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Pharmaceuticals

FDA approves another over-the-counter Naloxone nasal spray

July 31, 2023 By Sean Whooley

Harm Reduction Therapeutics FDA approved over the counter naloxone nasal spray

Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray. Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S. The FDA first approved Narcan 4 mg OTC […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: FDA, Harm Reduction Therapeutics, Narcan

UroGen to raise $120M to support sustained release hydrogel delivery platform

July 28, 2023 By Sean Whooley

UroGen Pharma

UroGen Pharma (Nasdaq:URGN) announced that it entered into a securities purchase agreement worth approximately $120 million. The placement includes the issuance of nearly 12.6 million ordinary shares or pre-funded warrants priced at $9.54 per share. UroGen expects the placement to close on or about today, subject to customary closing conditions. RA Capital Management and Great […]

Filed Under: Business/Financial News, Drug-Device Combinations, Funding Roundup, Hydrogels, Oncology, Pharmaceuticals

RenovoRx, Imugene collab on oncolytic virus therapy delivery

July 21, 2023 By Sean Whooley

RenovoRX RenovoGem drug-delivering pancreatic cancer treatment

RenovoRx (Nasdaq:RNXT) announced that it entered into a strategic research collaboration with Imugene to optimize oncolytic virus therapy delivery. Utilizing RenovoRx’s TAMP (Trans-Arterial Micro-Perfusion) therapy platform), the companies hope to enhance the treatment of difficult-to-access tumors. “Our collaboration with Imugene is an important milestone for RenovoRx as we expand our pipeline from exclusively treating locally […]

Filed Under: Business/Financial News, Oncology, Pharmaceuticals Tagged With: Imugene, RenovoRx

8 drug delivery innovations you should know

July 20, 2023 By Sean Whooley

8 drug delivery innovations you need to know 2023

Innovations in drug delivery never stop, and over the past 12 months or so a wide variety have been in the spotlight. Constant progress continues in the diabetes space, both in the form of insulin delivery and other drug delivery methods. Elsewhere, we see implants, patches, syringes and more showcasing the many ways we can […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Technology Tagged With: BD, Beta Bionics, biocorp, Humacyte, Innovation Zed, Insulet, Juvenile Diabetes Research Foundation (JDRF), Micron Biomedical, mit, Schott Pharma, Sernova Inc, Stevanato Group, Tandem Diabetes Care, tidepool, Vivani Medical, Ypsomed

Koru Medical submits infusion system for FDA 510(k) clearance

July 10, 2023 By Sean Whooley

Koru Medical Systems Freedom60 infusion system

Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe. In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: FDA, Koru Medical Systems

CellTrans wins FDA approval for first cell therapy that treats type 1 diabetes

June 30, 2023 By Sean Whooley

CellTrans

The FDA announced that it approved the Lantidra allogeneic pancreatic islet cellular therapy developed by CellTrans to treat diabetes. It marks the first approval of a donor pancreatic cellular therapy — made from deceased donor pancreatic cells — to treat type 1 diabetes. The approval covers adults with type 1 diabetes who prove unable to […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Stem Cells Tagged With: CellTrans, FDA

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

June 30, 2023 By Sean Whooley

American Diabetes Association ADA 2023 Medtronic MiniMed 780G Insulet Omnipod 5 Senseonics Eversense E3 GLP-1s

As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space. At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Pediatrics, Pharmaceuticals, Surgical, Technology, Wall Street Beat Tagged With: abbott, ADA 2023, American Diabetes Association, Bigfoot Biomedical, Dexcom, Eli Lilly & Co., Fractyl Health, Insulet, Medtronic, Novo Nordisk, Senseonics, Sernova Inc, Vida Health, Virta Health

Bausch + Lomb acquires XIIDRA eye drops, delivery system from Novartis in $2.5B deal

June 30, 2023 By Sean Whooley

Bausch + Lomb Novartis

Bausch + Lomb (NYSE:BLCO) announced today that it agreed to acquire XIIDRA non-steroid eye drops from Novartis. The company also acquired an investigational medicine and rights to a delivery device for treating dry eye disease (DED). AcuStream, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions, Optical/Ophthalmic, Pharmaceuticals Tagged With: bausch&lomb, Novartis

Lilly to acquire Sigilon, cell therapy for treating diabetes

June 29, 2023 By Sean Whooley

Eli Lilly Sigilon logo

Eli Lilly (NYSE:LLY) announced today that it entered a definitive agreement to acquire biopharmaceutical company Sigilon. Cambridge, Massachusetts-based Sigilon seeks to develop functional cures for patients with a range of acute and chronic diseases. The two companies have collaborated since 2018 to develop encapsulated cell therapies, including SIG-002. These therapies aim to treat type 1 […]

Filed Under: Business/Financial News, Diabetes, Featured, Mergers & Acquisitions, Pharmaceuticals, Stem Cells Tagged With: Eli Lilly, Eli Lilly & Co., sigilontherapeutics

PharmaJet Tropis becomes exclusive intradermal delivery system for two COVID-19 vaccines

June 28, 2023 By Sean Whooley

PharmaJet Tropis needle-free intradermal injection system

PharmaJet announced that its Tropis system is now the exclusive intradermal delivery system for two novel COVID-19 vaccines. Golden, Colorado-based PharmaJet engineers precision delivery systems that overcome the challenges of nucleic acid vaccine delivery. Its Tropis system now offers the delivery of the world’s first plasmid DNA COVID-19 vaccine from Zydus Lifesciences. Exclusively delivered with […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: coronavirus, COVID-19, PharmaJet

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