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Tag: Pharmaceuticals


News

27 drugmakers to provide generic COVID drug to low-income countries

January 21, 2022

Via: Pharmaphorum

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 […]


Industry, Vaccines

COVID vaccines help Pfizer, Moderna reign supreme reputation-wise, but they’re a double-edged sword for J&J and AZ

January 20, 2022

Via: FiercePharma

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 […]


Biotech, Industry

How CRO venture capital relationships can help biotech fundraising

January 18, 2022

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

January 12, 2022

Via: Biopharm International

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 […]


News

AstraZeneca picks up new weapon in rare disease fight with Alnylam and Pfizer, paying $30M for rights to an early-phase asset

January 7, 2022

Via: FierceBiotech

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 […]


News

Novartis taps Alnylam for ambitious push to fix liver function

January 6, 2022

Via: FierceBiotech

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 […]


FDA, Regulations

FDA Keeps New Drugs Coming

January 5, 2022

Via: Biopharm International

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 […]


FDA, Regulations

FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine

January 3, 2022

Via: Biopharm International

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 […]


Industry, Vaccines

In Silico Modeling for Vaccine Processing

December 28, 2021

Via: Genetic Engineering and Biotechnology News

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 […]


Biotech, Industry, Manufacturing, Research and Development

Industry Warming to 24/7 Production

December 28, 2021

Via: Genetic Engineering and Biotechnology News

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 […]


News

Biogen-Eisai’s potential Aduhelm sequel drug granted speedy review by FDA

December 27, 2021

Via: FierceBiotech

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 […]


Industry, Vaccines

SARS-CoV-2 vaccination creates a strong, persistent T-cell response

December 23, 2021

Via: Drugs.com

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. […]