Industry News

Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

A new initiative will advance access to quality medicines and vaccines in Africa.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.

Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

The PharmTech Group sat down with Himanshu Gadgil, CEO of Enzene Biosciences to discuss the benefits and challenges of continuous manufacturing of biopharmaceuticals.

Pharmaceutical Technology® spoke with Parviz Shamlou, senior vice-president of Science and Technology, Abzena, about the impact of the Biosecure Act on the bio/pharmaceutical industry, as well as the progress of continuous manufacturing in biopharma.

The political landscapes of both the EU and UK are set to change after the latest elections, which could affect the bio/pharma industry.

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

The PharmTech Group spoke with Stacey Treichler, senior director of Marketing and Strategy for Purolite at Ecolab, about the impact of advanced therapies, new innovations, and sustainability on the biopharmaceutical industry.

Pharmaceutical Technology® spoke with Jeff Clement, executive director of Technical Sales for Development and Manufacturing Group at PCI Pharma Services, about the challenges and benefits of incorporating robotics into aseptic manufacturing.

In an ASGCT Panel on nucleic acid- and cell-based vaccines in oncology, work on a personalized mRNA vaccine was highlighted.

The units are being recalled because of incomplete crimp seals and one complaint of a leaking unit.

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, Regeneron, discussed the utility of AI and how it can benefit R&D work.

Ken Keller, president and CEO, Daiichi Sankyo, discusses the foundation of partnership and takes a look at the future of biotech partnerships at the US Pharma and Biotech Summit.

TekniPlex recently acquired Seisa Medical, which has expanded the company's services into that of a CDMO.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.