Susan Haigney

Contract organizations offer assistance when managing changes to material suppliers during a product’s lifecycle.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

New and existing technologies, as well as a patient-centric focus, are pushing drug formulation into exciting directions.

Novo Nordisk will use Korro Bio’s OPERA platform to develop RNA editing candidates for two targets to treat cardiometabolic diseases.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

Susan J. Schniepp, member of the editorial advisory boards for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International, provides an update on her experience working in the pharmaceutical industry and what she sees for the industry’s future.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

Qualifying material suppliers is a crucial step in ensuring safe and effective drug products.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

For a preview of what's to come at the AAPS PharmSci 360 show in October, Pharmaceutical Technology® spoke with Vivek Gupta, PhD, associate dean for Graduate Education and Research, associate professor, Pharmaceutical Sciences, St. John’s University, Queens, New York, about the formulation of inhalation dosage forms.

The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

The acquisition provides Lantheus with worldwide exclusive rights to ß amyloid PET imaging agent, NAV-4694, for its Alzheimer’s disease diagnostic and treatment portfolio.

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

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.

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

In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

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.

The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

The PharmTech Group spoke with BIOVECTRA's director of Business Development, Nucleic Acid Modalities, Jessica Madigan, about the concept of flexibility in outsourcing and the 2024 BIO Convention.

Syntegon will expand its processing and packaging by acquiring the Spanish equipment supplier.

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.