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 | vitalstocks
| Comments Off on (GILD) Gilead’s Sofosbuvir under European Review
Sanofi (SNY) reported first quarter 2013 business earnings of 81 cents per American Depository Share (ADS), below the Zacks Consensus Estimate of 89 cents. Earnings were down 29.0% at constant exchange rates (CER) from the year-ago...
16May2013 | vitalstocks
| Comments Off on (SNY) Sanofi Earnings Plummet – Outlook Maintained
As expected, MedTech mergers and acquisitions (M&A) are heating up in 2013. Finally, the much-hyped takeover battle for Life Technologies Corporation (LIFE) came to an end last month with Thermo Fisher Scientific...
15May2013 | vitalstocks
| Comments Off on (LIFE) MedTech Industry Stock Update – May 2013 – Zacks Analyst Interviews
BioLineRx (BLRX) recently received approval in the US for the initiation of a multi-center, open-label phase IIa study on BL-8040. BioLineRx is looking to develop BL-8040 for the treatment of acute myeloid leukemia (AML) and other...
27Apr2013 | vitalstocks
| Comments Off on (JNJ) BioLineRx to Start BL-8040 Study
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 | vitalstocks
| Comments Off on (JNJ) Will Johnson & Johnson Miss on Earnings?
Pharmacyclics, Inc. (PCYC) recently announced the enrollment of the fifth patient in a phase III study, RESONATE-2, which is being conducted to evaluate ibrutinib as a monotherapy versus chlorambucil in elderly patients...
21Apr2013 | vitalstocks
| Comments Off on (PCYC) Pharmacyclics Earns 4th Milestone
OncoGenex Pharmaceuticals, Inc. (OGXI) recently announced that it is looking to move its oncology candidate, OGX-427, into a phase II study, Spruce, for the potential treatment of previously untreated advanced non-squamous non-small...
21Apr2013 | vitalstocks
| Comments Off on (OGXI) OncoGenex Pharmaceuticals’ OGX-427 Progresses
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 | vitalstocks
| Comments Off on (GILD) Gilead Sciences Seeks FDA Approval
Mallinckrodt, the Pharmaceuticals business of Covidien plc (COV), launched more dosages of the Concerta (methylphenidate HCl) Extended-Release (ER) Tablets USP (CII). The company introduced the new 36 mg and 54 mg dosage strengths.
11Apr2013 | vitalstocks
| Comments Off on (COV) Covidien plc Rolls Out More Concerta Drugs
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 | vitalstocks
| Comments Off on (MRK) Pharma & Biotech Stock Outlook – Apr 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 | aaroncampbell
| Comments Off on (JNJ) MedTech Industry Stock Outlook – January 2013 – Zacks Analyst Interviews
AstraZeneca (AZN) recently announced that the company has created seven positions in the senior executive team. At the same time, two senior roles were discontinued.
We note that three of the seven newly created positions are...
22Jan2013 | aaroncampbell
| Comments Off on (AZN) Management Expands at AstraZeneca
The fourth quarter reporting season gets into high gear this week, with 253 companies coming out with quarterly results, including 83 S&P 500 companies. The earnings season thus far has been relatively uneventful, but we will have a better idea by the end of this week; by then we will have seen...
20Jan2013 | aaroncampbell
| Comments Off on (AAPL) Fourth Quarter 2012 Earnings Season Gets Into High Gear – Earnings Preview
In order to expand its Australian footprints, Digital Realty Trust Inc. (DLR) recently acquired an established data center in Macquarie Park, New South Wales for AU$11.75 million. The inclusion of this high-quality...
16Jan2013 | aaroncampbell
| Comments Off on (DLR) Digital Realty Trust Expands in Australia
Alkermes plc (ALKS) recently reaffirmed its view for fiscal 2013 (ending March 31, 2013). The company continues to expect adjusted earnings per share in the range of $0.88-$1.02. The Zacks Consensus Estimate is pegged below the company’s...
15Jan2013 | aaroncampbell
| Comments Off on (ALKS) Alkermes Maintains Fiscal 2013 View
Shire plc (SHPG) recently announced its intention to acquire privately-held biotech company, Lotus Tissue Repair, Inc.
Lotus Tissue Repair is developing a protein replacement therapy for the treatment of dystrophic epidermolysis...
