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Sean Whooley

Medtronic touts trial results for InPen smart insulin pen, extended infusion system

June 28, 2021 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) today presented positive study results for its InPen smart insulin pen and its extended-wear infusion set. Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM). According to a news release, data […]

Filed Under: Auto-injectors, Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: Medtronic

Senseonics touts new next-gen Eversense CGM data

June 28, 2021 By Sean Whooley

Senseonics - updated logo

Senseonics (NYSE:SENS) today presented further positive data evaluating its next-generation Eversense continuous glucose monitoring system. Germantown, Md.–based Senseonics presented data from the Promise study at the American Diabetes Association Virtual 81st Annual Scientific Sessions. The data adds to positive results already presented by the company at the beginning of this month that demonstrated high levels […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring Tagged With: Senseonics

Europe approves Roche’s Enspryng subcutaneous NMOSD treatment

June 28, 2021 By Sean Whooley

Roche logo - updated

Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Approval comes for the treatment as a monotherapy or for use in […]

Filed Under: Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: European Commission, Roche

Bigfoot Biomedical diabetes management program rolls out in some U.S. states

June 24, 2021 By Sean Whooley

Bigfoot Biomedical smart insulin pen cap

Bigfoot Biomedical announced today that made its Bigfoot Unity diabetes management program available in select U.S. markets. Milpitas, Calif.-based Bigfoot’s program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts and other New England states. The program is offered as a bundle of devices, supplies and services and delivered as […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Bigfoot Biomedical

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

June 24, 2021 By Sean Whooley

Genentech Susvimo PDS implant

Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant that’s the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Genentech, Roche

Kansas Distric Court rules in favor of Mylan in EpiPen class action

June 24, 2021 By Sean Whooley

legal

Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action. Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Legal News, Pharmaceuticals Tagged With: epipen, Mylan, Viatris

Orum Therapeutics raises $84M for targeted protein degrader payloads

June 23, 2021 By Sean Whooley

Orum Therapeutics

Orum Therapeutics announced today that it closed an $84 million Series B financing for its targeted protein degraders for treating cancer. Boston-based Orum’s funding round includes a previously announced $30 million financing, plus another $54 million in new funds led by IMM Investment and joined by new investors KDB Investment and Atinum, among others. Existing […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Immunotherapy, Oncology Tagged With: Orum Therapeutics

Teva launches first U.S. generic Perforomist inhaled COPD treatment

June 23, 2021 By Sean Whooley

Teva

Teva Pharmaceuticals (NYSE:TEVA) announced the U.S. launch of the first generic version of the twice-daily Perforomist inhalation solution. Parsippany, N.J.-based Teva Pharmaceuticals — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries Ltd. — launched the formoterol fumarate inhalation solution (20 mcg/2 mL) with an indication for treating bronchoconstriction in patients with chronic obstructive […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory Tagged With: Teva, Teva Pharmaceuticals

Soleo Health appoints new VP of business development, industry relations

June 22, 2021 By Sean Whooley

Soleo Health

Soleo Health announced today that it appointed Becky Rand as its VP of business development and industry relations. Rand’s responsibilities include initiating and maintaining relationships with pharmaceutical manufacturers and biotechnology companies while also looking to broaden the company’s portfolio of exclusive and limited drug distribution partnerships and other strategic initiatives. Frisco, Texas-based Soleo Health is […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Personnel, Personnel Moves, Soleo Health

Pear Therapeutics to go public via merger with SPAC

June 22, 2021 By Sean Whooley

Pear Therapeutics

Prescription digital therapeutics pioneer Pear Therapeutics announced today that it will go public by merging with a SPAC called Thimble Point Acquisition Corp. Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Initial Public Offering (IPO), Mergers & Acquisitions, Neurological, Patient Monitoring, Pharmaceuticals, Wall Street Beat Tagged With: Pear Therapeutics, peartherapeutics, Thimble Point Acquisition Corp.

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