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)
