Some day in the not-too-distant future, a dry powder inhaler once used to deliver insulin may help Parkinson’s patients overcome some of the most debilitating symptoms of the disease. Back in 2008, in the wake of the Exhubera failure, Eli Lilly backed out of its partnership with Alkermes on the AIR inhaled insulin project. As a result, Alkermes shuttered a $40 … [Read more...] about Civitas looks to turn Parkinson’s patients “ON” with inhaled L-dopa
Features
A Q&A with the FDA’s Bill Doub
Bill Doub is Lead Chemist, R&D in the FDA's Division of Pharmaceutical Analysis, which is part of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research (CDER) Q. What does the Division of Pharmaceutical Analysis do? A. Over 30 years or so that I have worked for the FDA, the role of the lab has changed. Historically, we did almost … [Read more...] about A Q&A with the FDA’s Bill Doub
How an abandoned inhaler project led to a CDMO makeover
A new, or at least new-ish, contract development and manufacturing company called Formex LLC launched on March 8, 2013 after its parent company, Biotech Investment Group (B.I.G.), acquired all of the assets formerly belonging to Akela Pharma subsidiary PharmForm. Formex's services are the same as PharmaForm's, including formulation development and GMP clinical … [Read more...] about How an abandoned inhaler project led to a CDMO makeover
DDL 24 — Day 3
DDL24 concluded on Friday, December 13 with a half day of presentations and the final exhibition session. Bo Olsson of AstraZeneca kicked off the morning with a talk titled, "Validation of a General In Vitro Approach for Prediction of Total Lung Deposition in Healthy Adults." After Olsson's presentation, last year's Pat Burnell award winner, Martin Rowland of the … [Read more...] about DDL 24 — Day 3
DDL 24 — Day 2
The second day of DDL 24 opened with a posters on the podium session featuring the finalists for the 2013 Pat Burnell New Investigator Award. The six presenters were: Eva Faulhammer, Technical University, Austria: "Effect of Process Parameters and Powder Properties on Low Dose Dosator Capsule Filling" Judy Ching-Yee Loo, Faculty of Pharmacy, University of … [Read more...] about DDL 24 — Day 2
DDL 24 — Day 1
On day 1 of DDL 24, attendees gathered in the Pentland Auditorium of the Edinburgh International Conference Centre, where they were welcomed by conference chair Gary Pitcairn. In his opening remarks, Pitcairn noted that attendance had broken the 500 mark for the first time in the meeting's history. Following Pitcairn's remarks, OINDP consultant and Affiliate … [Read more...] about DDL 24 — Day 1
New Chinese inhaled drug delivery association forms
On the first day of the Inhalation Drug Symposium 2013 held November 8-9, 2013 in Nanjing, China, a group of five inhalation medicine specialists proposed the formation of a new organization to be called the the Inhalation Drug Delivery Association (IDDA), according to chairs Anny Shen and Shuguang Hou. The approximately 90 meeting participants, which included … [Read more...] about New Chinese inhaled drug delivery association forms
2013 AAPS Annual Meeting
Anyone who left the 2013 AAPS Annual Meeting after the first couple of days missed most of the highlights for OINDP specialists. The meeting, which took place November 10-14 in San Antonio, TX, saved most of the inhalation and nasal drug delivery events for the final two days. During the Monday-Wednesday exhibition, the majority of the exhibitors with products or … [Read more...] about 2013 AAPS Annual Meeting
Largest pharmacy benefit manager in US excludes popular OINDPs from 2014 formulary
Express Scripts, a pharmacy benefit manager (PBM) that administers prescription drug programs for more than 100 million Americans, has announced the exclusion of more than a dozen popular OINDPs from its 2014 national preferred drug list. The exclusion means that many of the patients whose benefits are administered by Express Scripts would have to pay full retail … [Read more...] about Largest pharmacy benefit manager in US excludes popular OINDPs from 2014 formulary
DDL 24 to take advantage of expanded conference space
Drug Delivery to the Lungs (DDL) 24 will take place December 11-13 2013 in the recently expanded Edinburgh International Conference Centre (EICC), and organizers from the Aerosol Society say that they are eager to make good use of the EICC's new facilities. After a multi-year construction project, the EICC has opened new exhibit and meeting spaces, providing … [Read more...] about DDL 24 to take advantage of expanded conference space