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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.

Jan 29, 2014

Biogen profit rises as new multiple sclerosis drug shines

Jan 29 (Reuters) – Biogen Idec Inc said on
Wednesday its new, high-profile oral multiple sclerosis drug
Tecfidera had sales of $398 million in the fourth quarter,
easily exceeding estimates for a third successive quarter and
keeping it on track to top $1 billion in its first year on the
market.

Some of those sales were due to U.S. inventory stocking
ahead of a 10 percent Tecfidera price increase in December.
Biogen said underlying patient demand for the drug represented
about $348 million of the U.S. sales, still ahead of analysts’
consensus expectations of about $335 million.

Jan 28, 2014

Amgen profit tops Street expectations; focus on new drugs

By Bill Berkrot

(Reuters) – Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) on Tuesday reported a quarterly profit that beat Wall Street forecasts, as it gained full control of its blockbuster rheumatoid arthritis drug Enbrel and saw solid growth in sales of newer products.

Amgen, the world’s biggest biotechnology company, also announced another positive result from a late-stage study of its high-profile experimental cholesterol drug, evolocumab.

Jan 28, 2014

Medivation prostate cancer drug impresses in pre-chemo study

By Bill Berkrot

(Reuters) – Medivation Inc’s drug for advanced prostate cancer significantly delayed progression of the disease and extended survival in a large, late stage study of patients who had not yet received chemotherapy, likely paving the way for an expanded approval of the medicine.

Xtandi, a pill known chemically as enzalutamide, is already approved to treat patients whose prostate cancer has spread and who had previously been treated with chemotherapy.

    • 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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