Latest Pharma Insights
CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
Scrip - April 30, 2025
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
Scrip - April 30, 2025
Financing Quarterly Statistics, Q1 2025
During Q1, biopharmas brought in an aggregate $13.1bn in financing and device company fundraising totaled $5bn; while in vitro diagnostic firms and research tools players raised $418m.
In Vivo - April 30, 2025
During Q1, biopharmas brought in an aggregate $13.1bn in financing and device company fundraising totaled $5bn; while in vitro diagnostic firms and research tools players raised $418m.
In Vivo - April 30, 2025
Rising Leaders 2025: Christina Ziegenberg On Keeping Medtechs Competitive And MDR Compliant
Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
In Vivo - April 30, 2025
Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
In Vivo - April 30, 2025
Cosmetics Consortium Shares Studies With FDA To Build Confidence In Animal Testing Alternatives
By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.
HBW Insight - April 30, 2025
By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.
HBW Insight - April 30, 2025
CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
Scrip - April 30, 2025
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
Scrip - April 30, 2025
No FDA Reorg Planned, Makary Says
FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.
Medtech Insight - April 29, 2025
FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.
Medtech Insight - April 29, 2025
Roche Diagnostics Hit By China Reforms As Q1 Sales Remain Flat
While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.
Medtech Insight - April 29, 2025
While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.
Medtech Insight - April 29, 2025
Roche’s $50Bn Bet On US Manufacturing: Tariff Shield But Cash Flow Strain
New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.
Medtech Insight - April 29, 2025
New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.
Medtech Insight - April 29, 2025
Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
Medtech Insight - April 29, 2025
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
Medtech Insight - April 29, 2025
Exact Sciences Enters MRD Market With Oncodetect Launch But Faces Competition, Reimbursement Challenges
The Oncodetect test is tumor-informed, tracking up to 200 circulating tumor DNA (ctDNA) variants. It delivers simple “detected” or “not detected” results alongside quantitative data to guide adjuvant therapy decisions, monitor treatment response, and detects up to 200 ctDNA variants identifying signs of colorectal cancer recurrence up to two years earlier than imaging.
Medtech Insight - April 29, 2025
The Oncodetect test is tumor-informed, tracking up to 200 circulating tumor DNA (ctDNA) variants. It delivers simple “detected” or “not detected” results alongside quantitative data to guide adjuvant therapy decisions, monitor treatment response, and detects up to 200 ctDNA variants identifying signs of colorectal cancer recurrence up to two years earlier than imaging.
Medtech Insight - April 29, 2025
Cosmetics Consortium Shares Studies With FDA To Build Confidence In Animal Testing Alternatives
By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.
HBW Insight - April 30, 2025
By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.
HBW Insight - April 30, 2025
Iconovo Slims Down As It Focuses On Commercialization
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
Generics Bulletin - April 29, 2025
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
Generics Bulletin - April 29, 2025
Roche Suggests Perjeta Biosimilars May Not Hit Until 2027 ‘Or Later’
Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.
Generics Bulletin - April 29, 2025
Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.
Generics Bulletin - April 29, 2025
Glenmark’s UK Dapagliflozin Blocked On Appeal After Teva Readied Launch
Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.
Generics Bulletin - April 29, 2025
Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.
Generics Bulletin - April 29, 2025
Financing Quarterly Statistics, Q1 2025
During Q1, biopharmas brought in an aggregate $13.1bn in financing and device company fundraising totaled $5bn; while in vitro diagnostic firms and research tools players raised $418m.
In Vivo - April 30, 2025
During Q1, biopharmas brought in an aggregate $13.1bn in financing and device company fundraising totaled $5bn; while in vitro diagnostic firms and research tools players raised $418m.
In Vivo - April 30, 2025
Rising Leaders 2025: Christina Ziegenberg On Keeping Medtechs Competitive And MDR Compliant
Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
In Vivo - April 30, 2025
Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
In Vivo - April 30, 2025