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Sarah Faulkner

Generic drug shows promise as diabetes vaccine in small, years-long study

June 21, 2018 By Sarah Faulkner

diabetes

A cheap, generic tuberculosis vaccine lowered blood glucose levels in nine patients with Type I diabetes and the effects lasted for years, according to a study published this week in npj Vaccines. The study was conducted at Massachusetts General Hospital by Dr. Denise Faustman – a name that has long been saddled with controversy in the […]

Filed Under: Diabetes, Featured, Pharmaceuticals, Research & Development Tagged With: Massachusetts General Hospital

Anika shares plummet after Phase III trial misses endpoint

June 21, 2018 By Sarah Faulkner

Anika Therapeutics

Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients […]

Filed Under: Clinical Trials, Featured, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Anika Therapeutics Inc.

ivWatch to integrate IV infiltration sensor into Philips’ patient monitors

June 21, 2018 By Sarah Faulkner

ivWatch

For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way. Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, […]

Filed Under: Drug-Device Combinations, Featured, Patient Monitoring, Pharmaceuticals, Vascular Tagged With: ivwatch, Philips, Terumo Corp.

Reva Medical wins CE Mark for full line of Fantom Encore bioresorbable scaffolds

June 21, 2018 By Sarah Faulkner

Reva Medical

Reva Medical (ASX:RVA) said this week that it won CE Mark clearance for its entire line of Fantom Encore bioresorbable, drug-eluting scaffolds. The new approval covers Reva’s Fantom 3.0 and 3.5 mm diameter devices, helping the company expand beyond its already-approved 2.5 mm diameter scaffold. Reva’s third-generation coronary bioresorbable scaffold features a thinner strut profile than […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Reva Medical

Mylan launches injectable Angiomax generic

June 18, 2018 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) today launched its bivalirudin injection in the U.S. as a generic version of The Medicines Co.‘s (NSDQ:MDCO) Angiomax product. The medicine is a direct thrombin inhibitor designed as an anticoagulant. Mylan’s bivalirudin single-dose vial was approved by the FDA for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. The product is also indicated […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Mylan, The Medicines Co.

Study finds nearly half of people with diabetes skip care due to costs

June 18, 2018 By Sarah Faulkner

diabetes

A newly-published report from UpWell Health found that nearly half of Americans with diabetes have skipped medical care at times because they couldn’t afford it. The 5,000-person survey showed that diabetes doesn’t just take a financial toll on people’s lives – it can impact their relationships, too; 37% of respondents reported that diabetes has harmed […]

Filed Under: Diabetes, Featured, Pharmaceuticals Tagged With: americandiabetesassociation

Foundation Medicine looks to expand oncology arsenal with precision drugs

June 18, 2018 By Sarah Faulkner

Foundation Medicine

Before she was Foundation Medicine‘s (NSDQ:FMI) chief business executive, Melanie Nallicheri was as an advisor to an ongoing project at the Cleveland Clinic, where she was witness to the power of personalized cancer treatment. Her team was caring for a patient with glioblastoma – an extremely aggressive form of brain cancer with a median survival time […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Foundation Medicine Inc.

Verrica Pharmaceuticals prices $75m IPO to fund drug-device skin therapy

June 15, 2018 By Sarah Faulkner

Verrica Pharmaceuticals

Verrica Pharmaceuticals said this week that it plans to offer 5 million shares priced between $14 to $16 apiece, setting its initial public offering at $75 million. The West Chester, PA-based company expects to use its newly-acquired funds to advance its lead product candidate: a drug-device combination product designed to administer a topical dermatological drug, […]

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

FDA approves first generic sublingual film to treat opioid addiction

June 15, 2018 By Sarah Faulkner

Dr. Reddy's Laboratories

The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. “The FDA […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Dr. Reddy's Laboratories, indivior, Mylan

HealthPrize takes aim at medication nonadherence with habit-forming tech

June 15, 2018 By Sarah Faulkner

HealthPrize Technologies

At HealthPrize Technologies, chief executive Tom Kottler is tackling a problem that many in the pharmaceutical industry are trying to solve: What stops people from taking their medications and how can the industry boost medication adherence rates? In order to encourage patient compliance, Kottler told Drug Delivery Business News that he’s taking a different approach than his […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: healthprizetechnologies

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