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.
Biopharma’s financing frenzy continued Thursday, with eight firms pricing public offerings – six follow-ons and two IPOs – to raise a total of about $760.7 million before overallotments.
SAN FRANCISCO – A shifting regulatory climate and an increasing push for innovation combined with a staggering amount of capital is expected to significantly increase the rate of cross-border dealmaking between China firms and U.S.-based and multinational companies, experts predicted during the Chinese American Biopharmaceutical Society meeting last week.
SAN FRANCISCO – A shifting regulatory climate and an increasing push for innovation combined with a staggering amount of capital is expected to significantly increase the rate of cross-border dealmaking between China firms and U.S.-based and multinational companies, experts predicted during the Chinese American Biopharmaceutical Society meeting Wednesday.
SAN FRANCISCO – While the past decade has seen the rise of money from family offices into direct investments, a lack of knowledge and expertise has kept many of those funds on the sidelines when it comes to the health care sector. But the ones willing to take risks on innovative prospects could help young firms bridge the gap between an idea and a much-needed inflection point.
