FDA OKs CSL Behring’s Idelvion
SILVER SPRING, Md. — Biotherapeutics company CSL Behring announced Friday that the Food and Drug Administration had approved its hemophilia B treatment Idelvion (coagulation factor IX (recombinant), albumin fusion protein).
The drug is indicated as a routine prophylactic treatment to prevent and reduce frequency of bleeding episodes, as an on-demand bleeding control and prevention and as a perioperative management for bleeding. Certain patients can go up to 14 days between infusions of Idelvion, the company said.
CSL Behring said it expects Idelvion to be available in late March.
CVS Health to offer naloxone without prescription in 23 states by month’s end
WOONSOCKET, R.I. – CVS Health announced Monday that it will expand access to the opioid overdose-reversal medication naloxone at the end of March at its CVS Pharmacy locations in eight new states, including: Connecticut, Kentucky, Maryland, North Carolina, New Hampshire, Ohio, Virginia and Vermont.
Under a physician-approved protocol permitted by the state, CVS Pharmacy will be able to dispense naloxone to patients in these states without the need for an individual prescription.
"Naloxone is a safe and effective antidote to opioid overdose and by expanding availability of this medication, we can save lives and give more people a chance to get the help they need for recovery," stated Tom Davis, VP pharmacy professional practices at CVS Pharmacy. "By establishing a physician-approved protocol that allows our pharmacies to dispense naloxone to patients without an individual prescription, we strengthen our commitment to help the communities we serve by preventing drug abuse."
Naloxone is already available without a prescription at CVS Pharmacy locations through standing order or collaborative practice agreements in 15 states, including: Arkansas, California, Indiana, Massachusetts, Minnesota, Mississippi, Montana, New Jersey, New York, North Dakota, Pennsylvania, Rhode Island, Tennessee, Utah and Wisconsin.
The company has said it will add a total of 20 states to its naloxone program in 2016 and expects to announce additional states throughout the remainder of the year.
"Expanding access to the overdose-reversal drug naloxone is a critical part of our national strategy to stop the prescription drug and heroin overdose epidemic–along with effective prevention, treatment, and enforcement," said Michael Botticelli, director of National Drug Control Policy. "Thanks to efforts on naloxone like those announced today by CVS Health, more Americans will have access to this lifesaving drug."
The move to expand access to naloxone builds on CVS Health's commitment to help communities address and prevent drug abuse through education, outreach and safe medication disposal. In 2015, CVS Health launched a community outreach program called Pharmacists Teach, which brings local pharmacists to high school health classes to talk to students about the dangers of drug abuse. More than 15,000 students have already been part of the program. High schools across the country can learn more about bringing Pharmacists Teach to their school here.
CVS Health has also joined with the Partnership for Drug-Free Kids for the Medication Disposal for Safer Communities Program, which has donated more than 500 drug disposal units to police departments around the country. The program gives members of the community a safe and environmentally friendly way to dispose of unwanted medication and has already collected more than 28 metric tons of prescription drugs. Police departments across the country can apply to receive a drug collection unit from the program here.
"CVS Health has been a leader in the work of preventing prescription drug abuse and ensuring safe disposal of unwanted medication that could otherwise be misused," said Marcia Lee Taylor, president and CEO, Partnership for Drug-Free Kids. "Tackling drug abuse in our communities requires a committed coalition of community partners and we have been proud to partner with CVS Health on the Safer Communities program since 2014."
Strides Shasun acquires Jointflex, Fergon and Vanquish OTC brands
BANGALORE – Strides Shasun on Monday announced that its wholly-owned subsidiary Strides Pharma has entered into an agreement with Moberg Pharma of Sweden to acquire Jointflex, Fergon and Vanquish brands for a total consideration of $10 million plus inventory value at closing.
The announced acquisition strengthens Strides Shasun’s strategy to build a global OTC franchise, the company stated.
The OTC portfolio now includes market leading Chemists Own umbrella brand in Australia and Nuprin in the U.S. Nuprin has the global rights to the first ibuprofen 12-hour extended-release tablets, as well as the associated controlled delivery technology.
The company has also filed ANDA’s that will further enhance its OTC portfolio in the U.S.
The transaction is expected to add $6.1 million in revenues when the deal closes in an approximate four weeks, Strides stated.
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