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Featured

aTyr Pharma wins FDA fast track for muscular dystrophy therapy

October 24, 2016 By Sarah Faulkner

aTyr Pharma wins FDA Fast Track designation for muscular dystrophy therapy

aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic candidate to receive the designation for the rare form of muscular dystrophy. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr is […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: aTyr Pharma

FDA delays Inovio phase III trial of DNA immunotherapy candidate

October 24, 2016 By Sarah Faulkner

Inovio Pharmaceuticals (NSDQ:INO) said today that the FDA placed a hold on its proposed Phase III clinical program for its investigational DNA immunotherapy candidate designed to treat pre-cancers and cancers caused by human papillomavirus. The California-based company completed a randomized, double-blind Phase II trial of the candidate in July 2014, evaluating the DNA immunotherapy treatment in women […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Oncology Tagged With: Inovio Pharmaceuticals

Cytori touts regenerative cell therapy data

October 24, 2016 By Sarah Faulkner

Cytori Therapeutics

Cytori Therapeutics (NSDQ:CYTX) touted the publication of preclinical safety and efficacy data for its cell therapy treatment for combined radiation and thermal injury. The San Diego-based company said the current healthcare system is ill-prepared to care for large numbers of patients that require simultaneous treatment and that patients with severe burns commonly suffer with prolonged […]

Filed Under: Featured, Preclinical Trials, Regenerative Medicine, Research & Development Tagged With: Cytori Therapeutics

Bacterial nanostructures developed to locally deliver proteins

October 24, 2016 By Sarah Faulkner

Bacterial nanostructures developed to locally deliver proteins

Spanish researchers demonstrated that bacterial inclusion bodies, non-toxic nanostructures, hold promise for a sustained, local delivery of protein drugs by mimicking components of a mammal’s endocrine system. New materials developed as controllable, localized systems of drug delivery often aim to be immobilized in a given tissue as a drug “depot” for long term supply of […]

Filed Under: Featured, Nanoparticles, Oncology, Research & Development

Solid drug nanoparticles could improve delivery of HIV therapies

October 21, 2016 By Sarah Faulkner

Researchers from the University of Liverpool have developed a method of delivering pediatric HIV drugs using solid drug nanoparticles, according to a study published today in Nature Communications.  There are no clinically available oral nanotherapies for HIV patients and pediatric HIV medicines are not widely available, according to the researchers. The team examined a current pediatric […]

Filed Under: Featured, Nanoparticles, Research & Development Tagged With: University of Liverpool

Medtronic secures Health Canada license for MiniMed 630G system

October 21, 2016 By Sarah Faulkner

Medtronic Minimed 630g

Medtronic (NYSE:MDT) subsidiary Medtronic Canada said today that it landed a license with Health Canada for its MiniMed 630G insulin pump system for patients with diabetes mellitus. The Fridley, Minn.-based company said it interviewed more than 1,000 diabetes patients to better understand the features they look for in an insulin pump. The final product has a […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Health Canada, Medtronic

Sunovion, medical society ally for COPD drug-delivery survey

October 21, 2016 By Sarah Faulkner

Sunovion, American College of Chest Physicians

Sunovion Pharmaceuticals and the American College of Chest Physicians yesterday launched a strategic initiative called Delivery Makes a Difference to better understand patient and healthcare provider practices in COPD therapy. A series of “nationally recognized COPD thought leaders” came together to be a part of the steering committee for the initiative. They developed a survey for 1,000 […]

Filed Under: Drug-Device Combinations, Featured, Respiratory Tagged With: American College of Chest Physicians, Sunovion Pharmaceuticals

Gold nanoparticles hold promise for pancreatic cancer treatment

October 21, 2016 By Sarah Faulkner

Gold nanoparticles could be an important part of developing a treatment for pancreatic cancer, according to new research published yesterday in the journal ACS Nano.  Previous work demonstrated that gold nanoparticles can be an effective vehicle to carry chemotherapy drugs into tumors. They can also act as a target to enhance the impact of radiation on […]

Filed Under: Drug-Device Combinations, Featured, Nanoparticles, Oncology, Research & Development

Mylan, Theravance touts Phase III data for COPD drug

October 20, 2016 By Sarah Faulkner

Mylan, Theravance

Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease, demonstrated positive results in 2 replicate phase III efficacy studies. Data from more than 1,250 moderate to severe COPD patients showed that both studies met their efficacy and safety endpoints. Revefenacin […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Respiratory Tagged With: Mylan, Theravance Biopharma

Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent

October 20, 2016 By Sarah Faulkner

Elixir Medical, Akesys Medical

Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery. The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents Tagged With: Akesys Medical, Elixir Medical Corporation

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