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Category: Today’s Highlights

Adaptimmune: The FDA Removed the Temporary Ban on the Trial with NY-ESOS PEAR T-Cell Therapy for Mixoid Round Cell Liposarcoma

The U.S. Food and Drug Administration (FDA) has removed the partial clinical hold it put on Adaptiimmune’s (ADAP) planned study of its NY ‑ ESO SPEAR ™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS)....

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November 14, 2016

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Exelixis: A Big Yes from the FDA

Based on statistically significant results from the randomized phase 2 CABOSUN trial in patients with previously untreated renal cell carcinoma (RCC), the U.S. Food and Drug Administration (FDA) approved  Exelixis’ (EXEL) drug Cabometyx ®  (cabozantinib) for the expanded indication of patients with...

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December 20, 2017

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PTC Therapeutics Stock Price Doubles. When the Data Are Not Good for Forecasting.

The media failure to forecast the results of the Presidential election has become the talk of the town and of the failed media itself. The New York Times’ article about this forecast fiasco titled “ How Data Failed Us In...

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November 11, 2016

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Juno and Spark: On the Road Towards Ambitious Goals

Juno Therapeutics (JUNO)  is one of the casualties that occurred during the 59 th  American Society of Hematology (ASH) Annual Meeting. The stock experienced undeserved selloff except for the fact that it had a deserved rally that we believe will remain...

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December 12, 2017

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Ionis Drug Spinraza Conquers Spinal Muscular Atrophy with Statistically Significant Results

Biogen (BIIB) and Ionis (IONS) announced that Spinraza (nusinersen), an antisense drug designed and developed by Ionis met its primary endpoint in Phase 3 trial of the CHERISH Study in later-onset spinal muscular atrophy (SMA) . This was the second...

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November 8, 2016

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Why Portola couldn’t flex its muscles or use them yet

All the buying and selling of Portola (PTLA)  will not make any sense to us until the firm fulfills its obligations towards what is required by the authorities, by health care and by private third-party payers.  So, in the reporting...

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August 9, 2018

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Ariad Pharmaceuticals: Substantiating Its Solid Scientific Fundamentals and the Value of Its Strategy

Ariad Pharmaceuticals (ARIA) : Good news from the U.S. Food and Drug Administration (FDA) affirmed that the agency accepted for review Ariad’s New Drug Application (NDA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib for patients with metastati...

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November 1, 2016

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Regeneron: Two good news and a rebound on the road

The FDA Approves Regeneron’s Product EyLea® (aflibercept) sBLA in Wet Age-Related Macular Degeneration Regeneron (REGN) has two good news. The first is from one of its approved products, EYLEA ® announcing that the U.S. Food and Drug Administration(FDA) has approved a...

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August 17, 2018

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The FDA Accepted Seattle Genetics’ sBLA for Adcetris in Combination with Chemotherapy for Front-Line Treatment of Advanced Classical Hodgkin Lymphoma.

The Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (BLA) for  Seattle Genetics’ (SGEN)  product  Adcetris (brentuximab vedotin)  in combination with chemotherapy for the frontline treatment of patients with  advanced classical Hodgkin lymphoma.  The Agency granted Priority...

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January 2, 2018

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Gilead's Positive News Exceeds By-Far Its Negative News. Who Said Gilead Needs Acquisitions to Maintain Its Growth?

Results from trials were negative in two phase 2 studies for Gilead (GILD) experimental drug GS-4997 ( selonsertib ) intended to treat pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). But the same drug selonsertib showed it might hit...

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October 21, 2016

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