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Brian Buntz

Satsuma launches Phase 3 trial for acute migraine combination product

July 28, 2021 By Brian Buntz

satsuma-pharmaceuticals

Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have […]

Filed Under: Clinical Trials, Drug-Device Combinations, Neurological Tagged With: DHE, dihydroergotamine, Satsuma Pharmaceuticals, STS101, SUMMIT

Nominations open for the Leonard Award celebrating 100 years of insulin

June 30, 2021 By Brian Buntz

Eli Lilly

Eli Lilly and Company (NYSE:LLY) is looking for nominations for its inaugural Leonard Award, which highlights advances in diabetes management. The company will select five winners and donate $100,00 to the non-profit Life for a Child, which provides medicines and supplies to children and youth with type 1 diabetes in developing countries.  Lilly is launching the […]

Filed Under: Diabetes, Featured Tagged With: Eli Lilly, insulin, Leonard Award, Life for a Child, type 1 diabetes

Walmart teams up with Novo Nordisk to launch private-brand analog insulin 

June 29, 2021 By Brian Buntz

Walmart/Novo-Nordisk

Walmart (NYSE:WMT) is launching what it describes as the first private label analog insulin. The company estimates the insulin products will save customers between 58% and 70% of the cost of branded insulin. Novo Nordisk (NYSE:NVO) will manufacture the analog insulin, which is a type of lab-grown insulin genetically engineered to optimize glucose control. The […]

Filed Under: Diabetes Tagged With: Diabetes, insulin, Novo Nordisk

San Diego company aiming to target glioblastoma with nanotechnology-based approach

June 28, 2021 By Brian Buntz

GCT

Glioblastoma, which kills roughly Americans each year, remains challenging to treat. The emerging biopharmaceutical company Global Cancer Technology (GCT; San Diego) is developing a novel x-ray activated modality for drug delivery to treat glioblastoma. GCT has a licensing agreement with the University of California, San Diego (UCSD) for a drug delivery platform that unites a […]

Filed Under: Drug-Device Combinations, Immunotherapy, Nanoparticles, Oncology Tagged With: GCT, Glioblastoma, Global Cancer Technology

Bionaut Labs receives orphan drug designation for its lead therapeutic 

June 23, 2021 By Brian Buntz

Bionaut Labs

FDA has granted orphan drug designation to the drug-device startup Bionaut Labs (Los Angeles) for the company’s lead therapeutic program, BNL-101, for the local treatment of malignant gliomas. BNL-101 is a drug-device combination that brings together remote-controllable microscale robotics and the chemotherapy agent doxorubicin. In March, the startup received $20 million in funding from Khosla Ventures. […]

Filed Under: Drug-Device Combinations, Regulatory/Compliance Tagged With: Bionaut Labs, BNL-101, FDA, malignant gliomas, orphan drug designation

FDA classifies Novo Nordisk insulin pen recalls as Class I

June 11, 2021 By Brian Buntz

FDA-logo-new

In May, Novo Nordisk announced that it voluntarily recalled 1,468 product samples related to its Levemir, Tresiba, Fiasp, Novolog and Xultophy insulin lines. The products were held at sub-freezing temperatures, prompting the FDA to recently classify the recalls as Class I. FDA uses the Class I designation for situations where there is “a reasonable probability” […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: FDA, Fiasp, https://www.drugdiscoverytrends.com/pharma50/novo-nordisk/, Levemir, Novo Nordisk, Novolog, recalls, Tresiba, Xultophy

Researchers reverse diabetes in mice using nanoscale device

June 3, 2021 By Brian Buntz

beta cells

Scientists at Washington University (St. Louis) and Cornell University (Ithaca, N.Y.) successfully implanted insulin-secreting cells in mice with type 1 diabetes. The cells proved capable of reversing chemically-induced diabetes for up to 200 days after implantation, according to a recent article in Science Translational Medicine.  To do so, they used a nanofiber-integrated cell encapsulation (NICE) device […]

Filed Under: Diabetes, Hydrogels Tagged With: Diabetes, insulin, nanofiber-integrated cell encapsulation, NICE

SEC lawsuit accuses RenovaCare of securities fraud

June 1, 2021 By Brian Buntz

RenovaCare

The biotech RenovaCare (OTCMKTS: RCAR) announced that it has received a civil complaint from the Securities and Exchange Commission (SEC). The SEC accuses Harmel S. Rayat, a controlling shareholder and chair of RenovaCare, of orchestrating a secret promotional campaign to elevate the company’s stock price. The agency claimed that Rayat and RenovaCare worked with the financial publishing […]

Filed Under: Drug-Device Combinations, Featured, Legal News Tagged With: Harmel S. Rayat, RenovaCare, SEC

How EyePoint Pharmaceuticals is developing sustained-release drug delivery for eye diseases

May 14, 2021 By Brian Buntz

EyePoint Pharmaceuticals

Dedicated to developing treatments for serious eye disorders, EyePoint Pharmaceuticals’ (NASDAQ: EYPT) pipeline includes a proprietary technology for sustained intraocular drug delivery known as Durasert. The technology supports the use of EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration, which can cause severe vision problems. To learn more about […]

Filed Under: Discovery, Drug-Device Combinations Tagged With: anti-VEGF, Durasert, EyePoint Pharmaceuticals, EYP-1901, Verisome, wet age-related macular degeneration

Insulet shares down after Q1 miss

May 7, 2021 By Brian Buntz

Insulet

Insulet (NSDQ:PODD) stock is down today — a day after the wearable insulin delivery system developer posted break-even Q1 results that were lower than analysts’ expectations. The company, however, yesterday evening raised the low end of its revenue guidance range to 16–20%. The range was previously 15–20%. The Acton, Mass.-based company a net loss of […]

Filed Under: Diabetes, Drug-Device Combinations, Featured Tagged With: automated insulin delivery system, Insulet, Omnipod 5

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