Pharmaceutical Technology ePT Weekly:
Having trouble viewing this e-mail? Click here.
You are subscribed to %%list.name%% as %%emailaddr%%.
Click here to unsubscribe your member profile
ePT by PharmTech logo
News
Company Notes
PharmTech,
the magazine
Product Spotlight
People Notes

Regulatory Roundup


 
 

About Us

Subscribe to Pharmaceutical Technology

Whitepaper Library

Podcasts

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
July 20, 2011—Sponsored by Dow Pharmaceutical Sciences

Events

Lyophilization Technology - Practical Application of the Scientific Principles
June 13–June 15, 2011
Los Angeles, CA

Chemspec Europe 2011
June 15–June 16, 2011
Geneva, Switzerland

10th Annual Biological Production Forum 2011
June 20–June 22, 2011
Frankfurt, Germany

IVT’s 2nd Annual ACE
June 21–June 23, 2011
Philadelphia, PA

NC3Rs/Society of Biology Symposium
June 22, 2011
London, United Kingdom

PharmaBrand Summit 2011
June 27–June 29, 2011
Montreux, Switzerland

More events


FindPharma Search
June 9, 2011 PharmTech.com

News

FDA Office of Compliance to Become a Super Office
CDER Director Janet Woodcock announces reorganization.
Click Here to Read More

J&J Ordered to Pay $327 Million Penalty in False-Claim Suit
A South Carolina court found that a subsidiary of Johnson & Johnson violated state consumer protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Click Here to Read More

US Supreme Court Rules in Favor of Roche in University Patent-Rights Case
The US Supreme Court ruled in favor of Roche in a patent-dispute case the pharmaceutical company had with Stanford University in a 7-2 vote. Click Here to Read More

AstraZeneca Settles Sex-Discrimination Lawsuit
AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company’s Philadelphia Business Center. Click Here to Read More

Alliance Calls for European Pricing Transparency
The European Public Health Alliance has called for greater pricing transparency, as well as the formation of a public website that provides comparative information on medicines' procurement prices. Click Here to Read More


Product Spotlight

Press produces various tablet formats

The FE55 tablet press from Fette Compacting can be configured for traditional monolayer use, monolayer use for direct compression, and double-layer use. When configured for double-layer tablets, the device uses its optional third compression station as a tamping station for the first tablet layer. The machine’s design enables it to produce approximately 90% of the most common tablet formats, according to the company.

When configured for bilayer manufacturing, the device’s pneumatically-actuated lower roll assembly instantaneously raises the first lower compression roll by as much as 2 mm. This action temporarily increases the hardness of the first tablet layer so that it can withstand the trip through the sampling chute and be weighed. The press reverts to normal operation without requiring operator input. In addition, the machine’s feeder assembly uses a single paddle with an inverted-cone shape. The feeder is designed to enable unrestricted product flow to the conical paddle, thus optimizing filling for difficult products.

Advertisement:
Low-Cost Laminar Flow Hoods - Terra Universal’s economical ValuLine Clean Benches provide a laminar flow of HEPA/ULPA-filtered air to protect contamination-sensitive materials. These dust-free enclosures come in many materials, including chemical-resistant polypropylene. Integral base panel with raised front lip safely contains spills. Optional ionization and UVC disinfection enhance static and microbial control. Laminar Flow Workstations with built-in stands also available.

 
Company Notes

The specialty chemicals and technologies provider Ashland has agreed to acquire International Specialty Products (ISP), a specialty chemical manufacturer of ingredients and technologies for $3.2 billion. The deal, which is subject to customary closing conditions and regulatory approvals, is expected to close before the end of the September quarter.

Advertisement:
Seem like the only thing some contract labs are testing is your patience?
With Celsis, you get fast, accurate testing for a full spectrum of CGMP lab services performed accurately, on time and on budget. We offer compendial, non-compendial or custom methods. Raw material to container and finished product testing. We even have HPLC, LC-MS/MS, GC, IC, dissolution, AA and more. Get a quote now. celsis.com/labs/quote

 

AstraZeneca and the drug-discovery and development company Heptares have entered into a four-year collaboration for the discovery and development of new medicines targeting G-protein coupled receptors. Under the terms of the agreement, AstraZeneca has worldwide commercial rights to product candidates emerging from the collaboration. Heptares will receive an upfront $6.25-million cash-payment fee plus committed research funding and also qualifies for future payments depending on delivery of agreed milestones. Heptares will also receive royalties on sales of all products discovered through the joint research.

