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AstraZeneca’s $4 billion Acerta deal endorsed by orphan drug status

AstraZeneca’s (AZN.L) bold move to buy 55 percent of privately held biotech firm Acerta Pharma for $4 billion in December has been vindicated, at least in part, by the award of special “orphan” status to the key experimental drug involved.   The drugmaker said on Thursday that the European Medicines Agency had recommended acalabrutinib as […]

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Brexit is the wrong prescription, says European pharma industry

Britain’s departure from the European Union would threaten scientific research and jeopardize the 28-nation bloc’s system of drug regulation, the European pharmaceutical industry said on Wednesday.   The declaration is the clearest statement yet on the issue by an industry that includes EU-based players such as Britain’s GlaxoSmithKline and AstraZeneca, France’s Sanofi and Germany’s Bayer. […]

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Otsuka Announces Worldwide Access Plan for Delamanid with Stop TB Partnership’s Global Drug Facility

MUNICH, February 24, 2016 /PRNewswire/ — Recognizing the immediate need for access to new therapeutic options for multidrug-resistant TB (MDR-TB), Otsuka Novel Products GmbH (Otsuka) today announced an ambitious new public-private partnership with the Stop TB Partnership (Stop TB) to increase access and scale-up treatment of delamanid (Deltyba™) in low- and middle-income countries. Any country […]

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For Clinical Trials, Centralized Imaging Data Collection and Review Is a Must

  By Joseph Pierro, chief medical officer of Biomedical Systems.   In many clinical trials, clinical imaging plays an important role in the drug development process. Whether the trial involves drugs, biologics, or devices, imaging may be used to measure the efficacy and safety of the investigational product. An independent assessment based on the centralized […]

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Proof Eating Chocolate Makes Your Brain Work Better, University of South Australia Study

The Cognitive Benefits Of Eating Chocolate With Easter about a month away, it’s good news for chocolate lovers as new research has revealed that those who eat chocolate at least once per week performed better on multiple cognitive tasks, compared to those who ate chocolate less frequently. This research was undertaken by Dr Georgie Crichton, […]

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Amgen, UCB say osteoporosis drug meets main goal in late-stage trial

Amgen Inc and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study. The results, from a Fracture study in postmenopausal women with osteoporosis (FRAME), showed that the drug Romosozumab met a secondary […]

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White House, House Republicans spar over Zika, Ebola funding

The White House said on Friday that it would be “profoundly unwise” to plow money set aside for Ebola-related projects into research and mitigation efforts for the mosquito-borne Zika virus as several top Republican lawmakers have requested. Democratic President Barack Obama has asked the U.S. Congress for more than $1.8 billion to fight Zika in […]

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Cambridge Biotech AVROBIO Launches with Former MassBio Chair as CEO

February 19, 2016By Mark Terry, Breaking News Staff   Cambridge, Mass.-based venture capital firm Atlas Venture launched another Cambridge biotech startup yesterday, AvroBio. No financial details were disclosed. The company is founded on two novel cell and gene therapies that came out of the laboratories of Christopher Paige and Jeffrey Medin at the University […]

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Novartis wins FDA breakthrough therapy for AML treatment

Novartis received breakthrough therapy designation from the U.S. Food and Drug Administration for an investigational treatment for newly-diagnosed FLT3-mutated acute myeloid leukemia, the Swiss drugmaker said on Friday. Patients who received PKC412, also called midostaurin, combined with standard induction and consolidation chemotherapy experienced what Novartis called “a significant improvement in overall survival”. With the announcement, […]

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Zafgen obesity drug succeeds in mid-stage trial, shares rise

Zafgen Inc’s controversial obesity drug reduced the weight of overweight diabetic patients, the second trial success in as many months for the drug on which all tests have been halted since December after two patients died. The company said on Thursday patients given 1.8 mg and 1.2 mg doses of beloranib lost 12.7 and 13.5 […]

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