News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

The European Commission has issued its decision on the Imvanex extension of indication in adolescents on 19 September 2024., EMA has recommended extending the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age.Imvanex is already authorised in the European Union…

Related Recalls – Plastic Syringes Made In China for Potential Device Failures

At its September 2024 meeting, EMA’s Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair. Professor Sepodes starts his three-year mandate on 21…, “As chair of the CHMP, my number one priority is ensuring the highest standards of medicine quality, safety and efficacy for patients in the European Union (EU).
Together, we…, Prof. Bruno Sepodes succeeds Dr Harald Enzmann as chair, who completed the maximum two three-year terms allowed for CHMP chairs.CHMP is the committee at EMA responsible for…

September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be con

Bivona tracheostomy tubes provide a secure airway in pediatric and adult patients. A manufacturing defect may lead to a tear in the tube’s flange.

2024 Medical Device Recalls

Neuralink’s groundbreaking Blindsight device, designed to restore vision for the blind, has been granted Breakthrough Device Designation by the FDA. This innovative technology has the potential to help individuals who have lost both eyes and their optic nerve regain sight, as long as their visual cortex remains functional. Remarkably, it could even allow people born…

Recommended submission dates for veterinary medicinal products

Listing of Medical Device 2024 Safety Communications

Infusomat Space Infusion Systems deliver fluids, blood, and blood products. The occlusion alarm may sound when there is no occlusion, leading to delayed therapy.

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture.

IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants

EMA’s Committee for Orphan Medicinal Products (COMP) elected a new chair. Tim Leest starts his three-year mandate today, 16 September.A Belgian national, Tim Leest holds a master’…, “We have a duty towards patients who go through life with the burden of an orphan disease.
I am fully committed to continuing our committee’s excellent work and fostering…, Tim Leest succeeds Dr Violeta Stoyanova-Beninska as a chair, following her completion of the maximum two three-year terms allowed for COMP chairs.COMP is responsible for…

Ivenix LVP infusion pump precisely controls the flow of fluids to a patient. A defect in pump administration sets may cause uncontrolled flow.

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury.

PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment

On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate.

Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.

Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.

In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.

Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.

EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizoleProduct information to be updated to raise awareness of known risk of…, Agenda Agenda of the PRAC meeting 2-5 September 2024DraftReference Number: EMA/PRAC/323875/2024 English (EN…, PRAC statistics: September 2024 , PRAC statistics: September 2024 English (EN) (33.15 MB – PDF)First published: 06/09/2024View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…, Ongoing referrals ProcedureStatusUpdateMetamizole containing medicinal products – referralUnder evaluationPRAC continued its assessment

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using…

McGrath MAC Video Laryngoscopes help visualize the trachea and larynx. The batteries on these devices may deplete too much, causing overheating and explosion.

Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time.

FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings