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IMS opens IPO at $20 per share

BY Michael Johnsen

DANBURY, Conn. — IMS Health Holdings on Thursday announced the pricing of its initial public offering of 65 million shares of its common stock at a price to the public of $20 per share, including 52 million shares to be sold by IMS Health and 13 million shares to be sold by selling shareholders. In addition, the selling shareholders have granted the underwriters a 30-day option to purchase up to an additional 9.75 million shares of common stock at the public offering price, less underwriting discounts and commissions.  

IMS Health expects to use substantially all of the net proceeds from the shares offered by it to repay existing long-term debt. IMS Health will not receive any of the proceeds from the sale of shares by the selling shareholders.

The offering is expected to close on April 9, 2014, subject to customary closing conditions. The shares are expected to begin trading on the New York Stock Exchange on April 4, 2014 under the ticker symbol “IMS.”

 

 

 

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NABP advises pharmacies not to dispense combination drugs with more than 325 mg of APAP per dose

BY Michael Johnsen

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.  

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

The Food and Drug Administration is withdrawing approval of 108 abbreviated new drug applications for prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit. For the 108 ANDAs, the manufacturers asked to withdraw their applications, as announced in the March 27, 2014 Federal Register notice. A second Federal Register notice addresses the applications of six manufacturers who have discontinued marketing their products, but who have not withdrawn their applications. 

The notice also announces FDA’s intention to begin the process of withdrawing approval of those applications.

FDA asked manufacturers to voluntarily withdraw these products from the market to reduce the risk of severe liver injury from inadvertent acetaminophen overdose. In January 2014, FDA recommended that providers consider prescribing acetaminophen products containing 325 mg or less per dose.

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A.Bauer says:
May-02-2014 10:59 am

Quoting an FDA report, acetaminophen's narrow safety margin places a large fraction of users close to a toxic dose in the ordinary course of use. Taken over several days, as little as 25 percent above the maximum daily dose – or just two additional extra strength pills a day – has been reported to cause liver damage, according to the agency. http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed

A.Bauer says:
May-02-2014 10:57 am

The list of risks for acetaminophen is long and growing. The most serious concerns are two new studies which show adverse neurodevelopment in children whose mothers used acetaminophen while they were pregnant. The study in 3 year olds (Brandlistuen et al. 2013) found a 70% increased risk of motor and behavioral problems and double the risk of communication problems (autism phenotypes). The study in 7 year olds (Liew et al. 2014) found increased risk of ADHD behaviors and Hyperkinetic Disorders. This is in addition to close to 30 studies finding an association to asthma and allergic disorders, 4 studies finding an association to male congenital malformations (cryptorchidism) and additional studies finding associations to skin disorders and mind numbing (relief of existential dread).

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FDA approves prescription hand held auto-injector designed for caregivers to treat opioid overdose

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. 

"Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety," stated Margaret Hamburg, FDA commissioner. "Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks."

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. 

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” stated Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.” 

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose. Family members or caregivers should also become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed.  

Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.

Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application. 

Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. The FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.

Evzio is manufactured for Kaléo of Richmond, Va.

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