Latest Pharma Insights
RAPID Comment Period Opens Aug. 11, With Post-IDE Eligibility On The Table
The Federal Register notice opening a 60-day comment period on the RAPID coverage pathway publishes Aug. 11. The notice also asks whether manufacturers already running IDE studies should have a temporary route into the program.
Medtech Insight - August 10, 2026
The Federal Register notice opening a 60-day comment period on the RAPID coverage pathway publishes Aug. 11. The notice also asks whether manufacturers already running IDE studies should have a temporary route into the program.
Medtech Insight - August 10, 2026
Interview: UK Healthtech Industry Builds For Further Networking Success In H2 2026
ABHI chief executive Peter Ellingworth summarized a busy first half year of 2026 for UK healthtech, and broached how the government’s reshuffle and new staffing at the industry association can give new impetus to the industry.
Medtech Insight - August 10, 2026
ABHI chief executive Peter Ellingworth summarized a busy first half year of 2026 for UK healthtech, and broached how the government’s reshuffle and new staffing at the industry association can give new impetus to the industry.
Medtech Insight - August 10, 2026
Tenax Sees A Path Forward For TNX-103 Despite Phase III LEVEL Miss
TNX-103 (oral levosimendan) missed the Phase III primary endpoint in pulmonary hypertension associated with HFpEF, but Tenax will seek regulatory input on a path forward in patients with more advanced disease.
Scrip - August 10, 2026
TNX-103 (oral levosimendan) missed the Phase III primary endpoint in pulmonary hypertension associated with HFpEF, but Tenax will seek regulatory input on a path forward in patients with more advanced disease.
Scrip - August 10, 2026
Silence Makes Noise With Positive Divesiran Results In Polycythemia Vera
Phase II results of the siRNA drug showed 88% of patients met the primary endpoint with dosing every 6-12 weeks, presenting competition to Takeda/Protagonist’s rusfertide.
Scrip - August 10, 2026
Phase II results of the siRNA drug showed 88% of patients met the primary endpoint with dosing every 6-12 weeks, presenting competition to Takeda/Protagonist’s rusfertide.
Scrip - August 10, 2026
Jazz Returns To Epilepsy Dealmaking With Actio Acquisition
The company will gain a Phase I/II first-in-class asset for a rare genetic and severe form of epilepsy in exchange for $820m up front and a $500m contingent consideration.
Scrip - August 10, 2026
The company will gain a Phase I/II first-in-class asset for a rare genetic and severe form of epilepsy in exchange for $820m up front and a $500m contingent consideration.
Scrip - August 10, 2026
US FDA Proposes Cutting Self-Affirmed GRAS Without Regulatory Notification
FDA publishes proposed rule to require manufacturers to notify the agency when they conclude the use of a substance added to is GRAS.
HBW Insight - August 10, 2026
FDA publishes proposed rule to require manufacturers to notify the agency when they conclude the use of a substance added to is GRAS.
HBW Insight - August 10, 2026
Execs On The Move: July 2026
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - August 10, 2026
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - August 10, 2026
GSCF Puts Rx-To-OTC Switch At Heart Of Prevention Push
The Global Self-Care Federation's second socio-economic report asks high-income governments to expand Rx-to-OTC switch as part of a wider repositioning of self-care as prevention.
HBW Insight - August 10, 2026
The Global Self-Care Federation's second socio-economic report asks high-income governments to expand Rx-to-OTC switch as part of a wider repositioning of self-care as prevention.
HBW Insight - August 10, 2026
Deals Shaping The Industry, July 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
Pipeline Watch: Three Approvals And Two Phase III Readouts
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - August 10, 2026
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - August 10, 2026
GI Endoscopy Carries Olympus As FDA Ship-Holds And China Test Its Recovery
Olympus's Q1 FY2027 beat — revenue up 16%, adjusted operating margin up 640bps to 12.8% — was driven almost entirely by GI endoscopy and a leaner cost base, but an unresolved FDA warning letter, US import alert and a 17% China decline kept management from touching full-year guidance.
Medtech Insight - August 10, 2026
Olympus's Q1 FY2027 beat — revenue up 16%, adjusted operating margin up 640bps to 12.8% — was driven almost entirely by GI endoscopy and a leaner cost base, but an unresolved FDA warning letter, US import alert and a 17% China decline kept management from touching full-year guidance.
Medtech Insight - August 10, 2026
Regulatory Recap: Biosimilar Legislations Progress In US Congress
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - August 10, 2026
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - August 10, 2026
Indian Panel Urges Full US Tariff Exemption For Generics
An Indian parliamentary committee wants generics fully protected from future US tariff hikes under a bilateral trade deal, while also urging faster mutual recognition agreements, pre-clearance mechanisms and policy support for exposed exporters.
Generics Bulletin - August 10, 2026
An Indian parliamentary committee wants generics fully protected from future US tariff hikes under a bilateral trade deal, while also urging faster mutual recognition agreements, pre-clearance mechanisms and policy support for exposed exporters.
