Pharmaceutical Technology Editors

BASi Restructures; Celerion, Ricerca Biosciences Form Biosimilars Alliance; and More.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other private and public organizations.

JHS Secures Four Sterile Parenteral Products Manufacturing Contracts; Samsung Biologics, Biogen Idec Establish Biosimilars Joint Venture; and More.

Biogen Idec to Acquire Stromedix; Mylan, Pfizer Announce Epinephrine Autoinjector Settlement Agreement; and More.

EMA Releases Genetic Variability Guideline.

Alexion Completes Acquisition of Enobia Pharma; BMS Completes Acquisition of Inhibitex; and More.

We need to measure the particle size of a moisture-sensitive powder. We would like to use dry analysis on our laser-diffraction system, but the particles are fragile and we're struggling to get robust results. Is wet measurement with a nonaqueous solvent the only option?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2012 edition from ACS Valves and G-Con.

Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.

FDA Addresses the Regulation and Approval Process of PET Drugs.

AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

Amgen Agrees to Micromet for $1.16 Billion; Cephalon Issues Recall of Treanda; and More.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other private and public organizations.

2012 Facility of the Year Awards are Announced; Suzhou Pharma Services Names Oliver Mueller President; and More.

The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.

Constellation Pharmaceuticals announced that it has entered into a broad collaboration with Genentech, a member of the Roche group, to discover and develop innovative treatments based on epigenetics, which focuses on the identification of small molecule inhibitors of protein activity.

Takeda Restructures; Savient Pharmaceuticals Names David Veitch President of Savient Europe; and More.

Understanding equipment design and product-contact surfaces enables strong cleaning action.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the January 2012 edition from ACS Valves and Terra Universal.

The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.

I work in a quality control laboratory and use a pH meter with a single-junction reference probe to test samples taken from various pharmaceutical (drug) production lines. The probe I use has a six-month warranty. It slowly stops working after just a couple weeks. I am replacing it once a month. We make sure to store it correctly according to the manufacturer's specifications and even use probe cleaner at the end of each shift to ensure that it stays clean. What can I do to increase the lifespan to at least cover the warranty period?

Xoma Restructures; AAIPharma Appoints Eric Evans as CFO; and More.

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. The recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules or caplets from other Novartis products.

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

AMRI Restructures; ISPE Appoints Nancy S. Berg as CEO; and More.

AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More.

On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.

Last week, Baxter International and Momenta Pharmaceuticals entered into a global collaboration to develop and commercialize follow-on biologic products. The two companies expect to close the transaction during the first quarter of 2012, subject to customary closing conditions.

Boehringer Ingelheim Expands Manufacturing Presence in China; Amgen CEO Kevin W. Sharer Announces Retirement Plans; and More.