All Posts Tagged With: "GILD"

(GILD) Gilead’s Sofosbuvir under European Review

Gilead Sciences Inc. (GILD) recently announced that its Marketing Authorisation Application (MAA) for HCV candidate sofosbuvir (formerly GS-7977), submitted to the European Medicines Agency (EMA) on Apr 17, 2013, has been validated...

4Aug2013 | | Comments Off | Continued

(GILD) Gilead Sciences Shows Pipeline Progress

Gilead Sciences, Inc. (GILD) recently presented encouraging data on its pipeline candidate idelalisib (formerly GS-1101) from a phase II study (study 101-08: n=64). The study is evaluating idelalisib combined with Roche Holding...

4Jun2013 | | Comments Off | Continued

(GILD) Gilead Sciences Suffers Double Setbacks

Gilead Sciences, Inc (GILD) suffered two successive setbacks when the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to the company’s HIV candidates, elvitegravir and cobicistat, for use as part of...

1May2013 | | Comments Off | Continued

(JNJ) Will Johnson & Johnson Miss on Earnings?

Johnson & Johnson (JNJ) is scheduled to report its first quarter 2013 results on Apr 16, 2013 before the opening bell. Last quarter, the company posted a 1.71% positive surprise. Let’s see how things are shaping up prior...

23Apr2013 | | Comments Off | Continued

(GILD) Gilead Sciences Seeks FDA Approval

Gilead Sciences (GILD) recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval to market its hepatitis C Virus (HCV) candidate sofosbuvir (formerly GS-7977). Gilead is looking...

18Apr2013 | | Comments Off | Continued

(MRK) Pharma & Biotech Stock Outlook – Apr 2013 – Zacks Analyst Interviews

The pharmaceutical industry has been showing signs of recovery from one of the biggest patent cliffs in recent times. The last few quarters saw major blockbusters like Merck’s (MRK) Singulair, Pfizer’s (PFE)...

7Apr2013 | | Comments Off | Continued

(JNJ) MedTech Industry Stock Outlook – January 2013 – Zacks Analyst Interviews

We are in the midst of the fourth quarter earnings season and it is once again time to review the players in the worldwide medical devices market. The US still holds the leading position with almost one-third of the market share. However, emerging economies like Brazil, Russia, India and China –...

31Jan2013 | | Comments Off | Continued

(MAA) Actelion Drug Accepted for Review

Switzerland-based Actelion (ALIOF) recently announced that the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for macitentan. Actelion is looking to get macitentan approved in the US as a treatment...

24Dec2012 | | Comments Off | Continued

(MRK) Pharmaceuticals and Biotech Stock Outlook – December 2012 – Industry Outlook

The pharmaceutical industry is slowly showing signs of recovery from one of the biggest patent cliffs in recent times. The last few quarters saw major blockbusters like Merck’s (MRK) Singulair, Pfizer’s...

7Dec2012 | | Comments Off | Continued

(GILD) Gilead Sciences Reports Positive HCV Data

Gilead Sciences (GILD) recently presented encouraging top-line data from a phase III study (Positron) which evaluated its candidate sofosbuvir (formerly GS-7977) combined with ribavirin in patients suffering...

4Dec2012 | | Comments Off | Continued

(ARNA) Arena Pharmaceuticals Initiates PAH Study

Arena Pharmaceuticals, Inc. (ARNA) recently initiated a phase I multiple dose study with APD811, which is being developed for the treatment of pulmonary arterial hypertension (PAH). Arena Pharma is expecting to enroll 30 healthy...

23Oct2012 | | Comments Off | Continued

(PFE) Pharma and Biotech Stock Outlook – August 2012 – Industry Outlook

The pharmaceutical industry is in the midst of one of the biggest patent cliffs with Pfizer’s (PFE) multi-billion-dollar blockbuster drug Lipitor losing patent protection in the US in late November 2011. Besides Lipitor, other major...

10Aug2012 | | Comments Off | Continued

(GILD) Gilead Sciences Analyst Maintains Neutral on Shares

We have maintained a Neutral rating on Gilead Sciences, Inc. (GILD) following appraisal of fourth quarter and full year 2011 results. Gilead’s adjusted earnings per share of 92 cents (including stock option expense) for the...

18Feb2012 | | 0 comments | Continued

(BMY) Bristol-Myers Squibb Company Kicks Off 2012 Pharma Deals

The spate of acquisitions in the pharma industry continues in 2012 with Bristol-Myers Squibb Company (BMY) announcing the first major deal of the new year. Major merger and acquisition (M&A) deals have taken place in the pharma...

9Jan2012 | | 0 comments | Continued

(JNJ) Pharma & Biotech Stock Review & Outlook – Industry Outlook

With 2011 coming to an end, the pharmaceutical industry continues to face challenges like sluggish prescription trends, EU pricing pressure, intensifying generic competition, pipeline failures and limited late-stage catalysts. The next five years are expected to reflect a significant imbalance between...

