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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.

Jan 23, 2014

Intuitive Surgical sees fewer da Vinci robot sales in 2014

By Bill Berkrot

(Reuters) – Intuitive Surgical Inc (ISRG.O: Quote, Profile, Research, Stock Buzz) on Thursday said it expects to sell fewer of its high-priced da Vinci surgical robot systems in 2014 than last year and diverged from past practice by not providing a revenue forecast for the year.

The company said it would issue a revenue forecast later in the year when it has a clearer view of business trends, such as da Vinci use for benign gynecology surgeries, which has been slowing in the United States, and whether it secures reimbursements for procedures in Japan in addition to prostate surgeries.

Jan 23, 2014

Amgen cholesterol drug meets goal of 3rd late stage trial

By Bill Berkrot

(Reuters) – A cholesterol fighter developed by Amgen Inc from a highly promising new class of medicines significantly lowered levels of “bad” LDL cholesterol in a late stage trial in patients unable to tolerate statin drugs, the company said on Thursday.

The results marked the third successful Phase III test of the drug evolocumab reported by Amgen in recent months – this one in a patient population among the most in need of alternative therapies.

Jan 17, 2014

U.S. FDA approves Medtronic heart valve system early

Jan 17 (Reuters) – Medtronic Inc’s minimally
invasive system for replacing diseased heart valves won U.S.
approval for use in patients deemed too frail to endure
traditional open heart surgery, the U.S. medical device maker
said on Friday.

The Food and Drug Administration approved Medtronic’s
CoreValve system based on U.S. clinical trials in which it was
shown to be safe and effective while demonstrating low rates of
stroke and valve leakage, the company said.

Jan 14, 2014

Teva did not infringe OxyContin patents, shares rise

By Jonathan Stempel and Bill Berkrot

(Reuters) – A federal judge said Teva Pharmaceutical Industries Ltd did not infringe five patents related to the painkiller OxyContin, helping push shares of the world’s largest generic drug manufacturer up 6.7 percent on Tuesday.

Earlier in the day, Teva executives said at a JPMorgan healthcare conference that they were confident a new version of its multiple sclerosis drug Copaxone that requires less frequent dosing will soon win regulatory approval for use in the United States.

Jan 14, 2014

Teva sees U.S. approval of three times weekly Copaxone soon

Jan 14 (Reuters) – Teva Pharmaceutical Industries Ltd
said on Tuesday it is “completely confident” the new
version of its flagship multiple sclerosis drug, Copaxone, which
features less frequent dosing, will be approved in the United
States in the near future.

The Israel-based company said it believes it will be able to
get 45 percent of regular Copaxone patients to switch to the new
drug, which is injected three times a week instead of daily.

Jan 14, 2014

Regeneron to report $400 mln 4th quarter Eylea sales-CEO

Jan 14 (Reuters) – Regeneron Pharmaceuticals Inc
will report about $400 million in U.S. sales of its high-profile
eye drug Eylea for the fourth quarter of 2013, bringing the
total for the year to about $1.4 billion with lots of room for
future sales growth, the U.S. biotech company’s chief executive
said on Tuesday.

Regeneron CEO Len Schleifer called the Eylea franchise far
from mature and said sales of the drug have “plenty of room for
growth” in both the United States and Europe through approvals
for additional uses and other initiatives.

Jan 13, 2014

Celgene raises forecasts on cancer drug sales strength

By Bill Berkrot

(Reuters) – U.S. biotech company Celgene Corp (CELG.O: Quote, Profile, Research, Stock Buzz) raised sales and profit forecasts for 2015 and 2017 on Monday, saying its improved long-term outlook was based on current momentum for its blood cancer medicines.

The relatively conservative increases, however, and a 2014 forecast that was slightly lower than current Wall Street estimates, were met with dampened shareholder enthusiasm and Celgene shares fell more than 3 percent.

    • 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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