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August 2012

Almirall announces that it will start clinical program on new COPD drug

By mid-2012, Almirall plans to begin clinical studies on a new inhaled drug for the treatment of COPD called LAS190792, the company has announced. The drug is a dry powder formulation of a dual, long-acting… Read more . . .
RDD Europe organizers expect largest meeting to date

RDD Europe 2011 will be the largest iteration so far of the European version of the Respiratory Drug Delivery meetings, says Richard Dalby of co-organizer RDD. Already, more than 400 people have registered for the… Read more . . .
Another FDA group seeks to review OINDPs

The 2011 IPAC-RS conference, held in Rockville, MD March 29-31, featured speakers from a number of FDA offices discussing the agency’s efforts relevant to orally inhaled and nasal drug products (OINDPs). Among those speakers was… Read more . . .
TOBI Podhaler gets market authorization in Canada

Novartis Canada has announced that it has received a Notice of Compliance from Health Canada for its TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The product has… Read more . . .
DDL 22

Full abstracts for posters and for podium presentations should be submitted by July 27, 2011. Beginning May 1, abstracts can be submitted on-line at www.ddl-conference.org.uk. Researchers studying for a degree or up to three years… Read more . . .
Pfizer sells Capsugel to KKR

Kohlberg Kravis Roberts & Co (KKR) will buy Pfizer’s Capsugel business for just under $2.4 billion. In addition to its Vcaps hydroxypropyl methyl cellulose (HPMC) capsules for dry powder inhalation products, Capsugel also manufactures the… Read more . . .
Meda submits NDA for Dymista

Soon after announcing positive Phase 3 results for Dymista and saying that it would file an NDA for the product by mid-2011, Meda announced that it has gone ahead with the filing. Dymista is a… Read more . . .
Biota gets US government contract for inhaled laninamivir

The Office of Biomedical Advanced Research and Development Authority (BARDA), an agency within the US Department of Health and Human Services under the Office of the Assistant Secretary for Preparedness and Response, has awarded a… Read more . . .
IPAC-RS conference — Day 2

Speakers representing the FDA and several IPAC-RS working groups dominated day 2 of the 2011 IPAC-RS conference, with presentations and panel discussions on the day’s main topic, “Product Quality.” The day began with the keynote… Read more . . .
IPAC-RS conference — Day 1

Day 1 of the 2011 IPAC-RS conference featured 13 talks and a panel discussion, covering two topics aligned with the conference theme of “Bring Value to the Patient in a Changing World.” The morning focus,… Read more . . .

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