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FDA Approves Portrazza for Specific Type of Lung Cancer

INDIANAPOLIS, Nov. 24, 2015 /PRNewswire/ —  Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Portrazza™ (necitumumab injection for intravenous use, 800 mg/50 mL), in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung […]

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FDA rejects Indivior’s nasal spray for opioid overdose

Indivior Plc said on Tuesday the U.S. Food and Drug Administration rejected its nasal spray for the emergency treatment of opioid overdose. The company said it was reviewing the health regulator’s response. These sprays contain naloxone, a drug that has been used to treat opioid overdose for nearly 45 years in injectable forms. Last week, […]

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FDA approves expanded use of Bristol-Myers’ skin cancer drug

Bristol-Myers Squibb Co said the U.S. Food and Drug Administration had approved the expanded use of its cancer drug, Opdivo, to treat an additional form of advanced skin cancer. Opdivo, first approved in December 2014, raked in worldwide revenue of $467 million in the nine months ended Sept. 30. The drug has been approved for […]

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Almost 16 million on HIV treatment as AIDS pandemic tide turns

Some 15.8 million people are now on HIV treatment and a five-year strategy to end the threat of a never-ending AIDS pandemic is starting to show results, the United Nations AIDS program said on Tuesday.   Estimates show new HIV infections have fallen by 35 percent since the peak of the three-decade-old pandemic in 2000, […]

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Array BioPharma’s New CFO to Step Down After Just Three Months on the Job

BOIULDER, Colo. – After three months on the job, Array BioPharma, Inc. (ARRY)’s Chief Financial Officer Patricia Henahan is resigning her position, the company disclosed in a federal filing. Henahan’s last day is set for Dec. 17, four months and nine days after assuming her post with the company. Array disclosed the job change in […]

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As Pfizer-Allergan Marry, Already Planning the Divorce

November 24, 2015By Mark Terry, BioSpace.com Breaking News Staff   Now that the Pfizer (PFE)-Allergan (AGN) merger is official, the company and analysts are looking at details about the merged company splitting into two or more companies. This isn’t exactly new thinking. All throughout the three weeks of rumors, the idea that the new mega-company […]

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Novartis heart failure medicine Entresto wins EU approval

The European Commission has approved Novartis’ Entresto drug for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction, the Swiss drugmaker said on Tuesday.   Entresto is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. Analysts estimate […]

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FDA approves expanded use of Emergent BioSolution’s anthrax vaccine

The U.S. Food and Drug Administration approved to expand the use of Emergent BioSolutions Inc’s anthrax vaccine to prevent suspected or confirmed exposure to the bacterium that causes the disease. The FDA approved the vaccine, BioThrax, for use in patients who are between 18-65 years of age in conjunction with antibiotic treatment. (1.usa.gov/1OcqiJE) BioThrax was […]

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Docs, and patients, should remember to use generics

(Reuters Health) – Prescribing generic medicines instead of brand name drugs whenever possible cuts costs, improves patient adherence and improves health outcomes, according to a new recommendation from the American College of Physicians. “Generic medications are cheaper and patients are more likely to get those prescriptions filled,” said Dr. Amir Qaseem of the American College […]

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Bristol-Myers signs deal with U.N. group for generic hepatitis C drug

A United Nations-backed organization working to cut the price of HIV drugs said it had signed a deal with Bristol-Myers Squibb Co to allow generic versions of the company’s hepatitis C drug to be sold in 112 low- and middle-income countries. The drug, Daklinza, is on the World Health Organization’s list of essential medicines. Hepatitis […]

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