Dive Brief: FDA said Thursday it issued an emergency use authorization to spur availability of infusion pumps as the lifesaving machines and accessories are in short supply for COVID-19 patients. The agency in early April issued guidance targeted at increasing access to…
Philips, startups look to deploy new ultrasound tech amid coronavirus
Dive Brief: Health tech giant Philips and diagnostic imaging startup Caption Health announced FDA clearances this week for ultrasound tools they say could aid healthcare professionals in point-of-care imaging for patients infected with the novel coronavirus. Philips said Wednesday it received…
Clovis steals march on AZ with PARP prostate approval
Shares in US-based Clovis Oncology have ticked up after the biotech became the first to get a PARP class drug approved in prostate cancer. The FDA has approved the company’s Rubraca (rucaparib) as monotherapy for patients with BRCA1/2 mutant castration-resistant disease (mCRPC), after…
AstraZeneca Aims for 30 Million Doses of COVID-19 Vaccine for U.K. by September
The University of Oxford’s partnership with AstraZeneca on the development and distribution of Oxford’s COVID-19 vaccine is one of the leaders in this project. AstraZeneca reported it plans to manufacture as much as 30 million doses of the vaccine for…
Moderna’s Preliminary Phase I COVID-19 Vaccine Data Shows Safety and Efficacy
Moderna released positive interim Phase I data from its clinical trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The vaccine, furthest along in human trials, showed overall positive results for both efficacy and safety.…
Verona says FDA backs plan to take COPD drug into phase 3
More than two years after first saying it would take its lead drug into a pivotal trial, Verona Pharma looks like it may finally follow through on that promise. The UK biopharma says it has received a positive response from…
Takeda posts surprise profit a year after Shire mega-merger
Japan’s Takeda has posted a surprise profit after its $59 billion merger with Shire just over a year ago, as the company shakes off the huge debts it incurred to get the deal done. Analysts had expected Takeda to turn…
Gilead Inks Manufacturing Deals to Make COVID-19 Drug Remdesivir Available in 127 Countries
Currently, Gilead Sciences has the only drug shown to be effective against COVID-19, antiviral drug Veklury (remdesivir). The company has now entered into licensing agreements with five generic drugmakers to make the drug available in 127 countries. They are Mylan,…
Sorrento and Mount Sinai Team Up for Antibody Cocktail COVI-SHIELD Project
San Diego-based Sorrento Therapeutics is teaming up with New York City-based Mount Sinai Health System to develop an antibody cocktail called COVI-SHIELD to treat COVID-19. The partnership is aimed at creating antibody products that could act as a “protective shield”…
Japanese regulator approves Gilead’s remdesivir to treat Covid-19
Gilead Sciences has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its antiviral drug remdesivir, under the brand name Veklury, to treat Covid-19 infection. The decision falls under an exceptional approval pathway, which is similar…
