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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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Sanofi Whistleblower Alleges Company Attorneys Destroyed Documents

As a whistleblower lawsuit against Paris-based Sanofi (SNY) steams ahead, ex-paralegal Diane Ponte alleges that Sanofi lawyers destroyed documents rather than provide them in other legal cases.   Ponte has accused Sanofi, among other things, of shifting $34 million in kickbacks and “incentive payments” to doctors and pharmacies to influence them to prescribe its diabetes […]

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Novartis AG Fesses Up to Valeant-Like Pharmacy Scheme in $390 Million Settlement

BASEL, Switzerland – Novartis AG (NVS) will pay $390 million to settle a civil lawsuit related to the kickback payments to specialty pharmacy companies that distributed the drugs Exjade and Myfortic, Novartis announced Friday. The settlement, which is between Novartis Pharmaceutical Corporation (NVS), a U.S. subsidiary of Novartis AG, will be paid to both the […]

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AstraZeneca Sells Crohn’s Drug Rights to Perrigo for $380 Million

AstraZeneca enters into agreement with Perrigo for rights to Entocort in the US Divestment  further sharpens focus on three main therapy areas Agreement follows ex-US divestment of Entocort in July 2015   23 November 2015 AstraZeneca today announced that it has entered into an agreement with Perrigo Company plc for the divestment of US rights […]

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Pfizer Marries Allergan in $160 Billion Deal With Pfizer’s Read to Stay as CEO and Chairman

After three weeks of speculation New York-based Pfizer Inc. (PFE) announced today that it was merging with Dublin, Ireland-based Allergan plc (AGN). Board members for both companies unanimously voted Sunday to approve the deal, which will have a total enterprise value of about $160 billion.   The deal will be a stock transaction of about […]

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Roche buoyed by early data on atezolizumab in advanced melanoma

Swiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma.   A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were […]

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Movember 2015 brings you the Sexy Men of Technology Calendar

More than just humor–it’s humor with a message   Columbus, Ohio – GSW, an industry leader in healthcare advertising and an inVentiv Health company, and LiveTiles, a global technology company headquartered in Times Square, NYC, have partnered to unveil the Sexy Men of Technology Calendar for Movember 2015, a public awareness campaign from the Movember […]

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Novartis gets FDA approval for skin cancer drug combination

Novartis AG said on Friday it received the U.S. Food and Drug Administration’s regular approval for a drug combination to treat an aggressive form of skin cancer. The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years overall survival in patients, the company said. The combination was initially approved based […]

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NovoCure’s cancer therapy effective in late-stage study

NovoCure Ltd said its lead cancer therapy improved survival rate in brain cancer patients in combination with Avastin in a late-stage study, sending its shares up 23 percent in extended trading. NovoCure’s therapy, Optune, which was evaluated in combination with Roche Holding AG’s cancer drug, reduced the risk of death by 39 percent in patients, […]

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Celldex vaccine improves long-term brain cancer survival in study

New data from a midstage trial show that Celldex Therapeutics Inc’s experimental brain cancer vaccine, combined with standard therapy, continues to improve chances of survival for patients with recurrent cancer. The updated results sent shares of Celldex up $1.74, or 12 percent, to $16.23 on the Nasdaq. The therapy, designed to enlist the body’s immune […]

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Bumper haul of expensive new drugs heads to U.S. and Europe

Drug companies have brought a host of expensive new medicines to market in the United States and Europe this year, figures show, another bumper haul for an industry often accused of over-charging. Drug prices are set to be a major issue in the run-up to the U.S. presidential election next year, with Democratic candidate Hillary […]

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