
ePT--the Electronic Newsletter of Pharmaceutical Technology
Bayer and its subsidiary Icon Genetics (Halle, Germany) have developed a production process to produce therapeutic proteins from tobacco plants.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Bayer and its subsidiary Icon Genetics (Halle, Germany) have developed a production process to produce therapeutic proteins from tobacco plants.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.

ePT--the Electronic Newsletter of Pharmaceutical Technology
In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Shire voluntarily recalls ADHD patch Daytrana

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

PTSM: Pharmaceutical Technology Sourcing and Management
The global and US biotechnology industries performed well in 2007 as each recorded higher revenues and inched toward aggregate profitability.

PTSM: Pharmaceutical Technology Sourcing and Management
As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.

Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs.

The good, the bad, and the ugly about direct-to-consumer advertising.

Pharmaceutical Technology Europe
When drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, GVK BIO and Wyeth Pharmaceuticals form research agreement, Eli Lilly announces changes to management, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
Eli Lilly completed the final and largest phase of a major biotechnology expansion in Indianapolis, Indiana.

PTSM: Pharmaceutical Technology Sourcing and Management
Increased investment by the pharmaceutical and biotechnology majors in offshore early drug development creates opportunities and challenges for outsourcing.

PTSM: Pharmaceutical Technology Sourcing and Management
Congress is considering proposing a new chemical policy similar to the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. Batch and custom manufacturers weigh in on the debate.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.