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Mar 18, 2014

Insight – Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK (Reuters) – Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.

Mar 18, 2014

Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK, March 18 (Reuters) – Some U.S. doctors
are becoming concerned about the quality of generic drugs
supplied by Indian manufacturers following a flurry of recalls
and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and
over-the-counter drugs used in the United States, making it the
second-biggest supplier after Canada.

Mar 14, 2014

Amgen vaccine triggers immune response in advanced melanoma -study

By Bill Berkrot

(Reuters) – An experimental Amgen Inc cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented on Friday.

The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.

Mar 4, 2014

Merck says dust mite allergy drug reduces symptoms in midstage study

March 4 (Reuters) – An immunotherapy pill to treat an
allergy to house dust mites being tested by Merck & Co
significantly reduced common nasal symptoms, such as sneezing
and stuffy nose, according to data from a midstage clinical
trial, the company said on Tuesday.

The drug, MK-8237, reduced nasal symptoms by 49 percent at
the higher tested dose and 27 percent at the lower dose compared
with a placebo after 24 weeks of treatment. The results, which
were deemed to be statistically significant, were presented on
Tuesday at the American Academy of Allergy, Asthma and
Immunology (AAAAI) meeting in San Diego.

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.

    • 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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