April 14th 2025
Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.
April 11th 2025
The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.
April 8th 2025
Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.
Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.
April 7th 2025
Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.
Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.
Wanted: Better Upstream Bioprocessing Technologies
A recent industry survey shows keen interest in improving bioreactors and cell-culture media.
Inhibiting the Precipitation of Poorly Water-Soluble Drugs from Labrasol Formulations
The study results suggested that Pluronic F127 might be a potent inhibitor of drug precipitation for Labrasol formulations.
Quality Overload
Sometimes, there are just too many cooks in the kitchen.
Optimizing High-Potency Manufacturing
Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
The Rising Uptake Of Immediate Release And ODT Formulations
BASF's Jan Bebber explains why immediate-release formulations boost drug efficacy and aid patient compliance.
Table Testing Techniques
The rising popularity of fast dissolving, immediate-release dosage forms can be attributed to their convenience and ease of administration.
Teva Acquires Majority Stake in Taiyo
Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo.
PhRMA Comments on USTR Report on Pharmaceutical Trade Practices
The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.
PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs
PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs.
Excipient-Certification Standards Presented for Comment
The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.
Report from Hungary
Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.
Pharmaceutical Excipients for Hot-Melt Extrusion
The authors examine the influence of glass-transition temperature, melt viscosity, degradation temperature, and process settings.
Beyond Micronization
Emerging methods could provide alternative ways of producing inhalable drug particles.
The Marriage of Small Molecules and Biologics
Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.
Formulation Development Forum: Nanosponges
Nanosponges, a controlled-release nanoparticle system, shows promise in targeted drug delivery
IBM Reboots Drug Discover
Can the semiconductor industry help Big Pharma develop therapies?
Common Sense Required
Many factors affect research results.
Perspectives in MicroRNA Therapeutics
The authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
Technologies for Downstream Processing in Biologics
The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.
Peptide PEGylation: The Next Generation
Linking peptides to polyethylene glycol, or PEGylation, has helped improve pharmaceutical therapeutics in several ways. A wave of new techniques is now ushering in further advances.
GlaxoSmithKline Plans to Divest Select OTC Brands
GlaxoSmithKline (GSK) identified certain over-the-counter (OTC) brands in its consumer healthcare business that the company plans to divest.
Week of Apr. 21, 2011: Company Notes: Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.
Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.
FDA and White House Combat Prescription Drug Abuse
On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama?s plan for curbing prescription-drug diversion and abuse.
FDA Publishes Guidance for Preventing Cross-Contamination
FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.
Biotechnology Loses Lead in Funding
An uncertain regulatory environment affects funding for biotechnology.
Advancing Small-Molecule Synthesis
Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.
Inspections Gone Mad
In any industry, inspections can be a pain, and pharma is no exception.
A QbD World for Suppliers
The need for greater process understanding raises the bar for suppliers.
Exploring Excipient Functionality
This technical forum is part of a special issue on Solid Dosage and Excipients.
Correlating Die-Filling Performance with Powder Properties
The author explains how to gain an understanding of the relationships between powder characteristics and process performance to match filling-machine geometry to the demands of specific formulations.