FDA Releases Trove Of Data On Use of Real-World Evidence In Device Clearances
A new report outlines use of real-world evidence in 73 post-2021 device submissions, reflecting the agency’s growing comfort with data drawn from medical records, registries and even data generated by the devices themselves.
Medtech Insight - April 3, 2026

Vedanta’s Phase III For Recurrent C. Diff Gets Nod To Continue
After giving up on a Phase II ulcerative colitis candidate, microbiome-focused Vedanta gets data monitoring committee approval to continue pivotal study of VE303 to prevent C. difficile recurrence.
Scrip - April 3, 2026

Acadia CEO Led The Company To A Key Goal In A Challenging Year For Biopharma
Catherine Owen Adams joined Acadia on the precipice of achieving a major goal – its first year with $1bn in revenue – as the company and the industry struggled to understand policy shifts under the Trump administration.
Scrip - April 3, 2026

No Evidence Of Benefit: Two Trials Prompt Calls to End Routine Use Of J&J’s Impella Heart Pump
Two randomized trials presented at a recent American College of Cardiology annual meeting failed to show benefit for J&J's Impella pumps – and one found higher mortality in the device arm.
Medtech Insight - April 3, 2026

Washington Sleep Doctor Gets Year In Prison For Distributing Recalled Philips CPAP, BiPAP Devices
Eric Haegar pleaded guilty to medical device adulteration. He bought recalled Philips Respironics devices online and pried out the hazardous foam inside before passing the products along to Medicaid patients. He then billed Medicaid as though the devices were new.
Medtech Insight - April 3, 2026

Atrogi Bets On Muscle Preservation And Exercise Mimetics To Drive Obesity Push
Atrogi is betting that preserving muscle will define the next wave of obesity treatments, with its drug ATR-258 aiming to deliver exercise-like metabolic benefits.
Scrip - April 3, 2026

Lipocine’s Oral Formulation Of Zulresso Fails Postpartum Depression Trial
The Phase III miss leaves Lipocine weighing its next steps as the field narrows to a single approved therapy for postpartum depression and limited options in development.
Scrip - April 3, 2026

US Shields Generics From Tariffs Amid Supply Chain Concerns
New US tariffs of up to 100% on patented drugs have spared generics and biosimilars for now, highlighting their role in supply chains, but officials have ordered a review of the sector within one year.
Generics Bulletin - April 3, 2026

‘It’s Day And Night’ – Haruvi On How The AAM Has Evolved
In the second part of Generics Bulletin’s interview with Keren Haruvi, the Sandoz executive talks about her role as outgoing chair of the US Association for Accessible Medicines, and the achievements made by the group since it came under new leadership.
Generics Bulletin - April 3, 2026

Hyloris Warns Valacyclovir Launch Could Slip Into 2027
Hyloris has received a CRL from the US FDA for its valacyclovir oral liquid due to manufacturing issues at its CDMO, with no concerns on the product itself, and warns resolution could delay approval into 2027 as it explores alternative production options.
Generics Bulletin - April 3, 2026

GDUFA IV: US FDA Worries About Revenue Shortfalls, Industry Does Not
The FDA said chronic under-collection of GDUFA revenue could create budget problems going forward unless the system is changed, but industry does not want to endanger the generic sector with higher fees.
Generics Bulletin - April 3, 2026

Executives On The Move: Five CEOs And Six CFOs Among This Week’s Changes
Recent moves in the industry include C-suite changes at Aurinia Pharmaceuticals, Averna Therapeutics and Biocon, plus new director appointments at Novo Nordisk and Takeda.
Scrip - April 3, 2026

Glenmark Reshapes US Ryaltris Strategy, Steps Away From Hikma Tie-Up
Glenmark is going solo with direct commercialization and distribution plans for Ryaltris in the US, effectively parting ways with partner Hikma.
Scrip - April 3, 2026

Bayer’s Men’s Pre-Conception Health Multivitamin Ad Claims Fail To Launch In NAD Review
NAD recommends Bayer HealthCare pull express claims including “Men’s Pre-Conception Health Complete Multivitamin to Support Healthy Sperm designed to provide nutritional support while trying to conceive.”
HBW Insight - April 3, 2026

LG Builds Global Oncology Ambitions With Novel Frontier Asset
Deal for first-in-class covalent p53 Y220C activator from Frontier's platform pushes Korean firm further along road to becoming global oncology player.
Scrip - April 3, 2026