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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
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.
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.
UPCOMING EVENTS
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.
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?
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.
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.
IPO
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.
PRESS RELEASES
• Recent U.K. MHRA Scientific Advice Meeting (SAM) that resulted in full alignment to initiate confirmatory Phase 3 trial in U.K. with existing Phase 2 drug product paved the way Conditional Marketing Authorisation Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalification • MHRA’s SAM participants’ recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA, coupled with granting the Company access to U.K. national patient registry, the UK Clinical Practice Research Datalink (CPRD) to strengthen comparator data while Phase 3 is ongoing to further improve interpretability of data during early market access phase • Since 2021, 29 MHRA-led products have been approved by U.S. FDA via Project Orbis • Company continues to engage with U.S. FDA on the non-Orbis Accelerated Approval route after successful Type C Statistical Methods Meeting that resulted in alignment on amended Phase 3 study design as buildout of OST-400 natural history database expands to include U.K. national patient registry data and Company awaits FDA decisions on RMAT, Rolling Review and CNPV ahead of the pending Q4/'26 completion of its ongoing BLA filing initiated in Q1/'26 • BLAs granted via Project Orbis are eligible to receive Priority Review Vouchers (PRVs) and may also be granted via the Accelerated Approval Program • Patient previously reported as lost to follow-up confirmed to be alive
Athens-based biotech will use the financing to advance AT001, its lead therapeutic program targeting the LRRK2–FADD interaction, through a key in vivo efficacy study.
Swiss Bioscience selected as OrganTech’s preferred strategic partner in Europe for regulatory development, GMP manufacturing, clinical research, and potential commercialization of the conditioned medium technology.
Following a horizontal acquisition in December 2025, the companies are realising marked synergies under an ambitious integration program that has successfully aligned manufacturing processes to enable a full dual source supply strategy, which is being launched at CPHI Milan, 6–8 October 2026.
The Company will provide an update on the clinical translation of its biomarker platform and showcase industry collaborations supporting scalable, high-throughput mass spectrometry.
· New U.S. subsidiary, NovAccel Isotopes Inc., established to support North American growth and long-term global supply ambitions in Ac-225 · Arnaud Lesegretain appointed Director and Chief Commercial and Business Officer of NovAccel, Inc., and CEO of NovAccel Isotopes Inc.; Takashi Mizukami appointed Director and Chief Strategy Officer
MARKET RESEARCH REPORTS