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Industry, Vaccines

Manufacturing mix-up could blunt supply boost from J&J vaccine

April 1, 2021

Via: Biopharma Dive

The FDA’s emergency authorization of J&J’s vaccine late last month boosted the quickening rollout of vaccines in the U.S., adding a third option in addition to shots from Pfizer and Moderna. Yet, previous delays in manufacturing meant J&J only had […]


Cell and Gene Therapy, FDA, Industry, Regulations

How to gear up for more stringent gene and cell therapy regulations

April 1, 2021

Via: EPM Magazine

In January 2020, the US Food and Drug Administration (FDA) published a series of seven guidances regarding cell and gene therapy. These have not come too soon, given some much-publicised regulatory rejections. For example, the FDA turning down the Biologics […]


Biotech, Industry, News

Amgen acquires a small biotech and its inflammatory disease research

March 31, 2021

Via: Biopharma Dive

Amgen has recently stepped up its dealmaking activity as it tries to bolster its pipeline of treatments for cancer and inflammation. Earlier this month, the California biotech announced plans to pay $1.9 billion for Five Prime Therapeutics, which is focused […]


FDA, Regulations

FDA advisers reassert case against approval of Biogen’s Alzheimer’s drug

March 31, 2021

Via: Biopharma Dive

One of the most important decisions in the history of the Food and Drug Administration is quickly approaching. By early June, the agency should have a verdict on whether to approve aducanumab, a potentially first-of-its-kind treatment for Alzheimer’s disease that […]


Clinical Trials, FDA, Regulations, Research and Development

FDA green light for BMS, bluebird bio’s CAR-T therapy Abecma in multiple myeloma

March 30, 2021

Via: Pharma Times

Abecma (idecabtagene vicleucel; ide-cel) has been cleared for use in adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. In the […]


Clinical Trials, News, Research and Development

Clinical Trial Management System Market: Software is anticipated to be Most Lucrative Segment

March 30, 2021

Via: BioSpace

According to Transparency Market Research’s latest report on the global clinical trials management system (CTMS)market for the historical period 2017–2018 and forecast period 2019–2027, rising demand for new therapies and increasing research and developmental activities to drive the global clinical […]


Industry, Manufacturing, Research and Development, Vaccines

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

March 29, 2021

Via: World Pharma News

EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. New manufacturing site for AstraZeneca’s COVID-19 vaccine A new manufacturing site has been approved for the production […]


Cell and Gene Therapy, Industry

How Cancer Immunotherapy Gets a STING

March 29, 2021

Via: Genetic Engineering and Biotechnology News

The innate immune system scans for signs—such as misplaced genetic material—that a pathogen or dangerous mutation could cause disease. When DNA is found in areas of the cell other than the nucleus, which can occur due to viruses or cancer, […]


Manufacturing, Research and Development

Nexus Pharmaceuticals Announces Verbal to Occupy Authorization

March 26, 2021

Via: BioSpace

Lincolnshire, Illinois—Nexus Pharmaceuticals, Inc. is pleased to announce that it has received authorization to occupy its new pharmaceutical manufacturing facility from the Village of Pleasant Prairie, Wisconsin. Nexus Pharmaceuticals, which specializes in developing innovative processes to manufacture specialty and generic […]


FDA, Regulations

Is the FDA Getting Tougher on Drug Applications?

March 26, 2021

Via: BioSpace

It’s already been reported that the U.S. Food and Drug Administration (FDA) is running an industry-wide evaluation of its accelerated approvals. These approvals were typically granted for drugs with a high unmet need and require the companies to conduct post-marketing […]


Biotech, Industry

Biotechs Bolstering Bank Accounts by Selling Stock This Week

March 25, 2021

Via: BioSpace

Several new initial public offering (IPO) announcements have been made by international and U.S.-based biopharmaceutical and biotechnology companies in the past couple of days, with Dutch biotechnology company LAVA Therapeutics leading the pact. LAVA, a company harnessing expertise in bispecific […]


Cell and Gene Therapy, Industry

Krystal Biotech Launches Spinoff for Gene-Based Anti-Wrinkle Products

March 25, 2021

Via: BioSpace

On the back of a $135 million public offering in February, rare disease gene therapy company Krystal Biotech has launched subsidiary Jeune Inc. to promote its gene therapies for aesthetic skin conditions. In conjunction with the launch, Jeune announced positive […]