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The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.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.
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).
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.
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.
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.
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.
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.
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.
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).
ReiThera and Exothera are partnering to develop what they call a large-scale, low cost per dose manufacturing process to deliver novel vaccines to low- and middle-income countries (LMICs).
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
List Bio, together with List Labs, is set to build a new US$125m plant in Indiana, offering end-to-end manufacturing for early-stage development through to commercial production of new microbiome therapeutics.
A single dose of the Human Papillomavirus (HPV) vaccine offers comparable protection to the current two dose schedule, according to a review from the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) released this week.
Microbiome-focused company, Kaleido Biosciences, in a filing with the US Securities and Exchange Commission (SEC) on Friday, announced its intention to cease all company operations, lay off its remaining staff and delist from the Nasdaq Exchange.
Thermo Fisher Scientific says its is leveraging the company’s global infrastructure to offer end-to-end services aimed at speeding up the introduction of cell and gene therapies.
The International Society for Cell & Gene Therapy (ISCT) has established a task force to ensure that the CGT field advances in an ethical manner and that the expanded access route is being used for its intended purpose.
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
Abzena, a global CDMO specializing in the integrated development and manufacture of complex biologics and bioconjugates, has secured $65M in new funding.
V-Bio Ventures, a venture capital firm supporting young pioneering biotech companies raises €110m (US$122m) in its second fund, V-Bio Fund 2, exceeding its target of €100m.
