Menu

Latest Pharma Insights



Medicare Set To Expand ACCESS Model With The Addition Of Four Chronic Conditions
CMS plans to add heart failure, COPD, substance use disorders, and nicotine dependence to its ACCESS model this spring. The voluntary program, which was launched in July and uses outcomes-based payments, includes virtual care, remote monitoring, health coaching, and connected devices.
Medtech Insight - September 17, 2026
Finance Watch: VC Mega-Rounds Begin A Comeback In September
Private Company Edition: Five companies revealed $100m-plus venture capital mega-rounds during the first half of September, already matching totals in July and August. Also, Luma Group raised $410m for its first VC fund and Circle Pharma announced a $92.5m series E round.
Scrip - September 17, 2026
Execs On The Move: September 7–11, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - September 17, 2026
Neutrogena BEMT Offerings Capture SPF Shift Into Everyday Skin Care
Kenvue brand Neutrogena leans into sunscreen filter bemotrizinol’s aesthetic properties for its new sunscreen products featuring Cloud-Tech.
HBW Insight - September 17, 2026
OTC Industry Makes First PDUFA Appearance After Months of Behind-the-Scenes Negotiations
FDA commissioner nominee Heidi Overton met with OTC stakeholders earlier this year, signaling Rx-to-OTC switch as a priority in line with the Trump administration's push to expand OTC access.
HBW Insight - September 17, 2026
PharmaSynergyOTC: Bayer Wants Healthspan, Not Multivitamins, From VMS Partners
Bayer Consumer Health's Xiaolan Guo outlined a "live shopping list" at the PharmaSynergyOTC in Rome of what it wants from potential partners, as well as what it will and won't pay a premium for.
HBW Insight - September 17, 2026
Roche’s Lunsumio Beats Rituxan Regimen In Phase III, Advancing Franchise Succession Plan
Roche’s latest Lunsumio data could move the drug into earlier-line follicular lymphoma, and supports the Swiss firm's succession plans for Rituxan.
Scrip - September 17, 2026
Novo And Anthropic Both Have Something To Prove In AI Drug Discovery Alliance
The two companies are looking to catch up with rivals in AI-assisted drug discovery, and want to help train AI to think like a scientist
Scrip - September 17, 2026
Aurobindo Gets FDA Nod For Second Generic QVAR Inhaler
Aurobindo's generic equivalent of Teva's branded QVAR inhaler has gained approval from the US regulator, following complicated legal battles over the originator delaying market entry.
Generics Bulletin - September 17, 2026
Regulatory Pushes To Accept Animal Test Alternatives: What Industry Needs To Know
Industry and regulators have a shared goal of replacing animal drug toxicity models with new approach methodologies where possible, but the road to adoption of novel tools has proven rocky. Several new regulatory initiatives and policies aim to address these historic challenges.
In Vivo - September 17, 2026
Medtronic Hit With Second Class I Recall For Bravo CF Capsule Delivery Device As Injuries Reach 184
The US FDA has escalated Medtronic’s removal of Bravo CF esophageal pH capsule delivery devices to a Class I recall after 184 serious injuries — the second most-serious action on the same device in just over a year, and this time traced to a different root cause.
Medtech Insight - September 17, 2026
Medtech’s Q2 Paradox: Rebounding Deal Activity, Declining Public Valuations
Medtech dealmaking jumped 36% in Q2 2026 even as public valuations fell — strategic buyers and private equity kept writing checks while stock markets marked the sector down, a divergence that is now driving where capital in the industry flows.
Medtech Insight - September 17, 2026
Exelixis Dismisses 505(b)(2) Cabozantinib Rivals As Commercial Threat
Exelixis says 505(b)(2) cabozantinib rivals such as Handa’s Omcazio pose limited commercial risk to Cabometyx, while the originator continues to plan around conventional generic entry from 2031.
Generics Bulletin - September 17, 2026
Hikma Adds Saudi Arabia To Generic Ozempic’s Expanding Footprint
Hikma’s Saudi launch gives it a first-mover position in generic Ozempic, extending OneSource’s semaglutide reach as the manufacturing partner expands capacity to serve growing international demand.
Generics Bulletin - September 17, 2026
In A Push To Build Africa’s Self-Sufficiency, Bio Usawa And Axmed Partner On Biosimilar Procurement
Bio Usawa and Axmed are combining manufacturing and procurement capabilities to reduce biosimilar access barriers in Sub-Saharan Africa, targeting demand aggregation, procurement efficiency, and access-oriented pricing.
Generics Bulletin - September 17, 2026
Opdivo Biosimilar Competition Ramps Up With Dr Reddy’s Launch In India
Further competition has been added to India’s biosimilar nivolumab market, after Dr Reddy’s launched its Nivorz rival to Opdivo.
Generics Bulletin - September 17, 2026
Roivant’s Push To Become More Than A Pipeline Story
With Lisraya now available in the US and mosliciguat entering late-stage testing, Roivant’s focus now shifts to execution, indication expansion and the next set of clinical milestones.
Scrip - September 17, 2026
‘A Tremendous Leader And Advocate For Consumer Health’: Industry Weighs In On Melville’s CHPA Legacy
Colleagues across the US and international self-care community paid tribute to outgoing CHPA CEO Scott Melville, crediting him as the driving force behind key regulatory wins, and praising a leadership style that has earned respect on every continent.
HBW Insight - September 17, 2026
Inside MHRA’s Plans To Build A Global ‘Blueprint’ For AI Regulation
Ricardo Baptista Leite, who helped build plans for a new MHRA AI regulatory framework, discusses the highlights and gaps in the current proposals.
Medtech Insight - September 17, 2026
Bird & Bird’s Baillieu On Venture Debt: ‘It’s Not Appropriate For Every Company’
Funding via growth lending has been taking off in Europe in the past few years. Bird & Bird partner James Baillieu describes when venture debt can form part of a funding strategy for life sciences companies – and why it is only for companies at a certain stage in their development.
In Vivo - September 17, 2026
Kenvue Argues Rules Of Evidence Against Plaintiffs’ Experts Testifying On OTC Acetaminophen Safety
Petition filed in US Second Circuit asking for reconsideration of decision allowing plaintiffs’ experts to testify addresses relevance of Federal Rules of Evidence section on determining whether witnesses should testify as experts.
HBW Insight - September 17, 2026

