Samsung Biologics and European pharma company enter major manufacturing deal
The global CDMO has entered into several high-value manufacturing deals this year.
Bio developments
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.
Vicebio closes $100m financing round to advance multivalent vaccine technology
The series B fundraising will support the clinical development of next-generation multivalent vaccines against respiratory viruses.
UCB and Biogen announce positive Phase 3 results for dapirolizumab pegol in systemic lupus erythematosus
UCB and Biogen revealed that their Phase 3 study testing dapirolizumab pegol in people with systemic lupus erythematosus met the primary and secondary endpoints.
AI study shows GLP-1s could help prevent heart disease in millions
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.
Pricing and logistics: The challenges of getting mpox vaccines to the front line
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.
Cellevate bags €3.2 million to smash viral vector manufacturing bottleneck
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.
Aurora Biosynthetics launches to boost RNA therapeutics manufacturing in Asia-Pacific
The new company focuses on producing components needed to manufacture RNA-based therapies for which there is increasing demand.
Eli Lilly expands manufacturing facilities in Ireland with $1.8bn investment
With a new investment in its two manufacturing sites in Ireland, Eli Lilly continues implementing the largest expansion program in the company’s history.
FDA designations boost AI-driven cell therapy approach for Duchenne muscular dystrophy
The FDA has granted Orphan Drug and Rare Pediatric Disease Designations to Somite’s cell replacement therapy for the treatment of Duchenne muscular dystrophy.
Vaxess' Rachel Sha - 'own the seat at the table that you have and have confidence'
Rachel Sha has had a colorful career not without its challenges, but she urges women in the science industry to have confidence and answer hard questions.
Eli Lilly reports positive phase 3 results for a weekly insulin formulation
New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
How modern trial designs propel cancer therapies to the market - interview
Clinical trials are becoming increasingly complex as emerging technologies such as immunotherapy enter the mainstream.
FDA lifts partial clinical hold on phase 3 low blood sugar treatment
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.