Despite the rise of biologics – and biosimilars – in the ulcerative colitis (UC) space, investors backed Dublin-based Sublimity Therapeutics Ltd. in a $64 million round to advance STI-0529, its orally delivered soluble version of cyclosporine, into a phase IIb study.
Heading toward the May 21 PDUFA date for its thrombocytopenia drug, avatrombopag, Dova Pharmaceuticals Inc. was determined to have its sales and marketing team ready to go for a June launch, optimism that appeared justified Monday afternoon when the FDA gave the nod to the second-generation, once-daily, oral thrombopoietin (TPO) receptor agonist following a priority review.
As Zymeworks Inc. prepares to unveil new phase I data from its lead bispecific antibody candidate at the upcoming American Society of Clinical Oncology meeting, its platform technology scored another win in the validation column. Less than two years after licensing rights to Zymeworks' Azymetric and EFECT technology platforms to develop one bispecific candidate, Daiichi Sankyo Co. Ltd. returned to the negotiating table for more.
The possibility of offering the first treatment in the U.S. for neurological muscle spasms that bears no warning of sedative side effects in the label attracted the interest of Sofinnova Ventures, which led to a $60 million series A round for Neurana Pharmaceuticals Inc. Funds will be used to support an upcoming phase II study testing a highly purified version of muscle relaxant tolperisone in neuromuscular spasms of the neck and back.
Coming off a strong first quarter, in which sales of cabozantinib solidly bested Street expectations, Exelixis Inc. made another move to expand its early stage pipeline via a collaboration with multispecific antibody firm Invenra Inc. The two will work together using Invenra's B-Body technology platform to identify candidates for treating cancer.
A potential 2018 launch for DLL3-targeting antibody-drug conjugate rovalpituzumab tesirine (Rova-T) is off the table, as Abbvie Inc. said it will not seek accelerated approval in third-line small-cell lung cancer (SCLC), based on the "magnitude of effect across multiple parameters" in the phase II TRINITY study, news that sent shares of the large-cap stock (NASDAQ:ABBV) sinking 12.8 percent Thursday, losing $14.35 to close at $98.10.
It's been nearly 15 years since the FDA cleared Amevive (alefacept) for use in psoriasis, making it one of the first biologic drugs approved for a dermatologic disease and ushering in a new wave of therapies that has not only transformed the treatment paradigm for psoriasis patients but also proved to big pharma that targeting skin conditions could be a lucrative venture.
NEW YORK – While listening to panelists during the BIO CEO & Investor conference discuss the current state of the opioid epidemic, it occurred to me that there was something about this narrative that seems familiar. I feel like I’ve written this story before. And I have. About 10 or 12 years ago. Only then, instead of pain drugs, it was antibiotics. Despite the need for new antimicrobial treatments to combat the growing resistance problem, many companies were shying away from antibiotic drug development. Part of that was due to the shifting regulatory landscape at the FDA regarding noninferiority studies....
NEW YORK – The double-digit reduction in the corporate tax rate and the repatriation provision included in the tax code changes signed into law late last year were hailed as boons for the U.S. biopharma sector, with many pundits predicting that 2018 will finally bring a much-anticipated M&A frenzy.
NEW YORK – Coming off a slower-than-usual year in biopharma M&A activity – due largely to drug pricing pressures and regulatory uncertainty, coupled with a robust financing environment – many industry observers have tagged 2018 to be a busy year in acquisitions.
