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AstraZeneca plc

AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers

April 9, 2018 By Sarah Faulkner

Owlstone Medical's breath biopsy device

Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]

Filed Under: Clinical Trials, Diagnostics, Drug-Device Combinations, Featured, Pharmaceuticals, Research & Development, Respiratory, Wall Street Beat Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Owlstone Medical

AstraZeneca’s once-weekly diabetes drug wins expanded FDA approval

April 3, 2018 By Sarah Faulkner

AstraZeneca Bydureon

AstraZeneca (NYSE:AZN) said today that the FDA approved its extended-release formulation of exenatide, Bydureon, for use as an add-on therapy to basal insulin in adults with Type II diabetes. The company’s once-weekly GLP-1 injectable was first approved in the U.S. in 2012. Bydureon’s expanded use is based on data from AstraZeneca’s 28-week Duration-7 trial, the company […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: AstraZeneca plc

FDA clears Adherium’s inhaler sensor for OTC sales

April 3, 2018 By Sarah Faulkner

The FDA gave Adherium (ASK:ADR) the go-ahead to launch over-the-counter sales of its Smartinhaler sensor for AstraZeneca‘s (NYSE:AZN) Symbicort asthma inhaler, the company touted last week. Adherium’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and date that a patient uses their inhaler and transmits […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Adherium, AstraZeneca plc

Myriad’s breast cancer diagnostic wins approval in Japan

April 2, 2018 By Sarah Faulkner

Myriad Genetics

Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK). Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck […]

Filed Under: Diagnostics, Featured, Oncology, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: AstraZeneca plc, Merck, myriadgenetics

Japan approves Novo Nordisk’s once-weekly Type II diabetes drug

March 23, 2018 By Sarah Faulkner

Novo Nordisk

The Japanese Ministry of Health, Labor and Welfare gave Novo Nordisk (NYSE:NVO) the green light to market its once-weekly type II diabetes drug, Ozempic, Reuters reported today. The pharma company’s drug, semaglutide, is a glucagon-like peptide-1 analog that mimics an intestinal hormone to trigger insulin production in people with diabetes. Novo Nordisk expects to launch Ozempic in Japan in […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: AstraZeneca plc, Eli Lilly & Co., Novo Nordisk

Needle-free flu vaccine will be back in clinics next flu season

February 23, 2018 By Sarah Faulkner

CDC

MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on Immunization Practices has voted to recommend the nasal spray’s use, reversing a two-year-old decision to keep the product out of clinics due to efficacy […]

Filed Under: Drug-Device Combinations, Featured, Hospital Care, Pharmaceuticals, Wall Street Beat Tagged With: AstraZeneca plc, medimmune

Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018 formulary

February 21, 2018 By Sarah Faulkner

Novo Nordisk

Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication. All three drugs […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: AstraZeneca plc, Eli Lilly & Co., Novo Nordisk

Pieris Pharmaceuticals prices $44m public offering

February 14, 2018 By Sarah Faulkner

Pieris Pharmaceuticals

Pieris Pharmaceuticals (NSDQ:PIRS) today priced an underwritten public offering of 5.5 million shares of its common stock at $8.00 per share. The company said it expects to generate $44 million from the offering, which it will use to fund the pre-clinical and clinical development of its pipeline. The offering also includes a 30-day option for underwriters […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Allergan, AstraZeneca plc, pierispharmaceuticals, Roche

Rani Therapeutics nabs $53m for robotic pill injection tech

February 8, 2018 By Sarah Faulkner

Rani Therapeutics

Rani Therapeutics has raised $53 million to support manufacturing as it gears up for clinical trials of its robotic pill technology. New investors like GeneScience Pharmaceuticals and Shire (NSDQ:SHPG) joined existing investors like Alphabet’s GV, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN). Rani Therapeutics, an InCube Lab spin-out started in 2012, has developed a capsule that delivers an intestinal injection […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals Tagged With: Allergan, AstraZeneca plc, Novartis, ranitherapeutics, Shire

TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer

January 23, 2018 By Sarah Faulkner

TapImmune

In the past decade, new innovations and well-funded research have heralded in the era of immunotherapy. The pace of change within the field has amazed Peter Hoang, the chief executive of a Jacksonville, Fl.-based company working to develop therapeutic vaccines for cancer. “15 years ago, if you or I walked into a venture capitalist’s office, […]

Filed Under: Clinical Trials, Featured, Immunotherapy, Oncology, Pharmaceuticals, Research & Development, Wall Street Beat Tagged With: AstraZeneca plc, Mayo Clinic, memorialsloankettering, tapimmune

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