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Drug-Device Combinations

Pear Therapeutics inks multiple agreements to expand digital therapeutic platform

April 6, 2021 By Sean Whooley

Pear Therapeutics

Pear Therapeutics announced today that it entered into multiple agreements to bolster its prescription digital therapeutics (PDT) platform. Boston-based Pear Therapeutics’ agreements are set to add to its library of digital biomarkers, machine learning algorithms, sensor-based technologies and digital therapeutics, according to a news release. The agreements have been struck with technology companies including Empatica, […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, Neurological, Patient Monitoring, Pharmaceuticals Tagged With: Empatica, etectrx, KeyWise, peartherapeutics

Seelos, Aptar sign deal for Bidose system to deliver ketamine candidate

April 6, 2021 By Sean Whooley

Seelos Therapeutics AptarGroup Aptar Pharma

Seelos Therapeutics (NSDQ:SEEL) announced today that it partnered with AptarGroup (NYSE:ATR) for the Bidose liquid system device. The agreement includes the co-exclusive use and supply of Aptar Pharma’s Bidose device to deliver Seelos’ intranasal ketamine product candidate, SLS-002, for treating suicidality, depression and post-traumatic stress disorder (PTSD). Under the agreement, Seelos garners certain rights to […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, Neurological Tagged With: aptarpharma, Seelos Therapeutics

Amneal completes acquisition of Kashiv Specialty Pharmaceuticals

April 5, 2021 By Sean Whooley

Amneal Pharmaceuticals Kashiv Specialy Pharmaceuticals

Amneal Pharmaceuticals (NYSE:AMRX) announced today that it completed the acquisition of a 98% interest in Kashiv Specialty Pharmaceuticals. Bridgewater, N.J.-based Amneal develops, manufactures and distributes generic and specialty drug products. Kashiv Specialty Pharmaceuticals, a wholly-owned subsidiary of Kashiv BioSiences, develops complex generics, novel drugs and innovative drug delivery platforms, according to a news release. No […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions, Pharmaceuticals Tagged With: amnealpharmaceuticals, Kashiv BioSciences, Kashiv Specialty Pharmaceuticals

Welldoc, Dexcom expand diabetes management tech partnership

April 5, 2021 By Sean Whooley

Welldoc Dexcom

Welldoc announced today that it will offer its BlueStar digital health solution with Dexcom’s G6 CGM system as a single platform. Columbia, Md.-based Welldoc’s FDA-cleared BlueStar system offers guidance to individuals through the self-management of diabetes, while Dexcom’s G6 continuous glucose monitoring (CGM) system measures glucose levels just beneath the skin’s surface and wirelessly transmits […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Pharmaceuticals Tagged With: Dexcom, welldoc

Prescryptive to offer benefit coverage for Pear Therapeutics opioid use disorder treatments

April 2, 2021 By Sean Whooley

Pear Therapeutics Prescryptive Health

Pear Therapeutics announced today that Prescryptive Health will offer and administer benefit coverage for its digital therapeutics. Boston-based Pear Therapeutics’ reSET and reSET-O, two FDA-cleared prescription digital therapeutics (PDTs) for treating substance and opioid use disorder, have been added to Prescryptive’s formularies and are being administered as standard pharmacy benefits for its members, according to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Patient Monitoring, Pharmaceuticals Tagged With: peartherapeutics, Prescryptive Health

Fresenius Kabi, Corvida Medical ink U.S. distribution deal for drug-transfer device

April 2, 2021 By Sean Whooley

Fresenius Kabi Halo

Fresenius Kabi announced that it entered into a U.S. distribution agreement with Corvida Medical for the HALO closed system drug-transfer device (CSTD). Under the distribution agreement, Lake Zurich, Ill.-based Fresenius Kabi will be the exclusive U.S. distributor for the HALO CSTD, an airtight and leak-proof CSTD designed to prohibit the transfer of environmental contaminants into […]

Filed Under: Business/Financial News, Distribution, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Corvida Medical, freseniuskabi

Eyenovia appoints Dr. Julia Haller to board of directors

April 1, 2021 By Sean Whooley

Eyenovia - updated logo

Eyenovia (NSDQ:EYEN) announced today that it appointed renowned ophthalmologist Dr. Julia Haller to its board of directors. New York-based Eyenovia adds the experienced Haller to its board as it continues to develop the MydCombi fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing to improve the patient […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: Eyenovia Inc., Personnel, Personnel Moves

FDA approves inhaled pulmonary hypertension treatment from United Therapeutics

April 1, 2021 By Sean Whooley

Tyvaso United Therapeutics

United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval for its Tyvaso inhalation solution for pulmonary hypertension. Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release. With approval, Tyvaso now […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory Tagged With: FDA, United Therapeutics

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

March 31, 2021 By Sean Whooley

B. Braun Interventional Systems Infraredx

B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX. Bethlehem, Pa.-based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: B. Braun Interventional Systems, Infraredx

Regeneron touts results of NIH-sponsored EYLEA injection study

March 31, 2021 By Sean Whooley

Regeneron - updated

Regeneron Pharmaceuticals (NSDQ:REGN) announced data supporting the use of its EYLEA injection in NPDR patients. Protocol W, a NIH-sponsored trial to evaluate the EYLEA (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME), had its initial results published in JAMA Ophthalmology. At two years, the primary […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: National Institutes of Health, Regeneron

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