Supplement Industry Backs House Bill With Multiple Tools To Work Around ‘Drug Preclusion’
Rep. Diana Harshbarger’s bill would allow FDA to use administrative orders to approve using otherwise precluded drug or biological product as dietary ingredient and make warnings asserting drug preclusion violations reviewable by courts, with burden of proof on agency.
HBW Insight - September 10, 2026

Biohaven’s Newly Out-Licensed Epilepsy Drug Put On A Partial Clinical Hold
Biohaven said the US FDA put a partial clinical hold on pivotal trials of opakalim (BHV-7000) in focal epilepsy pending further characterization of metabolites observed in nonclinical studies.
Scrip - September 10, 2026

US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post
Michael Davis and Karim Mikhail get permanent titles after months in acting roles, but their tenure may hinge on whether commissioner nominee Heidi Overton is confirmed and whether there are other leadership changes at the top.
HBW Insight - September 10, 2026

Takeda’s Plump To Retire As R&D Head After Shepherding New Drugs To Market
President-R&D Andy Plump will retire in June 2027, with the news coming on the heels of back-to-back FDA drug approvals and the ascendance of a new CEO.
Scrip - September 10, 2026

Bayer’s Hyrnuo Gets First-Line NSCLC Indication, Equal Footing With Hernexeos
The FDA’s accelerated approval of the drug in HER2-mutant NSCLC brings the drug into first-line competition against Boehringer Ingelheim’s Hernexeos.
Scrip - September 10, 2026

Ex-US FDA Chief Counsel Mark Raza Joins Hogan Lovells Cadwalader
Raza spent more than 35 years at the FDA, including four years as chief counsel, before retiring from the agency in spring 2025.
Medtech Insight - September 10, 2026

Cardiovascular’s Harder Second Act
Two cardiovascular outcomes study failures could wipe $3.9bn from cardiovascular pipeline forecasts as Novartis's pelacarsen and Novo Nordisk's ziltivekimab become the latest casualties of a rising standard of care.
In Vivo - September 10, 2026

XCath Robotics Receives FDA Breakthrough Device Designation For Endovascular Robot
XCath Robotics has received FDA breakthrough device designation for its Iris Surgical Robotic System. The product is the only endovascular robotic system under development to achieve intracranial navigation for neurointerventional treatments such as stroke and aneurysm care.
Medtech Insight - September 10, 2026

Sandoz’s Biosimilar Revolution Sets Stage For 100 Products By 2040
At the London Stock Exchange this week, 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. Generics Bulletin delves into the details.
Generics Bulletin - September 10, 2026

Deal By Deal: Warburg Pincus Adds Koye to India Platform Push
Less than two months after acquiring Integrace, Warburg Pincus is believed to have sealed a deal for Koye Pharmaceuticals, sharpening its platform strategy built around women's health and orthopedics.
Scrip - September 10, 2026

PharmaSynergyOTC 2026: The Machine Is A Harder Sell Than The Shopper
AI shopping agents apply a stricter evidence test than human consumers do, Euromonitor's Nick Stene told delegates at the PharmaSynergyOTC conference in Rome, Italy. AI prioritizes the regulatory and third-party signals that shoppers themselves mostly ignore.
HBW Insight - September 10, 2026

Roche Pushes Ahead With Pipeline-In-A-Product Plans For Enspryng
The FDA could soon make the IL-6 inhibitor the first approved drug for myelin oligodendrocyte glycoprotein antibody-associated disease and Enspryng may have three approvals by the end of January.
Scrip - September 10, 2026

Execs On The Move: August 31–September 4, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - September 10, 2026

Medicines For Europe Presses EU To Toughen Procurement Reform
Medicines for Europe has welcomed the EU’s shift toward quality-based procurement but wants tougher medicines-specific rules on tender criteria, multiple sourcing, low bids and supply resilience.
Generics Bulletin - September 10, 2026

As Radiopharma Comes Of Age, Generics Pose A New Kind Of Test
Novartis is betting that complex manufacturing and supply requirements will blunt generic erosion of Lutathera, even as Lantheus and Curium press closer to potential US competition after a sweeping patent defeat.
Generics Bulletin - September 10, 2026

AI Devices Could Get Faster UK Regulation – In Exchange For Lifelong Monitoring
Independent commission asks MHRA to introduce staged authorization, continuous monitoring and tougher enforcement for AI medtech in the UK.
Medtech Insight - September 10, 2026

Execs On The Move: August 2026
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - September 10, 2026

Smartphones Could Detect Alzheimer’s Symptoms To Improve Screening, Blood Tests
Evidence is growing for digital measures of cognitive decline including speech tracking, eye movements and spatial navigation – but pharma skepticism remains.
Medtech Insight - September 10, 2026

Chinese Advanced Molecular Therapy Firms Extend Funding Spree In August
Multiple Chinese ventures including Xianbo, MagicRNA, Siran and Leaderna secure new funding to push ahead with early- or mid-stage clinical studies for their novel assets.
Scrip - September 10, 2026

Kendal Formula Ad Claims For Superiority, Heritage Put In Context After Abbott Challenge
Kendal says its “whole milk recipe” exclusivity claim, which it withdrew during the review, was accurate when its Kendalmil formula reached US in 2022 during formula supply crisis, but “was removed from the marketplace as soon as new market entrants used this ingredient.”
HBW Insight - September 10, 2026

US Parenteral Nutrient Shortage Prompts ‘Temporary Flexibility’ From FDA To Boost Supply
Potential supply disruption is particularly important because currently there are no FDA-approved starter parenteral nutrition drug products, which include dextrose, amino acids and sometimes calcium and patient-specific formulas.
HBW Insight - September 10, 2026