Cell and gene therapy access model launches in US
The sickle cell gene therapies developed by Bluebird Bio and Vertex will be the first to be offered under the new scheme.
The sickle cell gene therapies developed by Bluebird Bio and Vertex will be the first to be offered under the new scheme.
The approval should provide competition for Pfizer, who has a very similar treatment on the market.
From developing treatments for Ebola to mastering karate with her daughters, Dr. Helen Harrington’s journey is one of resilience and curiosity.
PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.
A new case study released by AllazoHealth reveals that a leading rare disease pharmaceutical company achieved a 10.4% increase in therapy initiation, driven by AI-enabled patient outreach and personalized communications.
The new treatment will be a competitor of GSK’s Nucala (mepolizumab), which was approved in 2018 as the first targeted treatment for the same rare immune disease.
In a move set to transform drug discovery, CRO NovAliX has partnered with Bruker, a leader in scientific instruments, through a strategic investment aimed at enhancing drug development success rates.
Anu Codaty, VP of global marketing and strategy at Aldevron, is blazing trails in biotech, inspired by a family legacy in medicine and driven to create life-changing therapies.
The negative trial results have tanked the California-based biotech’s market value, with a 70% reduction in share price over the last week.
The US pharma giant Pfizer recently announced that its respiratory syncytial virus (RSV) vaccine Abrysvo has received FDA approval in adults aged 18 to 59 who are at an increased risk of developing lower respiratory tract disease caused by RSV (RSV-LRTD).
Thermo Fisher’s John Lesica discusses how mass spectrometry technology enables scientific breakthroughs in genomics and proteomics to provide valuable insights for drug discovery and development.
Investors and big pharma companies are waking up to the potential of techbio companies after years of avoidance, say experts at TechBio UK 2024, an event run by the BioIndustry Association (BIA).
A report of a case of motor neuropathy in a patient who received the vaccine last year has led the FDA to halt its development while more information is gathered.
Evaxion’s proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.
The US Biosecure Act was passed by the House of Representatives in September and seems likely to become law.
The UK cell therapy biotech will now advance its first candidate cell therapy to clinical trials for treatment of liver disease.
As CPHI Milan 2024 approaches, Symbiosis Pharmaceutical Services is gearing up to showcase major expansions and innovations in sterile biopharmaceutical manufacturing.
During the show, Quotient Sciences CEO Thierry Van Nieuwenhove will share insights on how the company is adapting to new FDA regulations.
The company will introduce its innovative siliconized moulded glass vials, positioning itself as the only global supplier offering this technology to pharmaceutical standards.
Enzene's monoclonal antibody production costs to dip below $40 per gram by 2025.
Dandelion Health used its new clinical AI marketplace to analyze real-world data, showing that GLP-1 drugs may help prevent cardiovascular disease (CVD) for a seven times larger population than previously researched.
Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive, HER2-negative) stage two or three early...
The Swedish biotech company Cellevate has raised €3.2 million in a seed round to fuel the commercialization of its nanofiber-based viral vector manufacturing technology in November.
The new company focuses on producing components needed to manufacture RNA-based therapies for which there is increasing demand.
Alison has more than 35 years of broad experience delivering clinical trials to sponsors with a patient centric mindset.
MinervaX and Wacker Biotech announced yesterday that they have entered into a manufacturing agreement for MinervaX’s prophylactic vaccine against Group B Streptococcus infections.
The original concerns of the US regulatory agency over the manufacturing of Eli Lilly’s Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.
Rare disease biotech Rezolute recently announced that the FDA has lifted the partial clinical hold on RZ358 (ersodetug), a novel therapy in development for the treatment of low blood sugar (hypoglycemia) resulting from congenital hyperinsulinism.
The San Diego-based biotech company Candid Therapeutics has launched with a huge $370 million with the aim to develop T-cell engager therapies for autoimmune diseases.
Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.
The European Commission has granted Orphan Drug Designation for Vivet Therapeutics’ gene therapy product VTX-806 for the treatment of Cerebrotendinous Xanthomatosis (CTX).
The U.S. company Emergent BioSolutions recently announced the FDA approval of its application to expand the indication for ACAM2000 – previously approved for smallpox – to include the prevention of mpox in high-risk individuals.
Neurocrine Biosciences has achieved late-stage success with muscarinic M4 selective agonist in schizophrenia.
Just months after facing a rejection in the US, the bispecific antibody odronextamab (Ordspono) has been approved by the European Commission for the treatment of two types of blood cancer in patients that have failed to respond to previous treatments.
Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis.
The US FDA has granted emergency use authorization to several updated COVID-19 vaccines against a new viral strain that is currently circulating.
The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.
Eisai and Biogen’s new Alzheimer’s treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimer’s disease.
As antibody-drug conjugates (ADCs) continue to heat up in the industry, Adcendo of Denmark has gained the global rights from Multitude Therapeutics to develop the Chinese company’s ADC for the treatment of cancer outside of the Greater China region.
In a promising advancement, scientists from the University of North Carolina at Chapel Hill and Emory University have developed a novel drug delivery system using synthetic amyloid beta (Aβ) peptides.
In a groundbreaking development, a team of biochemical engineers from South Korea has unveiled a new exosome-based delivery system, termed MAPLEX, that holds the potential to transform treatments for various diseases, including Alzheimer’s.
Recent advancements in injectable hydrogels are setting the stage for a new era in tissue engineering and regenerative medicine.
A team of scientists from the universities of Glasgow and Tel Aviv has developed a groundbreaking method to transform the brain parasite Toxoplasma gondii into a potential vehicle for delivering therapeutic treatments directly to brain cells.
In a significant leap forward for therapeutic science, researchers at Cornell University have developed a pioneering method to 'cloak' proteins, enabling their efficient delivery into living cells.
Two months after placing a partial hold on a phase 1 clinical trial evaluating an antibody-drug conjugate (ADC) in cancer patients, the FDA is allowing the study to proceed with the lower doses of the treatment.
Katarina Wikstrom has worked for over 20 years in the field of translational molecular oncology and holds the position of VP global product development at Almac Diagnostic Services.
The investment round will fund the first clinical trials for an innovative therapeutic modality designed to overcome drug resistance in patients with solid tumors.
The US approval of Nemluvio marks a major milestone for Galderma, a Swiss company developing treatments for a wide range of conditions affecting the skin.
The FDA has given the green light to Lymphir, the first immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) to get approval in over five years.
The agreement will give Genentech access to Sangamo’s capsid delivery platform and epigenetic regulation technology with applications in neurodegenerative disease.