Patrick Lavery

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

Manufacturing sites will be built or expanded in Research Triangle Park and Concord, both in North Carolina; Kenosha County, Wisconsin; Lebanon, Indiana; and Lilly’s home city of Indianapolis.

While the boards of directors of both companies have approved the transaction, it is not expected to close until the second quarter of 2025, as Mayne Pharma’s shareholders must still vote in favor of the acquisition.

With 2025 now in full swing, this article presents a review of the latest developments in outsourcing services, new facilities, and M&A activity thus far this year.

Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

Seladelpar, which is marketed in the US as Livdelzi, was recommended for an orphan drug designation by CHMP in December 2024.

The collaboration will utilize Genesis’ proprietary AI platform, initially focusing on targets selected by Incyte.

A capsule formulation may offer more consistent and reliable uptake versus a syringe, while being less dependent on food intake.

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

The pledge signifies ArisGlobal’s commitment to upholding high standards and best practices for the responsible use of artificial intelligence.

In seeking a data-driven approach to efficient drug development, MMS aims to enhance its capabilities in advanced clinical trial design, innovative statistics, and data science with the acquisition.

This site was previously the beneficiary of a €7.3 million (US$7.6 million) investment, made in 2022, earmarked for the production of HPAPIs to treat cancer.

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

The company says it is the pharmaceutical market’s first wet granulator with an integrated, truly continuous dryer.

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

These infections can be caused by certain Gram-negative microorganisms, making the infections challenging to control due to high antimicrobial resistance.

Survey results show that being intellectually stimulated and getting assigned challenging projects are two key drivers of employee satisfaction, yet job training is lacking.

Installation was performed during the summer of 2024, and the system has already successfully completed its first production run for a leading biotech company.

Patient enrollment is currently underway for the highest-dose cohort of AdvanCell’s potentially best-in-class targeted alpha therapy for metastatic prostate cancer.

A new bioanalytical lab being opened by Ardena at the site is expected to be operational by the third quarter of 2025.

The transaction is expected to enhance Jabil’s development and commercial production of auto-injectors, pen injectors, inhalers, and on-body pumps.

The tariffs President Trump wants to levy against Canada and Mexico are on hold, for now, but China has already announced it intends to proceed with retaliatory tariffs against the US.

While FMS has specialized in the design, installation, and maintenance of environmental monitoring systems, Trescal’s focus has been on calibration and metrology services.

Another eight medications already authorized in the EU were recommended for extensions of various indications.

The reduction is expected to be “substantially completed,” the San Diego-based company said, in the second quarter of 2025.

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

The deal is being made for an all-cash price of $250 million, but with an additional $752.5 million available in potential milestone payments.