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Sarah Faulkner

With weeks left in flu season, the FDA is already working on next year’s vaccine

February 16, 2018 By Sarah Faulkner

Flu Vaccine

There are still weeks left in this year’s flu season, according to the FDA, but the agency is already planning on how to better protect the nation’s public health next year. An initial report from the Centers for Disease Control and Prevention concluded that this year’s flu vaccine sported a 36% efficacy rate. Although that’s […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Research & Development, Wall Street Beat Tagged With: Centers for Disease Control & Prevention, FDA, National Institutes of Health

Tandem Diabetes touts pivotal study of insulin pump with low glucose suspend feature

February 15, 2018 By Sarah Faulkner

Tandem Diabetes

Tandem Diabetes Care (NSDQ:TNDM) touted data today from a pivotal study of its t:slim X2 insulin pump, which features a predictive low glucose suspend feature called Basal-IQ. The study showed that the system reduced time spent in hypoglycemia by 31% compared to just sensor-augmented pump therapy, according to Tandem. Tandem’s t:slim pump uses data from Dexcom’s G5 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Tandem Diabetes Care

Medtronic looks to expand MiniMed 670G into pediatric diabetes

February 15, 2018 By Sarah Faulkner

Medtronic

Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Pediatrics, Pharmaceuticals, Wall Street Beat Tagged With: Medtronic

Acorda posts Q4 revenue beat, but misses EPS estimates

February 15, 2018 By Sarah Faulkner

Acorda Therapeutics

Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates. The Ardsley, N.Y.-based company posted a net loss of -$171 million on sales of $188.4 million for the 3 months ended Dec.31, for sales growth of 34% compared with the same period […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: Acorda Therapeutics

After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA

February 15, 2018 By Sarah Faulkner

Paratek's Omadacycline

More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It’s a long-awaited milestone for Dr. Evan Loh, who serves as president, COO and CMO of Paratek Pharmaceuticals (NSDQ:PRTK), the company developing and commercializing omadacycline. It’s also emblematic of […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Hospital Care, Pharmaceuticals, Wall Street Beat Tagged With: Biogen Idec, paratek

DreaMed Diabetes wins CE Mark for insulin therapy management platform

February 15, 2018 By Sarah Faulkner

DreaMed Diabetes

DreaMed Diabetes has won CE Mark clearance for its Advisor Pro decision-support platform, designed to help healthcare professionals manage insulin therapy for their Type I diabetes patients. The company’s cloud-based platform provides personalized insulin treatment plans by combining data from insulin pumps and continuous glucose monitors. Using machine learning techniques, the system analyzes all of […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance Tagged With: DreaMed Diabetes, glooko

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

Sanofi touts real-world data for Toujeo insulin glargine injection

February 14, 2018 By Sarah Faulkner

Sanofi logo

Sanofi (NYSE:SNY) touted data today from its 10,000-patient Lightning study, which evaluated electronic medical records of adults with Type II diabetes to study its long-acting insulin glargine injection, Toujeo. The company found that Toujeo significantly lowered patients’ risk of experiencing severe low blood sugar compared to other long-acting insulin, like its own Lantus product. The data, […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Sanofi-Aventis

Nektar lands record $3.6B deal with Bristol-Myers Squibb for cancer immunotherapy

February 14, 2018 By Sarah Faulkner

Bristol-Myers Squibb

Bristol-Myers Squibb (NYSE:BMY) could fork over as much as $3.63 billion for the rights to Nektar Therapeutics‘ (NSDQ:NKTR) cancer immunotherapy drug, according to a deal announced today by the two companies. Nektar’s NKTR-214, which is still in development, is designed to boost the number of cancer-killing T-cells around the tumor’s micro-environment. Bristol-Myers Squibb plans to pair […]

Filed Under: Featured, Immunotherapy, Oncology, Pharmaceuticals, Research & Development, Wall Street Beat Tagged With: Bristol-Myers Squibb Co., nektartherapeutics

Tandem closes $69m underwritten public offering

February 14, 2018 By Sarah Faulkner

Tandem Diabetes

Tandem Diabetes Care (NSDQ:TNDM) has closed its previously-announced underwritten public offering of 30 million shares of common stock at $2.00 apiece. The San Diego, Calif.-based company reeled in $69 million from the offering, after underwriters exercised an option to buy 4.5 million additional shares of Tandem’s common stock. The insulin pump-maker has tried to drum up […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Tandem Diabetes Care

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