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pSivida Files Early with European Regulator for Eye Care Device, Possibly to FDA As Well

December 29, 2015By Mark Terry, BioSpace.com Breaking News Staff   Watertown, Mass.-based pSivida Corp. (PSDV) announced yesterday that it plans to file with the European Union (EU) for marketing approval for its Medidur sustained release drug delivery product to treat chronic non-infectious uveitis of the posterior segment of the eye. Only last week, on Dec. […]

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Guinea declared free of Ebola virus that killed over 2,500

Guinea was declared free of Ebola transmission on Tuesday after more than 2,500 people died from the virus in the West African nation, leaving Liberia as the only country still counting down the days until the end of the epidemic.   The announcement comes 42 days after the last person confirmed with Ebola tested negative […]

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U.S. patients get higher radiation doses in some heart tests

(Reuters Health) – Compared to patients in other countries, the typical U.S. patient is more often exposed to excessive radiation during myocardial perfusion imaging, a new study suggests. Myocardial perfusion imaging (also called a nuclear stress test) is performed on millions of people a year in the U.S. alone to help diagnose and treat coronary […]

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Chimerix antiviral drug fails, shares plummet to record low

Chimerix Inc said its oral antiviral drug did not significantly reduce a certain kind of infection in stem cell transplant patients in a late-stage study, sending its shares to a record low. The company’s shares fell as much as 79.7 percent in morning trading to $7.21. Patients taking the drug, brincidofovir, did not experience significant […]

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POZEN Announces Effectiveness Of Aralez Registration Statement On Form S-4 And Provides Update On Key Milestones For 2016

-POZEN schedules stockholder meeting for February 2, 2016-  -Plan to re-file YOSPRALA™ New Drug Application early in the second quarter; Approval and launch targeted in fourth quarter-  CHAPEL HILL, N.C., Dec. 28, 2015 /PRNewswire/ — POZEN Inc. (“POZEN”) (NASDAQ: POZN) today announced that the registration statement on Form S-4 filed by Aralez Pharmaceuticals Inc. (“Aralez”) on […]

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Valeant to be led by group of execs as CEO on medical leave

Valeant Pharmaceuticals International Inc said a group of company executives will take over in an interim capacity, until CEO Michael Pearson returns from medical leave. Pearson, who joined Valeant as CEO in 2010 after a 23-year career at McKinsey & Company, will be on a medical leave of absence, effective immediately, the company said in […]

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Immune Pharmaceuticals Announces Exclusive License to a Novel Bispecific Antibody Technology

NEW YORK, Dec. 28, 2015 /PRNewswire/ — Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (“Immune”) a clinical-stage company developing novel therapies for the treatment of immuno-inflammatory diseases and cancer, today announced it has entered into an exclusive license with Atlante Biotech SAS, to the patents and know-how for a new format of bispecific antibodies. Dr. Daniel Teper, CEO […]

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Proteostasis Therapeutics, Inc. Files for a $86 Million IPO

Proteostasis Therapeutics, which is developing combination therapeutics that use amplifier molecules to modulate proteins, filed on Wednesday with the SEC to raise up to $86 million in an initial public offering. The Cambridge, MA-based company, which was founded in 2006 and booked $4 million in sales for the 12 months ended September 30, 2015, plans […]

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Agenus Acquires PhosImmune in $44.9 Million Deal

December 28, 2015By Mark Terry, BioSpace.com Breaking News Staff   Lexington, Mass.-based Agenus Inc. (AGEN) announced last week that it was acquiring PhosImmune Inc. for $9.9 million, with an additional $35 million in milestone payments. Agenus focuses on immuno-oncology. It has an AutoSynVax vaccine program that targets patient-specific tumor neoantigens. PhosImmune has numerous neoantigen assets. […]

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New blood thinner ‘antidote’ to help doctors move past warfarin

A new class of blood thinners that competes with widely used warfarin should get a boost next year when an “antidote” that can reverse the medications’ effects in an emergency is expected to enter the market, according to top U.S. heart doctors and investors.   Xarelto, from Bayer AG and Johnson & Johnson, and Eliquis, […]

