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Home » Topics » Regulatory

Regulatory
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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.
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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.
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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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guardant bloodkit

Guardant wins over an FDA advisory panel for Shield CRC test

May 24, 2024
By Mark McCarty
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
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Concept art for targeting cancer
Cancer

Abdera’s DLL3-targeting radiopharmaceutical gets IND clearance

May 24, 2024
Abdera Therapeutics Inc. has received FDA clearance of its IND application for ABD-147, the first δ-like ligand 3 (DLL3)-targeting radiopharmaceutical for the treatment of small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma.
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Insulin pen

FDA adcom to weigh benefit, risk of Novo’s once-weekly insulin

May 23, 2024
By Lee Landenberger
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
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Disgorgement but no penalty for self-reported insider trader

May 23, 2024
By Mari Serebrov
A woman who allegedly made nearly $300,000 last year on insider trading based on undisclosed information about a pending biopharma acquisition will have to disgorge her profits, along with interest, to the U.S. Treasury, but she will face no other penalties.
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Regulatory icons

MHRA considers mutual recognition policy for devices by 2025

May 23, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency is considering a policy of mutual recognition of medical devices that have won marketing authorization in four other jurisdictions, including the U.S. and the EU. While there are significant exclusions – such as for some articles that qualify as software as a medical device – this policy would be in force at some point in 2025, easing the path forward for products in a market that is home to nearly 67 million potential patients.
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