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Posted April 14, 2020

GENEVA, Switzerland—Due to the ongoing COVID-19 pandemic, Vitafoods Europe has been postponed and will take place at Palexpo in Geneva on September 1-3. This decision reflects the ongoing health concerns and travel restrictions related to the novel coronavirus. All existing registrations and commitments will

Posted April 14, 2020

NAAS, Ireland—Kerry acquired Pevesa Biotech, Seville, Spain, a provider of non-allergenic, non-GMO plant proteins for the infant-, general-, and clinical-nutrition markets. The acquisition strengthens Kerry’s capabilities in the hydrolyzed plant protein space for specialized nutrition and expands the company’s capacity to serve the rapidly growing, high-quality, organic plant protein market.

Posted April 14, 2020

SAN FRANCISCO, CA—A blockchain-based drug product tracking network can meet the Drug Supply Chain Security Act (DSCSA) by 2023, according to report released by the MediLedger Pilot Project. The FDA’s DSCSA pilot project program selected various participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. The MediLedger Pilot Project was comprised of 25 companies that evaluated blockchain technologies like the MediLedger Network to track and trace prescription drugs across the US pharmaceutical supply chain. The final report proposed business rules and standards on how share data and using a blockchain-based network to enforce those standards. To read the full report, please visit www.mediledger.com/fda-pilot-project.

Posted April 14, 2020

BRIDGEWATER, NJ—Sanofi plans to create an API manufacturing company that would combine the pharmaceutical manufacturer’s six European API production sites located in Italy, Germany, France, Hungary, and the UK. The new API company will be the second largest in the world and is to be headquartered in France and have 3,100 employees.

In other news, the FDA approved Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone to treat adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Posted April 14, 2020

NEW HAVEN, CT—The FDA approved Nurtec (rimegepant) orally dissolving tablet (ODT) as an acute treatment for adults suffering from migraines. The product is owned by Biohaven Pharmaceuticals, which partnered with Catalent to create the migraine treatment. Using Catalent’s Zydis ODT platform, the companies created a freeze-dried tablet that disperses almost instantly in the mouth without water, allowing patients to treat their migraines in a convenient and discreet manner. The ODT is Biohaven’s first FDA-approved product and is currently the first and only calcitonin gene-related peptide receptor antagonist available in a fast-acting ODT.

Posted April 14, 2020

SILVER SPRING, MD—The FDA published 33 new and 10 revised product-specific guidances, which provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval. Of the 42 guidances, 38 are for products with no approved ANDAs. Guidances for generic products include treatments for ALS, diabetes, HIV, lung cancer, and melanoma.

Posted April 14, 2020

Due to the global rise of COVID-19, many industry events have cancelled, digitized, or rescheduled their conferences and events. Interpharm Berlin, the ACS National Meeting, DCAT Week, PharmChina, and the Drug Development Networking Summit have been canceled. The following spring conferences have been rescheduled: CPhI South East Asia (July 1-6), CPhI Japan (September 30-October 2), Parenteral Drug Association Annual Meeting (July 20-22), Phar-East (June 30-July 1), Analytica (October 19-22), Pharmaconex (TBD), Interphex (July 15-17), CPhI North America (September 9-11), Interpack (February 25-March 3, 2021), The Regulatory Affairs Professional Society Euro Convergence (TBD), LogiPharma (September 1-3), and Formulation and Delivery Series UK (July 8-9).