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- Amgen Exceeds Expectations, Again
- Mike Havrilla submits: Shares of Amgen AMGN have moved into the green in after-hours trading following a late-day Wall Street sell-off that had the Dow tanking by over 500 points. As I wrote earlier today, Amgen was able to both exceed profit and sales expectations for 3Q08 and raise its...
- External links 2008-10-22
- Achillion Pharma: Hepatitis Drug Dev Pipeline Now Fully Funded
- Mike Havrilla submits: Achillion Pharma ACHN is a promising micro-cap biotech, specializing in the development of new treatments for infectious diseases, such as the multi-billion dollar market for the chronic treatment of hepatitis C. As I recently wrote, several companies in this space have been bought out at huge premiums...
- External links 2008-11-25
- China Medical Embraces Molecular Diagnostics
- Mike Havrilla submits: China Medical CMED offers a compelling value since losing about 60% of its market value in the past year, with shares trading very close to August 2005 IPO levels at the close yesterday of under 18 bucks click on chart to enlarge. CMED is also included in...
- External links 2008-12-25
- Aspen BioPharma: Anticipating Active '09
- Mike Havrilla submits: Now that AspenBio Pharma APPY has completed enrollment earlier this month in its FDA 510k clinical study for the world's first blood-based appendicitis screening test, AppyScore, investors will not have to wait much longer to get the results. Results in the 800 patient trial are expected in...
- External links 2008-12-31
- A Closer Look at Sequenom's Offer for EXACT Sciences
- Mike Havrilla submits: Since I profiled EXACT Sciences EXAS in late December as part of the ETF Innovators Emerging Diagnostics Index, EXAS announced that its stool-based DNA [sDNA] screening test was added to the colorectal cancer screening options in 12 more states and Washington DC. In addition, the company...
- External links 2009-01-13
- Interested in Small-Cap Generic Drugs? Keep an Eye on Caraco Pharma
- Mike Havrilla submits: With shares of Hi-Tech Pharmacal HITK already up about 20% since I profiled the Company as a value play, investors interested in the small-cap generic drug industry should take a look at Caraco Pharma CPD at around 5 bucks. CPD reported results for its fiscal 3Q09 last...
- External links 2009-02-03
- Cell Therapeutics Is down but Not Out
- Mike Havrilla submits: Cell Therapeutics CTIC is a micro-cap cancer biotech which is down substantially in the past year in terms of stock price and market value, but not out after recently establishing a joint venture with Spectrum Pharma SPPI to market Zevalin, the potential for two FDA approvals this...
- External links 2009-02-03
- BioDelivery Sciences: A Bet on FDA Approval
- Mike Havrilla submits: While pending FDA new product decisions are never a sure thing, BioDelivery Sciences BDSI appears to have the odds stacked in its favor for approval of cancer breakthrough pain drug candidate Onsolis. by Mike Havrilla
- External links 2009-03-05
- More Than a Few Reasons to Buy CombiMatrix
- Mike Havrilla submits: CombiMatrix CBMX is an ETF Innovators Emerging Diagnostics Index component and spin-off company from Acacia Research ACTG, which has operated independently since August 2007 as a developer of DNA MicroArrays for lab-based personalized medicine applications to improve treatment outcomes, which are exempt from the more time-consuming and...
- External links 2009-03-13
- Cytori Therapeutics: 2009 Outlook
- Mike Havrilla submits: click to enlarge Cytori Therapeutics CYTX is a leading global innovator in the emerging field of regenerative medicine using adipose fat tissue as a rich source of adult stem cells capable of differentiating into a variety of cell types. The Company develops and markets cell banking, therapeutic,...
- External links 2009-03-16
- Javelin Pharma's Late-Stage Pipeline Pain
- Mike Havrilla submits: Javelin Pharma JAV is focused on the late stage clinical development of three Phase 3 compounds while seeking partnerships for a non-dilutive source of funding. In mid-January, JAV established a partnership for Dyloject injectable diclofenac with Therabel Pharma to market the drug in Europe, where it is...
- External links 2009-03-16
- Electro-Optical Sciences: Positive Results for MelaFind
- Mike Havrilla submits: Electro-Optical Sciences MELA recently announced positive topline results in a pivotal clinical trial for MelaFind, which was conducted at seven medical centers across the U.S. and included nearly 1,400 patients and over 1,800 pigmented skin lesions. A larger study will also be conducted for MelaFind, with the...
- External links 2009-03-17
- FDA, Clinical Trial Calendar Updates: Discovery, Impax Labs
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- FDA, Clinical Trial Calendar Updates: Thoratec, Allos Therapeutics
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- Allos Therapeutics: Smallcap Biotech with FDA Catalyst
- Mike Havrilla submits: Allos Therapeutics ALTH is small-cap cancer biotech which filed a NDA on 3/25/09 for pralatrexate (PDX) in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review for the application, with an expected 60-day period for the FDA to accept the filing...
- External links 2009-04-27
- Update on Rockwell Medical's Phase 2b Trial
- Mike Havrilla submits: Rockwell Medical (NASDAQ:RMTI) announced yesterday that patient enrollment is completed for the Company's ongoing Phase 2b dose-ranging study for its iron replacement therapy soluble ferric pyrophosphate SFP. Below is the entry from RMTI in the BioMedReports.com Clinical Trial Calendar database: RMTI is developing a water soluble iron...
- External links 2009-04-30
- FDA Calendar Updates: AMAG Pharma Up, Northfield Labs Down
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline...
- External links 2009-05-01
- FDA Calendar Updates: Acorda, Roche
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline...
- External links 2009-05-06
- Cell Therapeutics' Turnaround Remains on Track
- Mike Havrilla submits: The dramatic turnaround from lows of a nickel per share ealier this year at cancer biotech Cell Therapeutics (NASDAQ:CTIC) remains on track as the Company announced its 1Q09 results Thursday, which included a 76% reduction of net loss and expected completion of the pixantrone NDA filing this...
- External links 2009-05-08
- NeurogesX Awaiting Dual Regulatory Decisions
- Mike Havrilla submits: NeurogesX (NASDAQ:NGSX) represents a two-in-one extreme trade on pending FDA and EMEA regulatory decisions to market its nerve pain patch in both the E.U. and U.S. markets. NGSX was not included in my previous article of nine remaining extreme trades on pending FDA decisions since the Company...
- External links 2009-05-10
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