https://www.biospace.com/all-news All News en-US Mon, 21 Sep 2026 13:13:52 GMT https://www.biospace.com/business/telix-buys-itm-for-1-65b-in-supercritical-radiopharma-m-a Tristan Manalac Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns. Mon, 21 Sep 2026 13:13:52 GMT https://www.biospace.com/business/telix-buys-itm-for-1-65b-in-supercritical-radiopharma-m-a https://www.biospace.com/deals/novo-buys-three-early-stage-obesity-assets-from-kallyope-as-investor-pressure-mounts Tristan Manalac Investors and analysts have been hounding Novo to beef up its pipeline and advance new molecules as a majority of the company's sales stem from its semaglutide franchise. Mon, 21 Sep 2026 12:11:12 GMT https://www.biospace.com/deals/novo-buys-three-early-stage-obesity-assets-from-kallyope-as-investor-pressure-mounts https://www.biospace.com/drug-development/citing-replimune-approval-experts-say-localized-cancer-meds-could-redefine-care Michael Gibney Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but challenges remain before the method becomes a mainstay in treatment. Mon, 21 Sep 2026 04:05:00 GMT https://www.biospace.com/drug-development/citing-replimune-approval-experts-say-localized-cancer-meds-could-redefine-care https://www.biospace.com/fda/mikhail-davis-on-board-with-regulatory-framework-tailored-to-rare-disease-therapies Heather McKenzie Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the Senate, will commissioner nominee Heidi Overton stay the course? Mon, 21 Sep 2026 04:02:00 GMT https://www.biospace.com/fda/mikhail-davis-on-board-with-regulatory-framework-tailored-to-rare-disease-therapies https://www.biospace.com/drug-development/beyond-random-integration-transposase-cell-line-development-shortening-timeline-boosting-titers AGC Biologics As molecule complexity rises, advanced cell line development platforms are giving biopharma companies new tools to overcome expression challenges, improve stability and reach the clinic faster. Mon, 21 Sep 2026 04:00:00 GMT https://www.biospace.com/drug-development/beyond-random-integration-transposase-cell-line-development-shortening-timeline-boosting-titers https://www.biospace.com/business/china-plans-to-transform-3m-biotech-sector-into-522b-powerhouse-by-2030 Annalee Armstrong A new five-year biotech plan has been released by the Chinese government, revealing ambitious goals such as achieving five blockbuster medicines on the global markets in that time. Fri, 18 Sep 2026 18:36:37 GMT https://www.biospace.com/business/china-plans-to-transform-3m-biotech-sector-into-522b-powerhouse-by-2030 https://www.biospace.com/drug-development/electra-lights-up-with-350m-ipo-for-pivotal-immune-disease-drug-development Gabrielle Masson Electra Therapeutics has exceeded its initial fundraising plans as it becomes the 26th biotech to debut publicly this year and outlines pivotal development plans for its monoclonal antibody ipsoprubart. Fri, 18 Sep 2026 15:23:48 GMT https://www.biospace.com/drug-development/electra-lights-up-with-350m-ipo-for-pivotal-immune-disease-drug-development https://www.biospace.com/drug-development/xenon-tumbles-on-voluntary-psychiatry-hold-but-analysts-confident-in-2b-epilepsy-opportunity Annalee Armstrong As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause. Fri, 18 Sep 2026 13:59:04 GMT https://www.biospace.com/drug-development/xenon-tumbles-on-voluntary-psychiatry-hold-but-analysts-confident-in-2b-epilepsy-opportunity https://www.biospace.com/fda/ultragenyx-wins-fda-greenlight-for-first-sanfilippo-therapy-priced-at-nearly-4m Tristan Manalac The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month. Fri, 18 Sep 2026 12:32:03 GMT https://www.biospace.com/fda/ultragenyx-wins-fda-greenlight-for-first-sanfilippo-therapy-priced-at-nearly-4m https://www.biospace.com/drug-development/bms-scraps-orums-targeted-degrader-after-reviewing-phase-1-data Tristan Manalac Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones. Fri, 18 Sep 2026 12:19:39 GMT https://www.biospace.com/drug-development/bms-scraps-orums-targeted-degrader-after-reviewing-phase-1-data