Oct 30 (Reuters) – Treatment of advanced squamous cell
non-small cell lung cancer (NSCLC) with Bristol-Myers Squibb
Co’s experimental immunotherapy nivolumab led to a
one-year survival rate of 41 percent in a midstage clinical
trial, according to data being presented at a medical meeting.
While the study called CheckMate-063 did not compare
nivolumab with another drug or placebo, the historical one-year
survival rate for patients like those in the trial, whose cancer
had progressed after treatment with two or more prior therapies,
is between 5.5 percent and 18 percent, the company said.
NEW YORK, Oct 28 (Reuters) – Amgen Inc forecast
2015 earnings and revenue well ahead of Wall Street projections
Tuesday and announced plans to cut costs and increase returns to
shareholders through a dividend increase and share repurchases,
sending shares up more than 2 percent in premarket trading.
Amgen Chief Executive Robert Bradway said there is no plan
to split the company into mature and growth product businesses
as had been urged by Daniel Loeb’s Third Point hedge fund, a
NEW YORK, Oct 28 (Reuters) – Amgen Inc on Tuesday
forecast 2015 earnings and revenue well ahead of Wall Street
projections and announced plans to cut costs and increase
returns to shareholders through a dividend increase and share
The world’s largest biotechnology company, at a business
update for analysts and investors in New York, said it was
looking for 2015 adjusted earnings of $9.05 to $9.40 a share on
revenue of $20.8 billion to $21.3 billion.
By Bill Berkrot
(Reuters) – Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) on Monday reported higher-than-expected third quarter earnings and revenue, even as net profit fell due to a hefty restructuring charge, and the company raised its full-year forecast.
The world’s largest biotechnology company recorded a $376 million charge related to restructuring moves announced July 29 and expects to take another charge of up to $150 million in the fourth quarter.
By Bill Berkrot
(Reuters) – Celgene Corp (CELG.O: Quote, Profile, Research, Stock Buzz) on Thursday reported third-quarter profit rose 37 percent on a double-digit rise in sales of its flagship multiple myeloma drug Revlimid, and the U.S. biotechnology company expressed great confidence in a closely-watched treatment for Crohn’s disease it recently acquired.
Celgene shares jumped 5 percent after the company said it was finalizing plans to move the Crohn’s drug, GED-301, into Phase III trials following a presentation at a medical meeting this week of midstage data that showed high and durable remission rates.
NEW YORK (Reuters) – U.S. health officials unveiled new measures on Wednesday to carry out Ebola monitoring on anyone entering the country from the three nations at the center of a West African epidemic, increasing precautions to stop the spread of the virus.
The U.S. Centers for Disease Control and Prevention (CDC) said that beginning Monday, travelers from Liberia, Sierra Leone and Guinea will be directed to check in with health officials every day and report their temperatures and any Ebola symptoms for 21 days, the period of incubation for the virus.
By Bill Berkrot
(Reuters) – Biogen Idec Inc on Wednesday reported sales of its big-selling new multiple sclerosis drug, Tecfidera, that fell short of Wall Street’s lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares about 8 percent lower.
Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for four and a half years.
Oct 22 (Reuters) – Sales of Biogen Idec Inc’s
big-selling new oral multiple sclerosis drug Tecfidera fell
short of lofty Wall Street estimates for the first time and its
shares fell nearly 3 percent, even as the company reported
higher-than-expected third-quarter profit and raised its
full-year earnings forecast.
Tecfidera, which has enjoyed one of the best new drug
launches in pharmaceutical history since its March 2013 U.S.
approval, had sales of $787 million in the quarter. Analysts,
who in previous quarters had watched Tecfidera sail past their
sales estimates, were looking for about $800 million this time
By Bill Berkrot
(Reuters) – A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc’s cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said.
The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States.
NEW YORK (Reuters) – A young woman complaining of abdominal pain and nausea who had traveled to Africa arrived at a Long Island hospital fearful that she had contracted Ebola. She did not have the virus, but the pregnancy test was positive.
The woman had been to South Africa, more than 3,400 miles (5,400 km) from the three West African countries enduring the worst Ebola outbreak on record, and the trip ended six weeks prior, or twice the potential incubation period for Ebola infection.