MDC Associates, Inc.’s Post

❗️ 💥 Important news for IVD manufacturers of Class D devices (IVDR). 🎤 On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs) which will cover the following categories of class D IVDs: ·      Hepatitis and retroviruses ·      Herpesviruses ·      Bacterial agents ·      Respiratory viruses that cause life-threatening diseases ✔️The EURLs are expected to take up their tasks in conformity assessment of devices on 1 October 2024. ✔️Batch testing of devices already CE-marked under Regulation (EU) 2017/746 will begin after the end of the transitional period to ensure appropriate control of those IVDs. 👉  More information: https://lnkd.in/dkFZKbsg 👉 OJEU-EUR-LEx link: https://lnkd.in/dWBSfMra #IVD #IVDR #ClassD #EURL

JAKi Safety and Efficacy in bDMARD-IR Patients with RA: Results Through 5 Years Now in the RheumNow poster hall: Long-term extension outcomes from SELECT-BEYOND through 5 years in bDMARD-IR patients with RA. Sponsored by AbbVie US Medical Affairs.

JAKi Safety and Efficacy in bDMARD-IR Patients with RA: Results Through 5 Years Now in the RheumNow poster hall: Long-term extension outcomes from SELECT-BEYOND through 5 years in bDMARD-IR patients with RA. Sponsored by AbbVie US Medical Affairs.

📢 We have received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel. ➡️ The BIOFIRE® SPOTFIRE® R/ST Panel is a unique multiplex PCR test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in about 15 minutes. BIOFIRE® SPOTFIRE® is a fast and innovative syndromic testing range that makes diagnostic tests available as close as possible to the patient. The CLIA-waiver allows the system and its so-authorized panels to be used by non-lab professionals and in any clinical setting where patients seek care. 📰 Read the full press release: https://lnkd.in/geP3j5tp #PioneeringDiagnostics

I am thrilled to share our recently published work! You can read the full paper below! #Asthma #COPD #GPCR #Parmacology #Pharmaceuticalscience

FDA #advisorycommittees are an important way for #raredisease #patients and providers to weigh in on important agency decisions and to give patients a voice. The composition of these committees, and when and how they are asked to weigh in, is vitally important to their effectiveness though. Encouraging to see #FDA establish one on this important issues. https://lnkd.in/eiwBD34d.

Biosimilars Real World Evidence (RWE) plays a key role in addressing important questions on Biosimilars long term effectiveness, safety and immunogenicity while also providing additional confidence on the outcomes of switching patients from the reference biological to the Biosimilars.

The plasma and urine pharmacokinetics of cis- and trans-ceftibuten were explored at higher than licensed doses. Our data support the development of oral ceftibuten for single and multiple doses up to and including 800 mg twice-daily. Now available online - Open Access A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects

https://lnkd.in/eMBKGUeZ Good news for the Paroxysmal nocturnal hemoglobinuria (PNH) patients. Though it is quite rate, I knew one patient with PNH when I was still treating patients. PNH is a rare immune blood disorder that causes red blood cells (RBC) to break down easily, leading to anemia, constant fatigue, and weakness. It also leads to blood clots and related complications due to issues related to platelets. Iptacopan is an oral drug, first in its class that selectively inhibits factor B, the active component of the complement’s C3 and C5 convertases (alternative complement pathway of the immune system) to control RBC destruction within and outside the blood vessels. The drug is approved with the appropriate name "Fabhalta". #PNH #Iptacopan #OralSelectiveFactorBinhbitor

🫸🤬🫷How do we stop Rosacea in its tracks⁉️. Systematically, oral Isotretinoin seems most effective, followed by a combo of low dose oral doxycycline with ivermectin topically‼️ On its own topically, it seems ivermectin works best at quickly reducing lesion count‼️🫸🤬🫷