Dr. Sarah Mitchell PharmD, RPh

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The FDA has issued draft guidance on using MRD and complete response as endpoints in multiple myeloma trials.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FDA Draft Guidance Updates Payor Communications Rules

FDA issued draft guidance on June 2, 2026, addressing how drug and device companies may communicate health care economic information to payors and formulary committees.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.

Socioeconomic status shapes children’s brain development, study finds

Study highlights influence of socioeconomic status on children’s brain development, based on brain scans from nearly 12,000 children ages 9 to 10. The findings reinforce prior research on socioeconomic status and structural brain development and cognitive development.

FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options

FDA regulates sunscreens as OTC drug products and, in June 2026, added bemotrizinol as a permitted active ingredient. The change expands the available options for safe and effective sun protection products. Proper sunscreen use remains relevant to reducing sunburn, skin cancer, and early skin aging risk.

Biotech coming of age: market analysis of a sector in transition

Biotech is back, according to Nature Biotechnology, but the sector’s contours are changing as investor caution, China’s rise and fast-moving AI reshape the market. This plan stays tightly grounded in the cited article and avoids unsupported forecasts or quantitative claims.

FDA approves Vepdegestrant (Veppanu) for ESR1-mutated breast cancer

The FDA approved vepdegestrant (Veppanu) on May 1, 2026 for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy. For BD teams and investors, the key read-through is a new catalyst tied to an FDA-labeled oral protein degrader and a clearly defined biomarker-selected population.

CDC data show alcohol use during pregnancy is rising again

CDC data suggest alcohol use during pregnancy increased after 2020, rising from 13.5% in 2021 to 15% in 2024. The findings reinforce that alcohol during pregnancy remains an active public health concern, not a solved one.

Sensorion pivots to SENS-601 after Regeneron’s OTOF hearing loss advance

Sensorion has redirected its hearing-loss strategy after Regeneron’s Otarmeni became the first and only FDA-approved in vivo gene therapy for OTOF-related hearing loss. The move underscores a widening split between rare OTOF programs and broader GJB2-targeted opportunities.

Takeda TYK2 drug tops Bristol Myers’ Sotyktu in psoriasis head-to-head test

Takeda’s TYK2 inhibitor zasocitinib outperformed Bristol Myers Squibb’s Sotyktu in a head-to-head plaque psoriasis trial. The result strengthens Takeda’s dermatology story and gives BD teams and investors a clearer read on the program’s competitive position.

FDA Issues Guidance on Human Factors Information in Marketing Submissions

FDA released guidance that provides a risk-based framework for the human factors information to include in medical device marketing submissions. The document also recommends the content of human factors engineering and usability engineering information for FDA review.

FDA authorizes generic nitenpyram for New World screwworm in pets

FDA issued an Emergency Use Authorization for generic Nitenpyram Tablets to treat New World screwworm infestations in dogs, puppies, cats, and kittens. The authorization covers pets at least four weeks old and weighing at least two pounds.

SLS Stock Jumps on Biotech Momentum as SELLAS Gains 25.10%

SELLAS Life Sciences Group Inc. shares advanced 25.10% amid reported biotech momentum. The cited sources confirm the company’s clinical-stage oncology profile and SEC listing details.

Medicare GLP-1 coverage 2026: Bridge program starts July 1

CMS will launch a temporary Medicare GLP-1 Bridge program on July 1, 2026, creating a new access pathway for eligible beneficiaries. For BD teams, investors, and analysts, the key questions are coverage scope, pricing pressure, and what the demo signals for future reimbursement.

HHS responds coolly to alcohol risk paper amid cancer-warning debate

HHS has responded coolly to a paper and report on alcohol risk after withdrawing a government report that linked even small amounts of alcohol to cancer and other harms. Federal guidance still says to consume less alcohol for better health.

Sepsis AI algorithms need real-time data, not hindsight

STAT’s sepsis algorithm story centers on a core problem: sepsis prediction models can fail when they rely on data that already reflects the outcome. The grounded takeaway is that EHR-based, real-time models are designed to improve timing and accuracy in clinical settings.

FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria

The FDA approved Immgolis and Immgolis Intri as the first interchangeable biosimilars to Janssen’s Simponi and Simponi Aria. The decision covers rheumatoid arthritis and ulcerative colitis and creates a new catalyst for BD teams and investors tracking golimumab competition.

AstraZeneca expands obesity push as it invests $125M in ultrasound medicine

AstraZeneca’s obesity strategy widened after newly published data supported a sprawling late-stage program for its GLP-1 pill. The company also committed $125 million to ultrasound-aided genetic medicine, signaling continued platform investing.

FDA Drug Approval: What Approval Means for Pharma Marketing and BD

FDA approval means the agency has determined a drug’s benefits outweigh its risks for the intended use. This plan explains what approval allows, how NDAs are reviewed, and why that matters for BD teams, investors, and analysts.

Merck and Gilead report mixed outcomes in lung cancer and HIV studies

Merck Gilead report mixed outcomes in key lung cancer and HIV studies: a Phase 3 Trodelvy plus KEYTRUDA lung cancer trial was halted, while two Phase 3 HIV studies for islatravir/lenacapavir reported positive topline results. This plan focuses on the business and clinical implications for analysts and BD teams.