Dr. Sarah Mitchell PharmD, RPh

Biotech’s coming of age: AI, capital efficiency and China reshape the field

Biotech’s coming of age is being framed by three documented shifts: investor caution, AI-driven efficiency, and China’s growing role in drug development. This plan keeps the article tightly grounded in Nature Biotechnology and PubMed-confirmed facts.

Edgewise Therapeutics’ EDG-7500 clears key Phase 2 test

Edgewise Therapeutics says EDG-7500 met a key Phase 2 test in obstructive hypertrophic cardiomyopathy. The evidence points to a cardiac sarcomere modulator still in clinical development, with CIRRUS-HCM as the named study.

Celiac disease therapies enter a new era of innovation

New therapies in celiac disease are advancing as the field moves beyond diet-only management. Current evidence also highlights updated diagnostic thinking and a shift toward drugs in advanced clinical phases.

FDA approves OTC Rextovy, broadening naloxone access for opioid overdose

FDA approved Rextovy, an over-the-counter 4 mg naloxone hydrochloride nasal spray for emergency opioid overdose treatment. Consumers can buy it without a prescription at pharmacies, convenience stores, and online, broadening public access to overdose reversal.

Neumora navacaprant fails Phase 3 as EnGene cuts 50% of staff

Neumora is discontinuing navacaprant after two Phase 3 failures in major depressive disorder and is laying off 35% of its workforce. The available evidence also shows the program’s key Phase 3 studies and the drug’s mechanism.

Lilly buys 4E in non-opioid pain push: what investors should watch

Eli Lilly is buying 4E Therapeutics, adding another non-opioid pain pipeline to its portfolio after the SiteOne transaction. The move comes as Journavx (suzetrigine) advances in the market and in multiple clinical trials.

Global hematology trials keep research patient-centered and regionally relevant

Global hematology trials are increasingly framed around translational research and patient-centered outcomes. Regulators and trial designers must coordinate across regions as drug development globalizes.

Lilly’s early JAK data raises myelofibrosis competition question

Eli Lilly reported early positive data for a next-generation JAK inhibitor acquired through Ajax. The readout could position Lilly as a potential future competitor to Incyte’s Jakafi in myelofibrosis.

FDA authorizes emergency pet treatment for New World screwworm

The FDA issued Emergency Use Authorizations for NexGard and NexGard COMBO to treat New World screwworm in dogs and cats. Reuters also reported emergency use for nitenpyram tablets in pets meeting weight and age thresholds.

FDA guidance on sharing potential NDA patent information: what changes now

FDA has issued guidance on sharing potential NDA patent information, creating a regulatory update with implications for how teams track approval, patent, and disclosure timelines. For BD teams, investors, and analysts, the key question is how this fits with existing NDA disclosure rules and patent/exclusivity tracking.

Hillhurst Bio doses first subject in Phase 2a HBI-002 Parkinson's trial

Hillhurst Bio doses first subject in a Phase 2a clinical trial of HBI-002 for Parkinson's disease. The study is recruiting and is listed on ClinicalTrials.gov as a randomized, double-blind, placebo-controlled multiple-dose trial.

FDA expands Tzield to certain pediatric patients with recent Stage 3 T1D

The FDA granted accelerated approval to Tzield for certain pediatric patients ages 8 through 17 recently diagnosed with Stage 3 type 1 diabetes. This is the first FDA-approved treatment for this indication and a key catalyst for diabetes BD and investor tracking.

Medicare price rule could hit Keytruda and Opdivo subcutaneous launches

CMS is proposing a Medicare drug price rule that could shape the outlook for subcutaneous Keytruda and Opdivo. The products are expected to be eligible for selection in the 2027 negotiation round for IPAY 2029.

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer

FDA Approves Capivasertib for PTEN-Deficient prostate cancer, expanding TRUQAP into a new oncology setting. The approval pairs capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive disease.

FDA approves belzutifan plus pembrolizumab for adjuvant RCC

The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.

Prescription Drug Freight Fraud June 2026 report: what the record shows

Prescription Drug Freight Fraud June is a grounded summary of what the June 2026 report and cited U.S. regulatory records confirm. It covers the documented FTC lawsuit and the Federal Register notice without adding unsupported claims.

Planning a successful pivot from lab to clinic: a practical career map

Planning a successful pivot from lab to clinic starts with a clear, realistic process. The available evidence points to five core steps, plus practical transition etiquette for leaving a lab role.

HFMA conference: Affordability was the focus, but fixes remained unclear

At the HFMA conference, attendees broadly agreed that healthcare affordability is a major issue. The article frames hospital billing and financing friction as part of the cost problem, but the practical fix remains unclear.

FDA MRD guidance in multiple myeloma: what BD teams should track

The FDA has issued draft guidance on using MRD and complete response as endpoints in multiple myeloma trials. This plan frames what changed, why MRD matters for accelerated approval, and what BD teams and investors should watch next.

FDA Draft Guidance Updates Payor Communications Rules

FDA issued draft guidance on June 2, 2026, addressing how drug and device companies may communicate health care economic information to payors and formulary committees. The draft adds a statutory safe harbor and reflects updated protections for device firms.

Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules

Alembic Pharmaceuticals received tentative FDA approval for generic larotrectinib capsules in 25 mg and 100 mg strengths. The move marks a key catalyst for Vitrakvi competition, with final launch timing still dependent on remaining patent or exclusivity issues.

FDA Clears First OTC CGM for Children: Dexcom Expands Stelo

The FDA has cleared Dexcom Inc.’s Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor for children. The decision extends Stelo’s prior OTC clearance in adults and gives analysts a new regulatory catalyst to track in diabetes monitoring.

FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC

The FDA granted priority review to supplemental applications for belzutifan plus pembrolizumab in adjuvant renal cell carcinoma. The move extends Merck’s renal cancer catalyst path after evidence showed improved disease-free survival versus pembrolizumab alone.

Chile warning labels on food: new evidence on efficacy and obesity risk

Chile warning labels on food are back in focus as new reporting adds child obesity data to an established evidence base on purchase shifts. For B2B readers, the key question is whether Chile food labels continue to shape regulation, consumer behavior, and adjacent policy debates.