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1,492 stories matching this filter · ← front page

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  • Sleuth predicts surge in Western licensing of Chinese radioligand therapies by 2027
    Sleuth, a biopharma intelligence platform, says that while Chinese radiopharmaceutical assets have seen few licensing deals so far, the market is set to change. The firm notes that China now runs…
    BioSpace · 1mo agoNeutral↗ source
  • Novo outlines $23 billion 2035 revenue target, but investors react with a 7% share drop
    Novo’s chief executive used the recent Capital Markets Day to lay out a long‑term growth plan that targets $23 billion in annual sales by 2035. The strategy emphasizes expanding beyond its flagship…
    BioSpace · 1mo agoNegative↗ source
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Novo acquires three early-stage obesity assets from Kallyope to broaden pipeline amid investor pressure
Investors have been urging Novo to expand its pipeline beyond the semaglutide franchise that drives most of its sales. In response, Novo announced it will acquire three early-stage obesity candida…
BioSpace · 1mo agoDealPositive↗ source
  • TRex Bio and Retension Pharma announce plans for IPOs, outlining biotech pipeline funding
    Biotech companies Retension Pharmaceuticals and TRex Bio have filed with the SEC indicating they intend to go public this year, adding to the current wave of biotech IPOs. TRex Bio said it will us…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • FDA’s new CBER and CDER heads back adaptive framework for rare disease therapies
    Newly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3
    Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AVID Medical issues correction for convenience kits containing recalled Huons sodium chloride ampules
    AVID Medical has released a correction notice for certain convenience kits that include sodium chloride ampules from Huons Co., which are subject to a recall. The FDA has classified this recall as…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    BioSpace · 1mo ago↗ source
  • Beacon Therapeutics reports positive pivotal trial results for X-linked retinitis pigmentosa gene therapy
    Beacon Therapeutics said its gene therapy for X-linked retinitis pigmentosa (XLRP) met the primary endpoint in a phase 2/3 Vista study. The trial enrolled 85 male patients and compared two dose lev…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Ultragenyx receives FDA approval for Fayuvi, first therapy for Sanfilippo syndrome type A, priced at $3.95 M
    The FDA has approved Ultragenyx's gene therapy rebisufligene etisparvovec, to be sold under the brand name Fayuvi, for the treatment of Sanfilippo syndrome type A, an ultra-rare progressive neurolo…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Electra Therapeutics raises $350M in IPO to fund pivotal immune-disease antibody development
    Electra Therapeutics announced an initial public offering that raised $350 million, exceeding its earlier target. The IPO consisted of 23.3 million shares sold at $15 per share, and underwriters w…
    BioSpace · 1mo agoDealPositive↗ source
  • Xenon shares plunge 23% after voluntary hold on psychiatry trials, despite filing NDA for epilepsy drug
    Xenon Pharmaceuticals announced that its lead asset azetukalner (AZK) has been submitted to the FDA as a new drug application for focal onset seizures. At the same time, the company disclosed a vo…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Alkermes reports promising Phase 1b results for orexin agonist ALKS 7290 in ADHD
    Alkermes presented data from a Phase 1b study that evaluated its orexin-based compound ALKS 7290 in adults with attention-deficit/hyperactivity disorder. The trial enrolled 50 participants who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI's early, uneven impact on clinical trials sparks surprise
    The pharmaceutical industry is beginning to see artificial intelligence applied to clinical trial processes, though adoption is occurring in fits and starts. Early uses of AI are emerging in areas…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Medtronic secures FDA clearance for LigaSure vessel sealer on Hugo robotic platform
    Medtronic announced that the U.S. Food and Drug Administration has cleared its LigaSure RAS Maryland jaw vessel sealer-divider for use with the company's Hugo robotic-assisted surgery system. The…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Xenon pauses enrollment in phase 3 depression trials after reports of psychosis and other neuropsychiatric events
    Xenon Pharmaceuticals announced it has voluntarily stopped enrolling new patients in its two phase 3 studies of azetukalner for major depressive disorder and bipolar depression. The decision follo…
    Fierce Biotech · 1mo agoNegative↗ source
  • Spectra Medical recalls Sodium Chloride Flush ampules due to serious safety risk
    Spectra Medical Devices has issued a recall of its Sodium Chloride Injection 0.9% USP 10 mL flush ampules that were manufactured by Huons Co., Ltd. The FDA classified the recall as the most serious…
    fda medwatch · 1mo agoCRLNegative↗ source
  • BMS abandons $100 million Orum degrader-antibody conjugate after early phase-1 results
    Bristol Myers Squibb has decided to stop development of the degrader‑antibody conjugate it purchased from Orum Therapeutics for $100 million after reviewing data from a phase‑1 trial. The experime…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Electra Therapeutics raises $350 million in oversubscribed IPO
    Electra Therapeutics, a South San Francisco biotech focused on inflammation, completed its Nasdaq IPO, selling 23.3 million shares at $15 each and generating $350 million in gross proceeds. This a…
    Fierce Biotech · 1mo agoDealPositive↗ source