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FDA approves Vimpat C-V as monotherapy in the treatment of partial-onset seizures

BY Michael Johnsen

BRUSSELS, Belgium — UCB on Monday announced that the Food and Drug Administration has approved a supplemental new drug application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.
 
This is a new indication for Vimpat, which is already approved in the United States as an adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy.
 
UCB also announced that the FDA has approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.
 
“People living with epilepsy have individual needs. It’s our aim at UCB to provide as many patients as possible with various options to reduce their seizures," stated Iris Loew Friedrich, UCB chief medical officer and EVP. "Now, physicians and epilepsy patients in the United States have more Vimpat options to treat partial-onset seizures — Vimpat as an initial monotherapy, converting to Vimpat monotherapy and Vimpat as an adjunctive therapy. In addition, based on individual patients’ needs, physicians can choose between Vimpat formulations — tablets, oral solution or injection. Also, initiation of Vimpat as a single loading dose provides physicians with an alternative administration option to the standard titration schedule.” 
 
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Dollar General raises bid for Family Dollar

BY Michael Johnsen

GOODLETTSVILLE, Tenn. — Dollar General on Tuesday sweetened its deal for Family Dollar with an enhanced acquisition proposal with an offer worth about $9.1 billion. Under the terms of the revised proposal, Dollar General would increase its all-cash proposal for all outstanding shares of Family Dollar to $80 per share. To provide even greater certainty of consummation to the Family Dollar board, Dollar General also increased the number of stores that it would be willing to agree to divest to 1,500, if ordered by the Federal Trade Commission and, as further evidence of its confidence in its ability to obtain antitrust approval, has agreed to pay a $500 million reverse break-up fee to Family Dollar relating to antitrust matters. 
 
All other terms and conditions of the proposal remain unchanged.
 
Dollar General's revised proposal provides Family Dollar's shareholders with approximately $640 million of additional aggregate value over Dollar Tree's offer and represents a premium of 31.9% over the closing price of $60.66 for Family Dollar stock on the day prior to the Dollar Tree announcement.
 
"We are confident that our enhanced proposal sufficiently addresses any concerns that led Family Dollar's board of directors to reject our prior proposal without any discussions between our companies," stated Rick Dreiling, Dollar General's chairman and CEO. "Even as a secondary antitrust review supported our previous proposal, we revised our offer to demonstrate the seriousness of our commitment. Our revised proposal provides Family Dollar shareholders with significantly increased value over the existing agreement with Dollar Tree, as well as immediate and certain liquidity for their shares. If the Family Dollar board fails to seize this opportunity to maximize value for its shareholders, we will consider taking our superior proposal directly to the Family Dollar shareholders."
 
Goldman, Sachs & Co. is acting as financial adviser to Dollar General, and Simpson Thacher & Bartlett is acting as its legal counsel.
 
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CDC: U.S. infant vaccination rates high yet unvaccinated remain vulnerable

BY Antoinette Alexander

WASHINGTON — The vast majority of parents are making sure that their children get vaccinated against potentially serious diseases, according to data from CDC’s "2013 National Immunization Survey (NIS) – Children (19-35 months)" recently published in the Morbidity and Mortality Weekly Report. However, while vaccination coverage increased or remained stable for all routinely recommended childhood vaccines in 2013, coverage varied by state, and low coverage levels can leave states and communities vulnerable to outbreaks of potentially serious vaccine preventable diseases.



In 2013, vaccination coverage increased or remained stable for all routinely recommended childhood vaccines. Vaccination coverage remained more than 90% for the vaccines that prevent measles, mumps, and rubella; poliovirus; hepatitis B; and varicella. And it increased slightly for rotavirus vaccine, from 69% in 2012 to 73% in 2013, and for one or more doses of hepatitis A vaccine, from 82% in 2012 to 83% in 2013. Administration of the birth dose of hepatitis B rose from 72% to 74%.  The percentage of children who received no vaccines remained low, at less than 1% of children in 2013.



“I want to personally recognize the hard work of doctors and nurses coping with many challenges in the course of clinical work, and commend parents who, despite competing responsibilities, continue to prioritize immunization to keep their children healthy and safe,” stated Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases. “These people are central in keeping young children healthy by ensuring they receive the recommended vaccines on schedule.”



While overall immunization rates remain high, state immunization programs, clinicians, and parents are still challenged in getting all the recommended doses during the second year of life, according to the report. There are three vaccine series that include a booster dose in the second year of life: the vaccines that prevent diphtheria, tetanus, and pertussis (DTaP); Haemophilus influenzae type b (Hib); and Pneumococcal disease (PCV).  Coverage of these boosters remained at similar levels in 2012 and 2013. 

There was lower coverage for these booster doses among children living in poverty, compared with children living at or above the poverty line. These children also had lower coverage with the vaccines for poliovirus, rotavirus, and the hepatitis B series.  In addition to the booster doses, coverage was lower for black children compared with white children for the vaccine that protects against rotavirus.

Immunization coverage also varied by state, both for individual vaccines and for the series measure, which provides a shorthand assessment of overall performance by looking at the completion of immunizations against 11 different diseases (four doses of DTaP, three doses of poliovirus vaccine, one dose of measles-containing vaccine, full series of Hib vaccine, three doses of Hep B vaccine, one dose of varicella vaccine, and four doses of PCV). In that series measure, the range was from 82% in Rhode Island to 57% in Arkansas. The most critical coverage variation was the 17 states that had less than 90% coverage with the MMR vaccine.



National coverage of children 19 months to 35 months old with at least one dose of the measles, mumps, and rubella (MMR) vaccine is 92%.  While seemingly high, 1-out-of-12 children did not receive their first dose of MMR vaccine on time, underscoring a sizeable proportion of children that remain susceptible, the report stated. As of Aug. 22, 592 measles cases had been preliminarily reported in the United States, the most cases of any year since 1994. Measles is most frequently brought to the United States by unvaccinated U.S. travelers returning from abroad, and it can spread quickly in communities with groups of unvaccinated and under-vaccinated people.


 

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