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Wall Street Beat

The stem cell therapy that could reverse hearing loss

March 23, 2017 By Sarah Faulkner

Frequency Therapeutics is betting that it can change the lives of millions of Americans with hearing loss, by triggering the body’s natural ability to heal itself. Researchers have used cells in regenerative medicine for decades – in 1931, the father of cell therapy, Paul Niehans, treated a patient with material from calf embryos. Although today’s […]

Filed Under: Featured, Stem Cells, Wall Street Beat Tagged With: Frequency Therapeutics

Mylan recalls 81,000 EpiPens over reports of device failure

March 23, 2017 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Regulatory/Compliance, Wall Street Beat Tagged With: Centers for Medicare and Medicaid Services (CMS), Mylan

Origin treats first patients in study of nitric oxide for diabetic foot ulcers

March 22, 2017 By Sarah Faulkner

Origin treats first patients in study of nitric oxide for diabetic foot ulcers

Origin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers. The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, […]

Filed Under: Clinical Trials, Diabetes, Featured, Wall Street Beat, Wound Care Tagged With: Origin

Avrobio launches gene therapy program for Gaucher disease

March 22, 2017 By Sarah Faulkner

Avrobio launches gene therapy program for Gaucher disease

Cambridge, Mass.-based Avrobio said today that it expanded its pipeline to include a preclinical program focused on a gene therapy for Gaucher disease. The investigational gene therapy makes use of a patient’s blood stem cells, genetically modifying them with a fully functional copy of the faulty gene responsible for the glucosylceramide accumulation that is characteristic […]

Filed Under: Featured, Preclinical Trials, Research & Development, Stem Cells, Wall Street Beat Tagged With: Avrobio

Sanofi gains on Q4 results; a look at some of the top drug-delivery earners in 2016

March 22, 2017 By Sarah Faulkner

Prescription drugs

Shares in Sanofi (NYSE:SNY) have gained 11% to $44.58 apiece since the company released its 4th-quarter and full year 2016 financial results in February. The French company posted profits of $731.5 million on sales of $8.21 billion for the 3 months ended Dec. 31, for bottom-line growth of 136.5% on sales growth of 3.3% compared with […]

Filed Under: Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Abbott Laboratories, Amgen, Biogen Idec, Bristol-Myers Squibb Co., C.R. Bard, Catalent, Eli Lilly & Co., GlaxoSmithKline plc, Medtronic, Merck, Mylan, Novartis, Roche, Sanofi-Aventis, Teva Pharmaceuticals

Novaliq, AFT Pharmaceuticals ink licensing deal for NovaTears dry eye therapy

March 21, 2017 By Sarah Faulkner

Ocular therapeutics company Novaliq said today that it inked a strategic licensing agreement with AFT Pharmaceuticals for the commercialization of its dry eye therapy, NovaTears, in Australia and New Zealand. NovaTears is the Germany-based company’s 1st commercially available product indicated for the treatment of evaporative dry eye diseases. According to the agreement, AFT has an exclusive […]

Filed Under: Drug-Device Combinations, Featured, Optical/Ophthalmic, Wall Street Beat Tagged With: AFT Pharmaceuticals, Novaliq GmbH

Progenitor cell therapy improves motor function in patients with spinal cord injury

March 21, 2017 By Sarah Faulkner

Shares in Asterias Biotherapeutics (NYSE:AST) jumped 11% today to $3.53 apiece after the company reported positive data for its AST-OPC1 progenitor cell therapy in patients with spinal cord injuries. The Phase 1/2A clinical trial includes 6 patients in the AIS-A 10 million cell cohort. The company’s AST-OPC1 progenitor cell therapy is derived from human embryonic […]

Filed Under: Clinical Trials, Featured, Stem Cells, Wall Street Beat Tagged With: Asterias Biotherapeutics

Drug importation bills aim to improve access, lower costs for Americans

March 20, 2017 By Sarah Faulkner

capitol hill

Members of the U.S. House and Senate have introduced bills that would allow Americans to import prescription drugs from Canada in an attempt to increase accessibility and lower the cost of drugs. Sens. Bernie Sanders (I-Vermont), Cory Booker (D-N.J.) and Bob Casey (D-Penn.) introduced the “Affordable and Safe Prescription Drug Importation Act” at the end […]

Filed Under: Featured, Pharmaceuticals, Policy, Wall Street Beat Tagged With: Capitol Hill

Facing pressure from pharma, FDA delays off-label promotion rule

March 20, 2017 By Sarah Faulkner

FDA

After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year. The rule would expand the evidence that the […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Policy, Wall Street Beat

Under pricing pressure, insulin maker joins CVS Reduced Rx savings program

March 17, 2017 By Sarah Faulkner

Novo Nordisk

Facing pressure from lawmakers about the prices of their drugs, some pharmaceutical companies are looking for ways to make their products more affordable and more accessible. Novo Nordisk (NYSE:NVO) said yesterday that it is teaming up with CVS Health‘s (NYSE:CVS) new prescription savings program, Reduced Rx, to offer discounts on its insulin. The company’s insulin will be […]

Filed Under: Diabetes, Featured, Pharmaceuticals, Policy, Wall Street Beat Tagged With: CVS Health, Novo Nordisk

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