Pharmaceutical Technology ePT Weekly:
Having trouble viewing this e-mail? Click here.
ePT by PharmTech logo
News
Product Spotlight
Industry Briefs
PharmTech,
the magazine

About Us

Subscribe to Pharmaceutical Technology

Whitepaper Library

Podcasts

Webcast: Accelerate the Development of Chellenging Drug Candidates via Crystal Engineering
Sponsored by Catalent (On Demand)

Webcast: Best Practices for Achieving Product Quality in Sterile Manufacturing
Sponsored by Baxter (On Demand)

Webcast: Overcoming Formulation Challenges of Parenteral Drugs
Sponsored by Croda (On Demand)

MORE WEBCASTS

Events

11th Winter Conference on Medicinal & Bioorganic Chemistry
January 20, 2013–January 24, 2013
Steamboat Springs, Colorado

Quality by Design
January 23, 2013–January 24, 2013
London, United Kingdom

Social Media in the Pharmaceutical Industry
January 23, 2013–January 24, 2013
London, United Kingdom

Pre-Filled Syringes
January 28, 2013–January 29, 2013
London, United Kingdom

CBI's 4th Annual Effective Preparation for FDA Advisory Committee Meetings
February 5, 2013–February 6, 2013
Washington, DC

More events


FindPharma Search

December 27, 2012 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE

News

Amgen Settles False Claims Act Allegations
Amgen has agreed to pay a multimillion-dollar fine to resolve criminal liability and false claims act allegations.
Click Here to Read More

FDA Issues Final Guidance on Limiting the Use of Certain Phthalates as Excipients
The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.
Click Here to Read More

FDA Approves First Anthrax Antitoxin
Anthrax antitoxin is the first monoclonal antibody approved under FDA’s Animal Efficacy Rule, and the first product from BARDA’s Project Bioshield to receive FDA approval.
Click Here to Read More

First Commercially Available Mycoplasma Detection Test Accepted by FDA
Roche has received FDA approval for a polymerase chain reaction test for rapid detection of mycoplasms for the release testing of biopharmaceuticals.
Click Here to Read More

University of Connecticut Studies Drug-Carrying Nanoparticles
A University of Connecticut chemical engineering professor has received a National Science Foundation grant to study how nanoparticles flow in the bloodstream, which is crucial for their use in drug delivery.
Click Here to Read More


Product Spotlight

Software streamlines auditing processes

Sparta Systems has enhanced the audit capabilities of its TrackWise Enterprise Quality Management System. The Audit Execution Package includes a Solution Delivery Analyst to help create a customized deployment plan to accelerate user adoption and a Subject Matter Expert to train end users with the knowledge necessary to adhere to industry regulations. The package enables users to streamline auditing processes by creating tailored templates, as well as a scorecard to evaluate system effectiveness. Off-line capabilities include the ability to document results in real time that can be directly exported to provide data for tracking and trending. Auditors can also electronically send audit observations to suppliers and import responses directly into the TrackWise system.

Company Notes

AAIPharma, a provider of pharmaceutical product-development services, is expanding the capacity and capabilities of its parenteral manufacturing facility in Charleston, South Carolina. Facility expansions currently underway at AAIPharma’s Charleston location include the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial-filling machine, the expansion of the company’s microbiology laboratory, and the addition of on-site formulation development capabilities and enhanced analytical instrumentation. Read More

Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSUPx; Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSUPx is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis.
Enwave Optronics, Inc.
http://www.enwaveopt.com/EZRaman-H.htm

AIMM Therapeutics and Cosmo Pharmaceuticals have agreed to develop oral diagnostic and therapeutic antibodies for gastrointestinal diseases, including colon carcinoma. AIMM Therapeutics will generate human monoclonal antibodies, which will then be formulated by Cosmo Pharmaceuticals into an extended-release formulation using its proprietary MMX technology. Read More

Dendreon, a biotechnology company, has sold its 173,100-ft2 immunotherapy manufacturing facility (which features capabilities to manufacture Provenge [sipuleucel-T], an autologous cellular immunotherapy) in Morris Plains, New Jersey, to Novartis for USD 43 million in cash. Read More

Halozyme Therapeutics and Pfizer have agreed to develop and commercialize products combining proprietary Pfizer biologics with Halozyme’s Enhanze technology. Enhanze is Halozyme's proprietary drug-delivery platform and is based on the company’s patented recombinant human hyaluronidase enzyme (rHuPH20). Under the agreement, Halozyme has granted to Pfizer a worldwide license to develop and commercialize products combining rHuPH20 with Pfizer proprietary biologics directed to up to six targets. Targets may be selected on an exclusive or nonexclusive basis. Halozyme will receive an initial payment of USD 8 million, which includes the upfront fee for exclusive licenses to two specified therapeutic targets in primary care and specialty care indications and the right for Pfizer to select up to four additional targets upon payment of additional fees. Read More

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com


PharmTech, the magazine
Current Issue cover
Tracking the Supply Chain
by: Adeline Siew
As the battle against counterfeits gains momentum, PharmTech speaks to Mark Davison, CEO of Blue Sphere Health, and Craig Stobie, global life sciences sector manager at Domino Printing Sciences, about the challenges involved with coding and tracking drugs through the global supply chain. Potential solutions are discussed, including fingerprinting technologies and end-user verification.
Click Here to Read More

Coming soon: "Pharma Conversation & Community," a new section to debut in Pharm Tech's January 2013 issue, highlights key discussions and news briefs across our digital and social media platforms.


Know Before You Go—2012 Conference Previews

Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.

Find company backgrounds, new product releases, booth materials, and more.

PharmTech's online Gateway is your guide to the season's leading shows.

 

PharmTech Poll

Industry Changes
What area of the pharmaceutical industry do you think will experience the most change in 2013?

Vote here
View the poll archive.
 
On Our Blog PharmTech Talk

>>Recent Posts

North America News
Purchaser of Unapproved Drugs Pleads Guilty

Industry Conferences, Manufacturing, Regulation
PDA-EMA Joint Conference on Process & Validation

Industry Conferences, Manufacturing, Products & Equipment
Real-time Data Aids Continuous Manufacturing

>>Go to the Blog Homepage

| Subscribe | Send Feedback | Advertise With Us | Visit PharmTech.com |

Visit PharmTech.com Visit PharmTech.com About Us Subscribe Today! Start your RSS subscription today! Manufacturing Outsourcing Formulation Ingredients Testing Drug Delivery IT Packaging Regulation Visit PharmTech.com