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News Breaks
December 11, 2012
07:54 EDTMEDI, PFE, CELG, PRXL, ACOR, NPSP, ALKS, AZN, TEVAElsevier Business Intelligence to host a summit
The FDA/CMS Summit for Biopharma Executives: Life After 2012 is being held in Washington, D.C. on December 10-11.
News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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16:08 EDTTEVATeva initiated with a Buy at Deutsche Bank
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07:12 EDTCELGCelgene has upper hand in Revlimid case, says Bernstein
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05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
July 21, 2014
08:11 EDTTEVAArena Pharma' subsidiary enters into agreement for Belviq with Teva subsidiary
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08:01 EDTTEVATeva completes acquisition of Labrys
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July 17, 2014
11:07 EDTACORAcorda sues Mylan over plans to duplicate Ampyra MS drug, Bloomberg says
08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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07:05 EDTALKSAlkermes announces initiation of Phase 1 study of ALKS 8700 for treatment of MS
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July 16, 2014
10:36 EDTAZN, PFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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08:48 EDTTEVATeva says ISS supports company's nominees, shareholders' meeting proposals
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08:01 EDTAZNAlexion names former AstraZeneca CEO David Brennan to board
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07:59 EDTAZN, PFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
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10:56 EDTCELGFed calls small cap social media, biotech valuations 'stretched'
The Board of Governors of the Federal Reserve in its Monetary Policy Report dated today said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year." A later part in the document reads, "Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical norms." The specific targeting of sectors by the Fed seems to be having an impact on stocks in the social media and biotech spaces. Shares of Yelp (YELP) are down over 5% to $67.51, while Twitter (TWTR) and Facebook (FB) are each down 2%. Celgene (CELG) and Amgen (AMGN) are leading the biotech space lower with pullbacks of greater than 1%.
10:33 EDTCELGFacebook, Twitter slip following cautious valuation comments from Fed
Shares of a number of companies in the social media and biotech industries moved lower following the circulation of cautious comments about their stock valuations that were included in the Federal Reserve's latest Monetary Policy Report. WHAT'S NEW: In the report, presented by the Board of Governors of the Federal Reserve and signed on behalf of the governors by Chair Janet Yellen, the central bank wrote that some broad equity price indexes have increased to all-time highs in nominal terms since the end of 2013, but that valuation measures for the overall market in early July were "generally at levels not far above their historical averages." However, the Fed's report also cautioned that valuation metrics in some sectors do appear substantially "stretched," particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year. As support for its assessment, the Fed noted that ratios of prices to forward earnings for "smaller firms as well as social media and biotechnology firms" remain "high relative to historical norms." PRICE ACTION: Following the circulation of the comments in the Fed report, shares of Facebook (FB) are down 88c, or 1.3%, to $67.02, Twitter (TWTR) is down 24c, or 0.6%, to $38.07 and LinkedIn (LNKD), is down 21c, or 0.1%, to $159.57. Shares of some biotechnology companies including Celgene (CELG) and Amgen (AMGN) also ticked lower following the circulation of the comments from the Fed's report.
06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
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