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Pharmaceutical

8 drug delivery innovations you need to know

February 25, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Pharmaceutical Tagged With: dyvebioscience, Enable Injections, evoxtherapeutics, Inovio Pharmaceuticals, Johns Hopkins, Lyra Therapeutics, Medtronic, Tandem Diabetes Care, Teva Pharmaceuticals, Teva Respiratory

Axonics acquires Contura and its Bulkamid bulking agent for $235M

February 25, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Gynecological, Mergers & Acquisitions, Pharmaceutical, Women's Health Tagged With: Axonics Modulation Technologies, Contura Inc., hydrogels

Is J&J’s COVID-19 vaccine linked to tinnitus?

February 25, 2021 By Brian Buntz Leave a Comment

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical Tagged With: Ad26.COV2.S, Clinical Trials, coronavirus, COVID-19, COVID-19 vaccine, Johnson & Johnson, Johnson and Johnson, tinnitus

UK passes post-Brexit medical device regulation

February 25, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: Featured, Pharmaceutical, Regulatory/Compliance, Women's Health Tagged With: U.K. Medicines and Medical Devices Act

Kala Pharmaceuticals slides on missed Q4 projections

February 25, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceutical, Wall Street Beat Tagged With: Kala Pharmaceuticals

FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

February 24, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Janssen Pharmaceuticals, Johnson & Johnson

Re-Vana Therapeutics appoints new COO, VP of R&D

February 23, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Optical/Ophthalmic, Pharmaceutical Tagged With: Personnel Moves, Re-Vana Therapeutics

Pear Therapeutics touts cost-effectiveness of opioid use disorder treatment

February 23, 2021 By Sean Whooley Leave a Comment

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.

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceutical Tagged With: opioids, Pear Therapeutics

FDA issues guidelines to address COVID-19 variants

February 22, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 variants, FDA, Moderna, Pfizer

AmacaThera raises $10.3M in oversubscribed Series A

February 22, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Pain Management, Pharmaceutical, Surgical Tagged With: AmacaThera

Pfizer vaccine stable at standard freezer temps, effective with single dose

February 19, 2021 By Brian Buntz Leave a Comment

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 […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, Pfizer

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