Biopharma r3

BioPharmaceutical

Report

Mar 19, 2019
5 min

Aldeyra's Reproxalap has Experts Mixed on Seasonal Allergic Conjunctivitis Focus in Phase III

Biopharmaceutical Report I Issue18_December 2018 Aldeyra Therapeutics’ (NASDAQ:ALDX) focus on seasonal allergies in its Phase III study...

Mar 19, 2019
4 min

Eisai's Lenvima for First-line HCC Is Approvable but Noninferiority Data to SOC May Slow Uptake

Biopharmaceutical Report II Issue17_July 2018 Eisai’s (TYO:4523) Lenvima (lenvatinib) has a clear path to approval in first-line...

Mar 12, 2019
5 min

Immunomedics’ Sacituzumab Has Insufficient Dataset to Pursue Accelerated Approval

Biopharmaceutical Report I Issue17_July 2018 Immunomedics’ (NASDAQ:IMMU) Phase I/ II sacituzumab govitecan hormone receptor positive...

Mar 12, 2019
8 min

Shooting for the Universe

Biopharmaceutical Report III Issue16_April 2018 SHOOTING FOR THE UNIVERSE By Michael Leviten, Senior Writer CureVac AG is bringing a new...

Mar 12, 2019
5 min

Biosimilar Uptake Still Plagued by Interchangeability Hurdles

Biopharmaceutical Report II Issue17_July 2018 Biosimilar interchangeability with reference biologics remains a challenge years after...

Mar 12, 2019
5 min

Alnylam vs Dicerna Trade Secret Litigation May Be Influenced by Emotive Arguments

Biopharmaceutical Report I Issue16_April 2018 Alnylam’s (NASDAQ:ALNY) trade secrets litigation case against Dicerna (NASDAQ:DRNA) could...

Mar 12, 2019
4 min

BeiGene’s Phase III BGB-3111 in WMHas Unclear Efficacy Advantage Over Imbruvica

Biopharmaceutical Report II Issue15_November 2017 BeiGene’s (NASDAQ:BGNE) BGB-3111 for Waldenström’s macroglobulinemia (WM) will need...

Mar 12, 2019
6 min

Corbus’ Phase II Anabasum in Dermatomyositis Garners Mixed Expert Expectations

Biopharmaceutical Report I Issue15_November 2017 Corbus Pharmaceuticals’ (NASDAQ:CRBP) Phase II study of anabasum in skin-predominant...

Mar 12, 2019
7 min

Strategic Shift of Dong-A ST Co. Ltd. in Drug Discovery

Biopharmaceutical Report III Issue14_July 2017 BY EMILY CUKIER-MEISNER, SENIOR WRITER Dong-A ST Co. Ltd. has spent the last four years...

Mar 12, 2019
5 min

Medical Device: Growing Cybersecurity Threat and Need for More Regulation

Biopharmaceutical Report II Issue14_July 2017 Despite an expected increase in the frequency in cybersecurity threats in the near future...

Mar 12, 2019
5 min

Eisai’s Lenvima Should See FDA Approval in Hepatocellular Carcinoma (HCC)

Biopharmaceutical Report I Issue15_July 2017 • Valuations unreliable given large timeframe to market • Likely EU/US pricing pressures...

Mar 12, 2019
5 min

Western CAR-Ts face Chinese Development Hurdles Due to Regulatory Uncertainty

Biopharmaceutical Report II Issue13_April 2017 Western-origin chimeric antigen receptor T-cell (CAR-T) therapies being developed in China...

Mar 12, 2019
5 min

Legislation to Force Payer Coverage of AbuseDeterrent Opioids Faces Resistance

Biopharmaceutical Report I Issue13_April 2017 Proposed legislation across 23 US states to force payers to increase reimbursement of...

Mar 12, 2019
4 min

Roche’s GALLIUM Results Draw Skepticism about Changing Practice in First-Line Follicular Lymphoma

Biopharmaceutical Report III Issue12_December 2016 Roche’s (VTX:ROG) Phase III GALLIUM study of Gazyva (obinutuzumab) in first-line...

Mar 12, 2019
5 min

Humira Biosimilar Unlikely to Reach the Market Before 2020

Biopharmaceutical Report II Issue12_December 2016 The numerous biosimilars for AbbVie’s (NYSE:ABBV) Humira (adalimumab) are unlikely...