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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.

Jan 9, 2014

Roche’s Tamiflu for children temporarily in short supply in U.S.

By Bill Berkrot

(Reuters) – In what is shaping up to be a tough and widespread flu season in the United States, one of the leading medicines used to treat children with the sometimes deadly virus is in short supply.

“There has been strong and early demand for Tamiflu Oral Suspension (OS) and we are experiencing a temporary delay in the packaging of Tamiflu OS,” said Tara Iannuccillo, a spokeswoman for Roche Holding AG’s Genentech unit which manufactures the drug and uses distributors to supply retail pharmacies with the product.

Jan 8, 2014

FDA approves AstraZeneca type 2 diabetes drug

Jan 8 (Reuters) – U.S. health regulators on Wednesday
approved an AstraZeneca drug from a new class of
medicines to treat type 2 diabetes after previously rejecting it
over safety concerns.

The Food and Drug Administration’s approval had been
expected after an outside advisory panel of medical experts
voted by a wide margin in December to recommend its approval,
saying the benefits of the drug, dapagliflozin, outweighed its
safety risks. It will be sold in the United States under the
brand name Farxiga.

Jan 7, 2014

J&J, Pharmacyclics leukemia drug improves survival in study

By Bill Berkrot

(Reuters) – An independent committee recommended a late stage trial of a cancer drug developed by Pharmacyclics Inc and Johnson & Johnson be stopped early as it became clear it helped patients with chronic lymphocytic leukemia (CLL) live longer, paving the way for additional approval of the medicine.

The announcement of the study’s early success by Pharmacyclics on Tuesday sent its shares soaring 20 percent higher and took J&J shares up by nearly 2 percent.

Dec 19, 2013

Vertex cystic fibrosis drug misses trial goal, helps some

By Bill Berkrot

(Reuters) – Vertex Pharmaceuticals Inc’s Kalydeco cystic fibrosis drug failed to meet the main goal of a late-stage study aimed at expanding its use into patients with a specific gene mutation associated with the rare, life-threatening lung disease, the company said on Thursday.

Overall, Kalydeco (ivacaftor) did not significantly improve lung function in CF patients ages 6 and older with the R117H gene mutation. However, among those aged 18 and older in the 69-patient study with more advanced lung disease, Kalydeco led to a statistically significant improvement in lung function and other secondary measures, the company said.

    • 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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