Latest Pharma Insights
Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Medtech Insight - July 11, 2025
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Medtech Insight - July 11, 2025
Capricor Gets Complete Response For DMD Cell Therapy
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip - July 11, 2025
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip - July 11, 2025
Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Medtech Insight - July 11, 2025
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Medtech Insight - July 11, 2025
AI Is Inevitable, But Useful Only If Solves The Right Problems
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
Scrip - July 11, 2025
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
Scrip - July 11, 2025
Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Scrip - July 11, 2025
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Scrip - July 11, 2025
Deals Shaping The Medtech And Diagnostics Industries, June 2025
An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.
Medtech Insight - July 11, 2025
An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.
Medtech Insight - July 11, 2025
Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe
Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.
Generics Bulletin - July 11, 2025
Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.
Generics Bulletin - July 11, 2025
Water Pressure: How European Industry Is Pushing Back On The UWWTD
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Generics Bulletin - July 11, 2025
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Generics Bulletin - July 11, 2025
Bayer Bags First Global Okay For Hot Flashes Therapy
Lynkuet will compete with Astellas's Veozah/Veoza
Scrip - July 11, 2025
Lynkuet will compete with Astellas's Veozah/Veoza
Scrip - July 11, 2025
China’s Biotechs Were The Small-Cap Rising Stars In H1 2025
The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
Scrip - July 11, 2025
The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
Scrip - July 11, 2025
Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
Generics Bulletin - July 11, 2025
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
Generics Bulletin - July 11, 2025
Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medtech Insight - July 11, 2025
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medtech Insight - July 11, 2025
In Brief: Soleno To Raise $200m To Boost Vykat XR Launch
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat?XR, which became the first drug for?Prader-Willi syndrome to gain US approval on March 26.
Scrip - July 11, 2025
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat?XR, which became the first drug for?Prader-Willi syndrome to gain US approval on March 26.
Scrip - July 11, 2025
Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Scrip - July 11, 2025
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Scrip - July 11, 2025
Four Chinese Firms Snag Global First-In-Class Approvals In China
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Scrip - July 11, 2025
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Scrip - July 11, 2025
Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
Medtech Insight - July 11, 2025
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
Medtech Insight - July 11, 2025
Capricor Gets Complete Response For DMD Cell Therapy
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip - July 11, 2025
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip - July 11, 2025
AI Is Inevitable, But Useful Only If Solves The Right Problems
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
Scrip - July 11, 2025
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
Scrip - July 11, 2025
Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Scrip - July 11, 2025
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Scrip - July 11, 2025
Bayer Bags First Global Okay For Hot Flashes Therapy
Lynkuet will compete with Astellas's Veozah/Veoza
Scrip - July 11, 2025
Lynkuet will compete with Astellas's Veozah/Veoza
Scrip - July 11, 2025
China’s Biotechs Were The Small-Cap Rising Stars In H1 2025
The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
Scrip - July 11, 2025
The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.
Scrip - July 11, 2025
In Brief: Soleno To Raise $200m To Boost Vykat XR Launch
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat?XR, which became the first drug for?Prader-Willi syndrome to gain US approval on March 26.
Scrip - July 11, 2025
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat?XR, which became the first drug for?Prader-Willi syndrome to gain US approval on March 26.
Scrip - July 11, 2025
Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Scrip - July 11, 2025
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Scrip - July 11, 2025
Four Chinese Firms Snag Global First-In-Class Approvals In China
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Scrip - July 11, 2025
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
Scrip - July 11, 2025
Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Medtech Insight - July 11, 2025
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Medtech Insight - July 11, 2025
Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Medtech Insight - July 11, 2025
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Medtech Insight - July 11, 2025
Deals Shaping The Medtech And Diagnostics Industries, June 2025
An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.
Medtech Insight - July 11, 2025
An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.
Medtech Insight - July 11, 2025
Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medtech Insight - July 11, 2025
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medtech Insight - July 11, 2025
Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
Medtech Insight - July 11, 2025
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
Medtech Insight - July 11, 2025
People In US Consumer Health News: Bayer North America Treasurer Takes On CFO Role, Too
Bayer North America CFO with firm since 2008; Cosette VP for quality, regulatory affairs; FDA labeling review official joins ProPharma; Lifecykel, UFC veterans launch Mongolian training camp; and Beverly Hills surgeons offer skin care supplement.
HBW Insight - July 10, 2025
Bayer North America CFO with firm since 2008; Cosette VP for quality, regulatory affairs; FDA labeling review official joins ProPharma; Lifecykel, UFC veterans launch Mongolian training camp; and Beverly Hills surgeons offer skin care supplement.
HBW Insight - July 10, 2025
Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute
The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.
HBW Insight - July 10, 2025
The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.
HBW Insight - July 10, 2025
Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
HBW Insight - July 10, 2025
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
HBW Insight - July 10, 2025
Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe
Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.
Generics Bulletin - July 11, 2025
Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.
Generics Bulletin - July 11, 2025
Water Pressure: How European Industry Is Pushing Back On The UWWTD
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Generics Bulletin - July 11, 2025
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Generics Bulletin - July 11, 2025
Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
Generics Bulletin - July 11, 2025
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
Generics Bulletin - July 11, 2025
AI In Biologics Discovery: The Expensive Bet On Unproven Promise
Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.
In Vivo - July 10, 2025
Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.
In Vivo - July 10, 2025