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Mar 4, 2014

Roche drug cuts asthma attacks, improves lung function -study

March 4 (Reuters) – An experimental drug reduced asthma
attacks in patients with severe uncontrolled asthma by 60
percent and helped improve lung function in certain patients,
indicating that the drug could offer the first personalized
approach to treatment, according to data from a clinical trial
released on Tuesday.

The biotech drug lebrikizumab, which was developed by Roche
Holding’s Genentech unit, was tested at three doses in
patients whose asthma was not sufficiently controlled even with
high-dose, inhaled corticosteroids and a second
asthma-controlling therapy.

Feb 27, 2014

Drugmaker Mylan’s shares jump 10 percent on deal talk, rosy outlook

By Bill Berkrot

(Reuters) – Shares of Mylan Inc (MYL.O: Quote, Profile, Research, Stock Buzz) jumped more than 10 percent on Thursday after the U.S. generic drugmaker provided a 2014 forecast above analysts’ estimates and said it planned a major transaction this year that would add to future earnings.

Mylan’s plan for a big transaction comes amid a wave of recent acquisitions in the generic and specialty drug sectors.

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.

    • 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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