Data and Artificial Intelligence

Contract manufacturers of APIs and intermediates report gains, but express caution.

Also, GPC Biotech AG and Agennix to merge; BASi appoints COO of scientific services; more...

The US Food and Drug Administration posted the Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan on its website.

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...

A recent reader poll focused on predictions for the industry's future.

Efforts to cut healthcare outlays will focus on drug costs, despite a drop in prescription sales.

FDA's role should not be overlooked as it has been in years past.

Ask the Expert looks at logistic problems.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Also, Elan explores strategic alternatives; NanoGuardian appoints John D. Glover to lead its Security Advisory Board; more...

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

An integrated information technology environment can help pharmaceutical companies find new processes and approaches to improve manufacturing efficiency, productivity, and quality.

Also, Bristol-Myers Squibb forms collaboration with ZymoGenetics, Hana Biosciences appoints VP of regulatory affairs, more...

Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...

Editors' Picks of Pharmaceutical Science & Technology Innovations

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

Will more resources and new leadership fix FDA, or is a major overhaul in order?

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...

A surprising amount of the discovery and development life cycle is still based on manual and disconnected process steps.

Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...

Also, AstraZeneca announces changes to its supply chain operations; Christian Velmer appointed head of Wyeth Canada; More...

The past year saw major acquisitions attempted, completed, rejected, and stalled.

Readers provide insight into the best companies to work for as well as the ups and downs of their jobs.

China's quality approach to domestic versus exported products seems to be a lose-lose situation.