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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,"...

A congressional committee is proposing an amendment to a spending bill that may intensify the debate over the safety of compounded medicines...The House Appropriations Committee has introduced language that would alter a key requirement for pharmacists to make and dispense compounded medicines, which are generally customized for specific patient needs. And the language runs counter to a draft guidance that the US Food and Drug Administration released...that would govern compounding practices...Specifically, the amendment would allow pharmacists to compound medicines without needing prescriptions for individual patients. This has been a contentious issue in the wake of the 2012 outbreak of fungal meningitis that was tied to a compounding pharmacy and led to 64 deaths. The episode underscored confusion between federal and state oversight of compounders...the Drug Quality and Security Act went into effect to sort out enforcement authority...it...created two classes of compounders — traditional compounders who make medicines for individual patients, and others who resemble drug makers by making large amounts of a drug. These compounders must register with the FDA and are subject to greater federal oversight...The Pew Charitable Trusts...argued that the language proposed by the House committee would blur that distinction. And the nonprofit contended the change could jeopardize public safety...International Academy of Compounding Pharmacists..."The FDA continues to ignore clear congressional intent where the states have clearly indicated pathways in which pharmacies can participate in office-use compounding. The 2017 appropriations bill reinforces this intent."..."FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of bill when it comes to defining this practice,"…

Swiss biotechnology giant Roche has sued Ahmedabad-based drug maker Intas Pharmaceuticals in Delhi High Court, alleging infringement of its patent rights over Mircera (methoxy polyethylene glycol-epoetin beta), an injectable brand used to treat patients with anaemia in chronic kidney-related ailments...Roche has sought an injunction order against the brand launched by Intas...Roche had close to $500 million in global sales for its Mircera brand...Intas...is contending a non-infringing stand on its product. "We also have strong grounds of invalidation for the enforced patent,"...Roche officials did not comment, saying the case is sub-judice. Intas launched its product under the brand name Erypeg in India at prices to retailer ranging from Rs 4,080 ($62) to Rs 8,200 ($124), depending on the strength of the injection. Roche's product is priced between Rs 5285 ($80) and Rs 10,621 ($160) per injection.

The Illinois Department of Public Health said on Wednesday that five more people had died after being infected with Elizabethkingia, a disease linked to the deaths of 15 people in neighboring Wisconsin...The cause of death was not identified as Elizabethkingia because many of those people had underlying health conditions, the department said. Ten Illinois residents have been diagnosed with Elizabethkingia, and six have died...Symptoms of Elizabethkingia can include fever, shortness of breath and chills or cellulitis, but officials have said that the bacteria are rarely reported to cause illness in humans...Officials said the Illinois strain of Elizabethkingia differed from the Wisconsin one.

An influential federal advisory panel is calling for Congress to force private insurers to rein in rapid increases in prescription drug costs — by cutting some Medicare payments to insurance companies while shielding older Americans from higher out-of-pocket expenses...The recommendations by the nonpartisan Medicare Payment Advisory Commission would squeeze private insurers and drug makers alike, creating strong new incentives for insurance companies to manage the use of prescription medicines by beneficiaries and negotiate larger price discounts with pharmaceutical manufacturers...The recommendations will be included in a June report to Congress, which often heeds the panel’s advice...More than 40 million of the 56 million Medicare beneficiaries have drug coverage through Part D, and national surveys indicate that most are satisfied with the coverage. But out-of-pocket costs for some beneficiaries have increased in recent years as insurers require them to pay 25 percent or more of the cost for expensive specialty drugs to treat chronic or complex illnesses, including cancer, rheumatoid arthritis, multiple sclerosis and hepatitis C...Pharmaceutical companies and advocates for beneficiaries said some of the panel’s recommendations could harm patients’ access to certain medicines and raise costs for some low-income people...

Years after two AbbVie cholesterol-fighting combos were approved, the FDA has decided they shouldn’t be on the market. The agency pulled approvals on combination pills Advicor and Simcor altogether, and revoked approvals for Niaspan (niacin) and Trilipix (fenofibric acid) alongside standard statin therapy...The agency said its decisions stemmed from "collective evidence from several large cardiovascular outcome trials." The combination therapies delivered no CV benefits in those trials... There is no evidence for any meaningful benefit for addition of niacin or fibric acid derivatives to statins...All four of the brands are off patent, and with generics in the mix, AbbVie’s lipid drug sales had already taken a big plunge. The dyslipidemia franchise brought in just $179 million last year, down from more than $1 billion in 2013, when Trilipix and Niaspan went off patent...We might ask, why were the indications for these drugs granted in the first place?...This shows how far we have come in the evaluation of lipid-lowering drugs. It is now firmly established that improvements in the simple lipid profile are not enough, and that clear evidence of benefit on clinical outcomes is needed for routine use of lipid-lowering drugs as add-on to statin therapy.

An indictment was unsealed today charging a doctor and three other individuals with conspiracy to illegally distribute prescription drugs...Charged in the indictment are: Dr. Michael Weiss, D.O., Edgarten Howard, Carlos Johnson, and Ricky Easley...The indictment alleges that...Weiss conspired with the other defendants to write a large number of prescriptions for highly addictive controlled substances for supposed patients, who did not have a legitimate medical need for the drugs. Weiss primarily prescribed Roxicodone and its generic equivalent, oxycodone, and promethazine cough syrup. He saw the purported patients in Howard’s home, where Howard, Johnson, and Easley paid Weiss cash for his services. Howard, Johnson, and Easley then obtained the drugs that Weiss authorized through the prescriptions, and sold them on the street...Weiss caused Medicare to pay more than $250,000, and Blue Cross almost $40,000, for the illegitimate prescriptions...also...Weiss submitted about 950 claims to Medicare and Blue Cross for providing services to the supposed patients...received about $65,000 through the fraudulent bills.

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

Biogen, already battling in a patent fight over multiple sclerosis star Tecfidera (dimethyl fumarate), has run into another challenge--this time with fellow MS treatment Tysabri (natalizumab). And with IP pressure mounting, the company may need to revamp its commercial lineup to ensure that the revenue keeps on flowing...India’s Swiss Pharma International has filed a petition for inter partes review of one of Tysabri’s patents--and another two petitions are on the way...The move could potentially put sales of the drug, which tallied $1.89 billion in 2015, in jeopardy... Swiss Pharma’s chances of upturning Biogen’s patents are "relatively modest." The product is "thoroughly protected" when it comes to its IP shields, and the safety flags it carries...Pharma patent challenger Kyle Bass has been trying to bat down Tecfidera’s patents for months now...the company needs to head to the dealmaking table...We believe a strategic acquisition of key products in the neurological diseases field, but outside MS, could potentially mitigate the looming threat to the MS franchise that is on the horizon...

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...