Monster Energy Drinks Implied in Deaths|
Reports released on Monday implicates Monster Beverage Corp. (MNST) energy
drinks as a possible factor in the recent deaths of five people. Monster
spokesperson said that the company has not been notified by the U.S. Food and
Drug Administration about reports that its energy drinks have been cited.
Reports indicate the FDA had received five such reports of deaths, since the
beginning of the year. The company confirmed they are aware of a lawsuit filed
by the parents of 14-year-old Anais Fournier, who allegedly died after consuming
Monster drinks. Monster issued a statement Monday expressing sadness over the
teen's death, but asserting it does not believe its beverages were a factor.
"Monster is unaware of any fatality anywhere that has been caused by its drinks.
The Fournier family has chosen to file a lawsuit, which Monster intends to
vigorously defend and, in light of such pending litigation, Monster's policy is
to not comment further," the company stated. Monster shares were down 14% at the
closing bell on Monday.
Caterpillar Inc.'s (CAT) on Monday reported Q3 earnings rose 49% but, lowered
its 2012 outlook amid weaker-than-expected global economic conditions. CAT now
expects per-share earnings of $9 to $9.25 on revenue of nearly $66 billion,
compared with prior estimate for earnings of nearly $9.60 with revenue from $68
billion to $70 billion. Caterpillar reported a profit of $1.7 billion or $2.54 a
share, up from $1.14 billion, or $1.71 a share, for same period in 2011. The
latest period included a $273 million gain from the sale of its third-party
logistics business. Revenue increased 4.6% to $16.45 billion while operating
margin rose to 15.8% from 11.2%. For 2013, CAT expects sales and revenue to be
nearly the same as 2012, plus or minus 5%. The construction and mining equipment
maker benefited from an asset-sale gain and posted continued revenue growth. As
the world's largest manufacturer of bulldozers, excavators and other
construction machinery, Caterpillar is closely watched as a gauge of the
strength of the global economy. "We are taking a pragmatic view of 2013--we're
not expecting rapid growth, and we're not predicting a global recession," said
Chairman and Chief Executive Doug Oberhelman. "While machine deliveries to end
users have continued to hold up, our sales will probably remain relatively weak
early in 2013 as dealers are likely to continue reducing inventories."
Supernus Pharmaceuticals Inc. (SUPN) said Monday the U.S. Food and Drug
Administration gave final approval for its once-daily extended-release epilepsy
treatment, Oxtellar - an extended-release formulation of oxcarbazepine, is
indicated as an adjunctive therapy in the treatment of partial seizures in
adults and in children six to 17 years of age. Supernus Pharmaceuticals focus on
developing and commercializing products for diseases of the central nervous
system. The received a waiver from the FDA for the pediatric-study requirement
for ages birth to one month and a deferral for submission of post-marketing
assessments for children ages one month to six years. Its other products in
development include treatments for attention deficit hyperactivity disorder, or
ADHD. he company also received tentative approval for its Trokendi XR epilepsy
treatment. The Pharmaceutical firm has delayed plans to launch Trokendi XR to Q3
2013 from the end of 2012 on expectations that final FDA approval may not be
made effective until a marketing-exclusivity period expires. Supernus shares
were higher by at least 18% in pre-market trading Monday but ended the session
down less than one percent, as the markets tumbled during the session.
Eli Lilly & Co.'s (LLY) announced their investigational once-weekly diabetes
treatment showed positive results in lowering overall blood glucose levels in a
series of Phase III studies. In three long-term studies ranging from 26 weeks to
two years, dulaglutide for type 2 diabetes, showed improved glycemic control
when compared with a placebo and with other diabetes drugs. At scientific
meetings in 2013 and 2014, Lilly plans to give more details regarding the
dulaglutide data. Lilly said the timing of its application for U.S. approval
depends on satisfactory completion of U.S. Food and Drug Administration
requirements for assessment of cardiovascular risk and plans to seek regulatory
approval next year. Lilly shares ended the trading session on Monday, down
slightly over 1%.
Transcatheter aortic valve implantation system, CoreValve, from Medtronic Inc.
(MDT) medical-device maker said studies showed it improved patients' one-year
survival rate and quality of life, while its Symplicity system for renal
denervation reduced patients' blood pressure after two years. Medtronic said
initial one-year results of Advance study showed that patients implanted with
the CoreValve System had a survival rate of 82.1% and a cardiovascular survival
of 88.2%. "Transcatheter aortic valve implantation already has been shown to
improve survival compared with standard therapy, but quality of life can be at
least as important as survival in elderly patients, especially since TAVI
patients can be frail with multiple comorbidities," said Johan Bosmans,
professor at the University Hospital of Antwerp in Belgium. "We are extremely
proud of this data which confirms that the benefits of transcatheter aortic
therapy extend beyond survival even in this challenging patient population."
Health-related quality of life measures also improved significantly at one and
six months with the Advance study evaluating 996 patients at 44 TAVI centers in
12 countries. Medtronic also reported that Symplicity HTN-1, a series of pilot
studies at 19 centers in Australia, Europe and the U.S. showed patients who
received renal denervation treatment with the Symplicity system experienced
blood pressure reduction at 24 months. The safety of renal denervation with the
system was maintained after two years. "These data in nearly twice the number of
patients previously reported at two years in this trial provide us with a better
understanding of the patient response over time and add to the growing body of
evidence supporting the safety and sustained blood pressure reduction of renal
denervation treatment with the Symplicity system," said Markus Schlaich,
professor of medicine and head of hypertension and kidney disease at the Baker
IDI Heart and Diabetes Institute in Melbourne, Australia.
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