Manufacturing

...some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence...

Pharmaceutical Technology Europe interviews Bruce Davis, Chairman of the International Society for Pharmaceutical Engineering Board (ISPE), the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry.

We have to make the politicians understand that if we don't take biotech seriously then tourism will be our premier industry in the future.

The Pharm Exec 50 report for 2008 accounts for prescription drug sales of more than $510 billion. Interestingly, except for Pfizer, GSK, Sanofi-Aventis (numbers one to three, respectively), and Watson (number 50), every company on the list showed positive growth last year, including some solid double-digit performances.

EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.

The authors discuss advanced sonocrystallization particle-engineering techniques for manufacturing mesoscopic particles.

The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.

Recombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.

As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them?

The authors describe the critical aspects of an ideal fermentation services provider.

Pharmaceuticals used to be such a simple business when everyone knew their place.

The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use.

The Healthcare Institute of New Jersey (HINJ) released a new research study showing that New Jersey's life-science industry experienced stable growth in 2007.

The deadline for nominations for the Innovations in Pharma Science Awards is here. Check out http://pharmtech.com/Innovations to nominate your company's work in one of five areas by next week

Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more...

The specialty drug company King Pharmaceuticals is seeking to acquire the specialty pharmaceutical company Alpharma (Bridgewater, NJ) through an unsolicited bid of $33 per share or $1.4 billion in cash. Alpharma has rejected the bid.

The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use.

Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...

The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.

Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2008 edition from OYSTAR Manesty and Hawk.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008.

Next week, the US Food and Drug Administration's communications with pharmaceutical companies will change, and the agency will begin issuing complete response letters in place of approvable letters.

Bristol-Myers Squibb is seeking to acquire the biopharmaceutical company ImClone Systems (New York) for $4.5 billion or $60 per share. BMS currently holds a 17% stake in ImClone.

The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...