Generics Bulletin - August 10, 2026
Generics Price-Fixing Case Heads To Jury Trial In February 2027
A Connecticut federal judge has fixed a February 2027 jury trial for the sprawling generics antitrust case, while Perrigo has won dismissal of several product claims but remains exposed on a much broader set of alleged conspiracies.
Generics Bulletin - August 10, 2026
A Connecticut federal judge has fixed a February 2027 jury trial for the sprawling generics antitrust case, while Perrigo has won dismissal of several product claims but remains exposed on a much broader set of alleged conspiracies.
Generics Bulletin - August 10, 2026
Deals Shaping The Industry, July 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
Eli Lilly Looks To Block US Rivals To Mounjaro
Eli Lilly has sued 14 generic challengers seeking to rival Mounjaro and Zepbound, opening a broad US patent battle over tirzepatide that spans compound, composition and method-of-treatment claims running as late as 2041.
Generics Bulletin - August 10, 2026
Eli Lilly has sued 14 generic challengers seeking to rival Mounjaro and Zepbound, opening a broad US patent battle over tirzepatide that spans compound, composition and method-of-treatment claims running as late as 2041.
Generics Bulletin - August 10, 2026
Senate Includes One-Month Delay On Lower THC Limits For Hemp In Continuing Resolution
Senate adds language to continuing resolution to delay imposing lower limit on all forms of THC allowed in lawful hemp rather than 0.3% concentration for delta-9 THC alone used to define de-scheduled hemp in 2018 farm bill.
HBW Insight - August 10, 2026
Senate adds language to continuing resolution to delay imposing lower limit on all forms of THC allowed in lawful hemp rather than 0.3% concentration for delta-9 THC alone used to define de-scheduled hemp in 2018 farm bill.
HBW Insight - August 10, 2026
Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: Novo Nordisk weighs bolt-on deals; Bayer slams Germany pricing; Lilly soars despite Foundayo struggles; European biotech wants to leapfrog; and a look at the potential AstraZeneca/BMS combination in APAC.
Scrip - August 10, 2026
In this week's episode: Novo Nordisk weighs bolt-on deals; Bayer slams Germany pricing; Lilly soars despite Foundayo struggles; European biotech wants to leapfrog; and a look at the potential AstraZeneca/BMS combination in APAC.
Scrip - August 10, 2026
Tenax Sees A Path Forward For TNX-103 Despite Phase III LEVEL Miss
TNX-103 (oral levosimendan) missed the Phase III primary endpoint in pulmonary hypertension associated with HFpEF, but Tenax will seek regulatory input on a path forward in patients with more advanced disease.
Scrip - August 10, 2026
TNX-103 (oral levosimendan) missed the Phase III primary endpoint in pulmonary hypertension associated with HFpEF, but Tenax will seek regulatory input on a path forward in patients with more advanced disease.
Scrip - August 10, 2026
Silence Makes Noise With Positive Divesiran Results In Polycythemia Vera
Phase II results of the siRNA drug showed 88% of patients met the primary endpoint with dosing every 6-12 weeks, presenting competition to Takeda/Protagonist’s rusfertide.
Scrip - August 10, 2026
Phase II results of the siRNA drug showed 88% of patients met the primary endpoint with dosing every 6-12 weeks, presenting competition to Takeda/Protagonist’s rusfertide.
Scrip - August 10, 2026
Jazz Returns To Epilepsy Dealmaking With Actio Acquisition
The company will gain a Phase I/II first-in-class asset for a rare genetic and severe form of epilepsy in exchange for $820m up front and a $500m contingent consideration.
Scrip - August 10, 2026
The company will gain a Phase I/II first-in-class asset for a rare genetic and severe form of epilepsy in exchange for $820m up front and a $500m contingent consideration.
Scrip - August 10, 2026
Pipeline Watch: Three Approvals And Two Phase III Readouts
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - August 10, 2026
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - August 10, 2026
Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: Novo Nordisk weighs bolt-on deals; Bayer slams Germany pricing; Lilly soars despite Foundayo struggles; European biotech wants to leapfrog; and a look at the potential AstraZeneca/BMS combination in APAC.
Scrip - August 10, 2026
In this week's episode: Novo Nordisk weighs bolt-on deals; Bayer slams Germany pricing; Lilly soars despite Foundayo struggles; European biotech wants to leapfrog; and a look at the potential AstraZeneca/BMS combination in APAC.
Scrip - August 10, 2026
RAPID Comment Period Opens Aug. 11, With Post-IDE Eligibility On The Table
The Federal Register notice opening a 60-day comment period on the RAPID coverage pathway publishes Aug. 11. The notice also asks whether manufacturers already running IDE studies should have a temporary route into the program.
Medtech Insight - August 10, 2026
The Federal Register notice opening a 60-day comment period on the RAPID coverage pathway publishes Aug. 11. The notice also asks whether manufacturers already running IDE studies should have a temporary route into the program.
