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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Assemblymag reports that 63% of healthcare companies want manufacturing partners to help build new products.
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Tradersunion reports EQT acquired a German diagnostics company for €10.8 billion, reinforcing its healthcare strategy and medical-services expertise.
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Real Diagnostics acquired SimplyTest, adding saliva-based oral health and periodontal health testing to its laboratory portfolio.
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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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Medical Device Network reports Medtronic’s five-device Vitalis pacemaker portfolio has secured CE marking.
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MassDevice reports Teleflex received FDA Breakthrough Device designation for the Freesolve RMS resorbable scaffold.
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Med Techinsights reports that Great Britain will continue recognising CE-marked medical devices and in vitro diagnostic devices.
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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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AstraZeneca reports FDA accelerated approval of Ultomiris to reduce proteinuria in adults with primary IgA nephropathy at risk of progression.
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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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Rokit Healthcare said it is terminating its U.S. distribution deal with Tides Medical after an FDA warning letter tied to marketing.
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Medical Device Network reports the UK will continue recognizing EU CE-marked medtech, shelving plans for a separate UK tag by 2030.
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Myvetcandy reports FDA approval of Zoetis’ more concentrated, ready-to-use Convenia injection for bacterial skin infections in dogs.
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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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TradingView reports Abbott posted third-quarter sales growth of 7% and adjusted earnings-per-share growth of 9% alongside a nutrition separation plan.
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Medicaldesignandoutsourcing reports Bluestar Silicones introduced a PFAS-free liquid silicone for healthcare devices with up to 30 days of patient contact.
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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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Pluang cites Alcon acquisitions and FDA approvals as factors supporting its expanding eyecare portfolio and long-term demand outlook.
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Medical Product Outsourcing reports J&J debuted the Shockwave C2 Aero Fly coronary IVL catheter in the U.S.
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MassDevice reports FDA approval of Edwards’ Pascal Precision for tricuspid valve repair in tricuspid regurgitation.
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Woodtv reports that Kentwood-headquartered Michigan Instruments acquired Ada Township medical device company KEM Enterprises.
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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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Vohnetwork reports GE HealthCare has launched LOGIQ Focus with AI-enabled imaging, automated workflows and cybersecurity features.
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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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FDA advisories warn healthcare professionals and the public not to purchase or use a blood pressure monitor and disposable face mask.
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Biz reports that Korea and the WHO unveiled a Seoul declaration focused on responsible medical AI, global cooperation and equitable access.
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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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AmCham has called for a dedicated framework for medical devices and equipment, En reports, linking it to technology access and patient services.
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Auroratoday reports that Audacity North has launched in Aurora, bringing testing facilities, university expertise and business mentorship together.
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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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Newbeauty reports FDA approval of 28 new Motiva breast implant sizes, including some as small as 105 cc.
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MedTech Dive reports that a CE mark clears Medtronic to sell Vitalis conduction system pacing therapy devices in Europe.
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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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Simplywall reports Elanco Animal Health outperformed earnings forecasts in its last two reported quarters ahead of upcoming results.
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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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Medical Product Outsourcing reports that Meridian Bioscience received a Health Canada license for its Alethia CMV assay.
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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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Tbsnews reports AmCham made five recommendations on medical devices as a state minister said approvals will be expedited.
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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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South African and Namibian livestock bodies highlighted separate import protocols after FMD was confirmed in Namibia’s Karas Region.
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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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Newsbytes reports MNEX is investing P180 million in a Batangas plant for precision-molded components, with production targeted for early 2027.
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Newswire reports TAG Software Group, a Valsoft company, has acquired Positive Solutions, a healthcare and pharmacy software provider.
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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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AboutLawsuits reports that an FDA warning letter to Olympus followed inspections of six manufacturing facilities.
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Viatris announced U.S. FDA approval of RYZUMVI for the treatment of presbyopia, according to PR Newswire.
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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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Insights reports an FDA early alert after balloon ruptures during inflation involving some Commander M systems used with Sapien M3.
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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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Medical Device Network reports GE HealthCare secured CE Mark certification for MINItrace Magni and broadened Copper-64 manufacturing.
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Theedgemalaysia reports China is looking to tighten biotechnology exports while allowing licensing deals with foreign drugmakers.
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Medical Device Network reports Vivos Therapeutics agreed to an 11% equity interest in SOD Sciences and 50% co-ownership of its test.
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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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KalkineMedia reports that STERIS is expanding healthcare equipment operations through its Xodus Medical acquisition and manufacturing projects.
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MiniMed completed its separation from Medtronic and began its first day as a fully independent company, Investing News Network reported.
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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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MiniMed completed its separation from Medtronic and began its first day as a fully independent company, Investing News Network reported.
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Valsoft’s TAG Software Group has acquired Positive Solutions, a UK provider of pharmacy management and point-of-sale software.
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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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Modular Medical has launched digital learning tools to support adoption as it prepares for full commercialization, Valuethemarkets reports.
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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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Medical Device Network reports FDA 510(k) clearance for Stryker’s Sonopet 3 ultrasonic platform for bone and soft tissue removal.
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Citybiz reports that 8 Bridge Group has acquired a majority stake in 340BIntel, expanding its healthcare technology portfolio.
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Medicaldaily reports that Natera’s multi-cancer blood test received FDA breakthrough status, a faster review pathway that is not an approval.
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TradingView says Intuitive Surgical is scheduled to report third-quarter results after the market closes on Oct. 20.
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Scientistlive reports the launch of the Digital CMC Consortium to unite biotech industry stakeholders around digitalisation.
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Medical Product Outsourcing reports FDA approval for Gore’s VBX Stent Graft as a bridging stent in fenestrated and branched aortic repair.
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MassDevice reports FDA approval of Gore’s Viabahn VBX endoprosthesis for use in FEVAR and BEVAR procedures.
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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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Gore announced FDA approval of an expanded indication for its VIABAHN VBX Balloon Expandable Endoprosthesis in FEVAR and BEVAR.
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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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Einpresswire reports VMD Sciences unveiled an international portal supporting veterinarians seeking animal health products through export pathways.
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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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Yahoo News reports FDA 510(k) clearance for Vantis Vascular’s new 6F CrossFAST delivery system model.
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KuCoin reports that Apple Watch sleep apnea detection launched in China through an OTA update tied to iOS and watchOS upgrades.
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Kingsresearch says partnerships with chipmakers and cloud firms are transforming U.S. MedTech by enabling faster diagnostics.
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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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University of Cape Town partners with institutions in India, Russia and Brazil to develop medical device innovation and manufacturing capacity.
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TradingView reports CHS plans to acquire America’s Choice Healthplans, pairing Novus360 with third-party benefits administration.
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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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Cardiovascularbusiness reports a Class II recall of certain JenaValve TAVR delivery catheters over Trilogy system deployment concerns.
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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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Myvetcandy reports FDA approval of quarterable PREVICOX tablets, offering more flexible firocoxib dosing for dogs as small as 7 pounds.
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Seeking Alpha’s NVE Corporation analysis cites proprietary spintronics and implantable medical-device sensors.
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