Tag: Pharmaceuticals

January 21, 2022

In October, the Geneva-based Medicines Patent Pool, a United Nations-backed public health group announced a voluntary licensing agreement by which Merck would license the drug to companies that meet certain quality-assurance specifications. Neither Merck nor its development partners will receive […]

January 20, 2022

Pfizer and Moderna are now two of the leading pharma companies in the U.S. when it comes to public image, thanks to their COVID vaccines. On the flip side, vaccine rivals J&J and AstraZeneca have seen their reputations plummet. This […]

January 18, 2022

Developing drugs is a capital-intensive activity, and never more so than when a biotech company wants to move from preclinical development to more expensive clinical trials. Early on, there are often angel investments and/or academic or government grants, but the […]

January 12, 2022

In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination […]

January 7, 2022

AstraZeneca is stepping up its pursuit of a rare disease market targeted by Alnylam and Pfizer. Having entered the ATTR space through its takeover of Alexion, AstraZeneca is paying $30 million for worldwide rights to Neurimmune’s NI006 in its second […]

January 6, 2022

Novartis is getting back into bed with Alnylam. More than a decade after severing its ties to the RNAi pioneer, Novartis has returned to the deal table for an ambitious early-stage collaboration to restore liver function in patients with end-stage […]

January 5, 2022

Despite major challenges and demands created by the coronavirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19. Last year saw the Center for Drug Evaluation and […]

January 3, 2022

FDA announced on Jan. 3, 2022, that it was amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand single booster doses to children 12 through 15 years of age. The agency reviewed data from Israel from […]

December 28, 2021

A report in Trends in Biotechnology, on the potential for “mechanistically oriented in silico processes” in vaccine development, supports the idea that, whenever possible, developers can save time and cost by running virtual experiments on their computers. In this paper […]

December 28, 2021

Anton Middelberg, PhD, deputy vice-chancellor and vice-president of research at the University of Adelaide in Australia, believes industry reluctance to go continuous reflects the traditional focus on batch-mode production and, in some areas, the technical challenges. “The complexity in continuous […]

December 27, 2021

Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been granted a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s approved therapy Aduhelm, which […]

December 23, 2021

Scientists have harnessed T cells to better understand the immune response to mRNA vaccines against SARS-CoV-2, the virus that causes COVID-19. The findings from St. Jude Children’s Research Hospital and Washington University in St. Louis were published today in Cell. […]