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Home » Topics » Regulatory

Regulatory
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Stem cells
Immune

Tr1x’s TRX-103 to enter phase I following IND clearance

April 11, 2024
The U.S. FDA has cleared Tr1x Inc.’s IND application for TRX-103 for the prevention of graft-vs.-host disease (GVHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT).
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Blood clot under microscope.
Hematologic

Cereno Scientific submits CTA in Europe for phase I study of new antithrombotic treatment

April 11, 2024
Cereno Scientific AB has submitted a clinical trial application (CTA) to the EMA seeking approval for a first-in-human, phase I study of CS-014, a novel histone deacetylase (HDAC) inhibitor drug candidate under development as an antithrombotic treatment.
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Anvisa pilot program to spur biopharma innovation in Brazil

April 10, 2024
Anvisa launched a pilot program to help Brazilian biopharma startups navigate the regulatory path from the initial phases of product development. In addition to providing regulatory support, the goal of the program is to accelerate the process of drug innovation in the country.
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FDA: Would a new endpoint for accelerated approvals in MM work?

April 10, 2024
By Lee Landenberger
The U.S. FDA thinks using minimal residual disease as an endpoint for accelerated approval in new therapies to treat multiple myeloma (MM) might just be an idea whose time has come. The FDA now wants to know what its Oncologic Drugs Advisory Committee thinks about it, so the agency has convened a meeting of the committee for a deep dive into the subject on April 12.
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Generic drugs and bottle

Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t

April 10, 2024
By Mari Serebrov
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
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China flag and vial

Biosimilars coming into their own in China, despite concerns

April 10, 2024
By Ruchita Kumar, Sudha Saryu Malhotra, and Mari Serebrov
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
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Flag of Australia, sky background

TGA eyes guidance on regulatory status of CDS software

April 10, 2024
By Mark McCarty
Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements.
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Phillips Recall Mask BiPAP CPAP

Philips hit with consent decree over CPAP foam materials

April 10, 2024
By Mark McCarty
The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.
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Antibodies attacking cancer cell
Immuno-oncology

FDA clears IND for Biocity Biopharma’s BC-2027

April 10, 2024
The U.S. FDA has cleared Biocity Biopharma Co. Ltd.’s IND application for a phase I study of BC-2027. This is the company’s second first-in-class antibody-drug conjugate (ADC) to be approved for clinical trials, following BC-3195, which is directed against placental-cadherin (CDH3).
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Sanders proposes $10B more in NIH long COVID research

April 9, 2024
By Mari Serebrov
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
Read More
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