European Medicines Agency
Mar 05, 2024
Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...
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Jan 23, 2024
BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101
Opdivo in Combination with CABOMETYX Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma Bristol Myers Squibb and Exelixis, Inc. have released the four-year follow-up findings from the CheckMate -9ER trial, which investiga...
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Sep 19, 2023
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®
EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...
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Sep 12, 2023
BMS’s LPA1 Antagonist; Alnylam’s KARDIA-1 Phase 2 Study; Day One Biopharma Sought FDA Approval for Tovorafenib; EMA Orphan Drug Designation to MaaT Pharma’s MaaT033; Lundbeck and Otsuka Announce Topline Results from Two Phase III Trials of Brexpiprazole + Sertraline; Phase III CheckMate – 227 Trial Show Durable, Long-Term Survival with Opdivo Plus Yervoy
Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase II Study BMS-986278, a potential first-in-class oral lysophosphatidic acid receptor 1 (LPA1) antagonist, was studied in patients with progressive pulmonary fibrosis (PPF)...
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Jul 25, 2023
Gilead’s Magrolimab Plus Azacitidine for MDS; FDA Approveds VANFLYTA for Newly Diagnosed AML; FDA Awards Fast Track Designation to ARX517 mCRPC; EMA Rejects Mirati’s Krazati; Harmony Phase III Pitolisant Trial for PWS Patients; Belite Bio’s Phase 3 DRAGON Trial of Tinlarebant for STGD
Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...
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Jul 11, 2023
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD
Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...
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May 30, 2023
FDA Approves Lexicon’s INPEFA (Sotagliflozin); PTC Therapeutics’s Vatiquinone MOVE-FA Registration-Directed Trial; EU Approval to Novartis’s Sickle Cell Disease Drug; EMA Approves Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC; FDA Grants Priority Review to Fruquintinib for mCRC; FDA Orphan Drug Designation to Vega Therapeutics’s VGA039
Lexicon Announces FDA Approval of INPEFA (Sotagliflozin) For Treatment of Heart Failure Lexicon Pharmaceuticals, Inc. announced that the FDA has approved INPEFATM (sotagliflozin), a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure vis...
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Dec 04, 2019
The Regulatory process for drug approval in the MENA region
The MENA (the Middle East and North Africa) region is mostly an untouched market, which is an impetus for potential development and lucrative growth in the pharmaceutical market. The MENA region, a gamut of 22 countries, represent about 2% of the world’s pharmaceutical market. Out of which, Saudi Arabia, a country ...
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Mar 22, 2019
Complex regional pain syndrome (CRPS)-A debilitating disease
Did you ever feel chronic pain that is characterized by progressively worsening spontaneous regional pain without dermatomal distribution? If you did, then you might be suffering from Complex regional pain syndrome (CRPS). It is distinguished from other chronic pain conditions by the presence of signs indicatin...
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