News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The Danish biotech company Antag Therapeutics announced yesterday that it had raised €80 million ($84 million) in a Series A financing round to boost the clinical development of its next-generation weight loss therapy, AT-7687.
The two anti-TL1A antibodies are being tested in healthy people, with the first participants dosed.
The potential $2.9 billion deal stands the New Jersey company in good stead after recent disappointing results in its ALS program.
New Alzheimer’s drug tackles early disease progression.
MariTide is being studied for the treatment of obesity and Type 2 diabetes and demonstrated weight loss at 52 weeks.
Despite disappointing results in the genetic neurodegenerative disorder, the drug shows potential for treating obesity.
The global CDMO has entered into several high-value manufacturing deals this year.
A serious adverse event in the New York biotech’s phase 1/2 trial of its Rett syndrome gene therapy puts a question mark over the program.
The interim phase 2 trial results show a good immune response in participants and the therapy is well tolerated to date.
Results from the SURMOUNT-1 trial show that weekly injections of tirzepatide could stop the progression from pre-diabetes to type 2 diabetes in 99% of participants.
New cGMP fermentation facility in the UK set to meet growing demand for drug substance production, supporting biopharma manufacturing at scale.
The Series D financing will support the clinical development of two ADCs.
Emraclidine was expected to be a competitor to Bristol Myers Squibb’s recently approved Cobenfy, but trial results put its future in doubt.
The FDA had put a clinical hold on Novavax’s COVID-19-influenza combo vaccine after an adverse event in a patient.
The US biopharma will discontinue development of the Exondys 51 (eteplirsen) follow up treatment to focus on other treatment candidates.
Wegovy manufacturer Ascendis Pharma has been tasked with supporting the development of a once-monthly GLP-1 drug.
The two companies have formed Oblenio Bio to develop a tri-specific T-cell engager
The Simponi biosimilar, AVT05, has shown positive top-line results in patients with moderate to severe rheumatoid arthritis.
BigHat will have access to the clinical-stage ADC platform technology designed by Lonza’s Synaffix.
The expansion of its QC microbiology lab meets the growing demand for quality testing.
Backed by Medicxi, Ottimo Pharma is going to be working on Jankistomig and is headed by David Epstein
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).
The FDA has given clearance to Adcentrx Therapeutics’ IND application for an antibody-drug conjugate (ADC) targeting solid tumors.
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.
The FDA has simultaneously granted approval to Astellas’ cancer drug Vyloy and to a companion diagnostic test developed by Roche.
Wave Life Sciences reports that it has successfully carried out RNA editing in two patients with alpha-1 antitrypsin deficiency, the first time this kind of clinical RNA editing has been completed in humans according to the company.
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).
Merck has unveiled a large new biosafety testing facility in Rockville to meet the global demand.
The approval of Hympavzi makes it the first treatment for both hemophilia A and B to be administered through a pre-filled pen or syringe.
From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.
At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.
Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
The Japanese big pharma adds the new gene therapy candidate to its pipeline in a US$50 million deal in equity and upfront payments.
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.
As cell therapies continue to advance, the need for better automated, large-scale manufacturing options increases.
This year’s Nobel prize in physiology or medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking research on microRNA.
The newly opened Biotech Center of Excellence will be dedicated to developing and producing biological drugs, housing the entire supply chain.
During the show, Quotient Sciences CEO Thierry Van Nieuwenhove will share insights on how the company is adapting to new FDA regulations.
Cobenfy (KarXT) is the first completely new type of schizophrenia drug to be approved for more than 30 years.
A head-to-head study has revealed that CSL and Arcturus Therapeutic’s self-amplifying mRNA vaccine can maintain a stronger immune response than a conventional mRNA vaccine for up to one year and at a much lower dose.
David Carbone, Director of the James Thoracic Oncology Center and Professor of Internal Medicine at The Ohio State University Comprehensive Cancer Center, has dedicated his career to researching and treating lung cancer, with over 300 scientific...
The FDA has extended its approval of UCB’s BIMZELX to three new indications, extending the use of the drug to a total of four autoimmune diseases.
The series B fundraising will support the clinical development of next-generation multivalent vaccines against respiratory viruses.
UCB and Biogen revealed that their Phase 3 study testing dapirolizumab pegol in people with systemic lupus erythematosus met the primary and secondary endpoints.
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.
Although vaccines already exist to prevent mpox, high prices and the risk of side effects make it difficult to roll them out in the regions that need them most. Vaccine developers are working to offer better options.
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.