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Category: Today’s Highlights

Accelerated FDA Approvals of Immunotherapy Treatments Are Accelerating

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon...

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May 19, 2016

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Theravance Biopharma and Mylan COPD Product is Speeding Towards Approval

Enrollment has been completed in all the three ongoing clinical trials comprising the firm’s Phase 3 program for Theravance Biopharma’s ( TBPH ) revefenacin (TD-4208) . The drug is an investigational long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease...

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June 3, 2016

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At ASCO: Exelixis Has Great News for Cobimetyx on RCC

Additional data from pivotal METEOR trial underscore clinically meaningful benefit of Exelixis’ (EXEL) drug Cabometyx™ for patients with Advanced RCC AT the ASCO Meeting: ABSTRACT #4557, #4558 Cabometyx’™ benefit was robust and consistent regardless of prior treatment, location and extent...

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June 6, 2016

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CAR-T Great News and About the Biotech Sector in General

It is obvious that the CAR-T approach to cancer treatment is here to stay and to change the way cancer has been managed for decades. Attempts to improve the novel elegant procedure safety profile and efficacy on solid cancers are...

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June 1, 2017

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Great News for Celator That Might Be Great News for Jazz Pharmaceuticals

CELATOR PHARMACEUTICALS Good News That Might Go to JAZZ Pharmaceuticals Celator Pharmaceuticals ( CPXX ) : At the European Hematology Association (EHA) 21st Annual Congress, Celator  presented positive response rate results in acute myeloid leukemia ( AML) patients with the...

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June 16, 2016

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Ariad Pharmaceuticals Submits Early NDA for the Approval of Brigatinib. See Also: More News from Ariad

ARIAD Pharmaceuticals (ARIA) announced the initiation of a New Drug Application (NDA) submission for brigatinib , the firm’s investigational anaplastic lymphoma kinase (ALK) inhibitor to the FDA. Earlier than expected, ARIAD is seeking U.S. marketing approval of brigatinib for patients...

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June 17, 2016

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FDA Breakthrough Therapy Designation for Alnylam's RNAi Drug Givosiran

Alnylam Pharmaceutical (ALNY) calls RNAi (RNA interference) a revolution in biology. The FDA’s just granted the firm’s RNAi therapy breakthrough for a disease nobody has ever dreamed of conquering confirms this reality in spite of spending years of efforts and...

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June 2, 2017

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Data From ASCO and Data from the Internet

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer...

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June 6, 2017

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Paratek Antibiotic Omadacycline Meets Primary Endpoint in Resistant Infection

Paratek Pharmaceuticals (PRTK) announced positive results from Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline , to linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI) . The firm’s press release stated that...

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June 20, 2016

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Ignoring Incyte's Successive Good News Will Fail to Mislead Investors

GRAFT VERSUS HOST DISEASE (GVHD) INCYTE (INCY) HAS SEVERAL GOOD NEWS. As a matter of fact, Incyte has exciting news coming from innumerable activities strategized by the firm’s dynamic management. The first good news came from the FDA, granting Breakthrough...

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June 27, 2016

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