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News Breaks
May 12, 2014
08:25 EDTJNJ, BAYRY, PTLAPortola Pharmaceuticals begins enrollment in Phase 3 study for Xarelto
Portola Pharmaceuticals (PTLA) announced that enrollment has begun in a Phase 3 study to evaluate the safety and efficacy of andexanet alfa, the company's investigational recombinant Factor Xa inhibitor reversal agent, with Bayer (BAYRY) and Janssen Pharmaceuticals' (JNJ) Factor Xa inhibitor XARELTO. Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as a potential first-in-class agent to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are experiencing a major bleeding episode or who require emergency surgery.
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November 19, 2014
09:04 EDTJNJJohnson & Johnson submits NDA for three-month paliperidone palmitate
Janssen Research & Development, a Johnson & Johnson company, announced the submission of a New Drug Application, or NDA, for three-month atypical antipsychotic paliperidone palmitate to the FDA. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.
06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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November 18, 2014
05:43 EDTBAYRYRegeneron announces EYLEA injection approved for DME treatment in Japan
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November 17, 2014
09:22 EDTPTLAOn The Fly: Pre-market Movers
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08:13 EDTPTLAPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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07:16 EDTJNJMilken Institute--Faster Cures to hold a conference
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJCVS 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),
07:14 EDTBAYRYAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
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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09:33 EDTBAYRYZoetis could get bought by Bayer for $53/share, says Jefferies
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November 12, 2014
08:18 EDTBAYRYUBS to hold a conference
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08:02 EDTPTLACredit Suisse to hold a conference
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06:22 EDTBAYRYZoetis 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 10, 2014
16:14 EDTPTLAPortola says advancing oral, dual Syk-JAK kinase inhibitor to next stage
"The third quarter marked another successful period of execution for Portola as we achieved a number of milestones across our three wholly-owned clinical programs. We announced positive Phase 3 study results with our universal Factor Xa inhibitor antidote, andexanet alfa, in which all primary and secondary endpoints were achieved with high statistical significance. We increased enrollment and remain on track to complete the betrixaban pivotal Phase 3 APEX Study by the end of 2015. In addition, we have made the decision to advance our oral, dual Syk-JAK kinase inhibitor, cerdulatinib, to the next stage of development based on the tolerability and clinical activity seen thus far in the ongoing Phase 1 study in patients with hematologic cancers," said William Lis, chief executive officer of Portola.
16:13 EDTPTLAPortola Pharmaceuticals reports Q3 EPS (86c), consensus (92c)
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16:07 EDTBAYRYUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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