OxyContin Patent Allegations Dismissed Against Purdue
Six plaintiffs have dropped accusations that Purdue Pharma prevented generic competition for its painkiller OxyContin through misrepresentations to
the PTO and sham patent litigation.
OND Realignment Aims to Improve Review Process
Nearly 220 INDs will be moved March 15 from the Office of New Drugs’ (OND) Division of Anesthesia and Analgesia Products to the Division of Pulmonary
and Allergy Products (DPARP), as part of an OND realignment.
FDA Panel Recommends InterMune Drug Approval for Lung Disease
An FDA advisory panel voted 9–3 to recommend approval of InterMune’s Esbriet to slow the decline in lung function in patients with idiopathic
pulmonary fibrosis (IPF), despite agency staff concerns about proof of efficacy.
FDA’s Hamburg Testifies on Patient Protection, User Fees
FDA Commissioner Margaret Hamburg yesterday told a Senate appropriations subcommittee that an increase of $101 million in funding — $51 million
of which would come from two new user fees — would be needed to finance a critical patient-safety measure.
ExonHit, bioMerieux End Colon Cancer Collaboration
ExonHit Therapeutics and bioMerieux will discontinue development of biomarkers for the detection of colon cancer but will continue to work together
in the field of prostate cancer.
BMS to Pay Isis $6 Million for Regulatory Filings
Isis Pharmaceuticals has earned a $6 million milestone payment from Bristol-Myers Squibb (BMS) for successful initial regulatory filings to begin Phase
I testing of an experimental cholesterol drug.
FDA Panel to Vote on InterMune Drug for IPF
An FDA advisory panel will consider whether to recommend approval of InterMune’s Esbriet to slow the decline in lung function in patients with
idiopathic pulmonary fibrosis (IPF), after hearing agency staff concerns about proof of efficacy.
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