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Sean Whooley

Another BD Alaris infusion pump recall is Class I

April 16, 2021 By Sean Whooley

BD logo

The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall. BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: BD, Becton Dickinson, FDA

Amgen completes $1.9B acquisition of Five Prime Therapeutics

April 16, 2021 By Sean Whooley

Amgen Five Prime Therapeutics

Amgen (NSDQ:AMGN) announced today that it successfully completed its $1.9 billion acquisition of Five Prime Therapeutics (NSDQ:FPRX). Thousand Oaks, Calif.-based Amgen has officially acquired South San Francisco-based Five Prime for $38 per share in cash, reaching an equity value of approximately $1.9 billion. The acquisition was initially announced on March 4, 2021. As of the […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions, Oncology, Pharmaceuticals Tagged With: Amgen, Five Prime Therapeutics

Oncopeptides seeks EU marketing authorization for multiple myeloma treatment

April 16, 2021 By Sean Whooley

Oncopeptides

Oncopeptides announced today that it submitted an application for European marketing authorization of its melflufen therapeutic. Conditional marketing authorization from the European Medicines Agency (EMA) is the aim for the company after its pivotal phase 2 Horizon study provided positive outcomes with melflufen (melphalan flufenamide) in treating relapsed refractory multiple myeloma, according to a news […]

Filed Under: Featured, Oncology, Pharmaceuticals Tagged With: Oncopeptides

Horizon touts data from trials for thyroid eye disease infusion treatment

April 16, 2021 By Sean Whooley

Horizon Therapeutics

Horizon Therapeutics announced today that study results highlight the success of its Tepezza infusion for treating thyroid eye disease. Dublin, Ireland-based Horizon’s Tepezza proved in pooled Phase 2 and Phase 3 clinical trial data that it significantly improves proptosis (eye bulging) and diplopia (double vision) for TED patients in different subgroups, with most maintaining a […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals Tagged With: Horizon Therapeutics

Genentech touts study results for spinal muscular atrophy drug in babies

April 15, 2021 By Sean Whooley

Genentech logo updated

Genentech today touted two-year data evaluating the use of its Evrysdi therapeutic in infants with symptomatic Type 1 spinal muscular atrophy (SMA). South San Francisco, Calif.-based Genentech’s Firefish Phase 2/3 global study for Evrysdi (risdiplam) in infants between 1-7 months old showed that the orally administered (liquid or feeding tube) therapeutic continued to improve motor […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pediatrics Tagged With: Genentech, Roche

Innocoll Biotherapeutics initiates Phase 3 trials for collagen drug-device

April 14, 2021 By Sean Whooley

Innocoll

Innocoll Biotherapeutics announced today that it initiated two Phase 3 trials to support a label expansion for its collagen drug-device implant. Athlone, Ireland-based Innocoll’s trials are seeking label expansion for the FDA-approved Xaracoll (bupivacaine hydrochloride) implant, according to a news release. INN-CB-024, a Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Surgical Tagged With: innocoll

Better Therapeutics initiates real-world study for digital therapeutic for diabetes

April 14, 2021 By Sean Whooley

Better Therapeutics

Better Therapeutics announced today that it commenced a real-world evidence study to evaluate its treatment for Type 2 diabetes. Collaborating with Steward Health Care, Better Therapeutics is evaluating BT-001, an investigational, prescription digital therapeutic (PDT) designed to deliver a novel form of cognitive-behavioral therapy to patients with uncontrolled Type 2 diabetes, according to a news […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Better Therapeutics

OncoSec wins CE mark for electroporation device to treat solid tumors

April 14, 2021 By Sean Whooley

Oncosec

OncoSec Medical (NSDQ:ONCS) announced today that it received CE mark approval for its next-generation device to enable better uptake of anti-cancer therapies. GenPulse, part of OncoSec’s electroporation device platform for treating solid tumors, is designed to apply short electric impulses to a tumor, according to a news release. Get the full story at our sister site, […]

Filed Under: Oncology, Regulatory/Compliance Tagged With: OncoSec Medical

Medtronic launches 7-day infusion set for diabetes in Europe

April 14, 2021 By Sean Whooley

Medtronic Extended infusion set

Medtronic (NYSE:MDT) announced today that it launched the Medtronic Extended infusion set for diabetes in select European countries. Fridley, Minn.–based Medtronic touts the Extended infusion set as the first and only infusion set that a diabetes patient can wear for up to seven days, as most typically infusion pumps that deliver insulin to the body […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured Tagged With: insulin, Medtronic

SciNeuro inks licenscing deal with Eli Lilly for targeted antibody therapies

April 14, 2021 By Sean Whooley

SciNeuro

SciNeuro Pharmaceuticals announced today that it entered into an exclusive licensing agreement with Eli Lilly for antibody therapies. Under the agreement, Shanghai-based SciNeuro obtained an exclusive license to develop and commercialize alpha-synuclein targeted antibodies developed by Lilly within Greater China, which includes mainland China, Hong Kong, Macau and Taiwan, according to a news release. The […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, Neurological Tagged With: Eli Lilly & Co., SciNeuro

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