Sarah Chen

Adial Pharmaceuticals Completes Azora Merger, Expands Ulcerative Colitis Pipeline

Adial Pharmaceuticals completed its acquisition of Azora Therapeutics on June 11, 2026, and SEC filings show related equity issuance to Azora holders. The filings also show new RSUs and stock options granted to Adial’s CDO.

Weight Loss Medications in 2026: GLP-1 Market Shift

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.

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.

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.

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 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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.