Ascletis Reports the US FDA’s IND Submission for ASC36 and ASC36_35 FDC to Treat Obesity

Shots: The US FDA has received IND applications for ASC36, a QM to Q3M peptide amylin receptor agonist, & ASC36_35 FDC, a QM injection co-formulation of ASC36 + ASC35, for the treatment of obesity In NHP studies, ASC36 SALD showed ~6-fold longer half-life than eloralintide, supporting QM to Q3M SC dosing, while ASC36_35 FDC SALD…

ByRidhi RastogiJuly 6, 2026

NEWS

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Shots: The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure SkinTE is a first-in-class autologous…

ByRidhi RastogiJuly 3, 2026

NEWS

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Shots: The US FDA has granted clearance to Flu and COVID-19 Test, an at-home PCR test capable of detecting multiple respiratory viruses, expanding its portfolio of over-the-counter molecular diagnostics The test delivers PCR-quality results in 30min. & detects COVID-19 and influenza A/B at home, enabling earlier diagnosis & timely treatment decisions, incl. access to antiviral…

ByRidhi RastogiJuly 3, 2026

NEWS

United Therapeutics Acquires Thymmune Therapeutics for ~$300M

Shots: United Therapeutics has acquired Thymmune Therapeutics, incl. its lead asset THY-100, developed for the treatment of congenital athymia Under the deal, United Therapeutics has acquired Thymmune for $140M upfront, with up to $160M in additional earn-out payments tied to clinical & regulatory milestones through 2031 THY-100 is a preclinical regenerative therapy for congenital athymia…

ByRidhi RastogiJuly 3, 2026

NEWS

CSPC Group and AstraZeneca Partner to Develop siRNA Drugs in ~$1.77B Deal

Shots: CSPC & AstraZeneca have entered into a strategic collaboration, option & license agreement to leverage CSPC’s siRNA discovery & extrahepatic targeted delivery platforms to develop novel small nucleic acid therapeutics CSPC & AstraZeneca will jointly discover & develop preclinical candidates for two renal disease targets, with AstraZeneca holding options for global/ex-China rights to each…

ByRidhi RastogiJuly 3, 2026

NEWS

Median Technologies Receives CE Mark for eyonis LCS to Detect and Diagnose Lung Cancer

Shots: Median Technologies has received CE Mark for eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer In testing eyonis LCS has showed 93.3% sensitivity & 92.4% specificity, with 68% reduction of False Positives & 66% reduction of False Negatives, minimizing unnecessary follow-ups eyonis Lung Cancer Screening is an AI-powered computer-aided detection & diagnosis…

ByRidhi RastogiJuly 3, 2026

NEWS

AlzeCure Partners with QuantumCell for NeuroRestore ACD856 in a Deal Worth up to $2.2B

Shots: AlzeCure Pharma has entered into an out-licensing & collaboration agreement with QuantumCell for global rights to AlzeCure’s Alzheimer’s platform NeuroRestore, incl. ACD856 AlzeCure will receive $12M upfront, incl. a $5M investment, & is eligible for development & commercial milestones exceeding $2.2B (excl. royalties), plus tiered single to low double-digit royalties NeuroRestore ACD856 is a…

ByRidhi RastogiJuly 3, 2026

INSIGHTS+

Q2 in Review: Pharma’s Dealmaking Surge, a Wave of FDA Approvals, and AI’s Deepening Footprint

A PharmaShots Quarterly Analysis Q2 was one of the most active quarters in recent memory for the pharmaceutical and biotech industry. Big Pharma leaned hard into M&A and licensing to refill pipelines, the FDA cleared a broad slate of new therapies, and AI-native partnerships continued to reshape how drugs get discovered. Below, we break down the quarter…

ByRidhi RastogiJuly 2, 2026

NEWS

Inocras and AimedBio Collaborate on Precision Oncology and ADC Development

Shots: Inocras and AimedBio have partnered to integrate Inocras’ whole-genome sequencing (WGS) platform into AimedBio’s ADC clinical programs, alongside AimedBio’s strategic equity investment in Inocras As per the deal, AimedBio will use Inocras’ WGS, cancer intelligence platform, & multi-omics analyses across its ADC trials to enable biomarker discovery, patient selection, and novel target identification The…

ByRidhi RastogiJuly 2, 2026

NEWS

HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

Shots: The NMPA has granted conditional approval to Orpathys for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments Approval was supported by the P-II trial of Orpathys in GC/GEJ adenocarcinoma pts with MET amplification in China, which showed 32.3% ORR (1EP), & improved 2EPs, incl. 63.1% DCR, 1.4mos.…

ByRidhi RastogiJuly 2, 2026

Ridhi Rastogi

Ascletis Reports the US FDA’s IND Submission for ASC36 and ASC36_35 FDC to Treat Obesity

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

United Therapeutics Acquires Thymmune Therapeutics for ~$300M

CSPC Group and AstraZeneca Partner to Develop siRNA Drugs in ~$1.77B Deal

Median Technologies Receives CE Mark for eyonis LCS to Detect and Diagnose Lung Cancer

AlzeCure Partners with QuantumCell for NeuroRestore ACD856 in a Deal Worth up to $2.2B

Q2 in Review: Pharma’s Dealmaking Surge, a Wave of FDA Approvals, and AI’s Deepening Footprint

Inocras and AimedBio Collaborate on Precision Oncology and ADC Development

HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

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