
Brief pharmaceutical news items for September 2008.

This year, the employment survey will acknowledge the industry's best employers.

With economics and politics in the way, can we defeat the malaria epidemic before it defeats us?

Operators are hit hard by breakage problems and strike out on FDA inspections.

Are hypersanitation trends a result of scaremongering or a lack of faith in medicine?

Pharmaceutical Technology Europe
It's back to school. Another summer has flown past and here we all meet again, ready to return to work and face the winter with renewed energies. Welcome back!

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration may soon ask doctors to undergo special training to be able to prescribe powerful narcotics, Dr. Bob Rappaport told The New York Times last week. Rappaport, director of FDA's Anesthesia, Analgesia and Rheumatology Products division, said the agency is considering recommending additional education for doctors in early 2009.

Equipment and Processing Report
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.

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

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

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

PTSM: Pharmaceutical Technology Sourcing and Management
The pharmaceutical industry?s outsourcing practices receive increased attention as Congress evaluates the role of outsourcing in drug-safety issues.