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August 04, 2017
August 04, 2017
FDA has approved a fixed combination of two chemotherapies, daunorubicin and cytarabine (Vyxeos—Jazz Pharmaceuticals), for the treatment of adults...
FDA has approved a fixed combination of two chemotherapies, daunorubicin and cytarabine (Vyxeos—Jazz Pharmaceuticals), for the treatment of adults with two types of acute myeloid leukemia (AML). The two AML types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC).
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July 31, 2017
July 31, 2017
Phase II testing suggests that atezolizumab, a humanized anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, is an effective treatment for...
Phase II testing suggests that atezolizumab, a humanized anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, is an effective treatment for advanced non-small cell lung cancer (NSCLC) in patients with confirmed PD-L1 expression. The BIRCH study compared the drug's effect across samples of patients with different PD-L1 levels.
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July 31, 2017
July 31, 2017
FDA has agreed to speed up the process required for development and regulatory review of AstraZeneca's new lung cancer drug durvalumab (Imfinzi)....
FDA has agreed to speed up the process required for development and regulatory review of AstraZeneca's new lung cancer drug durvalumab (Imfinzi).
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July 31, 2017
July 31, 2017
AstraZeneca's growth plans, pinned on the promise of two novel cancer drugs, are questionable after an important clinical trial failed to...
AstraZeneca's growth plans, pinned on the promise of two novel cancer drugs, are questionable after an important clinical trial failed to demonstrate their superiority over usual care.
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July 19, 2017
July 19, 2017
FDA approved on July 18 a fixed-dose combination tablet (Vosevi—Gilead Sciences) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6...
FDA approved on July 18 a fixed-dose combination tablet (Vosevi—Gilead Sciences) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis. The treatment contains two previously approved drugs—sofosbuvir and velpatasvir—as well as a new drug, voxilaprevir.
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July 11, 2017
July 11, 2017
Beginning on July 13, providers at Walgreens Healthcare Clinics in 17 new markets will be able to prescribe HIV PrEP (Pre-Exposure Prophylaxis), the...
Beginning on July 13, providers at Walgreens Healthcare Clinics in 17 new markets will be able to prescribe HIV PrEP (Pre-Exposure Prophylaxis), the company announced Monday.
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July 11, 2017
July 11, 2017
Today's biosimilar reimbursement model could affect broad adoption, according to a new analysis from Navigant. To drive adoption, payers may need to...
Today's biosimilar reimbursement model could affect broad adoption, according to a new analysis from Navigant. To drive adoption, payers may need to consider alternative payment models to ensure providers do not sacrifice profits when adopting biosimilars.
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July 11, 2017
July 11, 2017
The results of a Phase III clinical trial indicate that emicizumab prophylaxis significantly reduces the rate of bleeding events in individuals with...
The results of a Phase III clinical trial indicate that emicizumab prophylaxis significantly reduces the rate of bleeding events in individuals with hemophilia A. Activated factor VIII is deficient in this population, but emicizumab restores it by bridging activated factor IX and factor X.
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July 07, 2017
July 07, 2017
Rare-disease drugmakers are expressing concern that the Republican health care bill—which the Senate could vote on as soon as next week—could allow...
Rare-disease drugmakers are expressing concern that the Republican health care bill—which the Senate could vote on as soon as next week—could allow insurers, including those that offer plans through employers, to cut off reimbursements once an insured person spends $1 million to $2 million on prescription drugs.
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June 20, 2017
June 20, 2017
Nearly 2 years after PCSK9 inhibitors were approved by FDA, doctors and patients say getting insurance to pay for the cholesterol drugs, which list...
Nearly 2 years after PCSK9 inhibitors were approved by FDA, doctors and patients say getting insurance to pay for the cholesterol drugs, which list for more than $14,000 a year before rebates or discounts, is a battle that requires countless hours, applications, and appeals.
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