Recon: FDA approves Stada’s Lucentis biosimilar; Lilly says ‘triple-G’ candidate bests Ozempic in diabetes

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Stada secures US approval for Lucentis biosimilar Lucamzi (The Pharma Letter)
• Citing 'safety' and 'freedom,' HHS will allow compounding of certain wellness peptides (Endpoints) (STAT)
• CDC deputy director resigns after four months in the job (New York Times)
• Amgen says FDA’s advertising warning letter was for the wrong promotional video (Pink Sheet)
• FDA introduces ‘individualized feature space’ to facilitate gene editing applications (Pink Sheet)
• Sydnexis will face FDA’s myopia data reliability concerns at pediatric adcomm (Pink Sheet)
• Medicaid cell and gene therapy model will expand beyond sickle cell to rare disease, some cancers (Pink Sheet)
• Phathom’s Voquezna tests limits of FDA’s ‘umbrella’ exclusivity policy (Pink Sheet)
• Merck to boost next decade revenue forecast on new drugs optimism (Reuters)
• Bristol Myers raises 2026 revenue forecast, lowers EPS due to charge (Reuters)

In Focus: International

• Pfizer India site closure risks exacerbating cancer drug shortages (Endpoints)
• Haleon shares tumble as weak flu medicine demand, China woes prompt outlook cut (Reuters)
• Pharma industry welcomes Budget move to lift VAT on free medicines (The Pharma Letter)
• Experts warn of wider spread as Ebola outbreak reaches plateau (AP News)
• EU plan to ease cross-border trial participation gathers pace (Pink Sheet)
• Don’t just reshuffle: EMA’s committee overhaul needs new mindset (Pink Sheet)
• Swiss biotech firm Molecular Partners to cut nearly half of workforce (Reuters)
• EMA admits new repurposing power is ‘new for us too’ as industry flags label uncertainty (Pink Sheet)
• Bundibugyo vaccine race steps up as platform trial begins and regulators map path for Studie (Pink Sheet)
• Indian regulator’s cancer drug margin cap sits heavy on Indian firms, lightly on MNCs (Pink Sheet)
• Biosplice’s disease-modifying osteoarthritis drug leads diverse group of new EMA filings (Pink Sheet)
• Eli Lilly international business chief Jonsson to retire; Yuffa to head global markets unit (Reuters)

Pharma & Biotech

• Anthropic buys Mithril to test AI-assisted drug development (The Pharma Letter) (Endpoints)
• Formation Bio unveils $600M fund to license and test more drugs (Endpoints) (The Pharma Letter)
• Flagship blends three biotech startups to form Etcelera (BioPharma Dive) (Endpoints)
• Lilly's triple-G outshines Novo's Ozempic in diabetes (Endpoints) (STAT)
• US estrogen supply crunch widens as women seek alternatives to scarce patches (Reuters)
• Genmab's $8B Merus bet delivers as bispecific combo halves risk of death in phase 3 (Fierce Biotech)
• Artiva to wind down after two patient deaths in autoimmune cell therapy trials (Endpoints) (STAT)
• Geron discontinues late-stage trial of blood cancer drug, shares plunge (Reuters) (Fierce Pharma)
• Astellas nabs option on preclinical IL-12 cancer drug from Australian biotech (Endpoints)
• Dren Bio nabs $350M for potential 2027 launch of blood cancer drug (Endpoints)
• Transpharmation acquires OrganoTherapeutics to advance neurodegenerative disease research (The Pharma Letter)

Medtech

• US FDA issues warning on Medline beds after 2 deaths, 16 serious injuries (Reuters)
• Boston Scientific cuts 2026 guidance for third time this year (MedTech Dive)
• Stryker completes ZuriMED takeover (MedTech Dive)
• Abbott launches MRD test with improved cancer detection tech (MedTech Dive)
• RadNet expands into teleradiology with $350M Onrad deal (MedTech Dive)
• Chirp Innovations, Pro-Optics and Peter Schiff Enterprises hit with FDA warning letters (Medtech Insight)
• EU council plans stronger trade secret protections for medtech under data act (Medtech Insight)
• Alzheimer’s blood tests need clearer primary care guidance, AdvaMed panelists say (Medtech Insight)
• GE HealthCare moves to own radiopharma’s last mile as Flyrcado targets SPECT users (Medtech Insight)
• Oura to study link between smart ring data and obesity treatment outcomes (Reuters)
• Nanexa’s atomic shell game: How ALD Tech landed a novo deal worth up to €1.165bn (Medtech Insight)

Food & Nutrition

• Attorney General says FDA can alter regs regarding release of information related to outbreak investigations (Food Safety News)
• US FDA proposes new nutrient limits, labeling rules for infant formula (Reuters)
• Perrigo to sell infant formula business to MeridianMade for up to $175 million (Reuters)
• FDA declares end to outbreak linked to Trader Joe's chicken wraps; a new outbreak is under investigation (Food Safety News)
• Number of incidents reported to global food safety network has increased sharply (Food Safety News)
• Proactive prevention of food contaminants: A review of FDA guidance and expectations (Food Safety Magazine)

Government & Legal

• Drug middlemen will soon have to share details on how they are paid (Wall Street Journal)
• Missouri AG warns Lilly to stop requiring data from hospitals seeking 340B drug discounts (STAT)
• The Trump administration is funding an experimental Ebola vaccine (Politico)
• Biopharma industry at odds over impact of Treasury’s new China rule (STAT) (Endpoints)
• Lawmaker wants government watchdog to probe TrumpRx over claims about drug savings (STAT)
• Pharma has friends in both parties this midterm season. Neither is offering a free pass. (PharmaVoice)
• Politicians have failed to tackle health care affordability. It’s now voters’ rallying cry (STAT)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.