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News Breaks
May 9, 2014
14:03 EDTSNY, JNJ, AGNAllergan rebuffed by white knights J&J, Sanofi, Bloomberg reports
News For AGN;JNJ;SNY From The Last 14 Days
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November 16, 2014
12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, SNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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07:23 EDTAGNValeant wooing doctors ahead of hoped for Allergan acquisition, WSJ says
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November 12, 2014
16:53 EDTAGNAllergan receives FDA approval for new styles of NATRELLE 410
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10:09 EDTAGNActavis in talks to buy Allergan for over $200 per share, Bloomberg says
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10:01 EDTAGNActavis in talks to buy Allergan for $60B, more than $200/share Bloomberg says
Actavis (ACT) is said to seek to pay about $200 per share, but Allergan (AGN) seeks about $210 per share, according to Bloomberg.
08:13 EDTSNYBoston Biotech to hold a conference
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07:01 EDTAGNAllergan announces approval of amendments to company bylaws
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06:22 EDTAGNZoetis price target raised to $49 from $44 at Citigroup
Citigroup raised its price target for Zoetis (ZTS) shares to $49 after activist Pershing Square confirmed the accumulation of a 10% stake in the company. Citi thinks Pershing is interested in advocating for a sale of Zoetis, potentially to Valeant (VRX) if its bid for Allergan (AGN) fails. Citi believes others, including Bayer (BAYRY), could be interested in acquiring Zoetis. It keeps a Buy rating on the stock.
November 11, 2014
15:46 EDTAGNPershing Square, Sachem Head build 10% stake in Zoetis, WSJ reports
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10:14 EDTSNYRegeneron data reinforce blockbuster potential of dupilumab, says Piper Jaffray
Piper Jaffray believes the Phase IIb results for dupilumab in patients with moderate to severe asthma reported by Regeneron (REGN) and partner Sanofi (SNY) reinforce the broad potential of the drug in a range of allergic diseases. The firm reiterates its $416 price target and Overweight rating on shares of Regeneron.
08:32 EDTAGNValeant likely to raise offer for Allergan again, says Bernstein
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05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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