Finance Watch: VC Mega-Rounds Begin A Comeback In September
Private Company Edition: Five companies revealed $100m-plus venture capital mega-rounds during the first half of September, already matching totals in July and August. Also, Luma Group raised $410m for its first VC fund and Circle Pharma announced a $92.5m series E round.
Scrip - September 17, 2026
Roche’s Lunsumio Beats Rituxan Regimen In Phase III, Advancing Franchise Succession Plan
Roche’s latest Lunsumio data could move the drug into earlier-line follicular lymphoma, and supports the Swiss firm's succession plans for Rituxan.
Scrip - September 17, 2026
Novo And Anthropic Both Have Something To Prove In AI Drug Discovery Alliance
The two companies are looking to catch up with rivals in AI-assisted drug discovery, and want to help train AI to think like a scientist
Scrip - September 17, 2026
Roivant’s Push To Become More Than A Pipeline Story
With Lisraya now available in the US and mosliciguat entering late-stage testing, Roivant’s focus now shifts to execution, indication expansion and the next set of clinical milestones.
Scrip - September 17, 2026

Medicare Set To Expand ACCESS Model With The Addition Of Four Chronic Conditions
CMS plans to add heart failure, COPD, substance use disorders, and nicotine dependence to its ACCESS model this spring. The voluntary program, which was launched in July and uses outcomes-based payments, includes virtual care, remote monitoring, health coaching, and connected devices.
Medtech Insight - September 17, 2026
Execs On The Move: September 7–11, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - September 17, 2026
Medtronic Hit With Second Class I Recall For Bravo CF Capsule Delivery Device As Injuries Reach 184
The US FDA has escalated Medtronic’s removal of Bravo CF esophageal pH capsule delivery devices to a Class I recall after 184 serious injuries — the second most-serious action on the same device in just over a year, and this time traced to a different root cause.
Medtech Insight - September 17, 2026
Medtech’s Q2 Paradox: Rebounding Deal Activity, Declining Public Valuations
Medtech dealmaking jumped 36% in Q2 2026 even as public valuations fell — strategic buyers and private equity kept writing checks while stock markets marked the sector down, a divergence that is now driving where capital in the industry flows.
Medtech Insight - September 17, 2026
Inside MHRA’s Plans To Build A Global ‘Blueprint’ For AI Regulation
Ricardo Baptista Leite, who helped build plans for a new MHRA AI regulatory framework, discusses the highlights and gaps in the current proposals.
Medtech Insight - September 17, 2026

