News

The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

New study shows that an antimicrobial peptide packaged in a silicon nanoparticle significantly reduced bacteria load in the lungs of mice infected with Pseudomonas aeruginosa.

The agency is asking the public to share their experiences with the drug so EMA can determine its safety.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The assay assesses the ability of antibodies to neutralize the Ebola virus.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

The suite installation increases PCI’s Hay-on-Wye site’s serialization capability to support clients in advance of meeting the implementation dates of the European Falsified Medicines Directive.

Fresenius Kabi has added two new antibiotics production lines at its plant in Santiago de Besteiros, Portugal.

A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.

TruTags, the company’s silicon dioxide microtags, won Frost & Sullivan's 2017 North American Award for Technology Innovation.

Sienna Biopharmaceuticals has filed for an IPO, expecting to raise over $74 million

Lilly will provide up to $52 million in funding for research, making this Purdue’s largest strategic corporate collaboration

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

Partners will use an AI-enabled platform to discover new small molecules across different therapeutic areas.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain