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AstraZeneca Seeks FDA Approval – Analyst Blog

Zacks Market Commentaries (November 20th, 2009) Writes:
Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

Company News for November 16, 2009 – Corporate Summary

Zacks Market Commentaries (November 16th, 2009) Writes:

• Boeing's (NYSE:BA) new head of its commercial aircraft division, Jim Albaugh, said the long-awaited Dreamliner test will happen by yearend

• Citigroup (NYSE:C) plans to sell Bellsystem 24, a Japanese telemarketing company, to Bain Capital for $1 billion, bringing to $10.8 billion the dollar amount Citi has raised from sales of Japanese assets

• Hedge fund Paulson & Co. reported in a September 30 filing Citigroup (NYSE:C) holdings of 300 million shares, valued at $1.45 billion

• Cisco (NASDAQ:CSCO) raised its bid for Tandberg ASA to $3.4 billion, or about an 11% increase, and extended its offer to December 1

• According to a Bloomberg report, Mitsubishi UFJ has hired JP Morgan (NYSE:JPM) and Morgan Stanley (NYSE:MS) to manage an $11 billion secondary offering, Japan's largest ever. The company plans to sell about 2.5 billion common shares

• Bristol-Myers Squibb (NYSE:BMY) said it plans to spin off its 83% stake in Mead Johnson Nutrition

...

Another Win for Mylan – Analyst Blog

Zacks Market Commentaries (November 13th, 2009) Writes:
Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.  The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.  Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb's (BMY) Sinemet ...

Glaxo Reports Higher Revenues – Analyst Blog

Zacks Market Commentaries (November 12th, 2009) Writes:
GlaxoSmithKline, plc (GSK) reported third quarter income of 92 cents per American Depository Share (ADS), 3 cents below the Zacks Consensus Estimate. The company reported earnings of 94 cents in the year-ago period. Third quarter 2009 revenue increased 3%, with growth being driven by strong performances in emerging markets (up 25%), Japan (up 19%) and Consumer Healthcare (up 8%). We were pleased to see growth in Consumer Healthcare revenue despite the global slowdown. Meanwhile, US sales continued to be impacted by generic competition with revenue declining 12%. Sales of products like Imigran (down 74%), Lamictal (down 21%) and Requip (down 30%) and Wellbutrin XL (down 81%) kept declining. Pharmaceutical product revenue increased 2% with sales being driven by Advair/Seretide (up 5%) and Relenza. Relenza benefited from continued orders from several governments for stockpiling. Although vaccine sales were lower in the third quarter due ...

Isis Diabetes Drug Shows Promise – Analyst Blog

Zacks Market Commentaries (October 23rd, 2009) Writes:
Earlier this week, Isis Pharmaceuticals, Inc. (ISIS) reported positive top-line results on its type II diabetes candidate, ISIS-113715. Results from the phase II study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control. Besides lowering blood glucose, the candidate also caused statistically significant and clinically meaningful reductions in low-density lipoprotein (LDL) cholesterol.   Importantly, a tendency towards weight loss was observed without strict dietary control. The candidate’s safety profile was favorable with no clinically significant adverse effects being observed. Full results will be presented at an upcoming medical meeting.   ISIS-113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The candidate’s ability to normalize glucose without exacerbating hypoglycemia, and reduce LDL-C levels and weight could provide patients who are obese and at high cardiovascular risk with a new treatment option.   ISIS-113715 has been developed using ...

Stock Market News for October 22, 2009 – Market News

Zacks Market Commentaries (October 22nd, 2009) Writes:

Weak global economic conditions and a downgrade of Well Fargo by prominent banking analyst Richard Bove spooked investors even as Morgan Stanley and Yahoo reported better-than-expected earnings.  The Dow Jones industrial average slipped below the 10,000 level yesterday as markets pulled back in the final hour of trading.

