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Illustration of immunoglobulin A with secretory IgA
Dermatologic

JJP Biologics’ CD89 antagonist receives EMA clearance for first-in-human studies

May 29, 2024
JJP Biologics Sp. z o.o. has received clearance from the EMA to conduct a first-in-human study of its CD89 antagonist, JJP-1212, for IgA-mediated autoimmune and fibrotic diseases. A phase I study in healthy participants will be conducted in Poland.
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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 28, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
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U.S. Capitol building

US Congress eyes FDA’s supply chain, recall issues

May 28, 2024
By Mark McCarty
A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress.
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Product recall concept image

Vyaire in class I recall of Twin Tube sample lines

May 28, 2024
By Mark McCarty
Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem.
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Test tube, dropper, DNA illustration
Endocrine/metabolic

US orphan drug status granted to Hanmi and GC Biopharma candidate for Fabry disease

May 28, 2024
The U.S. FDA has granted orphan drug status to HM-15421 (GC-1134A, LA-GLA) for the treatment of Fabry disease.
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Red blood cells, artery
Hematologic

Be Biopharma’s BE-101 cleared to enter clinic in US

May 28, 2024
Be Biopharma Inc. has announced the FDA’s clearance of its IND for BE-101, an autologous potentially first-in-class B-cell medicine in development for the treatment of hemophilia B.
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Woman wearing glucose monitor with smart phone

Adcom says risks outweigh benefits for Novo’s once-weekly insulin

May 24, 2024
By Lee Landenberger
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 24, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
Read More

US argues for drug, device companies in terrorism case

May 24, 2024
By Mari Serebrov
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
Read More
Israeli flag
Biomed Israel

Resilience overcomes war, capital challenges in Israel

May 24, 2024
By Annette Boyle
Despite the ongoing war, speakers at Biomed Israel this week reported that business and investment in Israel’s med-tech industry continues largely unchanged.
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