Advertisement:
It’s all about Aptuit service. Our customers say they respect our commitment to resolving challenging issues. They will work with us again because of our ability to accomplish goals in aggressive timelines while staying on budget. They are voicing their positive response to our recent breakthrough systems, and providing even greater global service efficiencies.
Across the entire drug development continuum, it’s all about Aptuit service.
http://www.aptuit.com/ItsAllAboutTheService/service.htm

  

Aveo, a company developing cancer therapeutics, has formed a drug-development pact with Centocor Ortho Biotech, a subsidiary of Johnson & Johnson (J&J) for the worldwide development and commercialization of Aveo's internally discovered antibodies targeting the RON receptor, which is believed to be involved in tumor growth. Under the terms of the agreement, Aveo will initially receive $15 million, half as an upfront payment from Centocor, and the remaining half through a separate equity private placement and stock purchase agreement of Aveo common stock to an affiliate of Centocor Ortho Biotech, Johnson & Johnson Development Corporation. Under the license agreement, Aveo is eligible to receive up to $540 million in milestone payments based upon the achievement of specified development, regulatory, and commercialization goals. Upon commercialization, Aveo will be entitled to a tiered, double-digit royalty on net sales worldwide. Centocor Ortho Biotech will be responsible for all clinical development, manufacturing, and commercialization activities and costs. Centocor Ortho Biotech will also fund certain research conducted by Aveo, including translational research studies.

Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required.http://www.grainprocessing.com

   

Bristol-Myers Squibb and Roche have entered into a clinical collaboration agreement to evaluate the effectiveness of Bristol-Myers Squibb's CTLA-4 inhibitor, Yervoy (ipilimumab), in combination with Roche's investigational oral BRAF inhibitor, vemurafenib, in treating patients with a specific type of metastatic melanoma. Under the terms of the agreement, the two companies will conduct a Phase I/II study to evaluate the safety and efficacy of the combination and may conduct further development of the combination.

Advertisement:
HPLC familiarity with UPLC performance.
For laboratories that perform routine analyses or develop methods, or simply prefer the flexibility of a multi-solvent delivery system, the only choice has been HPLC-until now.
The ACQUITY UPLC H-Class system can enable your laboratory to access the productivity and chromatographic performance of UPLC® in a system that combines the flexibility of ternary or quaternary solvent blending with the simplicity of flow-through needle injections. Learn More

 

Bruker, an analytical instrumentation company, has opened an applications, training, and technical services center in Shanghai. The new facility features multitechnology applications, training, and demonstration capabilities to support research collaborations in China. Bruker also intends to open an additional service and sales office in Guangzhou, China, later this year.

Advertisement:
At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash.
http://www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm

 

Elite Pharmaceuticals, a specialty pharmaceutical company, has entered into a commercial manufacturing and supply agreement with the pharmaceutical company Mikah Pharma. Under the terms of the agreement, Elite will perform the laboratory stability studies, manufacturing, and packaging for two generic products: isradipine capsules USP, 2.5 mg and 5 mg and phendimetrazine tartrate tablets USP, 35 mg. Elite will be compensated at an agreed-upon transfer price for the manufacturing and packaging of the products. For the isradipine product, Elite will receive a 10% royalty on net profits of the finished products. It will also receive a one-time milestone payment for each product for the work associated with the technology transfer.

Advertisement:
TABLET PRESS REPLACEMENT PARTS SHIPPED SAME-DAY!
By stocking over 300,000 parts for nearly every press on the market, Natoli is able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli parts are manufactured in the U.S.A. and are available for international delivery – and most items are available with same-day shipping! Browse online or request a FREE QUOTE now!
http://www.natoli.com/parts

  

Fujifilm Diosynth Biotechnologies, a contract biologics manufacturing organization, has added a 1000-L single-use bioreactor from the biomanufacturing company Xcellerex to its Research Triangle Park, North Carolina, cGMP manufacturing plant. The expansion is slated to be validated and operational by the first quarter of 2012. The project is the continuation of a cell-culture capacity expansion by Fujifilm Diosynth Biotechnologies. The addition complements the 200-L Xcellerex single-use bioreactor already in operation at the company's process-development laboratories in Cary, North Carolina, and the existing 2000-L stainless steel train located in the Research Triangle Park, North Carolina, facility.

Advertisement:
The latest in news and information from Bosch Packaging Technology At our new Blog http://boschpackagingpharmana.wordpress.com Currently on the blog 150 years of Packaging History, single-use dosing technology updates, and a capsule filling system comparison.

 

GE Healthcare has opened a new technology facility, called the GE Healthcare Life Sciences Demonstration Laboratory, at the Science for Life Laboratory (SciLifeLab) in Stockholm, Sweden, a national resource center for large-scale molecular biosciences and biomedical research.

Advertisement:
CBI’s 9th Product Complaints for Bio/Pharmaceuticals and Medical Devices— June 14–16, 2011, Arlington, VA
Create your own agenda at the QA/QC event of the year. Hear from the FDA and quality leaders from Abbott, Alcon Labs, American Medical Systems, Baxter Healthcare Corp., Becton Dickinson, GE Healthcare, Janssen Supply Group, LLC, Merck & Co., Inc. Philips Healthcare, Shire and more. Be the next to benefit.
Register today at www.cbinet.com/productcomplaints.

