Bolt, still flush with IPO cash, cans candidate over off-target toxicity, pauses other work to extend runway Band of biotechs cut pipeline prospects to focus cash on priority programs With no-go from FDA, Affimed looks elsewhere for its AML bispecific's first human study Q2 ‘22 was weakest quarter for biotech IPOs in more than 5 years Vedanta CEO blames 'challenging environment for biotech' for laying off 20% of staff Blood pressure med may slow progression of motor neuron diseases like ALS FDA declines to free MaaT's microbiome drug from clinical hold after a year Moderna CEO touts plan for triple combo respiratory shot in 'three to five years': report Vial adds cancer expert to scientific panel as CRO expands oncology trial offering Boehringer’s digital rewards club boosts COPD medication adherence by 44%: study Hims & Hers boosts 2022 outlook driven by strong Q2 revenue, subscription growth SFW invests in Sannova Analytical citing market opportunities and hinting at growth Featured Story | By Nick Paul Taylor Off-target toxicity has killed off one of Bolt Biotherapeutics’ lead programs. Rather than push BDC-2034 into the clinic, the immuno-oncology startup is winding down spending on the candidate and focusing its $223.6 million cash pile on two other prospects. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor Preparing for a prolonged bear market, a raft of biotechs have decided candidates that looked good a few months ago are now an extravagance, leading them to pull back from the programs. Bolt Biotherapeutics, which canned assets to extend its runway into 2025, is joined by ProQR Therapeutics, Harpoon Therapeutics, Kala Pharmaceuticals and Synthetic Biologics in the wave of pipeline cuts. read more By Annalee Armstrong With a no-go from the FDA, Affimed is redirecting clinical development for an acute myeloid leukemia med outside of the U.S. Affimed filed a new drug application to the U.S. agency in June seeking authorization to begin clinical study for AFM28 here. But the regulatory gatekeeper has said no. read more By Max Bayer Both the number of IPOs and the value of those that did get off the ground were the lowest since at least the first quarter of 2017, a new report says. read more By James Waldron In a LinkedIn post yesterday evening, Vedanta CEO Bernat Olle said that the company—which is focused on drugs targeting the human microbiome—will be “letting go approximately 20% of our staff. read more By Gabrielle Masson Terazosin, a drug currently prescribed for patients with high blood pressure or enlarged prostates, may hold therapeutic potential to slow the progression of motor neuron diseases—such as amyotrophic lateral sclerosis—according to new research findings. read more By Annalee Armstrong MaaT Pharma is not getting out from under an FDA clinical hold for its microbiome drug any time soon. MaaT013, in development for steroid-resistant acute graft-versus-host disease, was placed on hold a year ago, halting a phase 3 trial in the U.S. read more By Eric Sagonowsky During the worst of the COVID-19 pandemic, Moderna worked its way into the public consciousness by speeding an effective vaccine through the FDA authorization process. But as demand slows for the first generation of coronavirus vaccines, Moderna is laying plans to build out its portfolio in the years to come. read more By Gareth Macdonald San Francisco-based CRO Vial has beefed up its oncology expertise by adding expert cancer physician Neeraj Agarwal, M.D., to its scientific advisory board. read more By Andrea Park The RespiPoints program initially launched in 2016 with support for Spiriva Respimat, one of Boehringer’s inhaler-based prescription treatments for symptoms of COPD. read more By Heather Landi The telehealth company, which sells prescription and over-the-counter drugs online as well as personal care products, is well-positioned to "not only thrive in a recessionary dynamic but also to take meaningful market share," the company's CEO Andrew Dudum said during Hims & Hers' second-quarter earnings call this week. read more By Gareth Macdonald Private equity firm SFW Capital Partners has invested in Sannova Analytical, citing growing drug industry interest in outsourcing to specialists as motivation for the deal. read more Resources Sponsored by: Speid & Associates, Inc. The total immersion, transformative training will take place at the Harvard Club in Boston. VIRTUAL in real time is also available. Contingencies for COVID19 will apply. Register NOW for a large early bird discount www.drugstomarket.com/drugbootcamp. Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 