Teva Completes US Denosumab Set With Xgeva Biosimilar Nod
Teva is gearing up to enter the US denosumab market within months after receiving FDA approval for an Xgeva biosimilar, complementing its earlier nod for a Prolia equivalent. But with 10 denosumab rivals approved in the US, how does the firm plan to make a dent in such a competitive market?
Generics Bulletin - September 30, 2026

Vanda’s Hetlioz Expansion Push Faces A New Test After FDA Setbacks
Vanda is preparing another FDA bid to expand Hetlioz’s label, even as generic erosion and a complicated regulatory history cast a shadow over the aging franchise.
Scrip - September 30, 2026

EU Aligns Safety Reporting For Combined Drug-IVD/Device Studies, But Double Reporting Persists
New EU guidance aims to simplify safety reporting for studies of products that combine a drug and diagnostic or a drug and medical device, but sponsors still face duplicate reporting requirements for serious adverse events under separate frameworks.
Medtech Insight - September 30, 2026

Lilly’s Amylin Combo Could Be Best Weight Loss Drug Yet
The company looks to have raised the bar once more with Phase II results from its tirzepatide and eloralintide two-in-one product, although a high drop-out rate in some study arms raises tolerability questions.
Scrip - September 30, 2026

EU Medtech AI Regulation Still Has A Long Way To Go, Scientists Say
Report from EU policy advisory bodies says that more guidance is needed to provide strong AI medtech regulation under the AI Act and MDR.
Medtech Insight - September 30, 2026

Minoryx Eyes Pipeline-In-A-Product Prospects For Nezglyal After EU Okay
The Spanish biotech has big plans for its potential CNS blockbuster, CEO Marc Martinell tells Scrip.
Scrip - September 30, 2026

US Again Pushes For Domestic Generic Reshoring As Industry Questions Market Viability
A new market research inquiry into US production of essential generics builds on a recent Senate hearing advocating a 180-day exclusivity reform and country-of-origin labelling. However, industry witnesses warn economics must change first.
Generics Bulletin - September 30, 2026

Omega-3, Beta-Glucan Supplements Could Save EU Health Systems Billions in Cardiovascular Costs
Food Supplements Europe study finds omega-3 and beta-glucan supplementation could deliver tens of billions in annual EU healthcare savings, with returns of up to €7.77 per €1 spent, supporting calls for supplements to feature in national cardiovascular health strategies.
HBW Insight - September 30, 2026

Quotables: Pharma Leaders On The Month’s Hot Topics
The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
Scrip - September 30, 2026

UK Risks Getting Left Behind As Biosimilar Void Looms
In a report taking stock of the UK biosimilars market, Medicines UK recognizes success driving uptake and savings, but warns that without decisive action the country could get left behind as manufacturers prioritize more profitable markets such as the EU and US.
Generics Bulletin - September 30, 2026

GSK’s Zejula Faces Patent Challenge By Natco In India
GSK’s rising oncology ambitions face headwinds in India, with Natco challenging the validity of the patent underpinning ovarian cancer drug niraparib, seeking that it be quashed.
Scrip - September 30, 2026

Amgen Readies Daxdilimab For Phase III In Discoid Lupus After Mid-Stage Trial
Positive Phase II results for the ILT7-targeting antibody daxdilimab in discoid lupus erythematosus were presented at the EADV meeting. Preparations are underway for registrational studies.
Scrip - September 30, 2026

Oncology’s Blind Spot: Measuring Tumor Shrinkage, While Patients Die From Metastasis
Oncology drug development is built to reward tumour shrinkage, yet metastasis kills most patients. Closing this blind spot means testing invasion biology and tolerability far earlier.
In Vivo - September 30, 2026

Sandoz Aims High To Cement Biosimilars Leadership With ‘Bio100’ Strategy
At its capital markets day at the London Stock Exchange earlier this month, Sandoz set out plans to have 100 biosimilars in its portfolio by 2040, to double its sales between 2025 and 2035, and to invest heavily in biosimilar manufacturing to capture the benefits of vertical integration.
In Vivo - September 30, 2026

Reorganization Cuts US FDA Chief Counsel Oversight Position At HHS
HHS eliminated the chief counsel for food, research and drugs, which oversaw legal services for FDA and NIH.
HBW Insight - September 30, 2026