FDA Lays Out Requirements for ANDA Post-CRL Meetings
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to…
Court Rejects AbbVie Patent Suits, Boosting FTC Pay-for-Delay Claims
A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Source: Generic Line
FDA Issues PAS and DMF Guidances as GDUFA II Gets Underway
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Source: Generic Line
PTO Grants More Reviews of Herceptin Patents After Hospira Challenges
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by…
ANDA Submissions Topped 1,000 With Two Months to Go in FY 2017
The generic drug industry maintained its pace for a record-setting year in FDA approvals — and passed 1,000 in ANDA submissions. Source: Generic Line
Teva Sued by Hedge Funds for Late Disclosure of DOJ Subpoena
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena…
FDA Asks Drugmakers to Report PDUFA Products, Orange Book Changes
In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any eligible products and Orange Book changes involving their products by…
Lilly Settles on Cialis Patent, Pushing Generics to September 2018
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Source: Generic Line
Avastin, Herceptin Biosimilars Get OKs From FDA Advisory Committee
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Source: Generic Line
Merck and Samsung Bioepis Launch Biosimilar Early, After SCOTUS Ruling
Samsung Bioepis and Merck announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of Janssen’s Remicade (infliximab). Source: Generic Line