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Top stories summarized by our editors
7/9/2020

The FDA has given 510(k) clearance to Getinge for its Servo-air mechanical ventilator, a critical care ventilator for adult and pediatric patients that has invasive and noninvasive options for ventilation.

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FDAnews
7/9/2020

The NIH announced the launch of a national clinical trials network, dubbed the COVID-19 Prevention Trials Network, to help perform late-stage clinical trials of COVID-19 vaccines and other treatments. A vaccine co-developed by Moderna and the National Institute of Allergy and Infectious Diseases is expected to be tested in the first late-stage trial conducted through COVPN this summer.

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Regulatory Focus
7/9/2020

Mylan is recalling a single lot of injectable daptomycin after particulate matter was found in a single-dose sample vial manufactured at the firm's specialty formulation center in India. The affected lot was distributed to wholesalers and retail pharmacies across the US from April to May, the FDA said.

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FiercePharma
7/9/2020

While Johnson & Johnson is set to begin clinical testing of its prospective COVID-19 vaccine, the drug should not be considered "the single solution that is going to take us back to the old normal," said CEO Alex Gorsky. He lauded other drug companies' efforts and said it will "take multiple vaccines" to treat different patient groups.

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Reuters
7/9/2020

The Coalition for Epidemic Preparedness Innovation has invested $66 million to test Clover Biopharmaceuticals' potential vaccine for COVID-19, adding to $3.5 million the foundation gave the Chinese firm in April. The foundation said it will give significant additional support if early-stage trials are successful.

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Reuters
7/9/2020

Numab Therapeutics and Boehringer Ingelheim will collaborate on the development of antibody-based treatments for patients with gastrointestinal and lung cancers and geographic atrophy. Meanwhile, Artisan Bio signed a research and collaboration contract with Cabaletta Bio to "accelerate development of next-generation [chimeric autoantibody receptor] T cell therapies for patients with B cell-mediated autoimmune diseases."

7/9/2020

Bioprocessing 4.0 uses data to solve production problems and can be used to overcome bottlenecks in several areas. Before a company can adopt the approach, issues such as data collection, connectivity and analytics must be optimized; older equipment should be addressed; and upstream efficiencies must be matched with changes downstream to accommodate them.

7/9/2020

Researchers at the Fraunhofer Institute for Process Engineering and Packaging IVV in Germany developed the Mobile Cleaning Device 4.0 robot, and one model cleans conveyor belts, while the other cleans walls, floors, ceilings and machines. The robot uses a sensor to detect contaminants and emits cleaning substances through its robotic arm, and self-learning and autonomous motility technology enable it to improve over time.

7/9/2020

Regulatory obstacles, labor shortages and a risk of COVID-19 infection among workers at plants have slowed production for drug manufacturers. Technologies that address maintenance, digital review for batch records and employee infection screening can alleviate some of these challenges, say David Sprinzen, director of marketing for Vantiq, and Bryan Debois, director of industrial artificial intelligence for RoviSys.

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OutsourcingPharma
7/9/2020

Emergent BioSolutions and the Mount Sinai Health System have entered a partnership to develop an antibody from the plasma of people who have recovered from COVID-19. The US has provided $34.6 million for the study.

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Reuters