The drug delivery space has seen plenty of innovation over the years and there are no signs of that slowing down any time soon. Improvements upon established technologies like insulin delivery devices and inhalers have been presented by some, while others have unlocked new ways of delivering drugs through a variety of means. Among the […]
Pharmaceutical
Axonics acquires Contura and its Bulkamid bulking agent for $235M
Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million. London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural […]
Is J&J’s COVID-19 vaccine linked to tinnitus?
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. Get the full story from Drug […]
UK passes post-Brexit medical device regulation
The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by […]
Kala Pharmaceuticals slides on missed Q4 projections
Kala Pharmaceuticals (NSDQ:KALA) shares dipped this morning on fourth-quarter results that came up short of the consensus forecast. The Watertown, Mass.-based company posted losses of -$31.1 million, or -55¢ per share, on sales of $2.2 million for the three months ended Dec. 31, 2020, for a more than $10 million bottom-line slide on sales growth of […]
FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
Re-Vana Therapeutics appoints new COO, VP of R&D
Re-Vana Therapeutics announced today that it appointed Michael Nash as chief commercial officer and David Shima as VP of R&D. Belfast, Northern Ireland-based Re-Vana’s two new executives are set to help the company develop its sustained-release therapies for ophthalmic indications, including neovascular age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and glaucoma, according to a news […]
Pear Therapeutics touts cost-effectiveness of opioid use disorder treatment
Pear Therapeutics today touted analysis of its reSET-O therapeutic for opioid use disorder (OUD) that demonstrated cost-effectiveness. Boston-based Pear Therapeutics’ reSET-O is the first and only FDA-authorized prescription digital therapeutic for treating OUD, according to a news release. Get the full story at our sister site, Drug Delivery Business News.
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
AmacaThera raises $10.3M in oversubscribed Series A
AmacaThera announced today that it completed an oversubscribed $10.3 million Series A financing round. Lumira Ventures led the Series A funding, with existing investors Viva BioInnovator and Sprout BioVentures contributing as well. New investors BDC Capital Women in Technology Venture Fund, Inveready, MBX Capital, CR Capital Management, StandUp Ventures and MaRS IAF participated, too, according to […]
Pfizer vaccine stable at standard freezer temps, effective with single dose
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would […]