 

The contract manufacturing organization Goodwin Biotechnology and Alethia Biotherapeutics, a biotechnology company, have formed a collaboration for the development of a mammalian cell line-based IgG monoclonal antibody project for AB-165, an anticancer therapy.

Haupt Pharma, a contract development and manufacturing organization (CDMO), has passed an FDA inspection at its site in Regensburg, Germany, without any FDA-483 observation being issued.

The J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals (OMJPI) has returned the rights of the GAD65-based diabetes therapy Diamyd, to Diamyd Medical, a Swedish pharmaceutical company. The companies had formed a development and commercialization agreement in June 2010, under which Diamyd Medical received a nonrefundable upfront payment of $45 million and the parties began sharing the costs for the development program equally. Following termination of the agreement by OMJPI, all rights regarding Diamyd and the active substance GAD65 are returned to Diamyd Medical.

The German excipients manufacturer Meggle Business Group will begin operating its first American production site in Le Sueur, Minnesota, in September 2011.

Patrys, an Australian biopharmaceutical company, has extended its agreement with the biopharmaceutical CDMO Laureate Biopharmaceutical Services to manufacture the anticancer product PAT-LM1 for preclinical and clinical use. PAT-LM1 is a natural human antibody that has been shown to have anticancer properties. The companies also have an existing agreement for the production of another anticancer product, PAT-SM6.

Pfizer and Zhejiang Hisun Pharmaceuticals, a Chinese pharmaceutical company, have signed a memorandum of understanding (MOU) for a joint venture in China. Under the MOU, the two companies will explore a potential business collaboration focused on manufacturing cooperation, broader commercialization of medicines through a local and global sales and marketing infrastructure, and research and development of off-patent medicines.

R-Pharm, a Russian pharmaceutical company, has purchased a 2000-L FlexFactory line from Xcellerex. Under the agreement, Xcellerex will provide R-Pharm with the FlexFactory production line, along with bioprocess services and training. R-Pharm will use the line for large-scale production of innovator biologics and biosimilars.

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

People Notes

The Generic Pharmaceutical Association has appointed Jim Fenton as senior vice-president for government affairs, effective June 6, 2011. Fenton joins the association from the office of former Sen. Christopher Dodd (D-CT), where he served for 15 years, most recently as chief of staff.

Regulatory Roundup

FDA has issued a final guidance for sponsors and investigators regarding its enforcement of the agency’s final rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” The rule amended IND reporting requirements under 21 CFR part 312 and added safety reporting requirements for persons conducting bioavailability and bioequivalence studies under 21 CFR part 320, states the guidance. The final rule was released in September 2010 and took effect in March 2011. Enforcement of the reporting requirements outlined in the final rule will begin on Sept. 28, 2011. The final guidance replaces the draft guidance that was issued with the rule in September 2010.

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) celebrated its 40th anniversary on May 31, 2011, in Geneva, Switzerland. More than 160 individuals, including FDA Commissioner Margaret Hamburg, from around the world participated in the event. FDA’s participation was unique as it symbolized its recently accepted membership to the cooperation scheme. Also new to PIC/S is the Ukraine State Inspectorate. PIC/S is a global collaboration representing 39 competent authorities and focuses on GMP inspections of pharmaceutical manufacturing sites. PIC/S also works with the European Commission and has partnership agreements with regulatory and global health bodies such as EMA, EDQM, UNICEF, and WHO, and works with industry and academic groups globally on training programs.

PharmTech, the magazine
Current Issue cover
Next-Gen Expression Systems
By Amy Ritter
More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.
Click Here to Read More

Coming soon: The July issue of PharmTech will address particle characterization and process simulation.

 

 
 

PharmTech Poll

Atypical Actives
Should the regulation of atypical actives (i.e., the use of an excipient as an active ingredient in a drug) be changed?

Vote here
View the poll archive.

On Our Blog PharmTech Talk

>>Recent Posts

Manufacturing, North America News, Regulation
Bayer and “the Fairer Sex”

R&D
A Rat Is Not A Human!

North America News, Regulation
No Clear Benefit Predicted From an Extended Moratorium on Direct-to-Consumer Advertising

>>Go to the Blog Homepage

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

You are subscribed to %%list.name%% as %%emailaddr%%. Click here to unsubscribe your member profile.

To ensure delivery to your Inbox, please add %%email.list%% to your address book. If you need help doing this, click here.

Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call (toll free) 1-866-529-2922 at any time, or fax us at 1-218-740-6417. Outside the U.S., please phone 1-218-740-6395. Contact us by mail at Advanstar Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.

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