Medtech Insight RSS Feed - Infectious Diseases

Biosimilar Streamlining Takes A Further Step Forward In Europe

Dave Wallace — Fri, 03 Apr 2026 15:00:00 +0000

Almost a year to the day since the European Medicines Agency published a landmark draft reflection paper on streamlining the development and assessment of biosimilar medicines, the agency has formal

Trump 100% Tariffs On Drugs Make Big Pharma’s Negotiations A Smart Play

Jessica Merrill — Thu, 02 Apr 2026 22:45:25 +0000

The Trump administration announced 100% tariffs on some pharmaceuticals and pharmaceutical ingredients imported into the US on April 2 following a year-long Section 232 investigation into the sector.

US FDA Approval Output Still Not Showing Impact Of Departures

Derrick Gingery — Thu, 02 Apr 2026 20:00:56 +0000

The US Food and Drug Administration’s new and generic drug application approval output has not waned much in the wake of substantial personnel changes. NDA and BLA approval counts appears to have drop

Most Favored Nation Pricing Deals, Demos Complicate Medicare Negotiation Prospects

Cathy Kelly — Thu, 02 Apr 2026 19:59:56 +0000

The Trump Administration’s Most Favored Nation pricing initiative will complicate the operation of the Medicare price negotiation program and muddy efforts for stakeholders to predict outcomes, accord

US MFN Policies Are Driving The Need For Better RWE

Francesca Bruce — Thu, 02 Apr 2026 13:51:18 +0000

US most favored nations (MFN) drug pricing policies are driving the need for higher quality real-world evidence (RWE) that will help companies show the value of their products, said Mark Larkin, chief

EMA Explains How To Assess Quality Of RWD Used In Regulatory Submissions

Neena Brizmohun — Thu, 02 Apr 2026 13:40:45 +0000

The European Medicines Agency has published guidance on how to assess the quality of real-world data (RWD), and thereby enable regulators to evaluate the quality of data underpinning real-world eviden

The One-Day FDA: US Commissioner Sees Drastic Time Savings In Filing, Inspections

Bridget Silverman — Wed, 01 Apr 2026 23:09:57 +0000

The US Food and Drug Administration’s artificial intelligence tool will reshape the earliest stage of application review, cutting the filing review period of 60 days from submission to “a matter of mi

FDA Says Lilly’s Foundayo Approved In Record Time

Alaric DeArment|Mary Jo Laffler — Wed, 01 Apr 2026 20:35:09 +0000

The oral obesity market competition is about to take off, with the US Food and Drug Administration’s approval of Lilly’s Foundayo (orforglipron) on April 1 for adults with obesity or overweight with w

MFN: England’s HTA Appraisals ‘Hold Steady’ For Now

Francesca Bruce — Wed, 01 Apr 2026 13:25:25 +0000

Despite uncertainty about how US most favored nations (MFN) drug pricing policies will impact global launch strategies, health technology appraisals conducted by NICE, the HTA institute for England an

EU Critical Medicines Act: What You Need To Know

Anabel Costa-Ferreira|Eliza Slawther — Wed, 01 Apr 2026 12:51:57 +0000

EU CHMP Opinions And MAA Updates

Neena Brizmohun — Wed, 01 Apr 2026 12:45:27 +0000

The European Medicines Agency’s key scientific panel, the Committee for Medicinal Products for Human Use (CHMP), meets once a month and among other things adopts positive or negative opinions on EU ma

Why India Is Considering The Essential Commodities Act For Pharma Amid Iran War

Vibha Ravi — Wed, 01 Apr 2026 08:53:54 +0000

The war between the US-Israel coalition and Iran might prompt the Indian government to invoke the Essential Commodities Act to maintain equitable distribution and availability of pharmaceutical raw ma

Wegovy Becomes First GLP-1 Inhibitor To Win English Funding For Preventing Heart Attacks And Strokes

Neena Brizmohun — Wed, 01 Apr 2026 06:37:56 +0000

Around 1.2 million people in England and Wales could use Novo Nordisk’s Wegovy (semaglutide) to help protect them against having further heart attacks or strokes, after the health technology assessmen

US FDA Biomarker Qualification Process Improving, But Workload Remains An Issue

Grace Moser — Wed, 01 Apr 2026 06:33:58 +0000

Participants in the effort to qualify bone mineral density as a validated surrogate endpoint for osteoporosis are optimistic future efforts to use the US Food and Drug Administration qualification pat

MFN Dealmaker Exemption From GLOBE, GUARD Models Needs Separate Rulemaking, CMS Told

Cathy Kelly — Tue, 31 Mar 2026 21:01:15 +0000

The US Centers for Medicare and Medicaid Services may need to initiate new rulemaking to officially exempt the 16 large manufacturers that made Most Favored Nation pricing deals from mandatory partici

Boehringer Issues Warning To Innovation-Unfriendly Europe

Kevin Grogan — Tue, 31 Mar 2026 12:56:33 +0000

Boehringer Ingelheim chairman Shashank Deshpande has added his voice to the industry heavyweights in urging European countries to incentivize scientific innovation to prevent the continent slipping fu

A Look Behind Japan’s ‘Lost Decade’ Of HPV Vaccination

Lisa Takagi — Tue, 31 Mar 2026 07:04:19 +0000

Japan’s human papillomavirus (HPV) vaccination rate is rising slowly, but is still lower compared to other developed countries such as the US and the UK, held back by lingering hesitancy and concerns

Regulatory Hold For China’s Most Advanced Domestic Semaglutide Biosimilar Over ‘Data Protection’

Dexter Jie Yan — Tue, 31 Mar 2026 05:43:22 +0000

China’s most advanced biosimilar referencing Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic/Wegovy (semaglutide) has been suspended from regulatory review and approval in the country,

US FDA’s April User Fee Goals Give Biologics Center A Chance To Shift 2026 Narrative

Bridget Silverman — Tue, 31 Mar 2026 04:37:23 +0000

After posting its first novel approval of 2026 on March 26, the US Food and Drug Administration’s Center for Biologics Evaluation and Research is looking at two more decisions on novel biologics in qu

340B Providers Expect US Medicare Payment Cuts In 2027 Amid Payment Pilot Questions

Michael McCaughan — Tue, 31 Mar 2026 04:36:13 +0000

Safety net providers are expecting the US Centers for Medicare and Medicaid Services to propose reduced payment for drug purchases using the 340B drug discount in Medicare Part B. “We are expecting in