Regulatory

Endospan’s FDA nod for Nexus brings acquisition by Artivion closer

Thu, 09 Apr 2026 12:00:00 -0400

Endospan Ltd. Secured U.S. premarket approval for its Nexus aortic arch stent graft, bringing the company closer to being acquired by Artivion Inc. Under the terms of an existing agreement, Artivion has an option to acquire Endospan at any time within 90 days of the FDA approval.

FDA issues Medline with warning letter over Namic syringes

Thu, 09 Apr 2026 12:00:00 -0400

The U.S. FDA issued a warning letter to Medline Inc. having identified several issues with its Namic brand angiographic control syringes and manifolds used for the intra-arterial or intravenous administration of radiographic contrast media. The agency warned the company that failure to promptly address the violations identified in the letter may result in regulatory action being initiated, including seizure, injunction and civil money penalties.

Everest to acquire Singapore unit of Hasten Bio in $250M deal

Thu, 09 Apr 2026 12:00:00 -0400

Everest Medicines Ltd. has agreed to acquire a Singapore-based commercial unit of Hasten Biopharmaceuticals (Asia) Ltd. for $150 million up front, gaining market authorization holder rights to 14 marketed products originally developed by Takeda Pharmaceutical Co. Ltd.

Pediatric PRVs top the voucher popularity contest

Thu, 09 Apr 2026 12:00:00 -0400

With three rare pediatric disease priority review vouchers (RPD PRVs) awarded just since the end of March, the nearly year-and-a-half lapse in the program’s reauthorization seems to have had little short-term impact. The three new vouchers bring the total RPD PRVs granted so far this year to seven – one more than the agency issued all last year and down two from the nine given in 2024.

FDA says no to partial 510(k) exemption for some AI devices

Thu, 09 Apr 2026 12:00:00 -0400

In a decision that maintains the regulatory status quo, the U.S. FDA denied a petition from Harrison.ai to partially exempt certain diagnostic/detection AI devices from premarket review so long as the manufacturer has 510(k) clearance for a device in a similar category and a robust postmarket plan.

Ibio’s IBIO-600 cleared to enter clinic in Australia for obesity

Thu, 09 Apr 2026 09:00:00 -0400

Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia.

Ubl to step down from PhRMA

Wed, 08 Apr 2026 12:00:00 -0400

After more than a decade at the helm of the Pharmaceutical Research and Manufacturers of America (PhRMA), Stephen Ubl said he plans to step down as president and CEO of the trade organization at the end of the year.

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

J&J introduces Varipulse Pro to Europe after CE mark

Wed, 08 Apr 2026 12:00:00 -0400

Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.

South Korea streamlines biosimilar review, clinical trials

Tue, 07 Apr 2026 12:00:00 -0400

South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.

Kennedy sidestepping court order sidelining ACIP?

Tue, 07 Apr 2026 12:00:00 -0400

Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).

Sector tariff now more than a threat – for some Rx companies

Tue, 07 Apr 2026 11:00:00 -0400

Canwell gains IND clearance for ADC CAN-016

Tue, 07 Apr 2026 09:00:00 -0400

Canwell Pharma Inc. has obtained IND approval from the FDA for CAN-016, a novel antibody-drug conjugate (ADC). The company will initiate a phase I study in patients with HER2-expressing solid tumors who have experienced disease progression following prior ADC therapies.

Circuit split forming over state 340B laws

Mon, 06 Apr 2026 12:00:00 -0400

Do state laws requiring drug companies to give steep 340B drug discounts to an unlimited number of contract pharmacies, with no claims data required, interfere with a longstanding contract between the U.S. Congress and biopharma? Or do such laws merely flex states’ authority over pharmacy practices such as delivery?

Sector tariff now more than a threat – for some Rx companies

Mon, 06 Apr 2026 12:00:00 -0400

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies. However, depending on the drug, where it’s made and whether a manufacturer has reached onshoring and pricing agreements with the Department of Health and Human Services, the actual tariff could be as low as 0%.

LHON updates: Gene therapy progress; idebenone receives US CRL

Thu, 02 Apr 2026 12:00:00 -0400

Chiesi Group’s idebenone faced a regulatory setback last month after the U.S. FDA issued a complete response letter (CRL) to the company’s NDA for Leber hereditary optic neuropathy (LHON), a rare inherited disorder that causes sudden vision loss.But a chance missed for Chiesi may be an opportunity for gene therapies, including Gensight Biologics SA’s lenadogene nolparvovec (Lumevoq; GS-010).

EMA poised to approve first NAM to replace live animal controls in toxicity tests

Thu, 02 Apr 2026 12:00:00 -0400

The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.

Fosun gains clinical trial approval in China for FXB-0871

Thu, 02 Apr 2026 09:00:00 -0400

Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.

Trade secret theft results in loss of US citizenship