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News Breaks
February 14, 2013
12:15 EDTAZN, MYLAstraZeneca wins appeal to block generic Seroquel XR from Mylan, others
After a New Jersey district court ruled last March that AstraZeneca's (AZN) formulation patent protecting Seroquel XR extended release tablets was valid, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's ruling today. The lower court had also ruled that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals and Mylan Pharmaceuticals (MYL) have infringed the Seroquel XR formulation patent, which expires in 2017. Reference Link
News For AZN;MYL From The Last 14 Days
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September 15, 2014
06:34 EDTMYLMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
September 12, 2014
10:32 EDTAZNPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
September 10, 2014
15:21 EDTAZNAstraZeneca has a conference call hosted by JPMorgan
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07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
September 9, 2014
06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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September 8, 2014
14:13 EDTAZNConnecticut AG tells FDA to speed up generic Nexium
A news release from the Connecticut Attorney General George Jepsen, dated September 4, says: In comments to a Citizen Petition filed with the FDA, Attorney General George Jepsen called on the federal agency to expeditiously end several years of delays preventing the sale of a generic form of the drug esomeprazole magnesium , esomeprazole, currently marketed under the brand name Nexium. Nexium is the second highest-selling pharmaceutical drug in the United States, and delays in approving generic versions have cost consumers and government healthcare payers billions of dollars. In his comments, Attorney General Jepsen alleges that an agreement between drug manufacturers Ranbaxy (RBXLY) and AstraZeneca Pharmaceuticals (AZN), Nexium’s brand-name manufacturer, has prevented other drug-makers from launching a generic version of the drug, ultimately harming all consumers by artificially inflating prices. Ranbaxy was first-to-file with the FDA for approval of a generic form of Nexium. AstraZeneca sued Ranbaxy for patent infringement, and the dispute was settled by an agreement that provided financial incentives for Ranbaxy to delay entry of its generic into the consumer market. Reference Link
11:05 EDTMYLOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
10:04 EDTMYLMylan calls active on activist investor speculation
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09:57 EDTMYLRumor: Mylan moves up on activist investor speculation
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09:27 EDTMYLLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
07:03 EDTMYLMylan annoucnes court grants summary judgment in favor of company
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07:02 EDTAZNAstraZeneca announces availability of Bydureon pen 2mg
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September 5, 2014
10:11 EDTMYLGilead slips after VP discusses low-cost Sovaldi for 80 countries
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10:05 EDTMYLOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Actavis (ACT) initiated with a Buy at ISI Group... Akamai (AKAM) initiated with a Buy at UBS... Alexion (ALXN) initiated with a Buy at SunTrust... Allegion (ALLE) initiated with a Buy at Buckingham... Allergan (AGN) initiated with a Buy at ISI Group... Aviat Networks (AVNW) initiated with a Neutral at H.C. Wainwright... Celgene (CELG) initiated with a Buy at SunTrust... EZCORP (EZPW) initiated with a Hold at Jefferies... Eaton (ETN) initiated with a Neutral at Buckingham... Emerson (EMR) initiated with a Neutral at Buckingham... HMS Holdings (HMSY) initiated with an Overweight at Stephens... Incyte (INCY) initiated with a Buy at SunTrust... Ingersoll-Rand (IR) initiated with a Neutral at Buckingham... Insmed (INSM) initiated with an Outperform at Cowen... Intercept (ICPT) initiated with an Outperform at Cowen... Johnson & Johnson (JNJ) initiated with an Outperform at BMO Capital... Lennox (LII) initiated with a Neutral at Buckingham... Mylan (MYL) initiated with a Hold at ISI Group... Orion Engineered Carbons (OEC) initiated with a Buy at Goldman... Parker-Hannifin (PH) initiated with a Buy at Buckingham... Pentair (PNR) initiated with a Neutral at Buckingham... Pharmacyclics (PCYC) initiated with a Neutral at SunTrust... Rockwell Automation (ROK) initiated with a Neutral at Buckingham... Sabre (SABR) initiated with an Outperform at Oppenheimer... Santander Consumer (SC) initiated with a Buy at Jefferies... Springleaf (LEAF) initiated with a Buy at Jefferies... Susser Petroleum (SUSP) initiated with a Neutral at Credit Suisse... Teva (TEVA) initiated with a Buy at ISI Group... Valeant (VRX) initiated with a Buy at ISI Group... WESCO (WCC) initiated with a Neutral at Buckingham... Watsco (WSO) initiated with a Neutral at Buckingham... Weyerhaeuser (WY) initiated with a Neutral at JPMorgan... World Acceptance (WRLD) initiated with a Hold at Jefferies.
07:33 EDTMYLMylan launches generic Boniva injection
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September 4, 2014
17:17 EDTMYLMylan initiated with a Hold at ISI Group
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17:15 EDTAZNAstraZeneca granted orphan status for EFGR non-small cell lung cancer treatment
The FDA posted on its website that AstraZeneca has been granted orphan status for its treatment of epidermal growth factor receptor, or EFGR, mutation-positive non-small cell lung cancer. Reference Link
07:23 EDTAZNAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
September 3, 2014
05:44 EDTAZNTeva announces positive judgement in patent case against AstraZeneca
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September 2, 2014
06:45 EDTAZNAstraZeneca volatility elevated
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