Shares of Eiger Biopharmaceuticals Inc. (NASDAQ:EIGR) were trading midday Sept. 13 at 39 cents, down 30 cents, or 43%, on word that the company is discontinuing the phase III Limt-2 study with peginterferon lambda in patients with chronic hepatitis delta virus (HDV) infection. The Palo Alto, Calif.-based firm based its decision on the data safety monitoring board’s recommendation after a review. Four patients turned up with hepatobiliary events that resulted in liver decompensation, the board said.
Partisanship on full display in US congressional hearing for third-party litigation funding
The question of third-party litigation funding has been front and center for life science companies in recent years, with one of the key considerations a lack of transparency as to the source of the funding behind much of the litigation. That lack of transparency was front and center in the Sept. 13 hearing in the U.S. House of Representatives, but the tenor of the hearing made clear that the Democratic Party will stand in opposition to any reforms despite that the lack of transparency is widely seen as enabling meritless litigation.
‘Comfort blanket’ of biosimilar efficacy studies still needed?
To streamline the development of biosimilars and align it with current analytical science, regulators across the globe are reevaluating a routine requirement for comparative clinical efficacy studies for biosimilar candidates. Eliminating the studies would save biosimilar sponsors time and money and encourage the development of biosimilar competition for a broader range of biologics – without sacrificing quality and safety, several industry officials told the regulators at a three-day workshop hosted this week by the U.S. FDA and the International Pharmaceutical Regulators Program Biosimilars Working Group. In the early days of biosimilars, the efficacy studies were needed to give regulators, doctors and physicians confidence in the new follow-ons, Keith Watson, of KRW Bioreg Solutions LLC, said. But now, “they’re lovely comfort blankets” that don’t make sense scientifically or regulatorily, he added.
Ignition: Rocket Pharma offering and phase II launch the stock
The combination of new U.S. FDA phase II study guidance and a $175 million underwritten public offering sent Rocket Pharmaceuticals Inc.’s stock soaring. Shares (NASADQ:RCKT) were up 36% to $20.74 each at midday on Sept. 13. The offering is for 7.8 million shares at $16 each. Rocket and the agency also just arrived at a final alignment on a global, pivotal, 12-patient study of the gene therapy RP-A501 for Danon disease, a rare, X-linked affliction characterized by cardiomyopathy and other symptoms. There are between 15,000 and 30,000 Danon patients in the U.S. and Europe.
Hasten in-licenses Lib’s PCSK9 inhibitor for China rights in $325M deal
Hasten Biopharmaceutical Co. Ltd. has in-licensed greater China rights to Lib Therapeutics Inc.’s next-generation PCSK9 inhibitor lerodalcibep in a deal worth up to $325 million. Under terms of the deal, Cincinnati-based Lib will receive an up-front payment of $20 million and is eligible to receive future milestone payments of up to $305 million based on achieving clinical, regulatory, and commercial milestones. Lib is also entitled to sales-based royalties. In exchange, Hasten, of Shanghai, will have exclusive rights to develop and commercialize lerodalcibep in greater China.
Samsung fund buys equity in Korean ADC developer Aimedbio
The Samsung Life Science Fund made its fourth equity investment into a South Korean antibody-drug conjugate (ADC) developer, Aimedbio Inc., to round out its investment portfolio padded with three other firms, including Jaguar Gene Therapy LLC, Senda Biosciences Inc. and Araris Biotech AG. Details of the investment could not be disclosed, a Samsung Biologics Co. Ltd. official confirmed to BioWorld on Sept 13, but the move is expected to strengthen the conglomerate’s reach in the ADC sphere, which has been booming worldwide with seven $1 billion-plus ADC-related deals out of more than a dozen ADC deals total in 2023 alone.
MITA sees issues for radiopharmaceuticals in draft Medicare rules
The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures. MITA’s executive director, Patrick Hope, said the Medicare hospital outpatient program is overdue for an overhaul of its packaging policy for payments for radiopharmaceuticals and that the Medicare physician fee schedule should be insulated from further cuts for the professional component of imaging procedures, changes Hope said are necessary to ensure continued patient access to these services.
BioWorld Insider Podcast – AI: driving drug development from effective to remarkable
Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Among the gems and eyebrow raisers is talk of dramatic reductions in the time it takes to identify the right molecule for development and how digital clinical trials in the not-too-distant future will substantially shrink study times. This episode also provides a preview of the annual Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a gold sponsor of the Oct. 4-6 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Penberthy.