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FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan). Naloxone has been the standard of emergency treatment for opioid overdose …only injectable formulations of naloxone are currently approved for use…FDA has granted priority review to Adapt Pharma’s naloxone...nasal spray, which was previously given a fast track designation…

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter,…demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances…. the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine…the guidance attempts to create new regulatory authority without legislation to support that effort.

Texas prison officials are helping their counterparts in Virginia prepare for a scheduled execution next week by providing the state with pentobarbital, a lethal drug that corrections agencies nationwide have had difficulty obtaining…Virginia prison officials also confirmed the trade…Texas and Oklahoma are among a handful of states with laws — being challenged by death penalty opponents — that allow prison officials not to disclose where they get execution drugs…Death Penalty Information Center, an anti-death penalty organization, said the drug exchange raised concerns about government transparency.

CNBC's Meg Tirrell reports on a little-known law from 1983 that could negatively impact fair pricing in the drug marketplace.

Pharmaceutical companies that make minor tweaks to brand-name drugs in order to blunt competition from cheaper generic treatments may be violating antitrust laws, the Federal Trade Commission said…known as "product-hopping," harms consumers who save billions of dollars each year through generic competition and undermines laws that allow pharmacists to automatically substitute brand-name drugs with low-cost copycats, …"Such conduct could deprive generic companies of their most efficient means of distribution -- automatic substitution at the pharmacy -- and, as a result, maintain the brand’s monopoly through illegal means,"

It's October 1, 2015, the ICD-10 diagnostic code set is live at last, and medical professionals now have nearly 70,000 codes to choose from when filing patient claims…Healthcare IT News and sister site Healthcare Finance will be reporting on the changeover throughout the day, using the live blog below to highlight the latest news, real-time reactions and frequent updates from our cadre of volunteer ICD-10 correspondents, a group of healthcare insiders who have agreed to keep us posted on what they're seeing post-switchover.

Asia's largest vaccinemaker just made a play that could affect the race for a vaccine protecting against dengue fever,..Serum Institute of India announced…that it's seeking fast-track approval to launch a dengue treatment in India for which it purchased local rights from U.S. biotech Visterra earlier this month…If successful, the company could be the first globally to launch a drug for the mosquito-borne illness,..a development with potential implications in the ongoing dengue vaccine race between Sanofi, Takeda, and others.

In a letter to Health Secretary Jeremy Hunt on Thursday, the Coalition for Affordable T-DM1 said the government should grant a compulsory license for patents covering Kadcyla, or T-DMI (ado-trastuzumab emtansine)…allowing other companies to supply so-called biosimilar versions…As well as being rejected by NICE, from next month Kadcyla will also not be covered by the Cancer Drugs Fund…prompting Roche Chief Executive…to call Britain's drug system "stupid"…Issuing a compulsory license would put Britain on a collision course with the pharmaceuticals industry, something the government is unlikely to want given its desire to encourage life sciences.

In the largest settlement of its kind involving allegations of drug diversion…Massachusetts General Hospital has agreed to pay the United States $2.3 million to resolve allegations that lax controls enabled MGH employees to divert controlled substances for personal use…two of its nurses had stolen…nearly 16,000 pills, mostly oxycodone,…from automated dispensing machines…revealed pill count discrepancies totaling over 20,000, missing or incomplete medication inventories,..hundreds of missing drug records, all in violation of the…Controlled Substances Act...　

Food and Drug Administration has revoked an approval issued in March to India's Sun Pharma Advanced Research Company Ltd to launch a drug (Elepsia XR, levetiracetam), for seizures, citing manufacturing quality problems at its production site…setback to SPARC, the research arm of India's largest drugmaker,…FDA issued it a "Complete Response Letter" in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval".