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Sean Whooley

Code Biotherapeutics launches with $10M seed financing

April 20, 2021 By Sean Whooley

Code Biotherapeutics

Gene therapy developer Code Biotherapeutics announced today that it launched with $10 million in seed financing. Hatfield, Pa.-based Code Biotherapeutics develops 3DNA, a proprietary synthetic DNA-based vector designed to deliver genes of all sizes to multiple cell types as a re-dosable therapy, according to a news release. The company said it is focused on developing […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals Tagged With: Code Biotherapeutics

Elektrofi, Argenx enter collaboration for subcutaneous product formulations

April 20, 2021 By Sean Whooley

elektrofi-argenx

Elektrofi announced today that it is collaborating with Argenx to explore new subcutaneous formulations for therapeutics. Included in the collaboration are formulations for therapeutics directed at the human neonatal Fc receptor (FcRn), including efgartigimod and up to one additional target, according to a news release. The formulations are designed to promote additional optionality for patients […]

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

D&D Pharmatech to collaborate with Yale on brain cancer therapies

April 20, 2021 By Sean Whooley

D&D Pharmatech

D&D Pharmatec announced today that it is collaborating with Yale to optimize two approaches to treating brain cancer and other disorders. The sponsored research agreement is slated to work with two novel approaches that allow immune system cells and drug molecules to bypass the blood-brain barrier (BBB) when treating brain cancer, among other diseases, according […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Immunotherapy, Oncology, Pharmaceuticals Tagged With: D&D Pharmatech, Yale University

Once-a-week insulin dosing shows promise in studies

April 19, 2021 By Sean Whooley

Insulin

Studies suggest that a new once-per-week injectable insulin therapy is safe and as effective as daily injections for those with type 2 diabetes. Two international clinical trials published today in Diabetes Care found that the once-weekly treatment has the potential to offer a convenient alternative to daily insulin shots for those with type 2 diabetes, according […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: Diabetes, Novo Nordisk

Lyndra Therapeutics touts Phase 2 data for oral schizophrenia treatment

April 19, 2021 By Sean Whooley

lyndra-therapeutics-logo

Lyndra Therapeutics yesterday announced positive results from a Phase 2 study of its once-weekly, oral schizophrenia treatment. Watertown, Mass.-based Lyndra’s oral, long-acting, extended-release risperidone capsule, LYN-005, is designed for the weekly treatment of schizophrenia. Data from the company’s first repeat-dose Phase 2 study demonstrate that LYN-005 offered sustained therapeutic levels of risperidone over the one-week […]

Filed Under: Clinical Trials, Featured, Neurological, Pharmaceuticals Tagged With: lyndra

Pump problem prompts another Alaris recall

April 19, 2021 By Sean Whooley

Tenacore

Days after classifying one recall for the Alaris infusion pump, the FDA has issued another Class I recall for the device. On Friday of last week, the FDA issued a Class I recall — the most serious kind — for the BD (NYSE:BDX) Alaris because there is a risk of the keypad lifting up due to […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Alaris, BD, Tenacore

Virta Health raises $133M Series E for diabetes reversal tech

April 19, 2021 By Sean Whooley

Virta Health

Virta Health announced today that it raised $133 million in a Series E equity financing round led by Tiger Global. San Francisco-based Virta said in a news release that the funds will accelerate its efforts to drive the adoption of its telehealth-based diabetes reversal treatment that aims to reverse the chronic disease while removing the […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Funding Roundup, Patient Monitoring Tagged With: Virta Health

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

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