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News Breaks
June 18, 2014
05:36 EDTPFEPfizer, Cellectis enter global strategic cancer immunotherapy collaboration
Pfizer and Cellectis announced that they have entered into a global strategic collaboration to develop Chimeric Antigen Receptor T-cell, or CAR-T, immunotherapies in the field of oncology directed at select targets. Cellectis’ CAR-T platform technology provides a proprietary, allogeneic approach to developing CAR-T therapies that is distinct from other autologous approaches. Under the terms of the agreement, Pfizer has exclusive rights to pursue development and commercialization of CAR-T therapies, in the field of oncology, directed at a total of fifteen targets selected by Pfizer. Both companies will work together on preclinical research and Pfizer will be responsible for the development and potential commercialization of any CAR-T therapies for the Pfizer-selected targets. Cellectis will receive an upfront payment of $80M, as well as funding for research and development costs associated with Pfizer-selected targets and the four Cellectis-selected targets within the collaboration. Cellectis is eligible to receive development, regulatory and commercial milestone payments of up to $185M per Pfizer product. Cellectis is also eligible to receive tiered royalties on net sales of any products that are commercialized by Pfizer. Additionally, Pfizer will be entering into an equity agreement to purchase approximately 10% of the Cellectis capital through newly issued shares at EUR 9.25 per share, pending Cellectis shareholder approval. Approval by two-thirds of the votes cast by voting Cellectis shareholders is required for the issuance. Shareholders of Cellectis representing 52.8% of its voting rights have already undertaken to vote in favor of the issuance. In the event the sale of equity is not approved by the Cellectis shareholders, Pfizer has the option to terminate the collaboration agreement. Cellectis expects to open a site in the U.S. to work more closely with scientists at Pfizer.
News For PFE From The Last 14 Days
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October 21, 2014
07:15 EDTPFEFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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October 20, 2014
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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October 16, 2014
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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October 14, 2014
11:23 EDTPFEBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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October 10, 2014
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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October 8, 2014
10:55 EDTPFELeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
07:19 EDTPFECBI to hold a conference
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07:18 EDTPFEInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.

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