This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

Read More: Bayer

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Read More: Oryzon

Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Read More: Regeneron

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Read More: BridgeBio Oncology Therapeutics

AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-Mutated NSCLC

Read More: AstraZeneca and Daiichi Sankyo

HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC

Read More: HUTCHMED

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn's Disease (CD)

Read More: Eli Lilly

Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Read More: Innovent

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Read More: Innovent and Ask Biopharma

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Read More: Johnson & Johnson

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Read More: InflaRx

Merus and Biohaven Join Forces to Advance Three Bispecific ADC Programs

Read More: Merus and Biohaven

Telix to Acquire Therapeutic Assets & Biologics Platform from ImaginAb for ~$230M

Read More: Telix and ImaginAb

Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Read More: Gilead and LEO Pharma

AbbVie and Simcere Zaiming Collaborate to Develop SIM0500 for Treating Multiple Myeloma

Read More: AbbVie and Simcere Zaiming

REGENXBIO Join Forces with Nippon Shinyaku to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS)

Read More: REGENXBIO and Nippon Shinyaku

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Read More: Johnson & Johnson

The US FDA grants 510(k) Clearance to Werfen’s Aptiva Antiphospholipid Syndrome (APS) Reagents

Read More: Werfen

Neurogen Partners with Linus Health to Develop Early Detection Technology for Mild Cognitive Impairment and Dementia due to Alzheimer's Disease

Read More: Neurogen and Linus Health

NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Read More: NEXTBIOMEDICAL

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Read More: Mainstay Medical

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Read More: Sutter Health and GE HealthCare

GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio

Read More: GSK and IDRx

Johnson & Johnson to Acquire Intra-Cellular Therapies for ~14.6B, Boosting its Neuroscience Portfolio

Read More: Johnson & Johnson and Intra-Cellular Therapies

Eli Lilly Inks ~2.5B Deal to Acquire Scorpion Therapeutics

Read More: Eli Lilly and Scorpion Therapeutics

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in majority of Europe and in Israel

Read More: Teva, Klinge Biopharma & Formycon

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Read More: Formycon and Fresenius Kabi

Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Read More: Biothera and World Medicine

Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare

Read More: Ceva Animal Health and Touchlight

Silexion Therapeutics Reports Preclinical Data for SIL-204 in Combination with 1L Chemotherapies for Pancreatic Cancer

Read More: Silexion Therapeutics

Related Post: PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)