Neutrogena BEMT Offerings Capture SPF Shift Into Everyday Skin Care
Kenvue brand Neutrogena leans into sunscreen filter bemotrizinol’s aesthetic properties for its new sunscreen products featuring Cloud-Tech.
HBW Insight - September 17, 2026
OTC Industry Makes First PDUFA Appearance After Months of Behind-the-Scenes Negotiations
FDA commissioner nominee Heidi Overton met with OTC stakeholders earlier this year, signaling Rx-to-OTC switch as a priority in line with the Trump administration's push to expand OTC access.
HBW Insight - September 17, 2026
PharmaSynergyOTC: Bayer Wants Healthspan, Not Multivitamins, From VMS Partners
Bayer Consumer Health's Xiaolan Guo outlined a "live shopping list" at the PharmaSynergyOTC in Rome of what it wants from potential partners, as well as what it will and won't pay a premium for.
HBW Insight - September 17, 2026
‘A Tremendous Leader And Advocate For Consumer Health’: Industry Weighs In On Melville’s CHPA Legacy
Colleagues across the US and international self-care community paid tribute to outgoing CHPA CEO Scott Melville, crediting him as the driving force behind key regulatory wins, and praising a leadership style that has earned respect on every continent.
HBW Insight - September 17, 2026
Kenvue Argues Rules Of Evidence Against Plaintiffs’ Experts Testifying On OTC Acetaminophen Safety
Petition filed in US Second Circuit asking for reconsideration of decision allowing plaintiffs’ experts to testify addresses relevance of Federal Rules of Evidence section on determining whether witnesses should testify as experts.
HBW Insight - September 17, 2026

Aurobindo Gets FDA Nod For Second Generic QVAR Inhaler
Aurobindo's generic equivalent of Teva's branded QVAR inhaler has gained approval from the US regulator, following complicated legal battles over the originator delaying market entry.
Generics Bulletin - September 17, 2026
Exelixis Dismisses 505(b)(2) Cabozantinib Rivals As Commercial Threat
Exelixis says 505(b)(2) cabozantinib rivals such as Handa’s Omcazio pose limited commercial risk to Cabometyx, while the originator continues to plan around conventional generic entry from 2031.
Generics Bulletin - September 17, 2026
Hikma Adds Saudi Arabia To Generic Ozempic’s Expanding Footprint
Hikma’s Saudi launch gives it a first-mover position in generic Ozempic, extending OneSource’s semaglutide reach as the manufacturing partner expands capacity to serve growing international demand.
Generics Bulletin - September 17, 2026
In A Push To Build Africa’s Self-Sufficiency, Bio Usawa And Axmed Partner On Biosimilar Procurement
Bio Usawa and Axmed are combining manufacturing and procurement capabilities to reduce biosimilar access barriers in Sub-Saharan Africa, targeting demand aggregation, procurement efficiency, and access-oriented pricing.
Generics Bulletin - September 17, 2026
Opdivo Biosimilar Competition Ramps Up With Dr Reddy’s Launch In India
Further competition has been added to India’s biosimilar nivolumab market, after Dr Reddy’s launched its Nivorz rival to Opdivo.
Generics Bulletin - September 17, 2026

Regulatory Pushes To Accept Animal Test Alternatives: What Industry Needs To Know
Industry and regulators have a shared goal of replacing animal drug toxicity models with new approach methodologies where possible, but the road to adoption of novel tools has proven rocky. Several new regulatory initiatives and policies aim to address these historic challenges.
In Vivo - September 17, 2026
Bird & Bird’s Baillieu On Venture Debt: ‘It’s Not Appropriate For Every Company’
Funding via growth lending has been taking off in Europe in the past few years. Bird & Bird partner James Baillieu describes when venture debt can form part of a funding strategy for life sciences companies – and why it is only for companies at a certain stage in their development.
In Vivo - September 17, 2026