ROOK INDUSTRY NEWS
Stay current on the companies, products, approvals and industry moves shaping medical sales.
Finance reports that proposed Treasury outbound investment rules would add biotechnology as a regulated sector while new drug licensing gets a pass.
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Fierce Biotech reports Bolt Biotherapeutics is acquiring Prana Therapies in a reverse merger to advance its inflammation antibody pipeline.
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The Motley Fool compares pharmaceutical and biotechnology ETF exposure through risk, rewards and costs.
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Globalcosmeticsnews reports FDA clearance for a Phase 2 study of injectable rhPDGF-BB for under-eye hollowing.
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Fierce Biotech reports proposed Treasury rules would restrict certain China biotech investments while largely sparing traditional licensing.
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Stocktwits reports that Ionis Pharmaceuticals secured FDA orphan drug designation for a rare epilepsy treatment targeting SCN1A.
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Arbutus Biopharma says the FDA has lifted the clinical hold on AB-101 following a Phase 1 study.
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MVIC and Upperton Pharma Solutions are collaborating on an integrated pathway spanning discovery through clinical trial manufacturing.
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Stocktwits reports AstraZeneca launched Zegfrovy, a targeted lung cancer drug also known as sunvozertinib, in the United States.
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Pharmexec reports FDA approval of GSK’s Hibsago, described as the first functional-cure therapy for chronic hepatitis B.
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Seeking Alpha reports that FDA cleared BioCryst Pharmaceuticals’ oral pellet formulation of the once-daily therapy Orladeyo.
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The FDA has approved GSK’s Hibsago, or bepirovirsen, for chronic hepatitis B treatment, according to StreetInsider and Economictimes.
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Todaypress reports that OpenAI has acquired Orchestra Bio, a biotech startup developing AI agents for pharmaceutical drug development.
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Fierce Pharma reports that Cosette Pharmaceuticals secured FDA approval for Evoxac liquid in Sjögren’s disease.
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Amgen and AstraZeneca announced full Phase III CROSSING results for Tezspire in eosinophilic esophagitis.
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The FDA granted accelerated approval for a new use of GSK’s Jemperli in some patients with locally advanced rectal cancer.
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European Biotechnology reports Ambrose Healthcare acquired AM-Pharma for up to €161 million, adding an enzyme replacement therapy and Utrecht base.
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Clinicaltrialvanguard reports FDA clearance of Haemonetics’ PerQseal Elite system for large-bore arterial procedures.
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Medwatch reports Eli Lilly has signed a delivery-technology deal with Chinese AI biotech Metis Techbio.
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Visionmonday reports FDA approval of Roche’s Enspryng for adults with thyroid eye disease as an at-home subcutaneous treatment.
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BioSpace reports China is tightening oversight of biotech platform ownership while foreign licensing agreements remain a key deal structure.
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Fierce Biotech reports Roche and Hansoh expanded their ADC collaboration across preclinical programs and planned worldwide development.
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Citybiz reports Sensorion has appointed Peter Weber, MD, MBA, as chief medical officer for its hearing loss gene therapy efforts.
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Quiverquant reports FDA acceptance and priority review of CorMedix’s REZZAYO sNDA for invasive fungal disease prophylaxis.
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Visionmonday reports FDA approval of Opus Genetics’ phentolamine ophthalmic solution 0.75% for age-related presbyopia in adults.
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Simplywall reports FDA approval and U.S. launch of Teva’s WELTRUZA, a once-monthly injectable olanzapine for adults with schizophrenia.
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Simplywall reports that Asahi Kasei’s therapeutics arm secured FDA approval for HOVILPRI pritelivir in refractory herpes simplex virus infections.
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European Biotechnology reports linked CAR-T asset and ownership transactions involving Lakefront, Armed Cell and Mankind Pharma.
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Qz reports that China’s draft export-control plan would cover five biomedical technologies while exempting pharmaceutical licensing deals.
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Thepharmaletter reports Lakefront Biotherapeutics has sold its preclinical cell therapy pipeline as it completes an exit from the field.
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Zealand Pharma and Generate Biomedicines will develop multispecific protein candidates for obesity and other metabolic diseases.
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Theedgemalaysia reports China is looking to tighten biotechnology exports while allowing licensing deals with foreign drugmakers.
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En reports DongKoo Bio & Pharma will sign an LOI with Pelamore and Link Korea to commercialize transdermal drug delivery technology in Korea.
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FDA IND clearance enables Edesa Biotech to expand its ongoing Phase 2 EB06 vitiligo study to U.S. investigational sites.
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Business Standard reports Mankind Pharma plans to acquire 70% in a Belgian biotech firm for €48 million, entering next-generation CAR-T cancer therapies.
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Quiverquant reports FDA IND clearance for Edesa Biotech’s Phase 2 EB06 vitiligo study, enabling enrollment at U.S. sites.
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Ad Hoc News reports FDA approval expanding Zepzelca’s use in lung cancer care, with Jazz Pharmaceuticals also cited in the report.
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Scientistlive reports the launch of the Digital CMC Consortium to unite biotech industry stakeholders around digitalisation.
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Gilead and Vir Biotechnology formed an oncology alliance covering three dual-masked T-cell engager candidates for solid tumors.
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Fierce Biotech reports that up to 1,217 GSK employees in Belgium are at risk under the company’s global cost-saving program.
