Amgen Confident In Cardiometabolic Pipeline After Novartis’s Negative Lp(a) Readout
Amgen has not written off its Lp(a) inhibitor olpasiran after Novartis’s pelacarsen failure, but R&D leader James Bradner told a Morgan Stanley conference the company is awaiting detailed data to understand potential implications.
Scrip - September 16, 2026

RAPS Convergence: CDRH Stability Faces New Test As Center Begins To Rebuild Depleted Staff
Industry analysts at RAPS Convergence said CDRH has weathered 2025's turbulence well, but onboarding a large new cohort with weakened internal infrastructure poses fresh risks.
Medtech Insight - September 16, 2026

Novartis’s VHB937 Latest To Join ALS Clinical Development Graveyard
The Swiss drugmaker said it would discontinue development of the drug in amyotrophic lateral sclerosis after it failed to show efficacy in the Phase II ASTRALS trial.
Scrip - September 16, 2026

Big Pharma CEOs Outline US Policy Goals Heading Into Midterm Elections
Leaders at Merck & Co., Pfizer, Johnson & Johnson and AbbVie appear to see potential upside from US policies at the moment, pointing to PBM and 340B reform and US trade investigations as encouraging.
Scrip - September 16, 2026

FDA Rejects Harrison.ai Request To Exempt Some Radiology AI From 510(k) Requirements
The FDA has denied a request from an Australian firm to exempt four types of radiology AI software from 510(k) requirements under certain circumstances. The agency said the firm did not demonstrate that 510(k) review was not needed to ensure the safety and effectiveness within these categories.
Medtech Insight - September 16, 2026

Digital Health Roundup: Oura Plans IPO, FDA’s Home Health, Digital Tools For Alzheimer’s Detection
In this month: Marion Webb highlights Oura’s IPO, new partnerships, and a class-action lawsuit. George Underwood discusses digital tools for early Alzheimer’s detection and Brian Bossetta FDA’s READI-Home Innovation Challenge. Shubham Singh interviews AI longevity firm BAiO.
Medtech Insight - September 16, 2026

Deals In Depth: August 2026
Three $1bn+ alliances were penned in August, and two exceeded $2bn. In the top alliance by deal value, Hanmi entered into a potential $2.3bn agreement with Genentech.
In Vivo - September 16, 2026

‘Ozempic Face’ Is Great Marketing. It Can Also Be A Drug Claim
Guest article: The line between marketing beauty products to GLP-1 users and making a drug claim is shorter than most marketing teams expect — and much harder to draw once a strategy has already been built on top of it, writes Marcha I. Chaudry, regulatory attorney and founder of Equity Wellness Co.
HBW Insight - September 16, 2026

Sling Raises $123m As It Takes Oral TED Drug Contender Into Phase III
Sling Therapeutics’ series C venture round will fund a pivotal trial for its IGF-1R inhibitor linsitinib in thyroid eye disease. The oral drug could be a key competitor to I.V. drugs from Amgen and Viridian.
Scrip - September 16, 2026

Pfizer CEO Warns China May Follow US To Limit Biotech Deals
Big pharma execs are opposed to US lawmakers restricting cross-border biotech deals, but now must argue against similar moves from China.
Scrip - September 16, 2026

Is The Future Of Anaphylaxis Treatment A Needle-Free Nasal Spray? Hikma Makes Its Case
Hikma takes a further step towards advancing its epinephrine nasal spray for the treatment of anaphylaxis, following submissions accepted for regulatory review.
Generics Bulletin - September 16, 2026

CMS’s Move Against Alternative NTAP Leaves Breakthrough Device Makers In Limbo
CMS is phasing out the alternative NTAP pathway on disputed financial grounds, threatening the commercial rationale for FDA breakthrough device status. Its replacement, RAPID, may lack the capacity and evidence infrastructure to fill the gap — especially for smaller, VC-backed manufacturers.
Medtech Insight - September 16, 2026

The Challenges Facing New Chiesi CEO Khougazian
The Italian group is likely to expand its network of external partnerships, having poached David Khougazian from Flagship to be its new permanent CEO.
Scrip - September 16, 2026

‘It’s Incredibly Rare In A Career To Be In This Position’ – Sandoz CFO On Bio100 And The Path Ahead
In the wake of ambitious new long-term strategic targets revealed by Sandoz, the firm’s chief financial officer Remco Steenbergen talks to Generics Bulletin about how the company plans to achieve its targets of doubling sales by 2035 and building a portfolio of 100 biosimilars by 2040.
Generics Bulletin - September 16, 2026

Veracyte Completes Bladder Cancer Testing Loop With Third Urology Deal In Five Years
Veracyte has paid $150m for Convergent Genomics and its urine-based UroAmp platform, extending a portfolio that now spans tissue, blood and urine testing across bladder cancer.
Medtech Insight - September 16, 2026

New Kid On The Block: Renova Launches Its First Generics In The US
New Jersey-based Renova Pharmaceuticals made its US commercial debut with three generic drug launches – dimethyl sulfoxide irrigation, l-glutamine, and ascorbic acid injection.
Generics Bulletin - September 16, 2026

Samsung Bioepis Escapes Pfizer Damages Threat In Australia
Samsung Bioepis defeated Pfizer’s Australian Brenzys (etanercept) patent case, with the Federal Court finding no infringement and invalidating 13 of 14 asserted claims.
Generics Bulletin - September 16, 2026

Uniting Rx And Supplements Under One Brand: What Hypera’s GLP-1 Play Signals To The Companion Market
Brazil's Hypera has launched GLP-1 semaglutide and a companion dietary supplement range under the same brand name. Experts see significant opportunity for an “ecosystem” approach to the GLP-1 patient, but flag clinical credibility and regulatory transferability as key hurdles to global replication.
HBW Insight - September 16, 2026

Senlang/Tempest Option Marks China’s First Global Deal For In Vivo CAR-T
China’s Senlang reaches license option deal with Tempest for ex-China rights to a BCMA/GPRC5D-targeted in vivo CAR-T candidate delivered by a CD7-targeted lentiviral vector, plus its vector platform and other in vivo CAR-T assets.
Scrip - September 16, 2026

WCLC 2026: Leads Eyes Phase III For Novel Bispecific After Promising 1L NSCLC Data
Leads Biolabs’ anti-PD-L1/4-1BB bispecific combined with chemo achieved 71% ORR and 95% DCR in first-line, late-stage NSCLC in a China Phase II trial. The Chinese firm is upbeat about the outcomes although longer-term efficacy durability remains to be confirmed.
Scrip - September 16, 2026

Trump’s MFN Deals Reach 89% Of US Market As Benchmarking And Durability Remain In Doubt
The voluntary deals now reach most of the US branded market even as the scope of each agreement remains somewhat opaque. Meanwhile, the foreign price increases the policy implicitly relies on have refused to materialize.
In Vivo - September 16, 2026

US FDA Warning To Bausch + Lomb Suggests Potential For Recall, Production Interruption
Warning letter explains that both Rx and OTC products are made at B+L facility FDA officials inspected in March. FDA twice notes that recall would be needed if firm’s response to the warning isn’t satisfactory.
HBW Insight - September 16, 2026