29Dec2011 | | 0 comments | Continued

(JNJ) Spotlight on Hepatitis-C Market

Is the hepatitis-C market the next Mecca for the pharma/biotech sector? It seems so if we go by the flurry of activity and heightened interest in this market in the past few quarters. The hepatitis-C virus (HCV) market seems to have caught the eye of several pharma/biotech companies – as evident...

7Dec2011 | | 0 comments | Continued

(GILD) Gilead’s Eviplera Drug is Cleared by European Medicines Agency

Gilead Sciences, Inc (GILD), the world’s largest HIV drug maker, received marketing authorization from the European Medicines Agency (EMA) for the single tablet regimen (STR), Eviplera, for the treatment of HIV in previously untreated...

30Nov2011 | | 0 comments | Continued

(EU) Pharmaceuticals Stock Outlook – September 2011 – Industry Outlook

The pharmaceutical industry continues to be impacted by major issues such as sluggish prescription trends, European Union (EU) pricing pressure, intensifying generic competition and limited late-stage catalysts. The next five years are expected to witness a significant imbalance between new product...

23Sep2011 | | 0 comments | Continued

(GILD) Gilead Sciences Earnings Grow With HIV Franchise

Gilead Sciences Inc.’s (GILD) adjusted earnings per share of 95 cents for the second quarter of 2011 were 14 cents above the year-earlier earnings of 81 cents. The earnings growth was driven by a solid top-line performance in the...

3Aug2011 | | 0 comments | Continued

(MYL) Mylan Gets HIV Rights from Gilead

Mylan, Inc. (MYL) recently announced that its Indian subsidiary Matrix Laboratories has been granted future rights to produce and sell generic versions of three investigational HIV therapies of Gilead Sciences, Inc....

14Jul2011 | | 0 comments | Continued

(GILD) Gilead Sciences /Johnson & Johnson to Make HIV Combo Drug

Gilead Sciences, Inc.’s (GILD) strong HIV franchise received yet another shot in the arm with the announcement of a license agreement with Tibotec Pharmaceuticals, a division of Johnson & Johnson (JNJ),...

30Jun2011 | | 0 comments | Continued

(VRTX) Vertex Pharmaceuticals Get Positive Data on Incivek

Vertex Pharmaceuticals Inc. (VRTX) recently reported data from two late stage trials – ADVANCE and REALIZE – on Incivek (telaprevir). The data were published in the June edition of the New England Journal of Medicine. The...

24Jun2011 | | 0 comments | Continued

(JNJ) Pharma & Biotech Stock Outlook – June 2011 – Industry Outlook

Challenges like sluggish prescription trends, EU pricing pressure, intensifying generic competition, pipeline failures and limited late-stage catalysts continue to impact the pharmaceutical industry. The next five years are expected to reflect a significant imbalance between new product introductions...

14Jun2011 | | 0 comments | Continued

(ABT) Abbott Labs First Quarter 2011 Earnings Preview

Abbott Laboratories (ABT) is all set to announce its first quarter 2011 results on April 20, 2011 before the opening bell. The Zacks Consensus Estimate for the first quarter of 2011 is $0.90, representing a year-over-year increase...

18Apr2011 | | 0 comments | Continued

(BMY) Bristol-Myers Squibb Earns European Clearance for Baraclude

Recently, Bristol-Myers Squibb Company (BMY) received a boost with the European Commission (EC) approving Baraclude (entecavir) for an additional indication. The current approval by the European regulatory authorities allows...

16Mar2011 | | 0 comments | Continued

(GILD) Gilead Sciences Refiles FDA New Drug Application for HIV Combo Pill

Gilead Sciences Inc. (GILD) recently refiled a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for the single-tablet combination of Truvada and TMC-278 (rilpivirine). The company is seeking to get the combination...

14Feb2011 | | 0 comments | Continued

(GILD) Gilead Sciences Terminates Letairis Phase III Trial

Gilead Sciences Inc.(GILD) recently announced that it will terminate its phase III trial (ARTEMIS-IPF) studying Letairis (ambrisentan) for the treatment of idiopathic pulmonary fibrosis (IPF) due to lack of efficacy. The study’s...

24Dec2010 | | 0 comments | Continued

(BMY) Bristol-Myers Squibb Earns FDA Label Expansion

Recently, Bristol-Myers Squibb Co. (BMY) received a boost with the US Food and Drug Administration (FDA) approving Baraclude (entecavir) for an additional indication. The current approval by the US regulatory authorities allows Bristol-Myers...

17Nov2010 | | 0 comments | Continued

(GILD) Gilead Sciences Third Quarter 2010 Earnings Above Estimates on Antiviral Franchise

Gilead Sciences’ (GILD) third quarter 2010 earnings of $0.85 (excluding special items but including stock-based compensation expense) was a penny above the Zacks Consensus Estimate and well above the year-ago earnings of $0.74....

17Nov2010 | | 0 comments | Continued

(JNJ) Pharma & Biotech Industry Outlook – November 2010 – Industry Outlook

With 2010 coming to an end, the pharmaceutical industry continues to witness major challenges like sluggish prescription trends, EU pricing pressure, intensifying generic competition and limited late-stage catalysts. The next five years are expected to reflect a significant imbalance between new product...

15Nov2010 | | 0 comments | Continued