Biopharma Dealmaking Should Accelerate In 2026, PwC Predicts
The bigger biopharma M&A deals seen particularly during the second half of 2025 should continue into 2026, PwC said, driven by LOEs and a more precision-driven process.
Scrip - December 16, 2025

GAO Says Lack Of Staff And Regulatory Authority Hamper FDA From Effectively Managing Device Recalls
As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.
Medtech Insight - December 16, 2025

OrsoBio To Advance TLC-6740 After Successful Obesity Combo Trial
The California firm announced positive data from its early-stage randomized study of TLC-6740 combined with Lilly’s tirzepatide in patients with obesity.
Scrip - December 16, 2025

Pfizer Stands By Vaccines Investment Despite Political ‘Anomaly’
“We are not going back to Pasteur,” CEO Albert Bourla said, criticizing the US government’s current anti-vaccine rhetoric.
Scrip - December 16, 2025

Pfizer ’26 Guidance Puts Emphasis On The Long Term For A Return To Growth
The big pharma’s 2026 revenue guidance of $59.5bn-$62.5bn is roughly flat with what is expected in 2025, and EPS guidance is below analyst expectations.
Scrip - December 16, 2025

Commission’s Device Regulation Revision Promises 25%-35% Cost Savings For MedTech
The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.
Medtech Insight - December 16, 2025

MHRA Targets IVD Roadmap Goals From Q3 2026
Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.
Medtech Insight - December 16, 2025

Venture Life Offloads Oral Care Assets To Focus on Power Brands
Covestus Holdings will pay £4.3m to acquire UK-based Venture Life’s oral care brands Ultradex and Dentyl.
HBW Insight - December 16, 2025

Abivax Q3 Results Fail To Dampen M&A Speculation
The France-based biotech is making solid progress amid mounting talk of a sale.
Scrip - December 16, 2025

Third-Party Audit Results ‘Definitely The Direction’ For FDA Supplement Facility Inspection Planning
“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.
HBW Insight - December 16, 2025

Stock Watch: Regeneron Caught Between Success And Expiry
Regeneron epitomized best biotech practice by licensing its multi-blockbuster drugs to big pharma partners. Commercial success and the limitations of exclusivity have brought tensions to these relationships.
Scrip - December 16, 2025

Civica Secures Federal Supply Schedule Deal With US Veterans Health System
Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.
Generics Bulletin - December 16, 2025

Amphastar Cracks Forteo With FDA Approval After Years of Delays
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
Generics Bulletin - December 16, 2025

Stada-Bio-Thera Chase Alvotech-Advanz In Early EU Golimumab Biosimilar Market
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
Generics Bulletin - December 16, 2025

Sanofi Returns To Familiar Territory With New Dren Bio Pact
After buying the rights to Dren Bio’s lead candidate, DR-0201, in March, Sanofi has again tapped the start-up for a new drug discovery and development agreement for a potential new autoimmune therapy.
Scrip - December 16, 2025

EU’s Breakthrough Technologies Guidance: A Milestone For Medtech Innovation
New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.
Medtech Insight - December 16, 2025

Sanofi Lands ADEL’s Tau-Targeting Alzheimer’s Contender In $1Bn Deal
Despite recent setbacks in the field, big pharma still appears to have faith in the tau approach to Alzheimer's, as evidenced by Sanofi's new $1bn-plus deal with Korean venture ADEL for an early stage candidate.
Scrip - December 16, 2025

US FDA Makes Enforcement Discretion Official For Accepted Supplement Label Disclaimer Practice
“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.
HBW Insight - December 16, 2025

GLP-1 Sales and Fails Could Actually Inflate Gastric Balloon Market
Shantanu Gaur, CEO of Allurion Technologies, a company that has developed a swallowable gastric balloon, believes that GLP-1 sales could indirectly lead to increased demand for medical device-based bariatric procedures, especially as patients seek alternatives to drug side effects and weight regain.
Medtech Insight - December 16, 2025

In Brief: InnoCare’s BTK Inhibitor For SLE Hits Primary Endpoint In World-First
Clinical Data Readout: As a worldwide first mover, InnoCare’s BTK inhibitor orelabrutinib has hit its monotherapy primary endpoint of SRI-4 response rate at 48 weeks in a China-only Phase IIb trial in systemic lupus erythematosus.
Scrip - December 16, 2025

Immunome’s Phase III Varegacestat Data Show Best-In-Class Potential In Desmoid Tumors
Phase III results for gamma secretase inhibitor varegacestat in the treatment of desmoid tumors appear superior on both efficacy and safety to Merck KGaA’s Ogsiveo (nirogacestat).
Scrip - December 16, 2025