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Stock Market & Financial Investment News

News Breaks
June 26, 2014
06:03 EDTACT, ACORAcorda Therapeutics notified of Actavis' ANDA filing for generic Ampyra
Acorda Therapeutics (ACOR) received a Paragraph IV Certification Notice Letter advising that Actavis Laboratories (ACT) submitted an Abbreviated New Drug Application - ANDA - to the FDA requesting permission to manufacture and market a generic version of Ampyra Extended Release Tablets, 10 mg. Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Actavis Laboratories in order to trigger a statutory stay period under the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA until July 2017. Ampyra is currently protected by five patents listed in the FDAs Approved Drugs Product List. Acorda intends to vigorously defend its intellectual property rights.
News For ACOR;ACT From The Last 14 Days
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May 4, 2015
07:35 EDTACORNewYorkBio to hold a conference
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07:12 EDTACTAmerican Congress of Obstetrics and Gynecology
2015 ACOG Annual Clinical & Scientific Meeting is being held in San Francisco on May 2-6.
May 1, 2015
12:26 EDTACORBiogen patent challenged by Kyle Bass
The Coalition For Affordable Drugs, a group linked to Hayman Capital's Kyle Bass, has requested an Inter Partes Review of Claims 1-20 of US patent 8,399,514 held by Biogen (BIIB), according to a USPTO filing. The patent is related to the company's multiple sclerosis drug. BACKGROUND: Previously, the same coalition requested an Inter Partes Review of patents held by Celgene (CELG), Pharmacyclics (PCYC), Acorda Therapeutics (ACOR), Shire (SHPG) and Jazz Pharmaceuticals (JAZZ). PRICE ACTION: Shares of Biogen are up 3% to $385.29 in afternoon trading.
April 30, 2015
06:05 EDTACORAcorda Therapeutics backs FY15 Ampyra sales $405M-$420M
Backs FY15 R&D guidance of $150M-$160M; Backs FY15 SG&A guidance of $180M-$190m.
06:05 EDTACORAcorda Therapeutics reports Q1 Ampyra sales $92.4M
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06:04 EDTACORAcorda Therapeutics reports Q1 non-GAAP EPS 15c, consensus 14c
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April 28, 2015
17:00 EDTACTActavis, Medicines360 announce publication of ACCESS IUS study of LILETTA
Actavis and Medicines360, a nonprofit women's health pharmaceutical company, announced that the initial results of ACCESS IUS, or A Comprehensive Contraceptive Efficacy and Safety Study of an IUS, were published online today in the medical journal Contraception. The study found that LILETTA, or levonorgestrel-releasing intrauterine system, 52 mg, is 99.45% effective for the prevention of pregnancy for up to three years of use in women aged 16-35 regardless of race, parity, or body mass index. The ACCESS IUS trial is still ongoing and will evaluate the efficacy and safety of LILETTA for up to seven years of use.
10:19 EDTACTPershing Square lists Herbalife, Actavis as top Q1 losers
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April 24, 2015
09:27 EDTACTActavis' Dalvance shows positive Phase 3 results for skin infections
Actavis announced positive top-line results for study DUR001-303, a phase 3 study comparing a single 1500 mg dose of Dalvance with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus. Preliminary top-line data demonstrated the 1500 mg single-dose of Dalvance achieved its primary endpoint of non-inferiority to the two-dose regimen at 48-72 hours after initiation of therapy. Actavis plans to file a supplemental New Drug Application with these data in Q3.
07:09 EDTACTCipher Pharmaceuticals announces Markman hearing in Absorica patent suit
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April 23, 2015
09:20 EDTACORCelgene patent latest to be challenged by Hayman Capital's Bass
The Coalition For Affordable Drugs, a group linked to Hayman Capital's Kyle Bass, has requested an Inter Partes Review of Claims 110 of U.S. Patent No. 6,045,501 held by Celgene (CELG), according to a USPTO filing. The 501 patent claims methods for delivering a drug, including a teratogenic drug, to a patient while preventing the exposure of a fetus or other contraindicated individuals to the drug. The patent is related to the company's Revlimid drug. BACKGROUND: Previously, the same coalition requested an Inter Partes Review of patents held by Pharmacyclics (PCYC), Acorda Therapeutics (ACOR), Shire (SHPG) and Jazz Pharmaceuticals (JAZZ). On January 7, Reuters reported that Bass planned to take "around 15 pharmaceutical companies with a combined market capitalization of $450B" into an Inter Partes Review for extending patents in questionable ways, citing a presentation made by Bass in Oslo. PRICE ACTION: Shares of Celgene are down 0.5% to $114.92 in pre-market trading.
08:16 EDTACTActavis launches Avycaz anti-infective in U.S.
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April 22, 2015
07:37 EDTACTOrexigen and Takeda receive Paragraph IV certification notice
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07:33 EDTACORAcorda Therapeutics presents data on remyelinating anibody clinical study
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07:19 EDTACORAcorda Therapeutics assumed with a Neutral at Piper Jaffray
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