Roche and Prothena’s Parkinson’s antibody treatment fails at phase 2
The biologic treatment missed the primary endpoint, but did show some improvements in those given the drug and may be better for treating some subgroups than others.
Bio developments
Teva and Sanofi’s IBD drug hits Phase 2 targets
The anti-TL1A antibody allowed significantly more inflammatory bowel disease (IBD) patients to go into remission than those taking placebo treatment.
Orexo and Abera collaborate to develop nasal powder vaccines
The companies will work on the development of an influenza vaccine first.
SpliceBio gets FDA green light to start Phase 1/2 trial for inherited eye disease gene therapy
The company will start enrolling patients with Stargardt disease in the first half of 2025.
Relation and GSK join forces to advance fibrotic diseases and osteoarthritis therapies
Relation Therapeutics will receive $45 million upfront and potentially more in milestone payments.
GSK and Muna Therapeutics partner to develop new treatments for Alzheimer’s
The partnership revolves around Muna Therapeutics’ technology platform, which employs a spatial multi-omics approach to identify and validate new drug targets for neurodegenerative diseases.
Antag Therapeutics raises $84 million to advance its weight loss drug into the clinic
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.
Spyre Therapeutics launches Phase 1 trials for its extended half-life IBD therapy
The two anti-TL1A antibodies are being tested in healthy people, with the first participants dosed.
PTC Therapeutics boosted by Novartis rights deal for Huntington’s program
The potential $2.9 billion deal stands the New Jersey company in good stead after recent disappointing results in its ALS program.
Eisai and Biogen launch Alzheimer’s treatment in South Korea
New Alzheimer’s drug tackles early disease progression.
Amgen announces positive Phase 2 results for its GLP-1-GIP weight loss drug
MariTide is being studied for the treatment of obesity and Type 2 diabetes and demonstrated weight loss at 52 weeks.
Biohaven’s myostatin inhibitor fails in phase 3 spinal muscular atrophy trial
Despite disappointing results in the genetic neurodegenerative disorder, the drug shows potential for treating obesity.
Samsung Biologics and European pharma company enter major manufacturing deal
The global CDMO has entered into several high-value manufacturing deals this year.
Serious adverse event causes problems for Neurogene’s Rett gene therapy
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.
Promising early Parkinson’s immunotherapy results for AC Immune
The interim phase 2 trial results show a good immune response in participants and the therapy is well tolerated to date.
Tirzepatide prevents type 2 diabetes in 99% of prediabetic patients for 3 years
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.
SEKISUI Diagnostics completes £15.7M expansion to boost biopharma manufacturing capacity
New cGMP fermentation facility in the UK set to meet growing demand for drug substance production, supporting biopharma manufacturing at scale.
Alentis raises $181 million to advance ADCs to the clinic
The Series D financing will support the clinical development of two ADCs.
AbbVie’s schizophrenia candidate fails in two phase 2 trials
Emraclidine was expected to be a competitor to Bristol Myers Squibb’s recently approved Cobenfy, but trial results put its future in doubt.
FDA removes clinical hold on Novavax’s COVID-19-influenza combo vaccine
The FDA had put a clinical hold on Novavax’s COVID-19-influenza combo vaccine after an adverse event in a patient.
Sarepta discontinues development of Duchenne ASO treatment vesleteplirsen
The US biopharma will discontinue development of the Exondys 51 (eteplirsen) follow up treatment to focus on other treatment candidates.
Novo Nordisk signs $285 million deal for a once-monthly GLP-1 receptor agonist
Wegovy manufacturer Ascendis Pharma has been tasked with supporting the development of a once-monthly GLP-1 drug.
Aditum Bio and Leads Biolabs join forces in new company to fight autoimmune diseases
The two companies have formed Oblenio Bio to develop a tri-specific T-cell engager
EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi
The Simponi biosimilar, AVT05, has shown positive top-line results in patients with moderate to severe rheumatoid arthritis.
Synaffix and BigHat Biosciences collaborate to develop AI-designed ADC
BigHat will have access to the clinical-stage ADC platform technology designed by Lonza’s Synaffix.
Abzena announces major expansion of its biologics manufacturing facility
The expansion of its QC microbiology lab meets the growing demand for quality testing.
Ottimo Pharma emerges from stealth mode with prominent leadership and a promising cancer therapy
Backed by Medicxi, Ottimo Pharma is going to be working on Jankistomig and is headed by David Epstein
Alto Neuroscience’s depression drug trial fails at phase 2
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 FDA has approved Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59
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).
Adcentrx gets FDA clearance for phase 1 trial of ADC for tumors
The FDA has given clearance to Adcentrx Therapeutics’ IND application for an antibody-drug conjugate (ADC) targeting solid tumors.
Innovations in mass spectrometry accelerate the shift toward precision medicine
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.
FDA approves targeted therapy for gastric cancer and its companion diagnostic
The FDA has simultaneously granted approval to Astellas’ cancer drug Vyloy and to a companion diagnostic test developed by Roche.
Wave claims first clinical RNA editing title in rare genetic disease
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 no longer avoiding techbio companies
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 opens new €290m U.S. biosafety testing facility
Merck has unveiled a large new biosafety testing facility in Rockville to meet the global demand.
FDA approves Pfizer's antibody treatment for hemophilia
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.
Women in STEM: Gitte Barknowitz’s journey to leading global initiatives
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.
Women in Science: Sharmeen Roy - 'pharmacy is the perfect blend of all my favourite subjects'
At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.
Jane Koo on leading regulatory affairs at CTMC: A journey from mAbs to cellular therapies
Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
Astellas licenses AviadoBio’s dementia gene therapy candidate
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 AI-Immunology platform shines in multiple clinical trials
Evaxion’s proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.
Preparing for the US Biosecure Act - what does it mean for the pharma industry?
The US Biosecure Act was passed by the House of Representatives in September and seems likely to become law.
Automation in cell therapy manufacturing and CAR-T therapy: Cytiva puts the spotlight on future trends
As cell therapies continue to advance, the need for better automated, large-scale manufacturing options increases.
The discovery of microRNA is awarded with the 2024 Nobel prize in medicine
This year’s Nobel prize in physiology or medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking research on microRNA.
Chiesi Group launches biotechnology center in Italy, backed by a €400m investment
The newly opened Biotech Center of Excellence will be dedicated to developing and producing biological drugs, housing the entire supply chain.
Quotient Sciences expands with mRNA Focus at CPHI 2024
During the show, Quotient Sciences CEO Thierry Van Nieuwenhove will share insights on how the company is adapting to new FDA regulations.
BMS achieves FDA approval for schizophrenia drug Cobenfy
Cobenfy (KarXT) is the first completely new type of schizophrenia drug to be approved for more than 30 years.
Self-amplifying mRNA COVID-19 vaccine shows superiority over conventional mRNA vaccine
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.
Oncology expert reveals the impact of biomarker testing on the outcomes of targeted therapies for cancer
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...
UCB announces extended FDA approvals for BIMZELX for the treatment of inflammatory autoimmune diseases
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.