The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 20250Comments

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Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M

Shots:Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…

ByRidhi RastogiJuly 15, 20250Comments

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Becton Dickinson’s Biosciences & Diagnostic Solutions Business to Combine with Waters in a $17.5B Deal

Shots:BD to combine its Biosciences & Diagnostic Solutions business with Waters in a Reverse Morris Trust transactionAs per the deal, BD shareholders will receive $4B in cash & a 39.2% stake in the combined company, while Waters will assume $4B in debt & retain 60.8%, with the total deal value of $17.5B reflecting cash,…

ByRidhi RastogiJuly 15, 20250Comments

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Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Shots:The US FDA has granted clearance to TAVIPILOT Soft for real-time intra-operative guidance of transcatheter heart valve implantationTAVIPILOT Soft, set to launch by the end of 2025, is compatible with all cardiac imaging systems & will support all TAVI heart valves available on the market, thereby, allowing seamless integration in clinical settingsTAVIPILOT…

ByRidhi RastogiJuly 15, 20250Comments

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Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Shots:Sun Pharma has launched Leqselvi (deuruxolitinib; 8mg) for the treatment of pts with severe alopecia areata in the USFDA Approval was based on 2 P-III (THRIVE-AA1 & THRIVE-AA2) trials that assessed the scalp hair regrowth using the SALT score with Leqselvi (8 or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata…

ByDipanshu DixitJuly 15, 20250Comments

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Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Shots:Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos.Decision to initiate P-III…

ByDipanshu DixitJuly 15, 20250Comments

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Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots:Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFHApproval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…

ByDipanshu DixitJuly 15, 20250Comments

VIEWPOINTS

Retrieving Olfactory Prowess: Rick Geoffrion from Cyrano Therapeutics in Conversation with PharmaShots

Shots: Recently, Cyrano Therapeutics signed a licensing agreement with Resyca, integrating its novel therapy for post-viral smell loss, CYR-064, with Resyca’s Soft Mist Nasal Spray Technology PharmaShots welcomes Rick Geoffrion, President & CEO of Cyrano Therapeutics, in an illuminating dialogue exchange centered around CYR-064 and its role in treating post-viral hyposmia (smell loss) Rick highlights…

BySaurabh ChaubeyJuly 14, 20250Comments

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BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

Shots:LEO Pharma has entered into an exclusive global license & transfer agreement with BI to commercialize & advance the development of Spevigo (spesolimab)As per the deal, LEO Pharma will handle commercialization & further development of Spevigo in exchange for $105.18M (€90M) upfront, along with milestones & tiered royalties; closing expected in H2’25, subject…

ByRidhi RastogiJuly 14, 20250Comments

News

Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

Shots:Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO)Both studies showed improvements across all doses at Wk. 12…

ByRidhi RastogiJuly 14, 20250Comments

The US FDA New Drug Approvals in June 2025

Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M

Becton Dickinson’s Biosciences & Diagnostic Solutions Business to Combine with Waters in a $17.5B Deal

Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Retrieving Olfactory Prowess: Rick Geoffrion from Cyrano Therapeutics in Conversation with PharmaShots

BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

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