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BMS
News

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025) Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…
April 9, 20250Comments

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ThoughtSpot_Evans James
THOUGHTSPOT

Efficient DNA Amplification: The Foundations of Precise Genetic Analysis

The Importance of DNA Amplification in Modern Research DNA amplification is a cornerstone of molecular biology, enabling researchers to study genetic material with high precision. From medical diagnostics to forensic science and biotechnology, amplifying DNA sequences is essential for detecting genetic mutations, identifying pathogens, and conducting complex genetic modifications. The ability to accurately replicate small…
April 8, 20250Comments

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J&J Medtech
News

J&J MedTech Reports First Patient Enrollment in FORWARD CAD trial of Shockwave Javelin Coronary IVL Catheter

Shots: Shockwave Medical (J&J MedTech’s company) has initiated the pivotal FORWARD CAD IDE trial with first pts enrolled, evaluating safety & efficacy of the Shockwave Javelin coronary IVL catheter to treat calcified, hard-to-cross de novo coronary artery lesions prior to stenting    Trial will evaluate the coronary IVL catheter in ~158 pts with mod. to…
April 8, 20250Comments

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ThoughtSpot_Evans James
THOUGHTSPOT

Revolutionizing Cold Chain Logistics: Scalable and Sustainable Ultra-Low Temperature Freezer Solutions

The pharmaceutical and biotech industries are undergoing rapid transformation, with new therapies, biologics, and vaccines driving an increasing demand for reliable ultra-low temperature storage solutions. From large-scale vaccine rollouts to personalized medicine, temperature-sensitive products are at the heart of innovation in life sciences—making dependable cold storage infrastructure not just a necessity, but a strategic asset.…
April 8, 20250Comments

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Rhythm Pharmaceuticals
News

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…
April 8, 20250Comments

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Teva
News

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Shots: The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg) Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days Ajovy (CGRP antagonist) is…
April 8, 20250Comments

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Johnson & Johnson
News

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…
April 8, 20250Comments

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