We are a leading biopharmaceutical outsourcing services provider known for addressing clients’ global needs throughout the product life cycle, including preclinical development, clinical trial services, commercialization and ongoing supply.
On April 4, 2018, FDA released a report, developed in consultation with PricewaterhouseCoopers LLP, that outlines the agency’s use of user-fee funding, its plan to modernize its time-reporting approach, and the development of its resource forecas...
High-Throughput Flow Cytometry And Phenotypic Drug Discovery
Researchers from the Genomics Institute of the Novartis Research Foundation (GNF) highlight a diversity of approaches that their automated high-throughput flow cytometry has enabled for phenotypic drug discovery.
Fight Over Federal Drug Discount Program Continues in 2018
The battle over the fate of a 25-year-old federal drug discount program could heat up on Capitol Hill this year. At issue is the 340B discount program, which safety-net providers such as hospitals use to obtain often steep discounts on medications from...
Study Yields More Than a Million New Cyclic Compounds, Some with Pharmaceutical Potential
Researchers say they can now produce a vast library of unique cyclic compounds, some with the capacity to interrupt specific protein-protein interactions that play a role in disease. The new compounds have cyclic structures that give them stability and...
Physicists Bring Order To Liquid Droplets, Offering Promise For Pharmaceutical Development
A team of physicists has developed a method to generate and self-organize liquids into well-defined patterns, a breakthrough that offers potential new pathways for the development of more sophisticated pharmaceuticals and other consumer products.
These New Pharma Bros Are Wreaking Havoc on Prescription Drug Prices
For at least the past three years, Todd Smith and Benjamin Bove have crisscrossed the U.S., offering a sure-fire fix for struggling pharmaceutical companies. And wherever they go, the price of prescription drugs tends to skyrocket.
How Might Biopharma Manufacturing Differ In The Next Decade?
When embarking on our pulling together the manufacturing outlook article for our December 2017 issue, we faced what many might describe as a good problem to have - too much content and not enough pages.
Cloud Pharmaceuticals Enters Into Drug Discovery Collaboration With GSK
Cloud Pharmaceuticals, Inc., an Artificial Intelligence-driven drug design and development company, announced they have entered into drug discovery collaboration with GlaxoSmithKline (GSK). Cloud will design novel small-molecule agents to GSK specified...
FDA Prepping for Push of New Gene and Cell Therapies
In addition to new draft guidance documents on gene therapy-related issues, the U.S. Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell therapies, FDA Commissioner Scott Gottlieb said at the Allia...
Artificial Intelligence: Will It Change the Way Drugs Are Discovered?
The pharmaceutical industry is beginning to invest in artificial intelligence (AI), with many large pharmaceutical companies partnering with AI start-ups in 2017 in order to develop better diagnostics or biomarkers, to identify drug targets and to desi...
New Efforts Taking Root to Ease Off-Label Drug Promotion
Legislative campaigns to ease restrictions on the off-label promotion of medicines could put patients' health at risk and leave them paying for costly drugs for which there is little evidence in support of their use, researchers said in a recent article.
The Why, How And When Of AI In The Pharmaceutical Industry
Recently, pharmaceutical companies have been demonstrating a vivid interest in artificial intelligence (AI) applications for various research needs, catalyzed by the illustrative practical achievements of AI in solving more "traditional" tasks - overco...
FDA Lays Groundwork For Regulating 3D-Printed Drugs
The pharmaceutical industry tends to attract disruptive technology, as drug and device makers look to make therapeutic advances. But manufacturing - at least for the medicines themselves - has largely stuck to its tried-and-true ways, moving more slowl...
FDA officials continue to be alarmed about violative production practices and inadquate quality control at drug outsourcers, as seen in a rise in warning letters and citations to contractors and their pharma clients.
Drugmakers Can Give Free Drugs to Patients Losing Aid, US Says
Drugmakers can provide free medication to patients who can't afford their prescriptions after a major industry-funded charity said it wouldn't offer patients assistance in 2018, the federal government said.
Patent expirations, growth of disease prevalence, and the greater availability of advanced diagnostic procedures have increased the discovery and development of new biopharmaceutical compounds at an exponential rate. Pharmaceutical outsourcing has beco...
Pharmaceutical Companies Face Harsher Antitrust Compliance Challenges
On Nov. 16 2017, four months after seeking comments, the National Development and Reform Commission (NDRC) released its Price Conduct Guidelines for Operators of Drugs Prone to Shortages and APIs. These are the first price-related anti-monopoly guideli...
Senate Plans 340B Oversight Hearings As Transparency Push Mounts
The Senate health committee is planning an oversight hearing for the 340B drug discount program, signaling the first significant move in the upper chamber to follow the U.S. House of Representatives' push for 340B reforms.
Trump Hasn't Attacked Drug Prices, As He Promised He Would, During His First Year in Office
Donald Trump raged against the pharmaceutical industry as a candidate. He accused drug companies of "getting away with murder" as president-elect. But he hasn't done too much to tackle prices as president yet.
President Trump's Plan to Lower Drug Prices Spares Pharma Industry
President Donald Trump's long-promised plan to bring down drug prices would mostly spare the pharmaceutical industry he previously accused of "getting away with murder." Instead he focuses on private competition and more openness to reduce America's pr...