Regulation of food and dietary supplements by the U.S. Food and Drug Administration

FDA Approves Lilly's Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems

Retrieved on: 
Wednesday, November 8, 2023

INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those who are overweight (with a BMI of 27 kg/m2 or greater) and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity. Zepbound should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines, and it has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis.

Key Points: 
  • "Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke and diabetes.
  • Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey," said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition.
  • "New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management."
  • Tirzepatide is also under regulatory review for weight management in Europe, China, the United Kingdom and several additional markets.

Vaxxinity Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023

CAPE CANAVERAL, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of medicines, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • CAPE CANAVERAL, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of medicines, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • This quarter, we have demonstrated proof of technology with our third clinical program, as well as our first proof of mechanism in our UB-312 program for Parkinson’s.
  • Results from the Phase 2a trial of UB-311 in patients with mild AD were published in The Lancet’s eBioMedicine in August 2023.
  • General and administrative expenses were $5.5 million and $7.3 million for the three months ended September 30, 2023, and 2022, respectively.

Beam Therapeutics Reports Pipeline and Business Updates and Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023

CAMBRIDGE, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported third quarter 2023 financial results and provided an update on the business and its clinical and pipeline progress.

Key Points: 
  • Beam anticipates that currently consented patients are sufficient to both fill the sentinel cohort (n=3) and to initiate the expansion cohort.
  • Research & Development (R&D) Expenses: R&D expenses were $100.0 million for the third quarter of 2023, compared to $85.3 million for the third quarter of 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $25.4 million for the third quarter of 2023, compared to $21.8 million for the third quarter of 2022.
  • Net Loss: Net loss was $96.1 million for the third quarter of 2023, or $1.22 per share, compared to $109.6 million for the third quarter of 2022, or $1.56 per share.

Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023

-- Management to host a conference call today at 8:30 a.m. ET --

Key Points: 
  • ET --
    DUBLIN, Ireland, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2023.
  • R&D expenses were $2.8 million in the quarter ended September 30, 2023, compared to $2.9 million for the same period in 2022.
  • SG&A expenses were $39.2 million in the quarter ended September 30, 2023, compared to $14.1 million for the same period in 2022.
  • The Company drew the first $30.0 million tranche from a $75.0 million royalty financing arrangement on August 1, 2023.

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, November 8, 2023

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments.

Key Points: 
  • Orphan Drug Designation granted to PGN-EDODM1: In September 2023, the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
  • PepGen expects to report initial results from this study in 2024.
  • Financial Results for the Three Months Ended September 30, 2023
    Cash and cash equivalents were $129.5 million as of September 30, 2023, which is anticipated to fund currently planned operations into 2025.
  • PepGen had approximately 23.8 million shares outstanding on September 30, 2023.

Otsuka Medical Devices and Recor Medical Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023

Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and Recor Medical, Inc. (“Recor”, subsidiary of Otsuka Medical Devices) announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) and Recor Medical, Inc. (“Recor”, subsidiary of Otsuka Medical Devices) announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
  • It is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.
  • The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
  • The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.
  • The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") today announced the U.S. Food and Drug Administration (FDA) has approved Recor's Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

TraceLink Unveils Game-Changing Digital Recalls Solution for Health Systems and Retail Pharmacies

Retrieved on: 
Tuesday, November 7, 2023

This innovative solution offers health systems and retail pharmacies a new approach to receiving product recall information and enables them to manage those recalls with unprecedented speed and efficiency.

Key Points: 
  • This innovative solution offers health systems and retail pharmacies a new approach to receiving product recall information and enables them to manage those recalls with unprecedented speed and efficiency.
  • Managing product recalls has long been a manual and time-consuming process for health systems and retail pharmacies.
  • To address these critical issues and bolster patient safety, health systems, and retail pharmacies need a digital capability that leverages a proven digital network backbone to facilitate rapid and effective product recall notification, identification, and management.
  • With TraceLink Digital Recalls, communication between pharmacy leadership, individual dispensing sites, and supply chain stakeholders is streamlined and synchronized.