Bove of Rochdale Securities said earnings at Well Fargo (NYSE:WFC) were helped by mortgage-servicing fees rather than improving business trends, and trimmed his rating on the bank to “sell" from “hold."  However, Well Fargo and Morgan Stanley (NYSE:MS), which reported its first quarterly profit in a year, were behind the market’s strength earlier in the session.  Bove also cited accelerating loan losses at the firm for the downgrade.  After Bove’s cut, FBR slashed its rating on the firm to "underperform," questioning Well Fargo's earnings quality.

The Dow Jones industrial average fell below the psychologically important 10,000 level, declining 92.12 points, or

...

Zacks Analyst Blog Highlights: Biogen Idec Inc., Facet Biotech Corporation, Trubion Pharmaceuticals, Bristol-Myers Squibb and Acorda Therapeutics – Press Releases

Zacks Market Commentaries (October 20th, 2009) Writes:

For Immediate Release

Chicago, IL – October 20, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Biogen Idec Inc. (BIIB), Facet Biotech Corporation (FACT), Trubion Pharmaceuticals (TRBN), Bristol-Myers Squibb (BMY) and Acorda Therapeutics (ACOR).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Monday’s AnalystBlog:

Biogen Extends Hostile Bid

Biogen Idec Inc. (BIIB) extended its tender offer for the acquisition of all of the outstanding shares of Facet Biotech Corporation (FACT) to December 16, 2009. The offer was previously set to expire on October 19, 2009. As of October

...

Mylan Settles Dispute with Pfizer – Analyst Blog

Zacks Market Commentaries (October 15th, 2009) Writes:
Recently, Mylan (MYL) announced the settlement of its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole). Now Mylan can launch an authorized generic version of the drug in two dosage forms of 50 mg and 200 mg tablets in early 2011. Mylan’s subsidiary, Matrix Laboratories, has Food and Drug Administration (FDA) approval for the generic version of the drug. Being the first company to submit an Abbreviated New Drug Application (ANDA), Matrix expects to be eligible to receive 180 days of marketing exclusivity for the drug. However, the agreement does not include liquid or intravenous versions of Vfend. The agreement has yet to be approved by the US Department of Justice and the Federal Trade Commission. Vfend recorded sales of $164 million in the 12 months ended June 30. Mylan received quite a few approvals in the past few ...

Pharmaceutical Industry Consolidation

QualityStocks (October 13th, 2009) Writes:

Abbott Laboratories (NYSE: ABT) recently announced that the company will purchase the pharmaceutical arm of Belgium’s Solvay Group for $6.5 billion. This deal expands both the company’s product range and the company’s presence in fast-growing emerging countries, helping defer the effect of patent expiries and compensate for sluggish growth in its traditional markets, such as the United States.

We also have the recent $442 million paid by Johnson & Johnson (NYSE: JNJ) for 18% of Crucell ADR (NASDAQ: CRXL). This will give Johnson & Johnson the development rights on a flu vaccine designed to protect against all future strains of the virus. This deal confirms the company’s move into vaccines, alongside drugs and consumer products.

These deals are further confirmation of the consolidation trend that is occurring right now in the global pharmaceutical industry.

One major factor driving the consolidation trend is the slowdown in sales of pharmaceuticals, particularly in the United

...

Zacks Analyst Blog Highlights: Facet Biotech Corporation, Biogen Idec Inc., Trubion Pharmaceuticals, Bristol-Myers Squibb and Acorda Therapeutics – Press Releases

Zacks Market Commentaries (October 12th, 2009) Writes:

For Immediate Release

Chicago, IL – October 12, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Facet Biotech Corporation (FACT), Biogen Idec Inc. (BIIB), Trubion Pharmaceuticals (TRBN), Bristol-Myers Squibb (BMY) and Acorda Therapeutics (ACOR).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Friday’s Analyst Blog:

Facet Investors Urged to Deny Offer

In line with expectations, Facet Biotech Corporation’s (FACT) board of directors unanimously recommended that its stockholders should reject the unsolicited conditional tender offer from Biogen Idec Inc. (BIIB), which is seeking to acquire all the outstanding shares

...

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