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Baxalta Playing Hard to Get as Shire Sweetens Deal

Illinois-based Baxalta (BXLT) is still playing hard to get, as Dublin-based Shire (SHPGY) sweetened its deal to acquire the company. In July, Shire made a bid for Baxalta, which wasn’t accepted. In early August, Shire went public with the offer in hopes of pressuring the Baxalta board and shareholders to consider the deal. Baxalta had […]

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Adamas says lead drug meets late-stage study goals

Drugmaker Adamas Pharmaceuticals Inc’s experimental treatment to reduce the side effect of a commonly prescribed Parkinson’s drug met the main goal of a late-stage study, sending its shares up as much as 58.5 percent. Shares of the company jumped to $26.72 in Wednesday morning trade. The company was trading at similar levels in June when […]

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Kamada’s Human Rabies Immune Globulin Successfully Meets Primary Endpoint in U.S. Pivotal Phase 2/3 Clinical Trial as a Post-Exposure Treatment

Strategic agreement with Kedrion for clinical development and marketing Plans to file a BLA with the FDA in mid-2016   NESS ZIONA, Israel–(BUSINESS WIRE)–Kamada Ltd. (KMDA) (KMDA.TA), a plasma-derived protein therapeutics company focused on orphan indications, reports that the pivotal Phase 2/3 clinical trial with the Company’s human rabies immune globulin (IgG or KamRAB™ or […]

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Sanofi submits new diabetes drug application to U.S. regulator

French drugmaker Sanofi said on Wednesday it had submitted an application to the U.S. Food and Drug Administration (FDA) for a single daily insulin injection to treat adults with type 2 diabetes.   Sanofi said it had requested a six-month review of its new drug application by the FDA, rather than the standard 10 months. […]

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AstraZeneca gets U.S. approval for gout drug Zurampic

U.S. health regulators on Tuesday approved AstraZeneca’s drug Zurampic to treat a condition associated with gout to be used in combination with another type of drug that reduces production of uric acid in the body. Zurampic, known chemically as lesinurad, works by helping the kidneys to excrete uric acid. Gout is a painful form of […]

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Celgene settles U.S. patent litigation for top seller Revlimid

Celgene Corp said it would allow for the sale of a generic version of its flagship multiple myeloma drug, Revlimid, in the United States over a year before patents covering the drug expire. The company said it would provide India-based Natco Pharma Ltd and its U.S. partner, Arrow International Limited, a unit of Allergan Plc, […]

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Amgen Acquires MediGene AG Spin-off

December 22, 2015 By Mark Terry, BioSpace.com Breaking News Staff   Munich, Germany-based Medigene AG (MDGEF.PK) announced yesterday that it had sold its spinoff company, Catherex, Inc., to Amgen (AMGN). Medigene, as primary Catherex shareholder, will receive about 40 percent of the payments from Amgen. Catherex shareholders will receive an upfront payment of $10.5 million […]

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Clinton announces plan to battle Alzheimer’s

Democratic presidential candidate Hillary Clinton on Tuesday announced a slate of proposals to battle Alzheimer’s disease and seek a cure by 2025, including an increase in funding for research on the disease and related disorders.   Clinton called for a decade-long investment of $2 billion per year for research, which her campaign called a fourfold […]

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TPG invests $75 million into life sciences service firm: sources

The growth equity arm of buyout firm TPG Capital LP has invested $75 million in life sciences services company Precision for Medicine, according to people familiar with the matter, the latest in a string of TPG investments in the healthcare sector. The sources asked not to be identified ahead of an announcement of the investment […]

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PSivida Corp says experimental eye therapy meets study goal

Drugmaker pSivida Corp said its lead experimental therapy prevented inflammation in the back of patients’ eyes in a late-stage study. The company’s shares were up 27 percent at $4.70 in premarket trading on Tuesday. The drugmaker said only 18.4 percent of the patients given the treatment Medidur had the condition, posterior uveitis, return, compared with […]

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