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The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.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.
Sanofi held a ground-breaking ceremony for its new vaccine facility in Singapore on April 20. The US$475m site is pegged to become fully operational by Q1 2026.
BioConnection, an independent contract development manufacturing organization (CDMO) based in Oss in The Netherlands has completed a new capital raising round led by the European investment company, Gimv.
Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.
Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.
Bionova Scientific, a US biologics CDMO, is to be acquired by the US arm of Asahi Kasei Medical, part of the Asahi Kasei Group, owned by Tokyo based Asahi Kasei Corporation.
Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.
Chinese companies, Biocytogen Pharmaceuticals and CtM Biotech Co Ltd, are collaborating on the development of antibody drugs against intracellular tumor-associated antigens.
Moderna’s bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company...
Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
GC Corp, the holding company for GC group in South Korea, has moved to acquire 100% of the shares of BioCentriq, Inc, a US CDMO that designs and develops scalable cell and gene technologies (CGTs).
Dyadic licensee, Epygen Biotech, has received funding from the Government of India to advance a low-cost COVID-19 vaccine through Phase 1 and 2 clinical trials in India, using Dyadic’s C1 protein production platform.
