Leukemia (includes ALL, AML, APL, CLL, CML, MDS, Myeloproliferative Disorders, Myelofibrosis)

US Supreme Court to Consider Biosimilar Patent Process Next Week

(Regulatory Focus) Apr 20, 2017 - The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

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NIH Study in NEJM Shows Novartis Drug Eltrombopag As First-Line Therapy With Standard Treatment Improves Responses In Severe Aplastic Anemia

(Novartis) Apr 19, 2017 - Novartis today announced the publication of a study conducted by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) demonstrating that 58% of patients with treatment-naïve severe aplastic anemia (SAA) achieved complete response at six months when treated with eltrombopag at the initiation of and concurrently with standard immunosuppressive treatment.

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Agios Bags $250M In Offering as Cancer Drug Speeds Toward Approval

(Boston Business Journal) Apr 19, 2017 - Agios Pharmaceuticals has raised $250 million in a new stock offering as the Cambridge cancer biotech nears a possible FDA approval for its first drug this summer.

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Colombian Government Divided Over Moves To Lower Drug Prices

(STAT/Pharmalot) Apr 18, 2017 - Late last year, the Colombian Health Ministry unilaterally lowered the price of a Novartis cancer drug by 44 percent, a controversial step that underscored growing tensions between cash-strapped governments and the pharmaceutical industry.

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Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP

(European Pharmaceutical Review) Apr 18, 2017 - Rigel Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP).

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Novartis Snags Coveted FDA 'Breakthrough' Label for CAR-T, Trial Results Still Under Wraps

(TheStreet) Apr 18, 2017 - Results from the Novartis cell therapy cancer clinical trial known as JULIET remain out of sight to investors -- and its close competitor Kite Pharma -- but the Swiss pharma giant did snag a Breakthrough Therapy Designation from the FDA after sharing the trial data with regulators.

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Tiny Tech Reprograms Immune Cells To Fight Cancer

(Fred Hutch News Service) Apr 17, 2017 - Nanoparticles turn immune cells into leukemia-fighting powerhouses while they’re still inside the body.

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FDA Removes Risk Evaluation Management Strategies (REMS) for ESAs

(ASCO) Apr 13, 2017 - The U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy.

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FDA Ends REMS Requirement for Anemia Drugs

(MedPage Today) Apr 13, 2017 - The Risk Evaluation and Mitigation Strategy (REMS) established by the FDA for the anemia drugs epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp) is no longer necessary and will be dropped, the agency announced Thursday.

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Geron Announces Completion of Second Internal Data Reviews for Imetelstat Trials Being Conducted by Janssen

(Geron) Apr 10, 2017 - Geron Corporation today announced that Janssen Research & Development, LLC has completed the second internal data reviews of IMerge and IMbark, the clinical trials of the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively.

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FDA Approves Ipsogen JAK2 RGQ PCR Kit to Help Evaluate Suspected Polycythemia Vera

(ASCO in Action) Apr 7, 2017 - The U.S. Food and Drug Administration has granted marketing authorization to ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV).

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Novartis Keeps 'JULIET' Study Results Close as Investors and Rival Kite Pharma Wait

(TheStreet) Apr 5, 2017 - Juliet, where art thou? I'm referring to the Novartis clinical trial known as JULIET, investigating the use of the company's genetically altered cell therapy CTL019 in patients with diffuse large B-cell lymphoma (DLBCL) whose disease has returned or is unresponsive to prior treatments.

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Parental Smoking Linked to Genetic Changes Found in Childhood Cancer

(UCSF) Apr 3, 2017 - The link between acute lymphoblastic leukemia (ALL) and parental smoking – especially paternal smoking – has already been established, but this is the first study that points to specific genetic changes in the tumor cells of children with the cancer.

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Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia

(Yahoo! Finance) Apr 3, 2017 - Jazz Pharmaceuticals plc today announced the completion on March 31, 2017 of a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Vyxeos™ (cytarabine and daunorubicin) liposome for injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer.

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Durability of CAR T-cell Therapy Response May Depend on Pretreatment Disease Burden in Leukemia Patients

(AACR) Apr 3, 2017 - Although most patients with relapsed B-cell acute lymphoblastic leukemia (B-ALL) experienced complete response after treatment with a type of CAR T-cell immunotherapy, pretreatment disease burden impacted the durability of the responses and long-term survival, according to data from a clinical trial presented here at the AACR Annual Meeting 2017, April 1-5.

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MSK Expertise on Immunotherapy Highlighted in American Association for Cancer Research Annual Meeting Press Program

(MSK) Apr 3, 2017 - Jae Park, MD, a hematologic oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center (MSK), will present findings about the durability of CAR T cell therapy response in patients with relapsed B-cell acute lymphoblastic leukemia (B-ALL) at the American Association for Cancer Research (AACR) Annual Meeting.

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CAR-T Race Heats Up As Kite, Novartis Complete Filings to FDA

(BioPharma Dive) Apr 2, 2017 - Dive Brief: CAR-T therapy took another step to becoming a commercial reality over the past week as both Kite Pharma and Novartis completed filings to the Food and Drug Administration for their respective treatments, setting the stage for potential approvals to come later this year.

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7 Recently Approved Drugs That Cost More Than $100,000 A Year

(STAT Plus) Mar 30, 2017 - New cancer drugs cost about 17 times more than they did 40 years ago, according to Kaiser Health News.

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Novartis Makes Plans For Its Cancer-Killing T Cells

(Forbes) Mar 29, 2017 - There's a race on to be the first company to launch what's a CAR-T -- a technology that genetically alters cancer patients' white blood cells to kill tumor cells.

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Novartis Announces First CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with R/R B-Cell ALL Granted FDA Priority Review

(Novartis) Mar 29, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). This is the first BLA submission by Novartis for a CAR-T.

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