The Week Ahead In Biotech: Endo, Eagle Pharma FDA Decisions, ObsEva Late-Stage Readouts In Focus
Monday, 6 July 2020, 14:08:57
Biotech stocks rebounded in the holiday-shortened week ending July 2 as investors reacted to pending clinical trial readouts and the news flow surrounding COVID-19 vaccine and treatment development. Australian biopharma Alterity Therapeutics Ltd (NASDAQ: ATHE ) was among the biggest gainers of the week after the company said it received FDA guidance for the Phase 2 study for its Parkinsonian disorder drug. Inovio Pharmaceuticals Inc (NASDAQ: INO ) and Pfizer Inc. (NYSE: PFE )/ BioNTech SE – ADR (NASDAQ: BNTX ) were among the companies that issued updates on their coronavirus vaccine programs. The week also saw FDA issuing guidance on the approval of COVID-19 vaccines, with the agency suggesting a vaccine needs to demonstrate at least 50% efficacy in a placebo-controlled trial. The following are key catalysts for the unfolding … Full story available on Benzinga.com
Pharmaceutical Manufacturers and COVID-19 – Manufacturers Focus on Building Production Capacity Alongside Clinical Trials – ResearchAndMarkets.com
Friday, 3 July 2020, 15:58:00
DUBLIN–(BUSINESS WIRE)–ResearchAndMarkets.com published a new article on the pharma industry “Pharmaceutical Manufacturers and COVID-19 – Manufacturers Focus on Building Production Capacity Alongside Clinical Trials” Drug makers are moving forward with manufacturing plans while their vaccine candidates are still being developed to enable them to quickly begin mass manufacturing once the safety of the vaccine candidate has been proven. Inovio Pharmaceuticals has received $71 million funding fr
— Business Wire
Inovio under pressure as Pfizer vaccine data highlights its lack thereof (NASDAQ:INO)
Wednesday, 1 July 2020, 17:01:37
Inovio Pharmaceuticals (INO -15.4%) is down, albeit on average volume, pressured by a string of downgrades after it released “positive results” on COVID-19
— Seeking Alpha
Wednesday, 1 July 2020, 15:45:42
The summer will be a critical time for the race to develop effective coronavirus treatments and vaccines. Business Insider identified the nine most important events expected to happen in July. Expect a flood of data this month from vaccine and drug programs wrapping up clinical trials. Other promising therapeutics and vaccines are aiming to start human testing. And the speediest vaccine programs, like Moderna’s, will soon start massive late-stage trials — the crucial test in seeing how well these experimental shots work in humans. Visit Business Insider’s homepage for more stories . The dog days of summer are shaping into a critical stretch for developing COVID-19 drugs and vaccines. There are hundreds of research efforts across the world hunting for a potential cure. Business Insider reviewed what’s underway and identified the nine most important events slated for July. That includes potential vaccines from drugmakers like Johnson & Johnson starting human testing, while those that are farther along like Moderna’s experimental vaccine should be disclosing detailed results and even starting late-stage studies.
— Business Insider
Wednesday, 1 July 2020, 05:18:37
Inovio released a coronavirus vaccine update to announce that its experimental DNA drug generated immune responses in 94% of volunteers enrolled in Phase 1 trials. The company is part of the US government’s Operation Warp Speed initiative to fast-track the development of COVID-19 vaccines. A Phase 2/3 trial will follow this summer, pending regulatory approval. Inovio Pharmaceuticals kicked off the Phase 1 trial of its INO-4800 coronavirus vaccine candidate in early April, and the company has good news to report for the first stage of testing. The DNA vaccine is funded in part by the Bill and Melinda Gates Foundation, and it’s included in the US government’s Operation Warp Speed initiative to speed up COVID-19 vaccine research. The drug delivered promising results, the company said in a press release , with 94% of volunteers having developed the expected immune response following two doses of the drug. Moreover, a separate preclinical animal challenge study revealed the drug can prevent viral replication in the lungs in mice that were infected with the virus.