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TetraLogic Slashes Two-Thirds of Workforce After Mid-Stage Trial Failure

January 22, 2016By Alex Keown, BioSpace.com Breaking News Staff   PHILADELPHIA – TetraLogic Pharmaceuticals (TLOG) plans to eliminate two-thirds of its employees by next month following the failure of a Phase II treatment for high-risk patients with myelodysplastic syndromes earlier this month. The company filed a regulatory report with the U.S. Securities and Exchange Commission […]

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U.S. government suspends enrollment in Cigna Medicare Advantage, drug plans

The U.S. government has suspended new enrollment in Cigna Corp’s Medicare Advantage health plans for seniors and standalone Medicare prescription drug plans, citing noncompliance in its appeals and grievances procedures. The government said Cigna had deficiencies in its appeals and grievances processes in both Medicare Advantage and the Medicare prescription drug program, according to a […]

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Johnson & Johnson Halts Trial of Drug Similar to One Linked to Brain Dead Tragedy in France

NEW BRUNSWICK, N.J. — Johnson & Johnson (JNJ) has halted a trial of an experimental fatty acid amide hydrolase inhibitor, a drug similar to one being tested in France by a Portuguese pharmaceutical company that left one patient brain dead and five others hospitalized, Reuters reported this morning. A Johnson & Johnson spokesperson told Reuters […]

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GlaxoSmithKline (GSK) Kills U.S. Part of Eczema Treatment Deal With Basilea (BSLN.SW)

GlaxoSmithKline (GSK), headquartered in Basel, Switzerland, announced yesterday that it had ended its deal with Swiss company Basilea Pharmaceutica Ltd. (BSLN.SW) to develop alitretinoin in the U.S. In June 2012, the two companies, both headquartered in Basel, Switzerland, entered into an exclusive global agreement for Toctina. The drug was at that time being marketed in […]

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FDA gives full approval to Amgen blood cancer drug

The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc’s cancer drug Kyprolis in combination with certain other therapies to treat patients with multiple myeloma. The agency also approved the drug as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous treatments. […]

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Nephron Pharma Cuts Another 250 Employees At Orlando HQ

January 21, 2016By Alex Keown, BioSpace.com Breaking News Staff   ORLANDO – Florida-based Nephron Pharmaceuticals is slashing another 250 jobs at its Orlando manufacturing facility, the Orlando Business Journal reported Thursday afternoon. The maker of generic respiratory medications filed a WARN notice with the Florida Department of Economic Opportunity saying that 250 workers will be […]

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What to expect when you’re expecting two feet of snow

With a huge winter storm looming over the eastern United States, many of the region’s residents will stock up on canned goods, bottled water and – for some – diapers. The storm, which is expected to pound the Mid-Atlantic states on Friday and Saturday, has mothers-to-be asking a simple, yet vital, question: What do you […]

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Aetna’s deal for Humana will push up costs for seniors: think tank

Aetna Inc’s (AET.N) plan to buy smaller insurer Humana Inc (HUM.N) for $31 billion will mean seniors will pay higher Medicare Advantage premiums, according to a new report by the think tank Center for American Progress (CAP). Aetna’s proposed deal for Humana would combine Aetna’s 7 percent of the Medicare Advantage market with Humana’s 19 […]

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Novo aims to be ahead of pharma pack with Iran investment

Danish drugmaker Novo Nordisk, the world’s top insulin supplier, expects to be ahead of the pack now nuclear sanctions are lifted in Iran, thanks to a continuous presence and a pre-emptive investment plan.   The country is an attractive target for Big Pharma seeking to sell new medicines to its large and growing population, but […]

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Drug firms ask governments to do more in fight against superbugs

More than 80 international drug and biotech firms urged governments to work with them to combat drug-resistant superbugs which could kill tens of millions of people within decades unless progress is made and new antibiotics found.   In a declaration at the World Economic Forum in Davos, they called for coordinated efforts to cut unnecessary […]

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U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen®

INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s (NYSE: LLY) Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than […]

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Alkermes depression drug fails in studies, shares plunge

Alkermes Plc said its drug for major depressive disorder did not meet the main goal in two late-stage studies, sending its shares plunging by a third. The drug, ALKS 5461, is the company’s lead product designed to rebalance brain function that is dysregulated in the state of depression. “We believe trial failures present a major […]

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GSK chief reiterates standalone consumer unit is an option

GlaxoSmithKline’s chief executive, under pressure from some investors to break up the group, said on Thursday the drugmaker’s large consumer healthcare unit had the potential to be a standalone unit at some stage.   “For the first time at GSK we have created a business which has the potential to be of sufficient scale that […]

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After Restructuring that Includes 25% Employee Reduction, Bay Area’s StemCells CEO Given $1 Million Severance

January 21, 2016By Alex Keown, BioSpace.com Breaking News Staff   NEWARK, Calif. – Martin McGlynn, the departing chief executive officer of StemCells, Inc. (STEM), received a $1 million parting gift as he left the company, the San Francisco Business Times reported this morning. While a large severance package is not unusual, especially in the biotech […]

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Five, Including Two GlaxoSmithKline Scientists, Charged in Scheme to Steal Biopharma Secrets from GSK

PHILADELPHIA – Five people have been charged in a scheme to steal biopharmaceutical trade secrets from GlaxoSmithKline (GSK), including two GSK scientists, the U.S. Attorney’s Office of the Eastern District of Pennsylvania announced this afternoon. Following an investigation by the Federal Bureau of Investigation, the U.S. Attorney’s Office charged Yu Xue, 45, of Wayne, Pa., […]

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Zafgen soars on hope of reviving obesity drug tests

Zafgen Inc reported positive data on its obesity drug, which has been marred by two patient deaths, and said the data could help convince the U.S. Food and Drug Administration to allow it to restart trials on the drug. The company’s shares more than doubled on Wednesday on hopes that Zafgen could be allowed to […]

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High fish consumption in pregnancy tied to brain benefits for kids

(Reuters Health) – When mothers eat three sizeable servings of fish each week during pregnancy it may benefit children’s brains for years to come, according to a large study in Spain. Researchers followed nearly 2,000 mother-child pairs from the first trimester of pregnancy through the child’s fifth birthday and found improved brain function in the […]

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AbbVie CEO Argues Value of Company’s Pipeline, Piques Analysts Interest

At last week’s J.P. Morgan Healthcare Conference held in San Francisco, Chicago-based AbbVie (ABBV)’s chief executive officer, Richard Gonazalez, presented data in support of the company’s pipeline. The Motley Fool points out that many analysts believe the company depends too much on its anti-inflammatory drug, Humira. Gonzalez’s talk was an effort to show the company […]

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Vaccines alliance signs $5 million advance deal for Merck’s Ebola shot

The Gavi global alliance for vaccines and immunization group signed a $5 million advance purchase commitment on Wednesday to buy a vaccine being developed by Merck to protect against future outbreaks of the deadly Ebola virus.   Gavi said the agreement would help the U.S. drugmaker take the experimental Ebola vaccine through late-stage clinical trials […]

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CDC issues guidelines for pregnant women during Zika outbreak

The U.S. Centers for Disease Control and Prevention on Tuesday issued guidelines for doctors caring for pregnant women who might have been exposed to Zika virus, a mosquito-borne infection that can cause brain damage in a developing fetus. The new guidelines, first reported by Reuters, lay out recommendations for doctors whose pregnant patients have traveled […]

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