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

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma 

Read More: Merck and Eisai 

Novo Nordisk Completes P-Ib/IIa Study of Subcutaneous Amycretin in Overweight or Obese People 

Read More: Novo Nordisk 

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy 

Read More: Roche 

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) 

Read More: ITM Isotope Technologies 

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer 

Read More: Roche 

Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma 

Read More: Ethris 

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC 

Read More: Daiichi Sankyo and AstraZeneca 

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer 

Read More: Clarity 

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis 

Read More: Akeso Biopharma 

Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1 

Read More: Dyne Therapeutics 

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies 

Read More: Daiichi Sankyo and AstraZeneca 

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP 

Read More: GSK 

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) 

Read More: ImmunityBio 

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL) 

Read More: Amgen 

Scholar Rock Reports the US FDA's BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA) 

Read More: Scholar Rock 

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine 

Read More: Axsome Therapeutics 

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV 

Read More: ViiV Healthcare 

Sanofi Receives China’s NMPA Approval for Sarclisa + Standard-of-Care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)  

Read More: Sanofi 

Cstone Join Forces with SteinCares to Commercialize Sugemalimab in 10 Latin American Countries 

Read More: Cstone Pharmaceuticals and SteinCares 

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan 

Read More: Neurocrine Biosciences and Takeda 

Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex 

Read More: Siolta Therapeutics and Cowellnex 

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0 

Read More: ClearPoint Neuro 

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency 

Read More: Fresenius Kabi 

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System 

Read More: Life Spine 

Zimmer Biomet to Acquire Paragon 28 for ~$1.2B 

Read More: Zimmer Biomet and Paragon 28 

Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B 

Read More: Lantheus Holdings and Evergreen Theragnostics 

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria) 

Read More: Alvotech and Teva 

Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra) 

Read More: Celltrion 

Pet Honesty Introduces Urinary Tract Health for Cats 

Read More: Pet Honesty 

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support 

Read More: Bayer 

Related Post: PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)