Mylan N.V. announces that Teva (TEVA) has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL (39.13 +0.46)
The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.
Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims.
In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.
After the dismissals, Teva's only remaining patent challenges in the U.S. and Ireland against Mylan's Glatiramer Acetate Injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the U.S. District Court for Delaware, the U.S. Patent Trial and Appeal Board and the United Kingdom's High Court of Justice. Teva is appealing these decisions.
FDA head Scott Gottlieb favors generic drugs to combat high drug prices, according to FT (106.11)
FT Article (Note: In early October, FDA confirmed it is pursuing ways to streamline the generics drug review process. Related Stocks: PRGO, TEVA, MYL, VRX, IPXL, MNK, ENDP, LCI, AKRX).
December 13th, 2017 at 11:21 am
TEVA
12-Dec-17 07:22 ET
TEVA
Teva Pharma shares slip 2% in early trade amid reports it may look to refinance its debt early next year (16.44)
11-Dec-17 12:19 ET
MYL
Mylan N.V. announces that Teva (TEVA) has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL (39.13 +0.46)
The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.
Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims.
In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.
After the dismissals, Teva's only remaining patent challenges in the U.S. and Ireland against Mylan's Glatiramer Acetate Injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the U.S. District Court for Delaware, the U.S. Patent Trial and Appeal Board and the United Kingdom's High Court of Justice. Teva is appealing these decisions.
11-Dec-17 10:49 ET
IBB
FDA head Scott Gottlieb favors generic drugs to combat high drug prices, according to FT (106.11)
FT Article (Note: In early October, FDA confirmed it is pursuing ways to streamline the generics drug review process. Related Stocks: PRGO, TEVA, MYL, VRX, IPXL, MNK, ENDP, LCI, AKRX).
11-Dec-17 09:15 ET
TEVA
Teva Pharma announces launch of generic Viagra tablets in the United States (16.06)
08-Dec-17 10:52 ET
TEVA
Teva Pharma considering eliminating 10K jobs, according to Bloomberg (15.65 +0.64)
Bloomberg Article