Ed Price
From the earliest civilizations to astronauts in space, drying out food to preserve it and retain vital nutrients has been a common practice. Today, the same fundamental strategy of lyophilization is becoming a key method used by drug and medical device manufacturers for the development of polymers used in medical devices and for drug delivery.
Narine Baririan, PharmD, Bruno Speder
The first FDA-approved therapeutic monoclonal antibody (mAb) was muromonab in 1986, and since then, numerous mAb drugs have been approved, and many more are in the later stages of clinical development. In the main, mAbs are being developed against immunological and oncological targets, but their beneficial characteristics allow development of drugs for various therapeutic indications.
Pharmaceutics International Inc (Pii) is returning to its contract development and manufacturing organization (CDMO) foundation in order to help partners navigate product development from beginning to end.
Zvonimir Majic PhD, Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D., Eric Stener
Temperature sensitive pharmaceutical products should be transported under temperature-controlled conditions in order to maintain product quality using a Qualified Shipping System (QSS).
Joy L Silva
Pharmaceutical companies are looking for outsourcing partners with the necessary equipment, facilities, expertise and resources they need to avoid common manufacturing pitfalls that may prevent the success of their drug.
Chris Harvey
As the FDA moves into 2020, the agency is facing some hot button issues it failed to put to rest in 2019. Issues including NDMA, e-cigarettes and vaping, medical marijuana, the unregulated use of CBD oils, and asbestos in talc are all on the table.
Dr. Stephen Gately
Ringing in the new year with headlines about cancer deaths declining was a great way to start 2020 and celebrate the many innovative advancements pushing the industry forward.
Dominic Hyde
As we welcome the new decade and the exciting advances it is expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight and increasing automation are just a few. However, there are emerging trends that make 2020 unique.
Alan White
The challenge of retaining talent in life sciences, not least in safety and regulatory fields, has arguably never been higher up the list of industry conversation topics than now. This is particularly the case as younger professionals’ ambitions for a broad base of experience conflict with companies’ needs to hang onto the expertise they have invested in.
The challenge is acute in safety/quality and regulatory areas. Here,
companies’ ability to achieve and retain the optimum depth of skills
and experience is continuously threatened by employees’ ambitions to
build rounded CVs, and keep their work interesting - by trying out a
range of roles.
Jason Lacombe
With the introduction of serialization regulations and the prioritization of end-to-end visibility, the digitization of global supply chains is beginning to take center stage.
Moravek, Inc. is a leading provider of custom radiolabeled, stable labeled and non-labeled compounds and specializes in the manufacture and release of carbon-14 labeled APIs under cGMP conditions in support of clinical trials worldwide.
This quarterly review of new drug applications contain data for applications approved for the first time during the fourth quarter of 2019 which includes New Molecular Entities (NMEs) and new biologics.