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Bayer submits vericiguat for marketing authorization in China for the treatment of chronic heart failure

Bayer announced the submission of the regulatory application seeking the approval of vericiguat in China. Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection...

Gilead’s Investigational Antiviral Veklury Receives U.S. FDA Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19

Gilead Sciences, Inc. announced the U.S. FDA expanded the EUA enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The expanded...

Chiesi Group and JAGGAER Drive Strategic Supplier Management and Procurement Excellence

Chiesi Group, an international pharmaceutical corporation focused on research, development, and production of innovative medicines, has selected JAGGAER, the world’s largest independent spend management company, to strategically and progressively advance and expand its supplier management program across its 29...

Bruker and Purity-IQ sign partnership agreement to transform the cannabis regulatory landscape

Bruker and Purity-IQ have joined forces to create a powerful new testing system for medical cannabis in Canada. The Purity-IQ Cannabis Fingerprint™ combines Bruker’s expertise in nuclear magnetic resonance (NMR) based screening technology with Purity-IQ’s genomics capabilities to offer...

Novavax to Supply 76M Doses of COVID-19 Vax to Canada

Novavax, Inc. has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine. Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply...

FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials

Sound Pharmaceuticals, Inc. (SPI) received clearance from the FDA to begin two Phase 2 studies of ebselen (SPI-1005) in COVID-19 patients. SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication. The...

Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK

Alcami, a US-based contract development and manufacturing organization (CDMO), announced that it is providing commercial manufacturing services for Trevena’s newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough...

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