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BioWorld - Saturday, January 31, 2026
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Antibodies fighting coronavirus

Adaptive, Microsoft launch open database of immune response by COVID-19 patients

June 11, 2020
By Stacy Lawrence
Partners Adaptive Biotechnologies Corp., which is based in Seattle, and Redmond, Wash.-based Microsoft Corp. have started sharing an open database that details the immune response in COVID-19 patients with researchers and public health officials. The project is analyzing thousands of de-identified patient blood samples submitted from institutions around the world and is dubbed ImmuneCODE.
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Insulin vials and syringe

U.S. insulin market getting more competitive

June 11, 2020
By Mari Serebrov
The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.
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Shipping container with flag of China

Beijing export officials using black, whitelists to determine exportability of test kits

June 10, 2020
By Mark McCarty
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
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U.S. Capitol building

Senator: Now’s the time to plan for next pandemic

June 10, 2020
By Mari Serebrov
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed.
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Digital illustration of U.S., coronavirus

U.S. federal government eyes private sector role in strategic stockpile management

June 9, 2020
By Mark McCarty
Rear Admiral John Polowczyk, vice director of logistics for the Joint Chiefs of Staff, said in a Senate hearing that the one solution to managing pandemic supplies might be to use federal taxpayer dollars to sustain inventories in private-sector warehouses.
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FDA sign

Three months after FDA’s ‘all-clear,’ NDMA recalls taking down metformin ER

June 8, 2020
By Mari Serebrov
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
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Glass vial production line

Supply shortages continue to threaten pandemic response

June 4, 2020
By Mari Serebrov
During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm.
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Dilumen product image

Lumendi sees first incisionless appendectomy using its double-balloon EIP

June 3, 2020
By Liz Hollis
Westport, Conn.-based Lumendi LLC revealed that the first endoscopic appendectomy has taken place using its Dilumen Endolumenal Interventional Platform (EIP). The procedure represents a change from traditional appendectomies, which are performed through open or laparoscopic surgery, requiring an incision of the abdominal wall.
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Blister drug pack atop globe

How secure is the U.S. drug supply chain?

June 3, 2020
By Mari Serebrov
Security and safety, like beauty, are in the eye of the beholder, especially in the time of a politicized pandemic. “The U.S. drug supply chain is safe, and the supply chain is secure,” Judith McMeekin, associate commissioner for regulatory affairs at the FDA, testified before the Senate Finance Committee Tuesday.
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Coronavirus headlines

Kaiser survey provides encouraging news for med-tech industry

June 1, 2020
By Annette Boyle
The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months.
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