Medical Tidbits, FDA approves first drug to show survival benefit in liposarcoma

biosimilars, breaking medical news, biotech news

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. read more

Lynparza Granted BTD in US for Prostate Cancer

LYNPARZA ™ ( Olaparib ) granted Breakthrough Therapy Designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).  read more

Amgen’s 2015 Revenues Increased 8 Percent To $21.7 Billion And Adjusted Earnings Per Share (EPS) Increased 19 Percent To $10.38

THOUSAND OAKS, Calif., Jan. 28, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2015. Key results include:

  • For the fourth quarter, total revenues increased 4 percent to $5,536 million, with 3 percent product sales growth driven by Enbrel® (etanercept), Sensipar® (cinacalcet), Prolia® (denosumab), Kyprolis® (carfilzomib) and XGEVA® (denosumab). Adjusted operating income grew 16 percent to $2,366 million and adjusted EPS grew 21 percent to $2.61.read more

FDA approved eribulin (HALAVEN injection, Eisai Co., Ltd.) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.  January 28, 2016. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm483795.htm

Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for ZEMBRACESymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines in Adults

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously.1  read more

Merck Receives FDA Approval of ZEPATIER (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. ZEPATIER (pronounced ZEP-ah-teer) is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). The FDA previously granted two Breakthrough Therapy designations to ZEPATIER, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection. Breakthrough Therapy designation is given to investigational medicines for serious or life-threatening conditions that may offer substantial improvement over existing therapies. Across multiple clinical studies, ZEPATIER achieved high rates of sustained virologic response ranging from 94 to 97 percent in GT1-infected patients, and 97 to 100 percent in GT4-infected patients. Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient’s HCV infection has been cured.

OptiNose Announces FDA Approval for ONZETRA™ Xsail™ (sumatriptan nasal powder), a New Treatment for Acute Migraine Using Bi-Directional™ Breath Powered® Technology

YARDLEY, Pa.–(BUSINESS WIRE)–OptiNose, a privately-held specialty biopharmaceutical company, today announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults (see Full Prescribing Information and Limitations of Use at www.ONZETRA.com). ONZETRA Xsail is the first product developed by OptiNose to receive FDA approval and is an intranasal medication delivery system using the novel Xsail Breath Powered Delivery Device. The Xsail device is based on OptiNose’s unique and patented Bi-Directional Breath Powered technology platform and delivers a low dose of sumatriptan powder into the nose in a new and different way. read more

Exelixis Announces European Medicines Agency Acceptance of Marketing Authorization Application for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union.  read more

Walgreens Informs Theranos to Cease Use of its Newark, Calif. Lab for Blood Test Analysis

Theranos testing services at Palo Alto, Calif., store are immediately suspended

DEERFIELD, Ill.–(BUSINESS WIRE)–In light of the letter dated Jan. 25 from the Centers for Medicare and Medicaid Services (CMS) to Theranos, Inc., Walgreens said today that it has informed Theranos that it must immediately cease sending any clinical laboratory tests provided through Theranos Wellness Centers at Walgreens to the Theranos lab in Newark, Calif., for analysis. In addition, Walgreens is suspending Theranos laboratory services at its Palo Alto, Calif., store, effective immediately.

Walgreens informed Theranos that tests collected at 40 Theranos Wellness Centers located at stores in Arizona must be sent only to Theranos’ certified lab in the Phoenix area or to an accredited third-party lab for analysis. No patient samples will be sent to the Newark lab until all issues raised by CMS have been fully resolved.

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