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Bambusa Therapeutics and Aspen Neuroscience have filed for IPOs as they seek funding for further clinical trials, Thepharmaletter reports.
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Paragon Labs appointed former Apogee leaders as Velaris joined Alaunos Therapeutics in a transaction supporting its cardiopulmonary pipeline.
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Pfizer and Enodia Therapeutics formed a research and license collaboration to discover and develop Sec61 inhibitors, Fierce Biotech reports.
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Oncodaily reports FDA approval of atezolizumab for stage III dMMR colon cancer and identifies the ATOMIC clinical trial.
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Pharmaceutical Technology reports FDA approval of Hovilpri 100mg tablets for refractory mucocutaneous HSV lesions in immunocompromised adults.
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The FDA has approved pritelivir tablets for immunocompromised adults with mucocutaneous HSV lesions unresponsive to specified treatments.
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MarketBeat reports FDA approval of Teva’s WELTRUZA, a once-monthly subcutaneous long-acting olanzapine injectable for schizophrenia.
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The FDA has approved Teva’s Weltruza, a once-monthly subcutaneous long-acting injectable for adults with schizophrenia.
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Lupin announced U.S. FDA approval for Phytonadione Injectable Emulsion, USP, according to PR Newswire.
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Biobuzz reports that Incyte and Mirum Pharmaceuticals announced FDA approval of Atebrioz for FOP, an ultra-rare bone disease.
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Eli Lilly has expanded its Gate Bioscience alliance, adding an undisclosed target and an option for a second, Biospace reports.
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Medwatch reports that Tetra Pharm’s founders are leaving management as Martin Rose hands the CEO role to Rolf Sass Sørensen.
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The FDA approved Pfizer’s Tukysa combination regimen for maintenance treatment in adults with HER2-positive breast cancer.
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Japan is pursuing biotech reforms as U.S. drug pricing changes and China’s early-stage drug development growth reshape competition.
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Fierce Biotech reports Matchpoint Therapeutics raised $150 million to advance MPT-062 and its precision covalent medicine pipeline.
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PR Newswire reports that CraniUS Therapeutics received FDA 510(k) clearance for its NeuroPASS 3 cranial drug delivery system.
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Thepharmaletter reports Matchpoint Therapeutics has closed a $150 million Series B financing to advance its pipeline.
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Seeking Alpha reports Ultragenyx Pharmaceutical has a $210M deal to sell an FDA priority review voucher tied to recent Genglycos approval.
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Axios reports that Multiply Labs raised $75M to scale robot production and expand automation systems for pharmaceutical manufacturing.
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Simplywall reports ANI Pharmaceuticals received final FDA approval for Everolimus Tablets for Oral Suspension, a generic version of Afinitor Disperz.
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Investor’s Business Daily reported a Tuesday biotech sell-off, naming Vaxcyte, Moderna and Revolution Medicines among the steepest losers.
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Biopharma Dive reports that Forbion raised $2.6B for two venture funds in its largest fundraise to date.
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Thepharmaletter reports that Sensible Biotechnologies secured $47 million to scale its naturally modified, cell-made mRNA platform.
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BridgeBio says the FDA accepted its NDA for oral infigratinib under Priority Review for children with achondroplasia.
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Med Techinsights reports Ensera has launched a network uniting injector platform and fill-finish specialists for combination products.
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RougeTx launched with $58 million in Series A financing to advance RTX-001, a potential once-daily oral treatment for HHT.
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Clinicaltrialsarena reports that the FDA cleared Surrozen’s IND application for SZN-8141 in diabetic macular oedema.
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Alector entered an exclusive global licensing agreement with Genentech, a Roche subsidiary, The Pharma Letter reported.
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Jiangsu Nhwa granted Somnivera exclusive rights outside Greater China for a clinical-stage sleep disorder candidate.
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Eli Lilly added $870 million in potential biobucks to its existing Gate Bioscience collaboration, according to Fierce Biotech.
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Kymanox has launched KymaBridge, a platform designed to connect pharma and biotech innovators with drug delivery device technologies.
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Oncotelic and Pet2DAO announced PDAOAI’s BIO REBOOT collaboration and a partitioned literature aggregation showcase at Drug Discovery 2026.
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Afr reports CSL has signed a drug deal with Swiss biotech Alentis Therapeutics focused on a rare kidney disease.
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Dealroom.co reports that India-based Aurobindo Pharma received final FDA approval for generic epilepsy drug perampanel.
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Dealroom.co reports that AcuCort launched a $6.98M rights issue to push Zeqmelit toward FDA approval.
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Italfarmaco and JCR Pharmaceuticals entered an exclusive JR-141 license agreement for the USA, Europe and Latin America.
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Curaleaf International announced a TGA-registered liquid medical cannabis inhalation device in Australia and availability extended to New Zealand.
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Thepharmaletter reports a planned Phase III trial of Datroway with ivonescimab in first-line triple-negative breast cancer.
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SGGP reports the Ministry of Health plans to expand nearly 700 active ingredients at the primary healthcare level and study equipment price management.
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Emjreviews reports FDA approval of a gene therapy for Sanfilippo syndrome and highlights pediatric clinical trial data.
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Dispatch reports Bayer will invest $2.2 billion in a New Albany pharmaceutical plant, its first manufacturing site of this kind in North America.
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Abogen Biosciences granted Novartis an exclusive worldwide license to ABO2203, with options for further RNA-platform programs.
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