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

ISPE measures impact of biotechnology and globalization on personalized medicine.

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

Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.

Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.

Regulations and business changes have altered Big Pharma’s place in the industry.

Advancements in cell culture and protein technology have opened the door for new therapies.

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 determined additional guidance was needed to reduce regulatory compliance burden.

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

The company has broken ground on a R&D and process development facility in Missouri.

The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.

The directorate highlights its 2016 achievements.

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

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

An NIH study examined a dissolving microneedle technology as a way to deliver the influenza vaccine to patients.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.

The Minneapolis Medical Research Foundation has contracted Avista to manufacture an opioid-derived small molecule as a component for a vaccine to treat opioid addiction.

Krinsky joined the board of directors at Halo after working for Teva Pharmaceuticals for 12 years.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The companies expanded their alliance to develop plasmid DNA drugs.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

Sartorius Stedim Biotech expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes.