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Stock Market & Financial Investment News

News Breaks
March 18, 2013
10:03 EDTMYL, ACT, TEVAGeneric drug makers fall after Wells analyst downgrades sector
A number of generic drug makers are losing ground after Wells Fargo analyst Michael Tong downgraded the sector to Market Weight from Overweight in a note to investors earlier today. After four years of outperformance, companies in the sector may have to exploit new catalysts in order to advance further, Tong believes. These new catalysts, however, carry more risks than previous drivers of the stock, the analyst contended. Upcoming catalysts for the sector include profitable international expansion, diversified brand portfolio, and biosimilars, Tong wrote. Investors should move out of generic drug stocks and buy the stocks of large drug companies, the analyst recommended. In the same note, Tong downgraded two specific generic drug makers. He dropped Teva (TEVA) to Market Perform from Outperform and lowered Actavis (ACT) to Market Perform from Outperform. Teva is taking longer than expected to implement its turnaround plan and may face increased competition to its Copaxone MS treatment, while Actavis' stock price has risen to the point where the shares accurately reflect the company's long-term outlook, Tong believes. In early trading, Teva fell 1% to $40.35, Actavis gave back 2% to $90, and Mylan (MYL) lost 1% to $30.15.
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April 21, 2014
08:18 EDTMYL, TEVAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "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." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
April 19, 2014
18:50 EDTMYL, TEVAMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
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18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
April 17, 2014
16:18 EDTACTActavis to purchase four marketed products from Akorn and Hi-Tech Pharmacal
Actavis (ACT) announced that it has entered into agreements with Akorn (Akrx) and Hi-Tech Pharmacal (HITK) to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn's acquisition of Hi-Tech. Financial terms of the agreements were not disclosed. The agreements include three products marketed under Abbreviated New Drug Applications and one product marketed under a New Drug Application: Lidocaine/Prilocaine Topical Cream. The agreements also include one product under development.
16:08 EDTACTActavis, Forest Labs receive second request under Hart-Scott-Rodino from FTC
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08:38 EDTTEVATeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
04:22 EDTMYLMylan (MYL) implied volatility of 45 at upper end of index mean range
April 16, 2014
16:16 EDTMYLMylan launches first generic Ortho Evra patch
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10:00 EDTTEVA, ACTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
08:34 EDTACTPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:59 EDTACTActavis initiated with a Buy at Sterne Agee
Target $230.
07:00 EDTTEVATeva initiated with a Neutral at Sterne Agee
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April 15, 2014
12:26 EDTTEVATeva announces launch of generic Lunesta tablets in U.S.
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10:21 EDTMYL, ACTMylan announces settlement agreement for first-to-file Generess
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10:10 EDTMYLMylan launches generic Lunesta tablets
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08:07 EDTMYL, ACTActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess® FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
08:06 EDTMYLProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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April 11, 2014
11:50 EDTMYLStocks with call strike movement; TNA MYL
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10:30 EDTMYL, ACTActavis and Mylan shares recommended at Bernstein
07:31 EDTMYLMylan confirms judge enforces agreement with Endo regarding generic Frova
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