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Category: Today’s Highlights

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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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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Tesaro: The Time Has Come for Bringing Hope to Recurrent Ovarian Cancer Patients

- Tesaro's (TSRO) drug niraparib significantly improved progression-free survival for patients with ovarian cancer in both cohorts of the phase 3 NOVA trial - The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort  ...

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July 1, 2016

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Oncolytic Adenovirus Plus Opdivo Could Be a Game Changer in Late Stage Cancer. See Also: Gossip Surrounds Tesaro

PsiOxus Therapeutics’ adenovirus product in combination with Opdivo (nivo-lumab) for late-stage cancers.     Bristol-Myers Squibb (BMY) and PsiOxus Therapeutics (PsiOxus) announced an agreement to evaluate PsiOxus’ drug enadenotucirev , a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s...

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July 5, 2016

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JUNO: The CAR-T Approach Is Still a Source of Hope for Cancer Patients Who Have Lost It

Juno Therapeutics (JUNO) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known...

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July 8, 2016

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Why Amgen Is Still King. Why Roche Allergic Asthma Drug Xolair Is Becoming a Blockbuster.

AMGEN Repatha is the human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9) , which binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR). The binding  prevents PCSK9-mediated...

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July 11, 2016

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The FDA Approves INSIGHTEC's Non-Invasive Approach That Treats Tremors. Humans Can Make Miracles Too.

The FDA approved INSIGHTEC firm’s Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Using focused ultrasound waves Exablate Neuro precisely targets and ablates tissue deep within the brain with...

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July 15, 2016

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Coming from AstraZeneca and Juno: News That Makes a Big Difference

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even...

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July 18, 2016

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Array: Selumetinib Negative Results Are No Match to Its Binimetinib Positive Results

We do expect some selling of Array today after AstraZeneca’s announced negative results from Phase 3 SELECT-1 trial of the MEK inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment for KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell...

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August 9, 2016

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