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Galderma wins FDA nod for dermal fillers
Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made...
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TiGenix IPO raises $36m
TiGenix (EBR:TIG) said today that it raised $36 million in an initial public offering from the sale of 2.3 million American depository shares, representing 46 million ordinary shares, at $15.50...
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BD launches high volume syringe for biologics
Becton Dickinson (NYSE:BDX) said today that it launched its BD Neopak 2.25 milliliter prefillable glass syringe designed for high-volume injection of biologics. The Franklin Lakes, N.J.-based company...
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Baxter to put up $625m for Claris Injectables generics biz
Baxter (NYSE:BAX) said today that acquired Claris Lifesciences (BOM:533288) subsidiary Claris Injectables for $625 million. The deal is expected to close in the 2nd half of next year. Deerfield,...
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Ex pharma execs first to be charged in generic drug pricing case
Former Heritage Pharmaceuticals CEO Jeffrey Glazer and ex-president Jason Malek were hit yesterday with the 1st criminal charges from a 2-year federal investigation in an ongoing generic drug pricing...
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Lilly, Boehringer’s Basaglar long-acting insulin now available in the U.S.
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals said today that its insulin glargine injection, Basaglar, is available by prescription in the U.S. Basaglar is a long-acting insulin with...
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ClearLine wins CE Mark for intravenous line device
ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air...
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Researchers use nanoparticles to overcome treatment-resistant breast cancer
Researchers from the University of Cincinnati College of Medicine have developed RNA nanoparticles that show promise in overcoming treatment-resistant breast cancer. The team’s work was published in...
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SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step...
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Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous...
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Mylan launches first generic EpiPen as state AGs sue generics makers for...
Mylan (NSDQ:MYL) launched its 1st generic EpiPen emergency allergy treatment 1 day after attorney generals from 20 states filed a civil complaint against Mylan, Teva Pharmaceuticals (NYSE:TEVA), and 4...
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Actelion gains on Sanofi deal rumors
Actelion (VTX:ATLN) shares jumped more than 8% to 214 Swiss francs after reports that Sanofi (NYSE:SNY) and the Swiss biotech are nearing a takeover deal that would value Actelion at $29.6 billion....
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Evotec, Celgene ink drug development deal for stem cell treatments for...
Evotec (ETR:EVT) said today that it inked a 5-year drug discovery and development deal with Celgene (NSDQ:CELG) to identify stem cell therapies for a range of neurodegenerative diseases including...
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Flamel Technologies dose first patient in Phase III narcolepsy trial
Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and...
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GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in...
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Amgen wins recommendation for single injection Repatha device
Amgen (NSDQ:AMGN) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for its Repatha single monthly injection device. The device is...
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Anika Therapeutics wins CE Mark for tennis elbow injection
Anika Therapeutics (NSDQ:ANIK) said today that it won CE Mark approval in the European Union for its Orthovisc-T injection. The Bedford, Mass.-based company’s treatment is indicated to relieve pain...
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Researchers use gold nanoparticles to deliver hepatitis C vaccine
Researchers at Brigham & Women’s Hospital have developed electrically activated gold nanoparticles that can bore holes into cells’ outer membranes and allow DNA, RNA and proteins to pass through...
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Study: Laser-activated deep-sea drug kills prostate cancer
Researchers from the Weizmann Institute of Science and Steba Biotech have reportedly developed a light-sensitive drug derived from deep-sea bacteria that has been shown to kill cancer cells in low-risk...
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21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs....
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