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

Flow Neuroscience Launches At-Home, FDA-Approved Brain Stimulation Device For Depression In US
Flow Neuroscience launched its FDA-approved at-home tDCS device FL-100 in the US this week at a patient cost of $2,200 for an initial 10-week course and $325 for every additional four weeks of treatment.
Medtech Insight - September 11, 2026

CDRH Moves To Close Rare Disease Device Gap With New Initiative And Device List
CDRH’s Rare Disease Impact Initiative seeks to advance the development and authorization of devices to treat rare diseases. The effort aims to address development challenges, identify unmet device needs, strengthen collaboration, and provide resources including a Rare Disease Medical Device List.
Medtech Insight - September 11, 2026

German Industry Assesses Reimbursement And Health Reform Challenges As Bundestag Resumes
The German health system is broaching self-pay for certain diagnostics in certain settings. On one hand, it widens access, but on the other, patients’ inability or reluctance to pay might become a stumbling block.
Medtech Insight - September 11, 2026

FDA Approval In Hand, Implantica Prepares To Launch Mechanical GERD Fix In US
Implantica is launching RefluxStop in the US after a PMA approval that was based entirely on European trial data. A Medicare pass-through decision is expected in six to 12 months.
Medtech Insight - September 11, 2026

Bridge To Life’s $110m Bet On Making Hypothermic Perfusion —And Viability Testing— Standard Of Care
Bridge to Life closed a $110m Series C to fund a US commercial push for VitaSmart, its cold HOPE perfusion system, betting a simpler, cheaper workflow undercuts NMP rivals — with an FMN viability diagnostic, still in validation, as the intended moat.
Medtech Insight - September 11, 2026

Plaque Plus Physiology: Elucid’s $55m Series D Funds A Two-Front Coronary AI Push
Elucid has closed a $55m Series D to back a two-product platform strategy in coronary CT analysis — one tool measuring plaque already cleared, one measuring blood flow still under FDA review.
Medtech Insight - September 11, 2026

Diagnostics Firms Expect German Health Minister To Deliver On Market Access And ‘Dialog’ Agenda
Martin Walger sees change ahead for the German diagnostics industry, whose interests he has represented as head of the VDGH industry association since 2009. In a series of interviews, he describes an industry coping with financial realities, the EU IVDR, and first, adjusting to a new health minister
Medtech Insight - September 11, 2026

PharmaSynergyOTC: Rx-To-OTC Switch Should Be About Women’s Empowerment
Cemag Care's Clémence Desjardin told PharmaSynergyOTC delegates in Rome that switch is women's health's answer to decades of structural underinvestment, and set out the four dimensions behind the firm's 2025 reclassification of tranexamic acid in France.
HBW Insight - September 14, 2026

Premium Pricing And Brand Loyalty Face AI Reckoning In Consumer Health
AI is making product ingredients and price differentials more transparent, threatening the premium pricing strategies and brand loyalty that underpin much of the consumer health industry, according to Jefferies analyst David Hayes.
HBW Insight - September 14, 2026

FDA Consumer Health Advisory: Industry Titan Leaves Lasting Legacy
What's happening, why it matters and what's next at FDA. This edition explores Peter Barton Hutt's legacy, an infant formula dispute and exceptions to the drug preclusion impediment to introducing new dietary ingredients.
HBW Insight - September 14, 2026

Xlear Complaint Making Loper Bright Argument In Challenge To FTC Health Claim Policy Dismissed
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 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