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Podcasts

Webcast: Increasing Your Chances for Success in First-In-Man Studies
October 3, 2012—Sponsored by Patheon

Webcast: Overcoming Challenges with Pediatric Oral Solid Dose Development
October 3, 2012—Sponsored by Colorcon

Webcast: Achieving Sensory Benefits and Mildness in Dermatology Products
October 4, 2012—Sponsored by BASF

MORE WEBCASTS

Podcast: Topical Drug Development for Dermatology Products

Podcast: The Awesome Power of Virtual "Quality" in a Regulated Environment

MORE PODCASTS

Events

CPhI Worldwide
October 9, 2012–October 11, 2012
Madrid, Spain

2012 AAPS Annual Meeting and Exposition
October 14, 2012–October 18, 2012
Chicago, Illinois

The Universe of Prefilled Syringes & Injection Devices
October 15, 2012–October 17, 2012
Las Vegas, Nevada

PDA's 7th Annual Global Conference on Pharmaceutical Microbiology
October 22, 2012–October 24, 2012
Bethesda, Maryland

ICH Q9 Training Course
October 24, 2012–October 25, 2012
Vienna, Austria

ICH Q10 Training Course
October 25, 2012–October 26, 2012
Vienna, Austria

More events


FindPharma Search
October 4, 2012 PharmTech.com



News

US Science Advisors Issue Report on Innovation in Drug Discovery and Development
The President’s Council of Advisors on Science and Technology released a report containing recommendations for boosting innovation in drug discovery and development.
Click Here to Read More

Merck Serono Launches New Spin-off Company; Provides Update on Restructuring
Merck Serono’s Asceneuron is the third company to be spun off from the company’s Entrepreneur Partnership Program that was launched to mitigate the impact from recent restructuring at its Geneva site.
Click Here to Read More

EMA Aims to Facilitate Biosimilars Development
The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.
Click Here to Read More




Product Spotlight

Mass spectrometers increase analytical throughput

Shimadzu has added three new triple quadrupole mass spectrometers, LCMS-8040, LCMS-8080 and GCMS-TQ8030, to its UFMS series, which currently comprises seven systems. The LCMS-8040 combines improved ion optics and collision cell technology with proprietary ultrafast technologies, and provides an expanded range of ultra-fast, high-sensitivity applications. With the LCMS-8080, it is possible to conduct trace analysis of compounds in complex matrices as the system features high sensitivity with a large dynamic range and quantitation performance. The GCMS-TQ8030 achieves the highest sensitivity in its class for multiple reaction-monitoring measurements based on UFsweeper technology.



Company Notes

Ablynx and a Merck & Co. subsidiary have agreed to develop and commercialize Nanobody candidates directed toward a voltage gated ion channel with the option to develop and commercialize a Nanobody to a second target. Under the agreement, Merck gains exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck will pay Ablynx a EUR 6.5-million ($8.4 million) upfront payment and a EUR 2-million ($2.6 million) fee for research funding. In addition, Ablynx will be eligible to receive up to EUR 448 million ($580 million) in research, regulatory, and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx will be responsible for the discovery of Nanobody candidates and Merck will be responsible for the research, development, manufacturing, and commercialization of any Nanobody product resulting from the collaboration. Read More

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Catalent Pharma Solutions has established a global alliance with Parexel International to help streamline the clinical-trial supply process. The alliance will provide a fully integrated service offering aimed at ensuring the timely and efficient delivery of clinical-trial materials. Read More

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In other news, Catalent has agreed to supply to the biopharmaceutical company Vivus Qsymia once-daily combination extended-release capsules. Qsymia was recently been approved by FDA as a once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related comorbidity. Read More

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Janssen Biotech has entered into a license agreement with Astellas Pharma for the worldwide development and commercialization, except in Japan, of ASP015K, an oral, small-molecule Janus Kinase inhibitor. ASP015K is currently in Phase II-b development as a once-daily treatment for rheumatoid arthritis, following a successful Phase II-a study demonstrating its potential in the treatment of moderate-to-severe plaque psoriasis. Read More

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SAFC, part of Sigma-Aldrich, plans to expand its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5-million ($2.42 million) Regional Selective Assistance grant from Scottish Enterprise. Read More

Advertisement:
Increasing your chances for success in First-In-Man studies
Live Webcast: Wednesday, October 3, 2012 at 11:00 AM EDT.
Register Free at www.pharmtech.com/success

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

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Best Practices for Achieving Product Quality in Sterile Manufacturing
Live Webcast: Tuesday, November 6, 2012 at 11:00am–12:00pm EST.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com


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API Development: Risk Evaluation and Control of Genotoxic Impurities
Live Webcast: Thursday, November 8, 2012 at 10:00am EST
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Regulatory Roundup

FDA has launched BeSafeRx—Know Your Online Pharmacy, a national campaign designed to promote public awareness of fraudulent Internet pharmacies. The program offers consumers resources for educating themselves on FDA’s website at www.fda.gov/BeSafeRx. FDA warns that fake online pharmacies use sophisticated marketing tricks and that “less than 3% of online pharmacies meet state and federal laws.” FDA recommends consumers only purchase from online pharmacies located in the United States that require a valid doctor’s prescription, have a licensed pharmacist available, and are licensed with a state board of pharmacy.

FDA has released the following guidance documents:

Guidance for Industry, Acute Bacterial Otitis Media: Developing Drugs for Treatment (September 2012).

Guidance for Industry, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment (September 2012).

Guidance for Industry, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, Draft Guidance (September 2012).

Guidance for Industry, Initial Completeness Assessments for Type II API DMFs Under GDUFA, Draft Guidance (October 2012).

On Oct. 1, 2012, the European Medicines Agency announced publication of the “EURD list,” a list of European Union reference dates and frequency of submission of periodic safety update reports. The EURD list includes active substances and combinations of active substances in drugs that are subject to different marketing authorizations.

PharmTech, the magazine
Current Issue cover
Weighing Access and Affordability
by: Kenneth I. Kaitin and Joshua P. Cohen
Policymakers must balance fundamental issues involving access to medicines and pricing.
Click Here to Read More

Coming soon: Pharm Tech’s November issue will feature a biologics manufacturing marketing overview.


Solubilization Solutions

In a special PharmTech issue, current and emerging bioavailability challenges are examined. Articles address solutions and approaches for solubilization as related to solid dispersions by hot-melt extrusion, lipophilic excipients, lipid-based formulations, spray drying, and more. Read More


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

Preventing Counterfeiting
Do you think the growing number of anticounterfeiting technologies technologies, coupled with increased focus from regulators, have had a positive impact on reducing the number of counterfeit pharmaceuticals in the legal supply chain?

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