) of global R&D investment in the life sciences...it also pays closer to "the true cost of medicines developed...It means too many other nations aren’t doing their share to bear the costs of biomedical discovery and innovation...This underinvestment in biomedical research is one of the most significant factors slowing the pace of biomedical innovation. Moreover, there’s a game theory problem here where some nations are incented to free-ride off the investments of others...Countries must recognize that excessive price controls are actually damaging to long-term biopharmaceutical innovation...Strong intellectual property rights are vital for a robust life sciences innovation ecosystem; with biologic drugs the frontier of biomedical innovation, countries should implement strong IP protections for biologics, including biologics data exclusivity periods of at least 10 years or longer...

Adapt Pharma, maker of Narcan (naloxone) Nasal Spray announced...the launch of its smartphone app Narcan Now. The app provides patients information about how to recognize the signs and symptoms of an opioid overdose, an instructional video and a three-step administration guide for Narcan Nasal Spray, as well as emergency services access...The app is available through the iTunes App Store for iOS devices and the Google Play store for Android devices.

Researchers from MIT and Brigham and Women’s Hospital have designed a new type of pill that, once swallowed, can attach to the lining of the gastrointestinal tract and slowly release its contents. The tablet is engineered so that one side adheres to tissue, while the other repels food and liquids that would otherwise pull it away from the attachment site...Such extended-release pills could be used to reduce the dosage frequency of some drugs...The ability to precisely engineer the adhesiveness of a particle opens up possibilities of designing particles to selectively adhere to specific regions of the GI tract, which in turn can increase the local or systemic concentrations of a particular drug...In addition to delivering antibiotics, the two-sided material may help to simplify drug regimens for malaria or tuberculosis, among other diseases...The researchers may also further pursue the development of tablets with omniphobic coatings on both sides, which they believe could help patients who have trouble swallowing pills...Texturing the surfaces really opens up a new way of thinking about controlling and tuning how these drug formulations travel...

Maine Gov. Paul LePage has signed into law a bill that mandates electronic prescribing for controlled substances. Maine is the second state to do so. In New York the mandate took effect on March 27...An Act To Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program requires prescriber participation in the Prescription Monitoring Program and sets limits for the strength and duration of opioid prescriptions, beginning January 2017...also calls for prescribers to undergo addiction training every two years...The new law also makes Maine the third state in the nation to set a cap on the daily strength of opioid prescriptions

Scientists in Singapore have developed magnetic micro-sized bubbles with cancer drugs on their surface that can be guided to gather around a tumor and then release their payload...Filled with gas, the microbubbles can be coated with particles of both cancer drugs and iron oxide. The iron gives them their magnetic characteristic, allowing a robotic surgeon to guide the bubbles to a tumor’s location and thereby cutting back side effects associated with free chemotherapy in the bloodstream...Once they have reached a tumor, the surgeon would then apply ultrasound to vibrate the microbubbles, shaking loose the drug, which is then close enough to enter the cancer cells more effectively.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Commonly used drugs for problems like colds, allergies, depression, high blood pressure and heart disease have long been linked to cognitive impairment and dementia. Now researchers have some fresh evidence that may help explain the connection...anticholinergics, stop a chemical called acetylcholine from working properly in the nervous system...they...relieve unpleasant gastrointestinal, respiratory or urinary symptoms...The list of such drugs is long. Among them: Benadryl for allergies, the antidepressant Paxil and the antipsychotic Zyprexa, Dimetapp for colds and the sleep aid Unisom...brain scans of people who used anticholinergic drugs showed lower levels of glucose processing in the brain – an indicator of brain activity – in a region of the brain associated with memory that’s also affected early in the course of Alzheimer’s disease...There are definitely medical benefits to all of the anticholinergic medications we looked at, which could outweigh the cognitive risks...But if alternative therapies are available that provide effective treatment of these conditions, patients and doctors might want to consider avoiding anticholinergic medications...

The old process is slow and prone to errors...The process of biopharmaceutical drug manufacturing is stuck in the past. And the Food and Drug Administration is now openly calling for drugmakers to spring it forward into the 21st century..."batch" manufacturing technique used by the industry to an archaic relic...batch manufacturing in pharma involves regular breaks between spurts of production. Continuous manufacturing is usually a persistent, unbroken process wherein production plants keep humming... continuous manufacturing is more reliable...the (FDA) agency’s pioneering decision last week to approve Johnson & Johnson biotech arm Janssen’s request to switch over from batch to continuous manufacturing for the production of the HIV drug Prezista. And now, regulators are declaring outright that other biopharma players should "consider similar efforts."

The worlds of science, technology and patent law eagerly await the...government’s decision on who deserves patents on what many have referred to as the biotechnology invention of the century: the CRISPR/Cas9 gene-editing technique...Scientists hail CRISPR/Cas9 as more accurate and efficient than other, now-traditional genetic engineering methods...CRISPR has generated worldwide debate about how it could accelerate the manipulation of plants, animals and even human beings at the molecular level. That some DNA modifications can be passed on to future generations raises particular concern...But the patent dispute, focusing on whether scientists at the Broad Institute of MIT and Harvard or those at University of California, Berkeley invented the technology, seems far from these ethical concerns...the...Patent and Trademark Office, which will make a decision in the next few months...But amid all the breathless anticipation, we’ve been ignoring two important lessons from the CRISPR/Cas9 patent dispute: patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.

• Do we need patents to stimulate innovation?
• Power of patents, in absence of regulations
• CRISPR’s future use in one institution’s hands