Medtech Insight - August 10, 2026
Interview: UK Healthtech Industry Builds For Further Networking Success In H2 2026
ABHI chief executive Peter Ellingworth summarized a busy first half year of 2026 for UK healthtech, and broached how the government’s reshuffle and new staffing at the industry association can give new impetus to the industry.
Medtech Insight - August 10, 2026
ABHI chief executive Peter Ellingworth summarized a busy first half year of 2026 for UK healthtech, and broached how the government’s reshuffle and new staffing at the industry association can give new impetus to the industry.
Medtech Insight - August 10, 2026
GI Endoscopy Carries Olympus As FDA Ship-Holds And China Test Its Recovery
Olympus's Q1 FY2027 beat — revenue up 16%, adjusted operating margin up 640bps to 12.8% — was driven almost entirely by GI endoscopy and a leaner cost base, but an unresolved FDA warning letter, US import alert and a 17% China decline kept management from touching full-year guidance.
Medtech Insight - August 10, 2026
Olympus's Q1 FY2027 beat — revenue up 16%, adjusted operating margin up 640bps to 12.8% — was driven almost entirely by GI endoscopy and a leaner cost base, but an unresolved FDA warning letter, US import alert and a 17% China decline kept management from touching full-year guidance.
Medtech Insight - August 10, 2026
US FDA Proposes Cutting Self-Affirmed GRAS Without Regulatory Notification
FDA publishes proposed rule to require manufacturers to notify the agency when they conclude the use of a substance added to is GRAS.
HBW Insight - August 10, 2026
FDA publishes proposed rule to require manufacturers to notify the agency when they conclude the use of a substance added to is GRAS.
HBW Insight - August 10, 2026
GSCF Puts Rx-To-OTC Switch At Heart Of Prevention Push
The Global Self-Care Federation's second socio-economic report asks high-income governments to expand Rx-to-OTC switch as part of a wider repositioning of self-care as prevention.
HBW Insight - August 10, 2026
The Global Self-Care Federation's second socio-economic report asks high-income governments to expand Rx-to-OTC switch as part of a wider repositioning of self-care as prevention.
HBW Insight - August 10, 2026
Senate Includes One-Month Delay On Lower THC Limits For Hemp In Continuing Resolution
Senate adds language to continuing resolution to delay imposing lower limit on all forms of THC allowed in lawful hemp rather than 0.3% concentration for delta-9 THC alone used to define de-scheduled hemp in 2018 farm bill.
HBW Insight - August 10, 2026
Senate adds language to continuing resolution to delay imposing lower limit on all forms of THC allowed in lawful hemp rather than 0.3% concentration for delta-9 THC alone used to define de-scheduled hemp in 2018 farm bill.
HBW Insight - August 10, 2026
Regulatory Recap: Biosimilar Legislations Progress In US Congress
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - August 10, 2026
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - August 10, 2026
Indian Panel Urges Full US Tariff Exemption For Generics
An Indian parliamentary committee wants generics fully protected from future US tariff hikes under a bilateral trade deal, while also urging faster mutual recognition agreements, pre-clearance mechanisms and policy support for exposed exporters.
Generics Bulletin - August 10, 2026
An Indian parliamentary committee wants generics fully protected from future US tariff hikes under a bilateral trade deal, while also urging faster mutual recognition agreements, pre-clearance mechanisms and policy support for exposed exporters.
Generics Bulletin - August 10, 2026
Generics Price-Fixing Case Heads To Jury Trial In February 2027
A Connecticut federal judge has fixed a February 2027 jury trial for the sprawling generics antitrust case, while Perrigo has won dismissal of several product claims but remains exposed on a much broader set of alleged conspiracies.
Generics Bulletin - August 10, 2026
A Connecticut federal judge has fixed a February 2027 jury trial for the sprawling generics antitrust case, while Perrigo has won dismissal of several product claims but remains exposed on a much broader set of alleged conspiracies.
Generics Bulletin - August 10, 2026
Eli Lilly Looks To Block US Rivals To Mounjaro
Eli Lilly has sued 14 generic challengers seeking to rival Mounjaro and Zepbound, opening a broad US patent battle over tirzepatide that spans compound, composition and method-of-treatment claims running as late as 2041.
Generics Bulletin - August 10, 2026
Eli Lilly has sued 14 generic challengers seeking to rival Mounjaro and Zepbound, opening a broad US patent battle over tirzepatide that spans compound, composition and method-of-treatment claims running as late as 2041.
Generics Bulletin - August 10, 2026
Execs On The Move: July 2026
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - August 10, 2026
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - August 10, 2026
Deals Shaping The Industry, July 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
Deals Shaping The Industry, July 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026
An interactive look at pharma, medtech and diagnostics deals made during July 2026. Data courtesy of Biomedtracker.
In Vivo - August 10, 2026