https://www.biospace.com/deals/novo-notches-up-to-1-4b-pact-with-orbis-to-develop-oral-macrocycle-cardiometabolic-drugs Michael Gibney The multi-drug partnership with Orbis Medicines—which Novo Holdings has backed since the biotech's seed rounds—is focused on cardiometabolic targets, but the technology at the center of the deal could deliver oral weight loss candidates. Obesity rival Eli Lilly has also helped fund Orbis. Thu, 17 Sep 2026 15:21:34 GMT https://www.biospace.com/deals/novo-notches-up-to-1-4b-pact-with-orbis-to-develop-oral-macrocycle-cardiometabolic-drugs https://www.biospace.com/events/webinar-manufacturing-in-turbulent-times BioSpace Insights Learn what manufacturing challenges lie ahead, how to equip your team to protect your program from avoidable manufacturing and regulatory setbacks and forge partnerships that can withstand the next five years of industry turbulence. Thu, 17 Sep 2026 14:01:44 GMT https://www.biospace.com/events/webinar-manufacturing-in-turbulent-times https://www.biospace.com/business/fed-rate-hike-wont-hold-biotech-down-despite-climbing-capital-costs Annalee Armstrong While increases in the interest rate from the Federal Reserve are usually bad for biotech, the sector at this moment is poised to withstand the blow, according to analysts, though earlier stage companies may be left in the lurch. Thu, 17 Sep 2026 13:42:03 GMT https://www.biospace.com/business/fed-rate-hike-wont-hold-biotech-down-despite-climbing-capital-costs https://www.biospace.com/business/after-novartis-devastating-m-a-losses-long-live-the-executive-willing-to-try Annalee Armstrong Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month. Thu, 17 Sep 2026 13:39:53 GMT https://www.biospace.com/business/after-novartis-devastating-m-a-losses-long-live-the-executive-willing-to-try https://www.biospace.com/deals/novartis-drops-125m-for-sironaxs-tech-to-cross-blood-brain-barrier Tristan Manalac Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly. Thu, 17 Sep 2026 12:51:13 GMT https://www.biospace.com/deals/novartis-drops-125m-for-sironaxs-tech-to-cross-blood-brain-barrier https://www.biospace.com/drug-development/longeverons-shares-crash-as-stem-cell-therapy-flunks-mid-stage-cardio-trial Tristan Manalac With just over $10 million in cash available to fuel operations through the end of the year, Longeveron is undertaking a strategic review after the failure of a cardiovascular study. Thu, 17 Sep 2026 12:19:58 GMT https://www.biospace.com/drug-development/longeverons-shares-crash-as-stem-cell-therapy-flunks-mid-stage-cardio-trial https://www.biospace.com/deals/roche-bets-up-to-1b-to-advance-next-gen-bispecifics-with-dualitas Tristan Manalac The partners will focus R&D efforts on immunological and inflammatory conditions using Dualitas’ DualScreen Bispecific Discovery Engine platform. Thu, 17 Sep 2026 12:13:55 GMT https://www.biospace.com/deals/roche-bets-up-to-1b-to-advance-next-gen-bispecifics-with-dualitas https://www.biospace.com/drug-development/when-vision-fades-rethinking-wet-amd-and-the-durability-gap Jennifer C. Smith-Parker BioSpace Insights In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life. Thu, 17 Sep 2026 10:13:23 GMT https://www.biospace.com/drug-development/when-vision-fades-rethinking-wet-amd-and-the-durability-gap https://www.biospace.com/job-trends/biopharma-hiring-hotspots-states-disciplines-where-demand-is-highest Angela Gabriel As biopharma job openings rose this year, opportunities were greatest in Massachusetts and California and in the science/R&D and clinical disciplines, according to BioSpace data. Several other locations and functions have also been going strong. Thu, 17 Sep 2026 07:00:00 GMT https://www.biospace.com/job-trends/biopharma-hiring-hotspots-states-disciplines-where-demand-is-highest https://www.biospace.com/job-trends/trending-top-biopharma-disciplines-with-jobs-live-now Angela Gabriel From engineering to science/R&D, these top seven biopharma disciplines each have hundreds, and in one case over 1,000, positions posted on BioSpace. Thu, 17 Sep 2026 07:00:00 GMT https://www.biospace.com/job-trends/trending-top-biopharma-disciplines-with-jobs-live-now