In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
Boris Stoeber, PhD, Sahan Ranamukha, PhD, and Rory St. Clair describe the Microdermics technology and its improvements over the conventional subcutaneous route of administration.
SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
Vinayak Pathak, MPharm, MBA, indicates after reviewing clinical experiments published in this area, it is evident that formulation design, altering the physico-chemical properties of the drug, addition of absorption enhancers, and mucoadhesive polymers did result in higher bioavailability of drugs in animal models via the nasal route when compared to parenteral administration of the same drug.
Chris Evans explains how it is important that pharmaceutical companies and their drug delivery system partners proactively address the forgetting curve by rethinking how patients learn to use self-administration systems.
James Arps, PhD, and Matt Petersen, PhD, investigate how foamed silicone is capable of sustained, controlled elution of hydrophobic small molecule and large macromolecular payloads.
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
DEVICE REGULATIONS – Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations
Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.
TECHNOLOGY-ENABLED HEALTH – Digitally Connected Health Technologies: Blazing Meaningful Trails in Healthcare
Daniel Spors and Kyle Dolbow, PhD, say the overall digital health market is currently $76 billion, and is estimated to grow at 21%, and this space includes life sciences and medical device companies that are incorporating digital technology into their products and services, such as smart inhalers and remote therapy devices.
EXCLUSIVE ONLINE CONTENT
Zynerba Pharmaceuticals, Inc. recently announced the initiation of a multi-national, randomized, double blind placebo controlled Clinical study of Cannabidiol (CBD) in Children and Adolescents with…
As we come to learn more about the human body, the dynamics of the industry must react accordingly. A primary example of this is the fact that the dominating blockbuster drug model that was paramount in the industry until a couple of years ago is no longer valid……
Pfenex Inc. recently announced the receipt of a milestone payment from Merck associated with the initiation of the first Phase 3 clinical study of (V114), an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease.
Immatics Biotechnologies GmbH recently announced it has entered into a research collaboration and license agreement with Genmab A/S to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications.
With the acquisition of Sensile Medical AG, Switzerland under a recent share purchase agreement, Gerresheimer is extending its business model in the direction of an Original Equipment Manufacturer (OEM) for drug delivery platforms with digital and electronic capabilities for pharmaceutical and biopharmaceutical customers.