Drug Development

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

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

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

Cannabinoids have potential to treat a variety of diseases, but pharmaceutical companies must first develop cost-effective ways to access pharmaceutically pure materials without marijuana cultivation.

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.

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 collaboration will focus on the discovery, development, and commercialization of novel therapeutics targeting an undisclosed G protein-coupled receptor (GPCR) that plays an important role in inflammatory diseases.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.

Industrial-scale continuous API manufacturing may offer cost and safety benefits.

New ADC therapies must overcome manufacturing challenges to reach market.

As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.

The more pharma science and technology change, the more business and policy concerns stay the same.

Polymers and surfactants impact stability and long-term performance.

Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.

Drug costs, biosimilars, and cloud-based technologies will shape the pharmaceutical industry in the years to come.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

The agency announced a plan to eliminate its existing orphan designation request backlog.

BASF plans to build a new world-scale ibuprofen production plant in Ludwigshafen and expand ibuprofen capacities at its Bishop, Texas plant.

The patent was filed for a chewing gum composition with controlled release of cannabinoids and opioid agonists, and antagonists for addiction or dependence treatment.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

SK Biotek plans to operate the Swords, Ireland API manufacturing facility as a contract development and manufacturing site.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Acasti Pharma and CDMO CordenPharma designed and implemented a continuous process for purifying raw krill oil for production of omega-3 phospholipid.