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News Breaks
April 19, 2014
18:50 EDTTEVA, MYLMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
Mylan (MYL) announced that Supreme Court Chief Justice Roberts has denied Teva's (TEVA) application for an injunction seeking to prevent Mylan's launch of a generic version of Copaxone pending the Supreme Court's decision on Teva's appeal. This is the second time that the Chief Justice has denied Teva's request for such an injunction. In March, the Supreme Court granted Teva's petition for certiorari seeking clarification of the standard of review that appellate courts should apply when considering appeals relating to the construction of a patent claim. Oral argument is expected to be heard in the fall of 2014. Mylan CEO Heather Bresch commented: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014."
News For MYL;TEVA From The Last 14 Days
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October 13, 2015
06:18 EDTMYLIrish Takeover Panel spurns Perrigo's request on Mylan bid, Reuters says
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October 12, 2015
08:31 EDTTEVATeva launches Avodart capsules in U.S.
Teva Pharmaceuticals announced the exclusive launch of the generic equivalent to Avodart capsules, 0.5 mg, in the United States. Dutasteride is a 5 alpha-reductase enzyme inhibitor and works by lowering production of a hormone called dihydrotestosterone, or DHT. Dutasteride capsules are used to treat the symptoms of benign prostatic hyperplasia, or BPH, in men with an enlarged prostate. Teva was first to file and expects to be exclusive for several weeks. Avodart capsules, marketed by GlaxoSmithKline, had annual sales of approximately $467M in the United States, according to IMS data as of July 2015.
October 9, 2015
11:50 EDTMYLPerrigo releases full statement of Abbott CEO regarding Mylan stake
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07:53 EDTMYLMylan to hold a conference call for Perrigo shareholders
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October 8, 2015
08:03 EDTTEVATeva wins approval from Russia for new dose of RRMS treatment
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October 7, 2015
09:35 EDTMYLMylan potential acquisition of Perrigo looks questionable says Bernstein
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07:23 EDTTEVAEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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October 6, 2015
08:04 EDTTEVATeva to feature MS treatment at ECTRIMS Congress
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October 5, 2015
10:02 EDTMYL, TEVABofa/Merrill healthcare analysts hold an analyst/industry conference call
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October 1, 2015
08:02 EDTTEVATeva to acquire Rimsa for $2.3B
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07:39 EDTTEVAJPMorgan sees opportunities in pharma after pullback
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September 30, 2015
14:58 EDTMYLMylan volatility at 52-week high
Mylan October weekly put option implied volatility is at 70, October is at 57, November is at 54; compared to its 52-week range of 26 to 58, suggesting large price movement.
11:06 EDTMYLStocks with call strike movement; FSLR MYL
First Solar (FSLR) January 50 call option implied volatility decreased 5% to 47, Mylan (MYL) January 47 call option implied volatility increased 4% to 48 according to IVolatility.
08:05 EDTTEVATeva announces publication of two Phase 2b studies of TEV-48125
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September 29, 2015
12:35 EDTMYLPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
10:58 EDTTEVATeva volatility at 52-week high on wide price movement
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10:00 EDTTEVAOn The Fly: Analyst Initiation Summary
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08:18 EDTTEVATeva initiated with a Neutral at Nomura
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08:02 EDTTEVAEagle Pharma receives new patent for bendamustine rapid infusion product
Eagle Pharmaceuticals (EGRX) announced that the United States Patent and Trademark Office has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes. The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents, further expands and protects Eagle's bendamustine HCI intellectual property estate. The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture. The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. (TEVA) entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

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