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NAD’s Stronger State AG Ties Give Self-Regulation New Accountability Muscle
The National Advertising Division discusses its new or strengthened partnerships with recipient organizations to improve the advertising challenge process as well as procedural changes during a Sept. 28 session of its ‘Ad Law In Motion” annual conference.
HBW Insight - October 1, 2026
Life’s ‘Easier’ Using US FDA Draft Guidance On Manufacturers’ Form 483 Inspection Responses
Draft guidance “talks about things that'll make your life easier and our lives easier,” says CDER Manufacturing Quality director Francis Godwin. Warnings increase every year to foreign OTC firms have been “making for other markets where there are no requirements.”
HBW Insight - October 1, 2026

AbbVie Has Eye On Dupixent And Ebglyss As It Readies Zumilokibart For Phase III
With new Phase II atopic dermatitis data for the IL-13 blocker, AbbVie plans to compete with Dupixent and Ebglyss in first-line treatment, with AbbVie’s Rinvoq positioned for second-line.
Scrip - September 30, 2026
BMS Keeps Its Cardiomyopathy Lead, For Now, With Camzyos Pediatric Indication
The US FDA approved Camzyos (mavacamten) for pediatric patients with obstructive hypertrophic cardiomyopathy, giving the drug the broadest label of any cardiac myosin inhibitor.
Scrip - September 30, 2026
Lilly’s Ebglyss To Take On Dupixent In Hand, Foot Atopic Dermatitis
The drugmaker presented Phase IIIb data for the IL-13 inhibitor at EADV in patients with atopic dermatitis with hand and foot involvement and has filed for a labeling update with the FDA.
Scrip - September 30, 2026
Merck & Co.’s Phase II For Tulisokibart Is A First For TL1A In Dermatology
TL1A inhibition is a competitive area of R&D. Merck has the lead in IBD with tulisokibart, and new Phase II data support a role for the drug in hidradenitis suppurativa.
Scrip - 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
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
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
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
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

From IVF To At-Home Testing: How Elective Egg-Freezing Is Redrawing Fertility Medtech
PwC projects the global fertility market will reach $45bn by 2030, driven by a shift from treating infertility to elective egg-freezing. The trend is reshaping medtech, diagnostics, AI tools and workforce planning across the sector.
Medtech Insight - September 30, 2026
Consumer Rep Spots Open On 15 Of 18 FDA Device Panels, Including Circulatory and Neurological
The FDA has opened recruitment for voting and nonvoting device advisory committee members, with consumer representative spots available on 15 of 18 panels — part of an apparent effort to reverse a sharp drop in panel activity.
Medtech Insight - 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
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

NAD’s Stronger State AG Ties Give Self-Regulation New Accountability Muscle
The National Advertising Division discusses its new or strengthened partnerships with recipient organizations to improve the advertising challenge process as well as procedural changes during a Sept. 28 session of its ‘Ad Law In Motion” annual conference.
HBW Insight - October 1, 2026
Life’s ‘Easier’ Using US FDA Draft Guidance On Manufacturers’ Form 483 Inspection Responses
Draft guidance “talks about things that'll make your life easier and our lives easier,” says CDER Manufacturing Quality director Francis Godwin. Warnings increase every year to foreign OTC firms have been “making for other markets where there are no requirements.”
HBW Insight - October 1, 2026

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
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
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

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