Biopharmaceutical Manufacturing, Upstream, Downstream …
4 days ago · News on the biopharmaceutical manufacturing industry, focusing on biologics, technology, upstream/downstream processing, cell culture and regulations
How will the Biosecure Act impact the pharma industry?
Oct 8, 2024 · But what does the Act mean for the biotech and pharma industry and how can companies best prepare for any impacts on future business? The Biosecure Act was first proposed by the US government late last year due to concerns about national security and how genetic and other biological data could be misused by foreign adversarial governments with a focus on China.
FDA’s endorsement brings Amgen and AstraZeneca closer to …
Aug 8, 2024 · In its financial report for the second quarter of 2024, Amgen has announced that the FDA has granted Tezspire (tezepelumab-ekko) a breakthrough therapy designation as an add-on maintenance treatment for patients with moderate to very severe COPD with a high blood count of a type of white blood cells called eosinophils.
nChroma Bio formed by merging genetic medicine companies
Dec 12, 2024 · Chroma Bio was launched in 2021 with $125 million in seed funding and aimed to take gene editing one step further by editing the epigenome, namely, markers on the genome that control the way genes are expressed in response to different stimuli.. Nvelop began in stealth mode in 2022, but officially launched earlier this year with $100 million in funding.
Arrowhead Phamaceuticals’ plozarsiran and zodasiran hold …
Nov 21, 2023 · The phase 2 SHASTA-2 study showed that plozasiran decreased APOC3 to -79%, triglycerides (TGs) to -74%, remnant cholesterol to -65% and increased high-density lipoprotein (HDL)-cholesterol (HDL-C) to 68% at 24 weeks in patients with severe hypertriglyceridemia.
FDA delays Regeneron's linvoseltamab approval due to …
Aug 22, 2024 · Regeneron submitted linvoseltamab, a bispecific antibody treatment for relapsed/refractory multiple myeloma, for FDA priority review in February this year.. The drug works to destroy cancer cells by binding to both a cancer protein, BCMA, and the CD3 receptor on a patient’s T cells. The antibody has been tested in a phase 1/2 trial and after a median of 14 months follow-up the objective and ...
Thermo Fisher - accelerating the shift towards precision medicine
Oct 22, 2024 · Last year, Thermo Fisher Scientific launched a new mass spectrometer with high resolution and speed, designed to accelerate the discovery of new proteins and advance precision medicine.
Cell and gene therapy will be top industry trend for pharma in 2024
Jan 8, 2024 · Healthcare industry professionals scored cell and gene therapy (CGT) as the industry trend to have the greatest impact on the pharmaceutical industry in 2024, in a recent survey launched by data and analytics firm GlobalData.
News - biopharma-reporter.com
Jan 14, 2025 · News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Trends in biosimilars: Regulatory approvals in 2024
Jul 24, 2024 · The biosimilars market is rapidly growing as global demand for biosimilars continues to grow. The global biosimilar market is estimated to reach a size of $43.8 billion by the end of 2024, and to grow over $100 billion in the next 10 years.. Biologics are expensive medications, which is driving up the popularity of biosimilars as a more cost-effective alternative.