15Jan2013 | aaroncampbell
| Comments Off on (DEB) Shire to Buy Lotus Tissue Repair
Mallinckrodt, the Pharmaceuticals business of Covidien plc (COV), has won the U.S. Food and Drug Administration (FDA) approval to manufacture and sell a generic version of CONCERTA (methylphenidate HCl) Extended-Release (ER) Tablets...
3Jan2013 | aaroncampbell
| Comments Off on (COV) Covidien Drug Wins U.S. Food and Drug Administration Approval
We recently reiterated a Neutral recommendation on Medivation, Inc. (MDVN). Medivation received a major boost in late August when the FDA approved its prostate cancer treatment, Xtandi, several months ahead of the target date. Xtandi,...
2Jan2013 | aaroncampbell
| Comments Off on (MDVN) Medivation Analyst Neutral on Shares
We have reiterated our Neutral recommendation on leading health care products maker, Covidien plc. (COV), with a target price of $60.
The company’s adjusted earnings per share (from continuing operations) of $1.02 for the...
1Jan2013 | aaroncampbell
| Comments Off on (COV) Covidien Remains at Neutral
We are reverting to a Neutral recommendation on Bayer (BAYRY) as we believe that all the positive news that led to our previous Outperform recommendation on the stock are reflected in the current price.
Bayer performed impressively...
31Dec2012 | aaroncampbell
| Comments Off on (JNJ) Back to Neutral on Bayer
Covidien plc. (COV), a large-cap healthcare products company, has announced the five-year results of the ClosureFAST Long-Term European Multi-Center Study. The study revealed that the
28Dec2012 | aaroncampbell
| Comments Off on (COV) Covidien plc Presents Positive Study Results
Boston Scientific Corporation (BSX) recently commenced a trial for its next-generation Ingevity pacing leads. The first patient was implanted to evaluate the safety, effectiveness and
27Dec2012 | aaroncampbell
| Comments Off on (BSX) Boston Scientific Corporation Initiates Ingevity Trial
Following a strong first quarter result and an encouraging guidance, we upgrade our recommendation on Myriad Genetics (MYGN), provider of molecular diagnostic products, to Outperform with a target price of $33.
24Dec2012 | aaroncampbell
| Comments Off on (MYGN) Myriad Genetics Shares Upgraded to Outperform
GlaxoSmithKline (GSK) recently announced that its inhalation anthrax candidate, raxibacumab, has received US Food and Drug Administration (FDA) approval. Raxibacumab was approved for inhalational anthrax caused by bacillus anthracis...
23Dec2012 | aaroncampbell
| Comments Off on (GSK) GlaxoSmithKline Anthrax Drug Gets FDA Nod
Merck (MRK) is collaborating with GE Healthcare for the use of an investigational positron emission tomography (PET) imaging agent [18F (flutemetamol)] in the development of Merck’s Alzheimer’s disease candidate, MK-8931.
23Dec2012 | aaroncampbell
| Comments Off on (MRK) Merck Ties Up with GE Healthcare
Actelion (ALIOF) recently announced positive results from a phase II study on its S1P1 modulator, ponesimod. Actelion is evaluating ponesimod as a treatment for patients suffering from moderate-to-severe chronic plaque psoriasis.
21Dec2012 | aaroncampbell
| Comments Off on (JNJ) Actelion Announces Positive Data on Drug Candidate
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently did not recommend the approval of Isis Pharmaceuticals Inc. (ISIS) and partner Genzyme’s, a Sanofi (SNY)...
19Dec2012 | aaroncampbell
| Comments Off on (CHMP) Isis Pharmaceuticals’ Kynamro Earns Negative Report From European Medicines Agency
AstraZeneca (AZN) and its partner Rigel Pharmaceuticals (RIGL) recently announced top-line data from the phase IIb OSKIRA-4 study evaluating the use of oral fostamatinib...
14Dec2012 | aaroncampbell
| Comments Off on (AZN) AstraZeneca’s RA Drug Disappoints
Merck (MRK) recently moved its Alzheimer’s disease candidate, MK-8931, into a phase II/III study (EPOCH). The study will evaluate the safety and efficacy of MK-8931, an oral ?-amyloid precursor protein site-cleaving enzyme (BACE)...
11Dec2012 | aaroncampbell
| Comments Off on (MRK) Merck’s Alzheimer’s Drug Progresses
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 | vitalstocks
| Comments Off on (MRK) Pharmaceuticals and Biotech Stock Outlook – December 2012 – Industry Outlook