Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
Demand for biosimilars is booming, with no hints of slowing down as the number of biosimilars getting approved keeps growing. Here are all the biosimilars that have received approval in 2024 to date.
Samsung Bioepis Co., Ltd. announced yesterday (July 23) that the US Food and Drug Administration (FDA) has approved Epsyqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).
A gene therapy being developed by Lexeo Therapeutics to treat cardiomyopathy caused by Friedreich ataxia, a rare neurodegenerative genetic disease, has achieved good interim results in a phase 1/2 trial.
Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.
The US FDA has delayed approval of Rocket Pharmaceuticals’ gene therapy for treatment of a rare immune condition known as leukocyte adhesion deficiency, citing a need for more information about the manufacturing process.
Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) version of Entyvio, its treatment for adults with moderate to severe Crohn’s disease (CD).
Ipsen is expanding its oncology pipeline by securing the global licensing rights to an antibody-drug conjugate (ADC) for solid tumors from Sutro Biopharma, its first drug in the category.
The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice...
With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.
Biogen’s stance at the upcoming AD/PD 2024 International Conference on Alzheimer’s disease and Parkinson’s disease will demonstrate its future plans for treating Alzheimer’s, following the discontinuation of Aduhelm (aducanumab), its anti-amyloid beta...
Allecra Therapeutics, a biopharma company developing novel therapies to combat antibiotic resistance, has received FDA approval for its treatment tackling ‘complicated’ urinary tract infections (UTIs).
QBiotics’ lead intratumoural oncology asset, tigilanol tiglate, has been awarded Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) by the United States Food and Drug Administration (FDA).
The US FDA has granted fast track designation to CAN-3110, a viral immunotherapy candidate from Candel Therapeutics to treat patients with recurrent high-grade glioma (HGG) and improve overall survival.
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, exagamglogene autotemcel (Casgevy) for the treatment of sickle cell disease with vaso-occlusive crisis.
AstraZeneca and Ionis have received FDA approval for Waiuna, their treatment for polyneuropathy in life-threatening disease transthyretin-mediated amyloidosis (ATTR).
Novo Nordisk's Ozempic (semaglutide) took the weight loss sector by storm in 2023, propelled by strong efficacy and safety data, coupled with social media buzz and celebrity endorsements that elevated the drug to mainstream prominence.
Skye Bioscience has announced its plans to develop nimacimab, the company’s monoclonal antibody recently acquired from Bird Rock Bio, for weight loss and the treatment of obesity.
Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.
At the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia, Arrowhead Pharmaceuticals unveiled the phase 2 clinical data for plozasiran (ARO-APOC3) and zodasiran (ARO-ANG3).
As it extends its cash runway, the cell therapy developer Atara Biotherapeutics has expanded a partnership with Pierre Fabre Laboratories to commercialize the off-the-shelf T-cell therapy tabelecleucel (tab-cel) for a rare form of blood cancer.
Huadong has been granted exclusive rights in Greater China to develop and commercialize MC2’s drug, Wynzora Cream, for the treatment of plaque psoriasis.
Quest Diagnostics, a provider of diagnostic information services, has announced that its AAVrh74 ELISA assay (CDx) has been granted breakthrough device designation from the U.S. Food and Drug Administration (FDA).
Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.
Genprex has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).
Teva Pharmaceuticals, a provider of generic and innovative medicines, and Alvotech, a biotech company specializing in the development and manufacture of biosimilar medicines, have expanded their existing partnership agreement.
Locate Bio, a UK-based orthobiologics company, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for LDGraft.
Lumen Bioscience has announced that the US Food and Drug Administration (FDA) has granted fast track designation for LMN-201, its biologic drug to treat and prevent C. difficile infection (CDI).
SiSaf has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (PRDD) by the US Food and Drug Administration (FDA) for its osteopetrosis treatment, SIS-101-ADO.
The Japanese pharmaceutical giant Astellas Pharma has taken over the U.S. company Iveric Bio in a $5.9 billion deal to get hold of its ophthalmology-focused pipeline.
More than a year after imposing a clinical hold on MaaT Pharma’s lead microbiome therapeutic in 2021, the US Food and Drug Administration (FDA) has given clearance for the French firm to begin a phase 3 trial in the US.
Avidity Biosciences, a biopharmaceutical company developing a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1044.
bluebird bio has announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD).
The South Korean company is set to create a new facility in West Virginia to house insulin manufacturing and to deliver its insulin products in the country.
The clinical stage company announces that its potential treatment for relapsed or refractory multiple myeloma receives nod for speedier review by the FDA.
BrainStorm Cell Therapeutics reports that the FDA is to hold an advisory committee meeting to discuss the company’s BLA for NurOwn, a personalized stem cell treatment targeted at ALS.
A US FDA panel of advisors concluded that there was a lack of substantial evidence to indicate that Biogen’s investigational drug, tofersen, was effective in treating a rare and aggressive form of ALS. But the experts voted unanimously that the investigational...
A US Food and Drug Administration (FDA) advisory committee has recommended both Pfizer and GSK’s RSV vaccines: with a decision from the agency expected in May.
An experimental antibody drug developed by Regeneron Pharmaceuticals called pozelimab could become the first approved treatment of the hereditary immune disease CHAPLE, with a US Food and Drug Administration (FDA) approval decision expected by August...
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...
The FDA wants to simplify COVID-19 immunizations and will discuss various ideas for future immunization strategies at an advisory committee meeting this week.