Sernova and Evotec are teaming up on an implantable beta cell replacement therapy to replace insulin injections for the millions of patients with diabetes.
The World Health Organization (WHO) has today issued an emergency use listing (EUL) for Convidecia, a vaccine manufactured by CanSino Biologics, bringing the total number of COVID-19 vaccines validated by the organisation to 11.
Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.
AGC Biologics will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.
South Korean multinational, Lotte Corporation, is to acquire Bristol Myers Squibb's manufacturing facility in East Syracuse, New York. The deal is reportedly worth US$160m.
RQ Biotechnology is launching as a new UK-based biotech: following the completion of a successful licensing deal with AstraZeneca for early-stage monoclonal antibodies targeted against SARS-CoV-2.
A survey from Spherix gathered reactions from US neurologists after the US Centers for Medicare & Medicaid Services (CMS) announced its National Coverage Determination for monoclonal antibodies against amyloid for the treatment of Alzheimer’s.
Vaccine company Valneva has received notice from the European Commission of its intent to terminate the Advanced Purchase Agreement for Valneva’s COVID-19 vaccine.
Gerresheimer has enhanced its manufacturing capabilities in India, in an effort to ensure consistent, local supply for pharma and healthcare operations.
Taiwan based CDMO, Bora Pharmaceuticals, says the acquisition of CDMO assets from local player, Eden Biologics, will help it build a presence in large-molecule contract drug development and manufacturing.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.
Inventprise has inaugurated its new manufacturing facility for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.
Cytiva is opening a new 7,400m² manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the company’s cell and gene therapy business as well as a being a base for European customer training programs.
In a simulation model, lecanemab treatment was estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to early AD.
Capital investments in Swiss biotech companies reached CHF 3.33bn ($3.53bn) in 2021; while R&D investments increased to a record-high CHF 2.56bn ($2.71bn).
Last week the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, launched a clinical trial to investigate a preventative vaccine for Epstein-Barr virus (EBV). It’s part of growing efforts to create...
The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.
CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.
EU systems need to become more streamlined to help bring novel technologies to market - which would in turn encourage investment and activity in healthcare biotech, says EuropaBio as it publishes key policy recommendations for the sector.
Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the world’s first Phase 3 study of oral insulin under FDA approved protocols.
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.
CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
The US will play a key role in the development of advanced manufacturing technologies, predicts a report commissioned by CPhI North America ahead of the 2022 show.
‘Open science’ encourages the public sharing of research data, helping researchers tackle biological threats. And yet, as the biotech industry moves forward in leaps and bounds, the risk of accidental or deliberate misuse of biological research increases....
Astorg will acquire CDMO CordenPharma from ICIG: noting strong organic growth for the CDMO thanks to its position in fast-growing drug modalities such as mRNA vaccines, peptides and high-potency compounds notably for oncology therapeutics.
Biogen will ‘substantially eliminate’ commercial infrastructure for Alzheimer’s drug Aduhelm and take additional cost-reduction measures, the company announced as it released its Q1 2022 results this morning.
Prothena has been granted fast track designation from the US Food and Drug Administration (FDA) to develop a next-generation treatment for Alzheimer’s disease, PRX012.
Xbiome Inc, a China headquartered AI-based microbiome therapeutics startup, has acquired the clinical-stage M201 program developed by Assembly Biosciences, a firm developing therapeutics targeting hepatitis B virus and other viral diseases.
Korean contract development and manufacturing organization, Samsung Biologics, announced strong financial results today for Q1 of its fiscal year 2022.
Valneva and Pfizer report positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15: and now plan to include this population in an upcoming Phase 3 trial.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
The diagnostics and drug development company, Labcorp, is partnering with San Francisco based, Xcell Biosciences, to advance efforts to help clients bring cell and gene therapies to market.
