Adovate的动态

The #FDA released the?first annual report on submissions to?the Center for Biologics Evaluation and Research (#CBER) and the Center for Drug Evaluation and Research (#CDER) with #RWE describing #submissions with analyses of #RWD to generate RWE that support regulatory decision making about a drug or biological product’s #effectiveness or #safety: https://lnkd.in/ew52ZmCw #realworldevidence #realworldoutcomes #patientjourney #realworlddata #regulatory #evidence #heor #healtheconomics #medicalaffairs #pharma #biopharma #regulatoryaffairs

Every year, CIRS monitors the evolving #HTA landscape across Europe and publishes trends on #HTA outcomes and timelines. Our latest HTADock R&D Briefing examined common compounds rolled out to France, Germany, Sweden and Poland between 2018-2022, and found that the HTA outcome varied across the four jurisdictions. ? With the new EU HTA Regulation coming into force from 2025, we will continue monitoring the European #HTA landscape to see how it adapts to the implementation of the new legislation. Take a look at the full briefing >> https://lnkd.in/ePgpf_GA #reimbursement #EUHTA #pharmaceuticals #EUregulation #HEOR

A Special Protocol Assessment (SPA) can be invaluable for clinical trial sponsors who would otherwise have to conduct a new study if the FDA determined at a late stage that the study did not meet the FDA's requirements for an adequate and well-controlled study. "FDA Special Protocol Assessment (SPA) for a Drug or Biologic" in Practical Guidance Life Sciences takes you through the FDA's SPA process. https://bit.ly/3YDmR9d #LexisNexis #PracticalGuidance #FDA #Pharmaceuticals #LifeSciences

CCIT in the Spotlight ?? ! ?? New FDA Guidance for " Container Closure System and Component changes: Glass Vials and Stoppers" has been released. This guidance provides the industry with vital information on when CCIT data should be collected. ?? A great short read, that provides us much needed information. "FDA is issuing this guidance to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers." https://lnkd.in/dFu74BNz #FDA #CCIT #Packaging #lifescience #pharma #Biotech #Regulatory

FDA has granted approval to EOHILIA (Budesonide oral suspension) by Takeda for patients aged 11 years and older with Eosinophilic Esophagitis (EoE). It is the first and only FDA approved therapy for this indication. The approval is based on data from two double-blind, placebo-controlled 12-wk clinical trials (Histologic remission of 53.1% vs 1% in placebo arm in Study 1 and 38% vs 2.4% in placebo arm in Study 2) As per the company PR, The oral suspension will be available in 2mg/10mL single-dose stick packs by the end of february Prescribing information (https://bit.ly/3UEUzcO) indicates that use of EOHILIA for more than 12 weeks has not been shown to be safe and effective for the treatment of Eosinophilic Esophagitis. https://bit.ly/49yLVRq #esophagitis #takeda #corticosteroids #fda #fdaapproval #competitiveintelligence #pharma #pharmaceutical #biotech #healthcare #lifesciences #lifesciencesconsulting

Robert Horne Daniel Maley Elaine H.Andrew Satz Doug Nissinoff Joey Bose Rafael Rosengarten This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016. #fda #pharmaceuticals #clinicaltrials

In an effort to achieve self-sufficiency in clinical development and promote indigenous pharmaceutical innovations, the Indian Council of Medical Research (ICMR) announced on Saturday the formalization of memoranda of agreements (MoAs) with several sponsors to initiate first-in-human Phase 1 trials for four promising molecules. A first-in-human trial is a crucial step in clinical research where a new drug, procedure, or treatment is tested on humans for the first time, following successful laboratory and animal studies. These trials are typically categorized as Phase 1 clinical trials. #ICMR #ClinicalTrials #PharmaceuticalInnovation #FirstInHuman

POLYPHARMACY PARADOX: UNRAVELING ENTERIC ULCER CONUNDRUM Polypharmacy, the concurrent use of multiple medications by a single patient, is common in modern healthcare to manage multiple comorbidities. While it helps address complex health conditions, it also brings significant challenges, such as increased risks of drug interactions and adverse effects, including the development of enteric ulcer lesions in the gastrointestinal tract. Read complete article here: https://lnkd.in/gSzphiwd Follow our other media handles: International Journal of Pharmaceutical Sciences and Research (IJPSR) Society of Pharmaceutical Sciences and Research (SPSR) International Journal of Pharmacognosy (IJP) #spsr #researcharticle #ijpsr #ijp

?? Latest Pharma News You Can't-Miss! ?? ? Merck completes the acquisition of EyeBio, advancing Restoret? for retinal diseases. ? The Affordable Prescriptions for Patients Act advances in the Senate to foster generic drug competition. ? Alembic Pharmaceuticals Limited receives USFDA tentative approval for Selexipag Injection to treat PAH. ? AbbVie seeks FDA and EMA approval for Upadacitinib to treat Giant Cell Arteritis. ? Federal court rejects Boehringer Ingelheim's challenge to Medicare drug price negotiation. ?? Read the complete story at www.pharmanow.live Stay informed with the latest breakthroughs and regulatory updates! ??? #PharmaNow #Merck #EyeBio #AlembicPharma #AbbVie #BoehringerIngelheim #PharmaNews #IndustryUpdate

POLYPHARMACY PARADOX: UNRAVELING ENTERIC ULCER CONUNDRUM Polypharmacy, the concurrent use of multiple medications by a single patient, is common in modern healthcare to manage multiple comorbidities. While it helps address complex health conditions, it also brings significant challenges, such as increased risks of drug interactions and adverse effects, including the development of enteric ulcer lesions in the gastrointestinal tract. Read complete article here: https://lnkd.in/gSzphiwd Follow our other media handles: International Journal of Pharmaceutical Sciences and Research (IJPSR) Society of Pharmaceutical Sciences and Research (SPSR)- SPSR International Journal of Pharmacognosy (IJP) #spsr #researcharticle #ijpsr #ijp