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Pfenex Announces US Commercial Launch of Teriparatide Injection June 17, 2020
Pfenex Inc. recently announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the US. Teriparatide Injection (also referred...THERAPEUTIC PEPTIDES - Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality March 31, 2020
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
Zydus & XOMA Announce Exclusive Licensing Agreement March 12, 2020
Zydus Cadila and XOMA Corporation recently announced they have entered into a licensing agreement to advance an IL-2-based immuno-oncology (IO) drug candidate that….
BeyondSpring Files for Patent Protection on BPI-002 for the Treatment of Viral Infections, Including COVID-19 March 12, 2020
BeyondSpring Inc. recently announced the submission of a provisional US patent application for its pipeline asset BPI-002, for methods of...Zumutor Biologics & Catalent Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors February 14, 2020
Catalent recently announced it has signed an agreement with Zumutor Biologics, Inc., to manufacture Zumutor’s lead candidate, ZM008, for the...SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
European Commission Approves Treatment of Moderate-to-Severe Plaque Psoriasis April 30, 2019
AbbVie, a research-based global biopharmaceutical company, recently announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Altimmune Announces Positive Results From NasoVAX Extension Study March 20, 2019
Altimmune, Inc. recently announced additional positive data from a Phase 2 extension study of its NasoVAX intranasal influenza vaccine candidate....Imugene Announces First Patient Dosed in Open-Label Phase 2 Study March 14, 2019
Imugene Limited recently announced dosing of the first patient in an open-label, randomized multi-centre Phase 2 study with its HER-Vaxx...Immutep Enters Into Clinical Trial Collaboration, Service, and Supply Agreement January 11, 2019
Immutep Limited recently announce it has entered into a clinical trial collaboration agreement, a supply agreement, and a service agreement...REGENERATIVE MEDICINE - Cell Therapy - The Quest for Finding the Cure November 12, 2018
Aarti Chitale, MBA, believes as the therapeutic landscape evolves and transitions toward personalized and value-based care, regenerative medicine will play an increasingly important role, and moreover, the success of these therapies offers promising opportunities for previously untreated diseases areas.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
Inovio Closes License & Collaboration Agreement With ApolloBio March 23, 2018
Inovio Pharmaceuticals, Inc. recently announced it has closed an agreement providing ApolloBio Corp. with the exclusive right to develop, manufacture,...Vivos Receives FDA Confirmation of RadioGel Device Classification February 6, 2018
Vivos Inc recently announced it has been notified by the FDA that RadioGel is classified as a device for animal...Inovio Enters License & Collaboration Agreement With ApolloBio January 8, 2018
Inovio Pharmaceuticals, Inc. recently announced it entered an amended agreement providing ApolloBio Corporation with the exclusive right to develop and...NANOBIOTIX Plans to Conduct First Clinical Trial October 9, 2017
Nanobiotix recently announced its intention to start a new trial in the company's immuno-oncology (IO) program. The trial is aimed...SPECIAL FEATURE - Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands September 12, 2017
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
Inovio’s DNA-Based Monoclonal Antibody Platform Achieves Further Proof-of-Principle Validation July 7, 2017
Inovio Pharmaceuticals, Inc. recently announced its DNA-based monoclonal antibody product for flu produced broadly cross-reactive antibodies that provided complete protection...SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
EXECUTIVE INTERVIEW - Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics April 3, 2017
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
