A December report on healthcare from the Congressional Budget Office (CBO) proposes that an abbreviated regulatory process for follow-on biologics could result in more than $10 billion in savings by the year 2020.

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

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

A California jury ordered Pfizer (New York) to pay $38 million to the Ischemia Research and Education Foundation (IREF), a medical-research nonprofit group, for stealing trade secrets to develop its "Bextra" analgesic.

Outsourcing sterile manufacturing involves an integrated approach in product life-cycle management.

Achieving double-digit growth through 2011, biotech-based active pharmaceutical ingredients (APIs) are expected to far surpass growth rates for chemically synthesized APIs.

Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors.

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

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

President Obama's choice for agency leadership should take into account several factors.

Readers give advice on their best approach to handling (batch) rejection

Jim Miller's presentation at the 2008 AAPS Annual Meeting provides insight into outsourcing solutions.

Christmas is over. Everybody is back at work feeling a bit hungover, a lot poorer and alarmingly heavier...

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

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.

The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The European Commission issued proposals last week to improve Europe's pharmaceutical market and patient safety.

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

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week.

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the December 2008 edition from Spiroflow Systems and Sepha.

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