Scrip Asia Pacific

Rare Diseases: US FDA Looking For Ways To Increase Appeal Of Randomized Trials

Derrick Gingery — Mon, 14 Sep 2026 17:06:39 +0000

The US Food and Drug Administration is seeking ideas for making randomized trials in rare diseases more attractive for patients and sponsors, an issue that likely will concern advocates pushing for mo

US Vaccine Guidance Paralysis Leaves Moderna’s mFlusiva Without A Launchpad

Aakash Babu — Mon, 14 Sep 2026 17:01:13 +0000

The US Centers for Disease Control and Prevention’s decision to maintain its existing recommendations for seasonal influenza vaccination from the 2025-2026 season raises questions about the potential

What’s Hot, Who’s Buying and Why Valuations Are Diverging In Consumer Health M&A

Tom Gallen — Mon, 14 Sep 2026 16:13:24 +0000

Senior advisors at five of the most active advisory firms in consumer health M&A point to the same underlying dynamic: there are effectively two markets operating right now, and the gap between th

Novo Slims Down Name In Corporate Rebrand And Reset

Andrew McConaghie — Mon, 14 Sep 2026 16:08:25 +0000

Novo Nordisk is rebranding and fostering a new corporate culture, to raise its profile with the public and refresh its appeal to investors after a rocky couple of years. The Copenhagen, Denmark-headqu

No Surprise As SERENA-4 Serves Up A Miss For AstraZeneca’s Etcamah

Kevin Grogan — Mon, 14 Sep 2026 14:57:58 +0000

AstraZeneca has suffered its third high-profile Phase III setback in recent months but the failure of its recently approved oral selective estrogen receptor degrader (SERD) Etcamah in a pivotal first-

Better Data, Second Chance? – Philogen Resubmits Melanoma Drug Nidlegy To EMA

Neena Brizmohun — Mon, 14 Sep 2026 14:11:26 +0000

Philogen has renewed its bid for pan-EU approval of its investigational neoadjuvant treatment for melanoma, Nidlegy (bifikafusp alfa/onfekafusp alfa). It has resubmitted its marketing authorization ap

Germany: Will EU Joint Clinical Assessments Drive More Comparative Studies?

Francesca Bruce — Mon, 14 Sep 2026 14:03:10 +0000

After completing 1,000 assessments of the benefits new drugs offer over alternative treatment options, IQWiG, the German health technology assessment (HTA) body, says pharmaceutical companies still ro

Scrip Asks... What Does 2026 Hold For Biopharma? Part 2: Competitive Dynamics -A Landscape Reshaped

Mon, 14 Sep 2026 13:29:38 +0000

The competitive landscape in biopharma is undergoing a significant shift as new forces challenge established approaches to innovation and growth. China’s emergence as an innovation powerhouse, advance

Pipeline Watch: One Approval And Three Phase III Readouts

Mon, 14 Sep 2026 12:22:42 +0000

The table above records the past week’s major catalyst events that occurred in the late-stage pipeline during the past week (see table for relevant dates), created using Citeline’s Biomedtracker . Th

Impose Tariffs Or Fix The Oncology Drug Shortage – The US Can’t Do Both

Vibha Ravi — Mon, 14 Sep 2026 12:08:54 +0000

US President Donald Trump’s proposed tariffs on generics is likely to not only burden manufacturers but also add to the problems facing the country’s cancer care centers, as latest data from the N

Advicenne Withdraws US 505(b)(2) Application For A Rare Kidney Disease Drug

Urtė Fultinavičiūtė — Mon, 14 Sep 2026 11:09:21 +0000

In a surprising move, Advicenne has voluntarily withdrawn its US application for Sibnayal (potassium citrate/potassium bicarbonate), three days before US Food and Drug Administration’s decision was su

EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver

Dean Rudge — Mon, 14 Sep 2026 10:30:29 +0000

European biosimilars manufacturers could gain significantly more freedom to build up stocks ahead of originator protection expiry after the European Parliament’s Legal Affairs Committee (JURI) backed

Amgen Leads The Pack With First Filing For US Opdivo Biosimilar

Dave Wallace — Mon, 14 Sep 2026 10:30:13 +0000

Amgen has revealed a US Food and Drug Administration filing for an Opdivo (nivolumab) biosimilar as well as an imminent submission for a Keytruda (pembrolizumab) rival by the end of the year, putting

A Blood Test Rewrites The Economics Of Alzheimer’s Diagnosis

Palani Kumaresan — Mon, 14 Sep 2026 08:51:26 +0000

For decades, confirming the amyloid pathology behind Alzheimer’s has meant a PET scan or a lumbar puncture in a specialist clinic — and roughly three in four patients never got that far. The US FDA’s

PharmaSynergyOTC: Rx-To-OTC Switch Should Be About Women’s Empowerment

David Ridley — Mon, 14 Sep 2026 08:49:35 +0000

Reclassification in women’s health is not just a commercial exercise that happens to help women, Cemag Care’s chief business officer, Clémence Desjardin, told delegates at the PharmaSynergyOTC confere

WCLC 2026: GSK Sees The Start Of A Lung Cancer Franchise

Andrew McConaghie — Mon, 14 Sep 2026 08:42:34 +0000

GSK’s return to oncology is moving up a gear after two novel assets generated strong data at a lung cancer congress, with the firm confident that these could lay the foundations for a highly competiti

WCLC 2026: Hansoh And GSK’s Ris-Rez Comes Out On Top In SCLC

Andrew McConaghie — Mon, 14 Sep 2026 08:39:19 +0000

Hansoh and GSK’s ris-rez (risvutatug rezetecan) has significantly extended survival in small-cell lung cancer patients in a Phase III study, leading analysts to hail it as a potential next standard-of

Premium Pricing And Brand Loyalty Face AI Reckoning In Consumer Health

Tom Gallen — Mon, 14 Sep 2026 08:36:04 +0000

Artificial intelligence is transforming how consumers search for and select healthcare products but this may not be to the benefit of the industry’s established players. While the technology promises

WCLC 2026: Phase III Overall Survival Win In SCLC For MediLink’s ADC

Xu Hu — Mon, 14 Sep 2026 08:33:26 +0000

The China Phase III TAISHAN-302 trial with MediLink Therapeutics’s anti-B7-H3 antibody-drug conjugate (ADC) tambotatug pelitecan (tam-peli) in relapsed small cell lung cancer (SCLC) met its primary an

FDA Consumer Health Advisory: Industry Titan Leaves Lasting Legacy

Malcolm Spicer|Tom Gallen — Mon, 14 Sep 2026 08:29:33 +0000

Peter Barton Hutt What is happening : Peter Barton Hutt’s accomplishments as the principal author of modern US food and drug regulation included leading the launch of the Food and Drug Administration