Phalguni Deswal
phalguniddw.bsky.social
Phalguni Deswal
@phalguniddw.bsky.social
17 followers 11 following 160 posts
Editor - Drug and Device World
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Sanofi presents data from a Phase II clinical trial for an investigational targeted alpha therapy, AlphaMedix , as a treatment approach for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) at #ESMOef="/hashtag/ESMO25" class="hover:underline text-blue-600 dark:text-sky-400 no-card-link">#ESMO25.

#News #ESMO #CancerResearch #ClinicalTrial #cancer #oncology
ESMO 2025: Promising Phase II data for Sanofi’s alpha therapy
Investigational targeted alpha therapy AlphaMedix shows clinical activity in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
druganddeviceworld.com
Grifols plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.

#News #USAref="/hashtag/USAmanufacturing" class="hover:underline text-blue-600 dark:text-sky-400 no-card-link">#USAmanufacturing #manufacturing #onshoring #USA #Grifols #BloodTransusion
Grifols expands US diagnostic manufacturing with new San Diego facility
The company plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.
druganddeviceworld.com
The US FDA granted the drug Breakthrough Therapy designation to Cidara Therapeutics’ its investigational influenza prophylactic, CD388, for the prevention of influenza A and B in high-risk adults and adolescents.

#News #FluTherapy #CD388
FDA grants breakthrough status to Cidara’s flu drug
Cidara Therapeutics' CD388, a long-acting influenza prophylactic, has previously received funding worth up to $339 million from the US BARDA.
druganddeviceworld.com
Synchrony Medical has announced the US launch of its LibAirty Airway Clearance System, a new at-home therapy designed to assist people living with chronic lung diseases such as chronic obstructive pulmonary disease (#COPD), #bronchiectasis, and cystic fibrosis.

#News #FDAapproval
Synchrony Medical launches LibAirty airway clearance system in the US
The FDA-cleared at-home system is designed to assist people living with chronic lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.
druganddeviceworld.com
The US FDA has approved an expanded indication for Teva Pharmaceuticals' Uzedy (risperidone) extended-release injectable suspension, authorizing its use for the maintenance treatment of bipolar I disorder (BD-I) in adults.
#News #Bipolar #Schizophrenia #FDAapproval
FDA expands Teva’s Uzedy approval to include bipolar I disorder
Teva’s long-acting subcutaneous formulation of Johnson and Johnson’s (J&J) Risperdal is already approved for schizophrenia.
druganddeviceworld.com
Grifols and Biotest have launched Yimmugo in the US. The FDA-approved intravenous immunoglobulin (IVIg) provides a new treatment option for individuals with primary immunodeficiencies (PID), expanding access to critical care.

#News #Yimmugo #Immunodeficiency #PID #RareDisease #FDAapproved
Grifols’ Biotest launches Yimmugo immunoglobulin therapy in US market
The US FDA approved the intravenous immunoglobulin (IVIg) therapy for the treatment of primary immunodeficiencies (PID) last year.
druganddeviceworld.com
Cidara Therapeutics secures up to $339M from BARDA to expand U.S. manufacturing and clinical development of CD388, its long-acting, non-vaccine influenza preventative designed to offer broad protection against all flu strains.
#News #BARDA #InfluenzaPrevention #CD388 #Biotech #PandemicPreparedness
Cidara secures $339m from BARDA for non-vaccine flu therapy
Cidara Therapeutics wins BARDA backing to expand US manufacturing and clinical development of its long-acting, non-vaccine influenza therapeutic, CD388.
druganddeviceworld.com
PureTech Health’s Phase IIb data show deupirfenidone (LYT-100) may stabilize lung function in #IPF patients with good tolerability—potentially a new standard of care. PureTech's Camilla Graham talks IPF landscape and drug development. #ERS2025 #PulmonaryFibrosis #ClinicalTrials #Biotech
PureTech’s deupirfenidone: Overcoming the efficacy paradigm in IPF
PureTech’s Camilla Graham talks about the IPF landscape, barriers to antifibrotic use, and the development of deupirfenidone.
druganddeviceworld.com
AI adoption in MedTech is cautious but accelerating. Propel’s Chuck Serrin explains how trust, collaboration & data integrity are driving early wins in diagnostics, product ops & personalization. #MedTech
#AIinHealthcare #DigitalHealth #MedicalDevices #Innovation
AI in MedTech: Risks, wins, and the road ahead
AI adoption in MedTech lags, but Propel’s Chuck Serrin notes how collaboration and data are unlocking new potential.
druganddeviceworld.com
🚨 The FDA has granted Priority Review to Chiesi's Raxone (idebenone), a potential first treatment for Leber Hereditary Optic Neuropathy (LHON), a rare disease causing sudden vision loss. Decision expected by Feb 2026.

#News #RareDisease #Ophthalmology #FDA #LHON #VisionResearch #DrugDevelopment
Chiesi scores FDA priority review for rare vision disorder
Raxone is approved for Leber Hereditary Optic Neuropathy (LHON), a rapid vision-loss disease, in multiple countries, including the EU.
druganddeviceworld.com
At #EASD2025, Amgen shared real-world data showing low GLP-1 adherence and highlighted MariTide, its monthly obesity therapy in late-stage trials. As next-gen treatments emerge, the focus shifts from short-term efficacy to sustainable, long-term care.

#News #Obesity #Diabetes #Pharma
EASD 2025: Amgen highlights real-world challenges in obesity management
Amgen spotlights real-world GLP-1 adherence challenges and advances MariTide in the evolving obesity treatment landscape.
druganddeviceworld.com