Blog
Regulatory Update: Amylyx’s ALS drug faces rejection by the European Medicines Agency (EMA)
Source – Amylyx Pharmaceuticals On June 23, 2023, the European Medicines Agency (EMA) has formally issued a negative opinion regarding ...
Jazz Files Lawsuit Against FDA Over Avadel’s Narcolepsy Medication Approval
Source – Jazz Pharmaceuticals In a legal battle against the FDA, Jazz Pharmaceuticals alleges that the agency violated the orphan ...
Altuviiio a weekly Administration Provides Effective Bleed Prevention for Severe Hemophilia A in Children
Source – Sanofi On June 26, 2023, at the Annual Meeting of the International Society on Thrombosis and Haemostasis (ISTH) ...
Addressing Low Diagnosis Rates for Kidney Disease: The Urgent Need for Better Screening, as Highlighted by AstraZeneca
How AstraZeneca’s Research Shows the Need for Improved Screening Methods to Tackle Low Diagnosis Rates for Kidney Disease AstraZeneca, the ...
Lilly’s SURMOUNT-2 Study Shows Tirzepatide Achieves Significant 15.7% Weight Reduction in Adults with Obesity and Type 2 Diabetes
Source – Eli Lilly On June 24, 2023, Eli Lilly and Company’s tirzepatide showed promising results in the SURMOUNT-2 Phase ...
Positive Phase IIIa Results: Once-Weekly Insulin Icodec Benefits Adults with Type 2 Diabetes
Source – Novo Nordisk Novo Nordisk, on June 25, 2023, released new findings from Phase IIIa trials, ONWARDS 1 and ...
GSK Resolves First Jury Trial in Zantac Litigation Through Settlement
Source – GSK GSK has chosen to settle a significant lawsuit related to allegations that its drug Zantac caused cancer ...
FDA Grants Approval to Pfizer’s LITFULO (Ritlecitinib) for Severe Alopecia Areata in Adults and Adolescents
Source: Pfizer Pfizer announced on June 23, 2023, that the U.S. Food and Drug Administration (FDA) has granted approval to ...
Lilly’s Orforglipron Shows Promising Weight Reduction in Obesity and Overweight Patients: Phase II Findings
Source – Eli Lilly On June 23, 2023, Eli Lilly and Company announced the Phase II results for orforglipron, an ...
AbbVie Receives Favorable CHMP Opinion for Atogepant as Preventive Treatment for Migraine in Adults
Source – AbbVie AbbVie announced on June 23, 2023, that the Committee for Medicinal Products for Human Use (CHMP) of ...
Bayer Initiates Phase III Trial of Finerenone in Adults with Type 1 Diabetes and Chronic Kidney Disease
Source – Bayer On June 22, 2023, Bayer Initiates Phase III Trial of Finerenone, Bayer announced the initiation of a ...
Stem Cell Transplant: A Definitive Insight
Introduction Stem cell transplant, also known as bone marrow transplant, is a procedure that can save the lives of people ...
DEMYSTIFYING MYELOFIBROSIS SYMPTOMS: A Closer Look
Introduction: Myelofibrosis symptoms Myelofibrosis is a rare and serious blood cancer that affects the bone marrow, the soft tissue inside ...
Understanding Myelofibrosis Treatment: What You Need to Know
Introduction: Myelofibrosis Treatments In this article, we will discuss some of the most common Myelofibrosis treatments and what to expect ...
Evolution of Myelofibrosis Treatment Paradigm: Unleashing the Potential of Combination Therapies
Introduction In the rapidly advancing field of myelofibrosis treatment, significant strides have been made in recent years, ushering in a ...
Advanced Classical Hodgkin Lymphoma: BrECADD Shows Noninferiority to eBEACOPP
Source – BrECADD According to information from the Phase III HD21 trial (NCT02661503), which included patients with advanced classical Hodgkin ...
In R/R TRBC1+ Patients, AUTO4 CAR T-Cell Therapy Is Well Tolerated Lymphoma T-cell in the periphery
Findings from the first-in-human AUTO4-TL1 trial (NCT03590574), which were presented at the 17th Annual International Conference on Malignant Lymphoma, showed ...
In patients with treatment-naive CLL, Venetoclax Plus Obinutuzumab Shows Durable Survival Benefits
According to 6-year results from the Phase III CLL14 trial (NCT02242942), fixed-duration venetoclax (Venclexta) plus obinutuzumab (Gazyva) therapy resulted in ...
uniQure craters on the gene therapy data from Huntington Disease
Source –uniQure On June 21, 2023 uniQure announced promising interim data, including up to 24 months of follow-up, from 26 ...
Inselspital at Bern University Hospital uses Bayer’s radiological AI platform
Source – Bayer Bayer’s collection of digital X-ray, MRI, and CT imaging instruments powered by artificial intelligence will be used ...
CDC panel supports this year’s RSV vaccinations from GSK and Pfizer
If the Centres for Disease Control and Prevention (CDC) heed the counsel of professional advisers, adults in the US 60 ...
FDA rejects Aldeyra’s eye cancer treatment, citing a lack of clinical data, shattering hopes
Source – Aldeyra Therapeutics On June 21, 2023, Aldeyra disclosed that they have received a Complete Response Letter from the ...
EU Drug Regulator Scrutinizes Novo Nordisk and Eli Lilly Over GLP-1 Safety
The increased inspection of GLP-I therapies by the European Medicines Agency (EMA) has raised a warning about the possibility that ...
Intercept Implements Restructuring as Ocaliva’s Hopes for NASH Treatment Suffer Another FDA Rejection
Source – Intercept Ocaliva by Intercept wasn’t the fatty liver disease breakthrough that the company had anticipated it would be, ...
Sarepta Therapeutics Makes History with FDA Approval of Elevidys, the First Gene Therapy for Duchenne Muscular Dystrophy
Source – Sarepta Therapeutics On June 22, 2023, Sarepta Therapeutics made an announcement regarding the accelerated approval granted by the ...
Sarepta’s Breakthrough DMD Gene Treatment, Elevidys, Triumphs FDA Hurdles at $3.2M
The speedy approval of Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has been achieved after several delays and a close ...
Moderna Application For FDA Approval Of Updated Covid-19 Vaccine
Source – Moderna On June 22, 2023, a regulatory application for Moderna’s updated COVID-19 mRNA vaccine (mRNA-1273.815), which contains spike ...
Kite Successfully Transfers Marketing Authorization for Yescarta CAR T-cell Therapy in Japan
Source – Gilead Sciences According to Kite Pharma on June 22, 2023, the marketing authorization for Yescarta, a chimeric antigen ...
FDA Grants Priority Review for Bluebird Bio’s Sickle Cell Treatment
Source – bluebird bio On June 21, 2023, the US Food and Drug Administration (FDA) accepted the Biologics Licence Application ...
FDA rejects F2G’s innovative antimicrobial
Source – F2G After the FDA declared it was unable to approve its Olorofim candidate, F2G’s quest to break a ...
