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Feb 25, 2014

Lilly weekly diabetes drug as effective as market leader Victoza-study

Feb 25 (Reuters) – An experimental once-weekly medicine for
type 2 diabetes developed by Eli Lilly and Co proved as
effective in lowering blood sugar as Victoza from Danish
drugmaker Novo Nordisk in an eagerly anticipated late
stage study.

The Lilly drug, dulaglutide, achieved the primary goal of
the 599-patient study by demonstrating so-called non-inferiority
to the highest approved dose of Victoza after 26 weeks,
according to initial results released by the company on Tuesday.
Lilly shares rose more than 1 percent before retreating.

Feb 25, 2014

Lilly weekly diabetes drug succeeds vs market leader Victoza -study

By Bill Berkrot

(Reuters) – An experimental once-weekly medicine for type 2 diabetes developed by Eli Lilly and Co proved as effective in lowering blood sugar as Victoza from Danish drugmaker Novo Nordisk in an eagerly anticipated late stage study.

The Lilly drug, dulaglutide, achieved the primary goal of the 599-patient study by demonstrating so-called non-inferiority to the highest approved dose of Victoza after 26 weeks, according to initial results released by the company on Tuesday.

Feb 21, 2014

FDA seeks to modernize over-the counter drug reviews

WASHINGTON/NEW YORK (Reuters) – The U.S. Food and Drug Administration is proposing sweeping changes to how it regulates over-the-counter drugs from aspirin to allergy medications to make it easier to react to new information on a product’s safety or recommended use.

The agency’s current rules for nonprescription medicines are more than 40 years old, and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medications. They do not allow the agency to respond quickly when new data emerges about a drug’s potential side effects, the agency said in documents filed on Friday .

Feb 11, 2014

Gilead COO: Analysts’ sky-high hep C drug view ‘not unreasonable’

NEW YORK, Feb 11 (Reuters) – When Gilead Sciences Inc
declined to project 2014 revenue for its high-profile
new hepatitis C drug last week, its shares fell nearly 7 percent
over the next two days.

Wall Street analysts say investors were likely spooked by
the omission, concerned it could signal that sales of the new
drug, Sovaldi, might not approach sky-high forecasts.

Feb 7, 2014

More U.S. pressure on India sought over patent issue

By Bill Berkrot

(Reuters) – The U.S. Chamber of Commerce on Friday called on the government to ratchet up pressure on India over intellectual property rights, in a move that could help prevent Indian companies from producing cheap generic versions of medicines still under patent protection.

In a submission to the Office of U.S. Trade Representative (USTR), the Chamber of Commerce requested that India be classified as a Priority Foreign Country, a tag given to the worst offenders when it comes to protecting intellectual property and one that could trigger trade sanctions.

Feb 7, 2014

Trade group seeks more U.S. pressure on India over patent protection

By Bill Berkrot

(Reuters) – The U.S. Chamber of Commerce on Friday called on the government to ratchet up pressure on India over intellectual property rights, in a move that could help prevent Indian companies from producing cheap generic versions of medicines still under patent protection.

In a submission to the Office of U.S. Trade Representative (USTR), the Chamber of Commerce requested that India be classified a Priority Foreign Country, a tag given to the worst offenders when it comes to protecting intellectual property, and one that could trigger trade sanctions.

Feb 4, 2014

Furiex irritable bowel syndrome drug succeeds in large trials

Feb 4 (Reuters) – An experimental drug developed by Furiex
Pharmaceuticals Inc met the main goal of a pair of
large Phase III clinical trials by significantly alleviating
diarrhea and abdominal pain associated with irritable bowel
syndrome, the company said on Tuesday.

Based on the results of the studies, Furiex said it planned
to apply by mid-year for U.S. approval of the drug, eluxadoline,
to treat diarrhea-predominant irritable bowel syndrome (IBS-d),
a debilitating bowel disorder that affects about 28 million
people in the United States and major European markets.

Feb 3, 2014

Biogen multiple sclerosis drug Tecfidera wins European approval

By Bill Berkrot

(Reuters) – Biogen Idec Inc’s high profile new multiple sclerosis drug Tecfidera won European approval, the company said on Monday, opening the door for its launch in one of the world’s largest markets for MS treatments.

The approval was widely expected after the European Medicines Agency endorsed the drug in November. European health regulators typically follow EMA recommendations within a couple of months.

Jan 31, 2014

Sanofi sues Eli Lilly over challenge to top diabetes drug Lantus

NEW YORK/PARIS (Reuters) – French drugmaker Sanofi is suing Eli Lilly and Co for alleged patent infringements concerning its top-selling Lantus diabetes treatment, delaying the U.S. firm’s plans to produce a copycat version of Lantus.

Lantus is the world’s most prescribed insulin product, with annual worldwide sales of about $7 billion, but is set to lose patent protection in the United States, the world’s largest pharmaceutical market, in February 2015.

Jan 30, 2014

PerkinElmer optimistic about 2014; EPS forecast in line

Jan 30 (Reuters) – Scientific instruments maker PerkinElmer
Inc on Thursday forecast full-year earnings in line with
current Wall Street estimates and its CEO sees a rosier 2014
after a year filled with uncertainty in the markets it serves.

The company, which also sells medical diagnostic equipment,
such as for prenatal screening, and environmental testing
products, sees full-year earnings of $2.40 to $2.45 per share,
excluding special items. Analysts on average are looking for
$2.42 per share.

    • About Bill

      "Based in New York, I primarily cover the pharmaceutical and biotechnology sectors as well as other publicly traded companies involved in health care. Previously covered a wide range of sports for Reuters."
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