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Dynavax releases results of hepatitis B vaccine phase-3 trial

BY Alaric DeArment

BERKELEY, Calif. — An experimental vaccine for hepatitis B made by Dynavax Technologies appears to work better in patients with diabetes than current treatments, the company said.

The company announced results of two phase-3 trials of the vaccine Heplisav, one of which was the first to prospectively evaluate the effectiveness of vaccinations with recombinant hepatitis B vaccines in patients with diabetes. Dynavax said results from that trial showed that Heplisav provided faster, more orbits and convenient, longer-lasting immunity in people with diabetes than a currently available vaccine, GlaxoSmithKline’s Engerix-B.

The trial enrolled 218 adults older than 40 with diabetes, of whom 179 were given Heplisav, while 39 received Engerix-B; Dynavax said Heplisav showed better protection than Engerix-B in week 8 through week 52.

On Tuesday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to recommend that patients with diabetes older than 60 years be vaccinated against hepatitis B. The CDC has recommended that infants be routinely vaccinated against hepatitis B since 1991.

"Given [Tuesday’s] ACIP recommendation, we believe Heplisav will, if approved, play an important role in meeting the needs of these patients," Dynavax president and chief medical officer Tyler Martin said. "In addition, Dynavax has demonstrated similar advantages in other hard-to-immunize populations, including males, smokers and obese subjects."


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P&G’s fiscal year ‘off to a good start’ as Q1 net sales climb

BY Antoinette Alexander

CINCINNATI — Procter & Gamble delivered “strong” first-quarter sales growth, kicking off a “good start to the fiscal year” as net sales climbed 9% and organic sales grew 4%, the company announced on Thursday.

“The first quarter was a good start to the fiscal year,” stated chairman, president and CEO Bob McDonald. “We maintained strong top-line growth momentum in a difficult operating environment. We are well-positioned — due to continued top-line strength, recently implemented price increases and our productivity improvement and cost savings efforts — to improve earnings growth as we progress through the fiscal year.”

Net sales rose 9% to $21.9 billion during the quarter.

Net earnings slipped 2% to $3.02 billion, or $1.03 per diluted share, compared with $3.08 billion, in the year-ago period.

In beauty, net sales rose 9% to $5.4 billion and organic sales grew 4%. Price increases added 2% to net sales growth. Net earnings declined 12% to $731 million as lower operating margin more than offset the impact of sales growth, the company stated. Operating margin declined because of a commodity cost driven reduction in gross margin and increased marketing and research and development investments.

In grooming, net sales rose 10% to $2.1 billion and organic sales rose 3%. Price increases added 2% to net sales growth. Net earnings increased 10% to $438 million, in line with net sales growth.

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CallingAllTypes.com to serve as online diabetes health movement

BY Allison Cerra

BOSTON — An online social health initiative for people with Type 1 and Type 2 diabetes will make its debut in honor of American Diabetes Month in November.

CallingAllTypes.com encourages people with Type 1 and Type 2 diabetes to become active members of online health communities so they can continue to share, learn and benefit from peer-to-peer interaction. The website is sponsored by healthcare communications company and patient advocacy organization BBK Worldwide, online health data sharing platform PatientsLikeMe and the American Diabetes Association.

"We have created a one-stop rallying point for people with Type 1 and Type 2 diabetes to tell their stories," BBK Worldwide founding principal Bonnie Brescia said. "Awareness is the first step toward social change. And without public and private understanding of the devastating effect of this condition, we are in a weakened position to do anything about it. This makes social media the obvious choice to facilitate this type of change."

PatientsLikeMe cofounder Ben Heywood added, "We’ve seen first-hand, when patients become empowered through online peer interaction, they take control of their conditions and improve their outcomes."


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