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Regeneron’s Praluent sidekick nabs speedy FDA review, with February PDUFA date

Regeneron has taken a step closer to getting a green light for its experimental high cholesterol drug as the FDA allows a swift review of evicanumab. Patients with high cholesterol from a rare genetic disorder struggle to keep their cholesterol levels in check, despite taking multiple lipid-busting drugs. A new drug from Regeneron may change…

A look at Inovio’s Philly local coronavirus vaccine-in-progress

Operation Warp Speed, the federal government’s multi-agency push to develop a COVID-19 vaccine, is promising to provide 300 million doses by January 2021. That means funding for several of the top candidates. Moderna, one of the leaders of the pack, is already in Phase III trials after creating its first vaccine in a record-breaking 42…

Israeli scientist uses microbubbles to explode cancer cells

An international team of researchers led by an Israeli scientist has developed a noninvasive technology to kill breast cancer cells, an innovation that in the future could perhaps also be used to treat diseases such as brain cancer, Alzheimer’s and Parkinson’s. The groundbreaking technique, developed by Tel Aviv University’s Tali Ilovitsh during her post-doctorate period…

Bausch Health Announces Its Intention To Spin Off Its Eye Health Business Into An Independent Publicly Traded Company

LAVAL, QC, Aug. 6, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) today announced that it intends to spin off its leading eye health business into an independent publicly traded entity (“Bausch + Lomb – NewCo”) from the remainder of Bausch Health (“BHC”). The spinoff will establish two separate…

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ — Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK)…

Pfizer could earn $15B-plus in COVID-19 vaccine sales: analyst

On the heels of Pfizer’s $1.95 billion COVID-19 vaccine deal with the U.S. government, one analyst says the drugmaker could earn many more billions in revenue on its potential vaccine—if the program succeeds. At $1.95 billion for 100 million doses, Pfizer’s deal sets a price-per-dose of $19.50, which Bloomberg Intelligence analyst Sam Fazeli sees as…

Partnered and backed by AbbVie, but cancer I-O biotech Tizona targeted by Gilead

Headed up by Scott Clarke, an ex-Roche exec who served as its global head of oncology partnering for Asia and emerging markets, the cancer immunotherapy company is working on several early assets, including TTX-030, a CD39-targeting antibody that last year attracted AbbVie’s interest and, according to preclinical data, seems to block an immune-inhibiting pathway in…

The CRA’s Guide to Monitoring Clinical Research

The guide that has trained thousands of CRAs is updated! The CRA’s Guide to Monitoring Clinical Research: A definitive resource for building mastery and complying with official regulations and guidelines. Use this guide to advance your career — plus ensure your trials follow critical requirements from FDA, ICH and NIH. In order to play a…

Novartis promises zero profit for 15 symptomatic COVID-19 drugs in low-income countries

Novartis’ generic hydroxychloroquine may have little use in COVID-19, but the Swiss pharma still wants to contribute its low-cost drugs in some way in the current fight. Novartis’ Sandoz unit will offer 15 generic and over-the-counter medicines at zero profit to developing countries during the pandemic, the company said Thursday. The portfolio covers widely used antibiotics and…

Imvax Inc. Raises $112 Million in Series C Financing

Imvax Inc. Raises $112 Million in Series C Financing Funds to support Phase 2 Clinical Development of IGV-001 for treatment of Glioblastoma multiforme,  Phase 1 research into additional solid tumor indications and build out of the operational capabilities PHILADELPHIA, JULY 16, 2020 – Imvax, Inc., a clinical-stage biotechnology company whose groundbreaking personalized neo-antigen immunotherapy, IGV-001, is being…