Cullinan/Taiho’s Zipalertinib Ready To Challenge Rybrevant In NSCLC
Strong PFS data and oral convenience may enable zipalertinib to compete against J&J’s bispecific Rybrevant in NSCLC patients with EGFR exon 20 mutations.
Scrip - September 14, 2026

Scholar Rock Bringing First SMA Add-On Treatment To US Patients, At $310,000 Net Cost
The US FDA approved the myostatin inhibitor Isembyld (apitegromab) on top of SMN-targeted therapies for spinal muscular atrophy. Its wholesale acquisition cost is more than $450,000 per year.
Scrip - September 14, 2026

WCLC 2026: Enhertu Stands To Expand Into First-Line HER2-Mutant NSCLC
AstraZeneca and Daiichi Sankyo’s HER2-targeting ADC showed a PFS benefit in first-line treatment of HER2-mutant non-small cell lung cancer at the World Conference on Lung Cancer.
Scrip - September 14, 2026

Sanofi Shifts Mature Brands To Cheplapharm, In Line With Big Pharma Trend
Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood thinner Lovenox (enoxaparin), in a strategic partnership.
Scrip - September 14, 2026

Novo Slims Down Name In Corporate Rebrand And Reset
After a troubled few years, the Denmark-headquartered firm is to shorten its name to simply 'Novo' and sharpen its corporate culture, though some investors believe major M&A would be the real answer to its problems.
Scrip - September 14, 2026

No Surprise As SERENA-4 Serves Up A Miss For AstraZeneca’s Etcamah
Just days after securing FDA approval in a narrowly defined indication, the oral SERD failed to show significant improvement in progression-free survival in a Phase III first-line study.
Scrip - September 14, 2026

Scrip Asks... What Does 2026 Hold For Biopharma? Part 2: Competitive Dynamics -A Landscape Reshaped
Key opinion leaders share their perspectives on the competitive dynamics reshaping the biopharma industry in 2026.
Scrip - September 14, 2026

Pipeline Watch: One Approval And Three Phase III Readouts
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - September 14, 2026

WCLC 2026: GSK Sees The Start Of A Lung Cancer Franchise
For many years GSK insisted that it would only target specialist oncology indications but it is now looking to build a broad portfolio in lung cancer
Scrip - September 14, 2026

WCLC 2026: Hansoh And GSK’s Ris-Rez Comes Out On Top In SCLC
Impressive Phase III results from China put the B7-H3–targeting ADC in the driving seat in second line small-cell lung cancer, with GSK aiming to replicate the survival improvement in a global study.
Scrip - September 14, 2026

WCLC 2026: Phase III Overall Survival Win In SCLC For MediLink’s ADC
MediLink’s B7-H3-targeted antibody-drug conjugate tambotatug pelitecan achieves overall survival and progression-free survival benefits in Chinese patients with relapsed small cell lung cancer.
Scrip - September 14, 2026

Rakuten Fortifies Global Expertise With Ex-Takeda CEO Weber
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026

Quick Listen: Scrip’s Five Must-Know Things
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026

FDA Cor MDx Clearance Puts Peerbridge’s Predictive Health Ambitions Within Reach
Peerbridge plans to introduce its newly FDA-cleared second-generation Cor MDx patch for detecting heart arrythmias to health systems and heart specialists in New York, Kansas and Southern California. Trials are underway for ejection fraction, sleep detection and other cardiac indications.
Medtech Insight - September 14, 2026

German IVD Industry Targets Late 2027 For Revised EU Regulation
VDGH chief executive Martin Walger is putting his hopes on positive EU trilog outcomes regarding the IVDR and MDR amendments, and resulting legislation possibly in place by the end of 2027 – albeit an ambitious timeline.
Medtech Insight - September 14, 2026

TAVR Coverage Expansion A Boost For Medicare Beneficiaries And Edwards Lifesciences
Medicare has finalized expanded coverage for TAVR, including certain asymptomatic patients with severe aortic stenosis, while removing coverage with evidence development requirements for symptomatic patients. Analysts say the decision could boost TAVR volumes and benefit its leading manufacturer.
Medtech Insight - September 14, 2026

Certifications Over Speed: Tandem Health’s $100m Strategy To Win European AI
Tandem's $100m funding will be used to accelerate the adoption of AI across European healthcare, expanding from an AI medical assistant to an AI-native clinic operating system and doubling down across European markets.
Medtech Insight - September 14, 2026

Leaky Roof, Other Risks At Abbott Infant Formula Plant Linked To $385M False Claims Settlement
Abbott closes one door on its infant formula problems linked to a widespread recall and supply crisis in the US but still faces class action complaints alleging harm from the products.
HBW Insight - September 15, 2026

Arizona Lawsuit Against L’Oréal Places Hair Relaxer Health Risk Back in Spotlight
Arizona’s lawsuit against L’Oréal USA, Inc. and associated companies alleges the company concealed cancer risks tied to chemical hair relaxers marketed to women and girls of African descent.
HBW Insight - September 15, 2026

Advicenne Withdraws US 505(b)(2) Application For A Rare Kidney Disease Drug
Despite satisfying other regulators, Advicenne cited CMC-related requirements in its decision to withdraw its US application for Sibnayal (potassium citrate/potassium bicarbonate).
Generics Bulletin - September 14, 2026

EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver
The EU’s JURI committee has backed removing the six-month stockpiling limit for biosimilars under the SPC waiver, a move welcomed by Medicines for Europe as a boost to EU manufacturing, competition and day-one market entry.
Generics Bulletin - September 14, 2026

Amgen Leads The Pack With First Filing For US Opdivo Biosimilar
Amgen has revealed the first disclosed Opdivo (nivolumab) biosimilar filing with the US FDA, while also pointing to an imminent US submission for a Keytruda (pembrolizumab) rival by the end of the year, following positive trial readouts.
Generics Bulletin - September 14, 2026

A Blood Test Rewrites The Economics Of Alzheimer’s Diagnosis
When a simple blood test can reduce reliance on complex, costly procedures and onward referral, specialist resources and expertise can be spent where they make the greatest difference.
In Vivo - September 14, 2026

Graveyard Drug Hunters: How Racura And Cereno Are Repurposing Drugs That Pharma Threw Away
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026