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Stock Market & Financial Investment News

News Breaks
April 4, 2014
10:45 EDTCELG, TEVA, MYLMylan rises despite Meda rejecting takeover offer
Mylan (MYL) shares are higher this morning following a Financial Times report of its desire to buy Swedish rival Meda. Subsequent to the story being published, Meda confirmed it had been in talks with Mylan but rejected the company's takeover offer. WHAT'S NEW: The Financial Times reported that Mylan was considering buying Meda, a Swedish drugmaker, in a deal that would create a $23B+ pharmaceuticals business. Mylan reportedly hired advisers to put a deal together for Meda, and though the value of a deal was not noted, sources said Mylan was likely to pay a "significant" premium to Meda's market value, which was $4.5B at the end of trading on Thursday. Mylan's market value currently stands at $18.5B. A combination of the drugmakers would create a company with annual revenues of around $9B, the FT said, noting that would be half the size of generic drug rival Teva (TEVA). WHAT'S NOTABLE: Meda's board of directors confirmed that it was contacted by Mylan regarding a proposal to merge the companies, but the board decided to reject the proposal. Meda said all discussions between the company and Mylan have been terminated "without further actions." ANALYST REACTION: Citigroup upgraded Mylan to Buy from Neutral and raised its price target on the stock to $61 from $52 this morning. The firm cited potential operational and tax benefits from an acquisition of Meda, stating that in addition to expanding Mylan's geographic presence, the deal would increase its presence in specialty, OTC and branded generics. OTHER NEWS: Mylan sued Celgene (CELG) to block that company's efforts to keep generic versions of Revlimid and Thalomid off the market, Reuters reported. PRICE ACTION: Mylan shares are up $2.98, or 5.98%, to $52.84 in mid-morning trading.
News For MYL;TEVA;CELG From The Last 14 Days
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January 26, 2015
11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
January 23, 2015
16:08 EDTTEVATeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTTEVATeva rebuffed Pfizer approach late last year, Bloomberg says
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07:21 EDTCELGCelgene receives positive CHMP opinion for ABRAXANE
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January 21, 2015
08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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08:36 EDTCELGCelgene price target raised to $139 from $115 at RW Baird
Baird raised its price target on Celgene to $139 from $115 following last week's guidance from the company. Baird reiterated its Outperform rating on Celgene shares.
January 20, 2015
14:37 EDTMYL, TEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYL, TEVAMylan says continues to believe '808 patent is 'invalid'
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11:29 EDTTEVATeva says Supreme Court reverses circuit court judgment on Copaxone 20 mg/mL
Teva Pharmaceutical announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for COPAXONE 20 mg/mL. The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating the ‘808 patent that is set to expire on September 1, 2015. “We are encouraged by the U.S. Supreme Court’s Decision and look forward to the Federal Circuit’s review. We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL,” said Erez Vigodman, President and CEO of Teva. “There is currently no FDA-approved follow-on version of Teva’s COPAXONE. We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of COPAXONE 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions,” added Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva.
10:45 EDTTEVATeva spikes, retraces, after win in Copaxone patent case
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10:40 EDTMYL, TEVAMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link
January 16, 2015
09:11 EDTCELGCelgene says oral Otezla approved by European Commission in 2 indications
Celgene International, a wholly-owned subsidiary of Celgene Corporation, announced that the European Commission has granted marketing authorisation for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, in two therapeutic indications: For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light. Alone or in combination with Disease Modifying Antirheumatic Drugs, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The marketing authorization is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis and psoriatic arthritis treated with OTEZLA through 52 weeks, across multiple endpoints. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2014.12 OTEZLA will be launched in the European Union in the coming months in accordance with local requirements.
January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
07:59 EDTCELGAmerican Society of Clinical Oncology to hold a symposium
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January 13, 2015
16:00 EDTCELGOptions Update; January 13, 2015
iPath S&P 500 VIX Short-Term Futures up 66c to 34.42. Option volume leaders: AAPL JNJ CELG WFM TSLA TWTR AMZN GILD according to Track Data.
12:48 EDTCELGOn The Fly: Midday Wrap
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09:36 EDTCELGActive equity options trading
Active equity options trading according to Track Data: AAPL AMD AA TWTR GILD C CELG TSLA GOOG
07:43 EDTCELGCelgene price target raised to $142 from $109 at Bernstein
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07:24 EDTCELGCelgene 2015 guidance conservative, says Cantor
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