ePT--the Electronic Newsletter of Pharmaceutical Technology
Interphex Mexico, Pfizer, Dalton Pharma Services...
Interphex (Norwalk, CT, www.interphex.com) has introduced its Interphex Mexico (Norwalk, CT, www.interphexmexico.com) conference to give pharmaceutical manufacturing professionals the opportunity to access new equipment, technologies, and services from top suppliers. The conference will cover the latest developments and applications to increase productivity and will give attendees the opportunity to network with colleagues. High-level general sessions will feature industry leaders. Additional suppliers and solutions can be found at colocated EXPO PACK Mexico and PROCESA. Interphex Mexico is scheduled for June 27–30 in Mexico City, Mexico.
Pfizer (New York, NY, www.pfizer.com) will acquire exclusive rights to Schwarz Pharma AG's (Monheim, Germany, www.schwarzusa.com) fesoterodine drug candidate for the treatment of overactive bladder. Pfizer will pay $100 million to Schwarz Pharma plus additional payments based on certain milestones. Earlier this year, Schwarz submitted new drug applications for the drug to the US Food and Drug Administration and the European Medicines Evaluation Agency.
Dalton Pharma Services (Toronto, ON, Canada, www.dalton.com) completed its new GMP oligonucleotide manufacturing facility. The production suite can handle small- to large-scale oligo production and purification projects. New equipment includes four "AKTA OligoPilots," each capable of producing 500-umole to 50-g oligos per run. Purification is achieved with reverse-phase or ion-exchange chromatographic techniques.
Cancer therapeutics developer YM BioSciences Inc. (Mississauga, ON, Canada, www.ymbiosciences.com) will acquire Eximias Pharmaceutical Corporation (Berwyn, PA, www.eximiaspharm.com), a company that develops and commercializes products to treat cancer and cancer-related disorders. The transaction is expected to close in early May.
Specialty pharmaceutical company Watson Pharmaceuticals (Corona, CA, www.watsonpharm.com) completed the acquisition of Sekhsaria Chemicals Ltd. (Mumbai, India). Sekhsaria provides research and development as well as contract manufacturing to the global pharmaceutical industry.
Smiths Detection Scientific (Danbury, CT, www.smithsdetection.com), a provider of trace-detection equipment, formed a partnership with Lancaster Laboratories (Lancaster, PA, www.lancasterlabs.com) to introduce CGMP-compliant services for cleaning validation in the pharmaceutical manufacturing market.
Cold-chain storage and third-party logistics provider Sentry Logistic Solutions (Indianapolis, IN, www.sentrylogistic.com) announced the launch of new services and the opening of its $8-million, 53,000-ft2 facility for cold-chain logistics, storage, and packing of bulk pharmaceutical and biotechnology components and finished products. The warehouse and logistics center is classified as a highly protected risk facility and provides cold storage at 2–8 °C, frozen storage at –10 to –20 °C, and ambient room temperature storage.
Bruker BioSciences Corporation (Billerica, MA, www.bruker-biosciences.com) agreed to acquire molecular spectroscopy company Bruker Optics Inc. (Billerica, MA, www.brukeroptics.com) for $135 million. The combined company will provide mass spectrometry, X-ray analysis, and molecular spectroscopy technology for the pharmaceutical and biotechnology industries and for process analysis technologies.
Dowpharma contract manufacturing services, a business unit of The Dow Chemical Company (Midland, MI, www.dow.com), signed a collaboration agreement with Insmed Inc. (Glen Allen, VA, www.insmed.com) for Dowpharma's "Pfenex" expression technology, a Pseudomonas-based technology. Under the terms of the agreement, Dowpharma will express two proprietary Insmed proteins that are administered as a single complex, known as "IPLEX," using the Pfenex technology.
People
The US Food and Drug Administration (Rockville, MD, www.fda.gov) named Capt. Paul Seligman, MD, associate center director for safety policy and communication in the Center for Drug Evaluation and Research. Seligman will oversee drug safety issues and policies.
Utz-Hellmuth Felcht, chairman of the management board of the specialty and fine chemical company Degussa AG (Düsseldorf, Germany, www.degussa.com) will be leaving the company at the end of May. He will be succeeded by Klaus Engel, currently managing director of Brenntag Management GmbH (Mülheim an der Ruhr, Germany), effective June 1. Bernhard Hofmann and Thomas Schoeneberg also will be stepping down as members of Degussa's management board, effective April 30 and June 30, respectively. Alfred Oberholz will become board's deputy chairman on May 1.
Aptuit, Inc. (Greenwich, CT, www.aptuit.com) appointed Michael J. Butler president and scientific operations of its drug development services offerings. Butler has 20 years of experience in pharmaceutical drug development, most recently at MDS Pharma Services where he led multisite operations and oversaw the strategic alignment of the largest segments of the company’s global operations.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.