Articles By Estel Grace Masangkay

  1. FDA Allows Abuse Deterrent Label Update For Pfizer's Embeda 10/22/2014

    Pfizer reported that the U.S. Food and Drug Administration (FDA) has approved its application to update the label of its oral painkiller, Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, to include abuse-deterrence studies.

  2. Alexion Files NDA In Japan For Asfotase Alfa For HPP 10/21/2014

    Alexion Pharmaceuticals announced that it has filed the New Drug Application (NDA) with the Ministry of Health, Labor, and Welfare (MHLW) in Japan for its asfotase alfa as treatment for hypophosphatasia (HPP).

  3. Novartis And Penn Post Positive Data For ALL Drug 10/20/2014

    Novartis and its partner the University of Pennsylvania's Perelman School of Medicine (Penn) announced positive preliminary results from two pilot clinical trials evaluating CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).

  4. Prosensa Begins NDA Filing For DMD Drug Lead 10/15/2014

    Prosensa, a biotech firm focused on RNA-modulating therapeutics for genetic disorders, announced that it has kickstarted the submission process for a New Drug Application (NDA) for its lead drug drisapersen as treatment for Duchenne muscular dystrophy (DMD).

  5. AstraZeneca, Charles River Partnership Turns Out New Respiratory Drug 10/10/2014

    Charles River Laboratories announced that its partnership with British drug firm AstraZeneca has led to the advancement of an oral respiratory drug candidate into preclinical development.

  6. Sorrento, Lee's Pharma Ink Immuno-Oncology Licensing Agreement 10/8/2014

    Late-stage clinical oncology firm Sorrento Therapeutics announced its agreement with Lee’s Pharma for the exclusive licensing of Sorrento’s anti-PD-L1 immunotherapy in China.

  7. Prima BioMed Announces Plan To Acquire Immutep For $28M 10/8/2014

    Australia-based Prima BioMed announced its plan to acquire French biopharmaceutical Immutep for up to $28 million.

  8. Alcobra Posts Positive Phase 3 Results For ADHD Drug 10/8/2014

    Alcobra, a pharmaceutical company focused on developing treatments for cognitive disorders, announced positive top line results from the Phase 3 study of Metadoxine Extended Release (MDX) in adult patients with ADHD.

  9. Novartis, Bristol-Myers Squibb Partner To Test Combo Treatments For NSCLC 10/7/2014

    Novartis announced that it has linked arms with Bristol-Myers Squibb to jointly conduct clinical trials investigating the combination of three of Novartis’ compounds with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with non-small cell lung cancer (NSCLC).

  10. Lilly Halts Phase 3 Trials For Lupus Drug Tabalumab 10/7/2014

    Eli Lilly & Co. announced that it is pulling the plug on the development of its candidate drug tabalumab under investigation as a potential treatment for systemic lupus erythematosus (SLE). The company said the decision to halt tabalumab’s development is due to a lack of efficacy and not because of safety concerns.