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News Breaks
February 3, 2013
14:25 EDTMDT, BMY, AZN, RHHBY, STJ, MRK, PFE, GSK, BSX, LLY, SNY, JNJDrug, medical device makers must disclose doctor payments, Bloomberg says
Payments from drugmakers and medical device companies to doctors must be disclosed to the U.S. government beginning next March, says Bloomberg. Reference Link
News For RHHBY;JNJ;GSK;AZN;SNY;PFE;BMY;LLY;MRK;MDT;BSX;STJ From The Last 14 Days
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May 13, 2015
08:08 EDTSTJSt. Jude Medical receives CE Mark approval of Ellipse expanded labeling
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07:31 EDTBSX, STJ, PFE, SNYHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
07:07 EDTGSKGSK, Emergent BioSolutions, Oxford initiate Prime Boost study of Ebola vaccine
A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara, or MVA, Ebola Zaire vaccine candidate, or MVA EBOZ, as a prime-boost to GlaxoSmithKline's (GSK) Chimp Adenovirus type 3, or ChAd3, Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost. Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.
07:05 EDTSNYSanofi exercises option on therapeutic program with Selecta Biosciences
Selecta Biosciences., a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies, today announced that, under the terms of an existing strategic global collaboration, Sanofi has exercised its option to an exclusive license to develop an immunotherapy for the treatment of celiac disease. Under the terms of the collaboration, Selecta is eligible to receive research support and several pre-clinical, clinical, regulatory and sales milestones totaling up to $300 million for this new program in celiac disease. Additionally, Selecta is also entitled to up to double digit tiered royalties as percentage of product net sales for any commercialized immunotherapy resulting from these efforts with Sanofi. November 2012, Selecta announced that they had formed a strategic global collaboration to discover highly targeted, antigen-specific immunotherapies for life threatening allergies. Under the agreement, Sanofi obtained a first exclusive license to develop an immunotherapy designed to abate acute immune responses against a life threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease. With the exercise of this option by Sanofi, Selecta and Sanofi now have two initiatives actively advancing immune tolerance treatments under the terms of the 2012 agreement. In October 2014, Selecta and JDRF announced another collaboration with Sanofi to research novel antigen-specific immune therapies for Type 1 Diabetes.
May 12, 2015
13:13 EDTMRKExpert says Norway biosimilar case an 'outlier,' CT Financial News reports
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10:02 EDTMDTMedtronic receives FDA approval and CE Mark for Advance ST cryoballoon
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07:35 EDTSTJBofA/Merrill to hold a conference
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06:09 EDTMRKThreshold announces Merck receives FDA Fast Track designation for evofosfamide
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06:02 EDTGSKGSK CEO cites 'poor choices' in rivals' M&A deals, Financial Times reports
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05:23 EDTBSXNevro announces filing of petitions for inter partes review by Boston Scientific
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May 11, 2015
17:58 EDTJNJJ&J's Janssen gets complete response letter regarding sNDA for Invega Sustenna
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17:36 EDTPFEAthersys down 10.1% after Pfizer notified that it will terminate agreement
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17:34 EDTPFEAthersys receives notification that Pfizer will terminate agreement
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16:33 EDTPFEPfizer takes minority interest in AM-Pharma, secures option to acquire company
AM-Pharma and Pfizer announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, Pfizer has made an upfront payment of $87.5M for the minority equity interest and exclusive option, with additional potential payments of up to $512.5M upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed. “Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”
15:54 EDTGSKGlaxo CEO defends strategy, warns of risks of chasing higher prices, FT says
GlaxoSmithKline (GSK) CEO Andrew Witty defends the company's shift in focus from high-priced prescription drugs to higher volume, but lower priced, products, warning that chasing ever-higher prices risks undermining the industry and may create "its own tension that leads to some kind of change,” reported Financial Times, citing an interview. Witty acknowledges the company's asset swap with Novartis (NVS) opens the door to a potential break up, but argues there are benefits to keeping pharmaceuticals, vaccines and consumer goods together and there would be “no logic” in a split at this early time after the Novartis deal, the report added. Reference Link
15:19 EDTLLYEli Lilly, BioNTech enter into research collaboration
Eli Lilly and BioNTech announced they have entered into a research collaboration to discover novel cancer immunotherapies. The companies will seek to use the power of the body's own immune system to attack cancer cells and create possible new treatment options for cancer patients. Leveraging the scientific expertise between the two organizations, Lilly and BioNTech will collaborate to identify and validate novel tumor targets and their corresponding T cell receptors in one or more types of cancer. These tumor targets and TCRs may then be engineered and developed into potent and selective cancer therapies. Under the terms of the agreement, BioNTech will receive a $30M signing fee. For each potential medicine, BioNTech could receive over $300M in development, regulatory and commercial milestones. If successfully commercialized, BioNTech would also be eligible for tiered royalty payments up to double-digits. In addition, subject to the terms of the agreement, Lilly will make a $30M equity investment in BioNTech's subsidiary, Cell & Gene Therapies GmbH, which specializes in the research and development of TCR and chimeric antigen receptor immunotherapeutics. Further financial terms were not disclosed.
05:58 EDTGSKUNC, GlaxoSmithKline create dedicated HIV Cure center
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05:11 EDTRHHBYRoche receives FDA approval for cobas KRAS Mutation Test
Roche announced that the FDA has approved the cobas KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer, or mCRC, patients and aid clinicians in determining a therapeutic path for them.
May 10, 2015
19:25 EDTJNJCourt rejects claim that drugmakers misled opiate patients, Bloomberg says
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14:05 EDTJNJJohnson & Johnson shares may deliver double-digit returns, Barron's says
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