Recon: FDA approves Taiho’s Lonsurf for metastatic colorectal cancer; Jeanne Marrazzo chosen to succeed Fauci as NIAID head

• FDA Clears Taiho’s Lonsurf in Metastatic Colorectal Cancer Ahead of Takeda, Hutchmed (BioSpace) (Endpoints)
• HIV Drugmakers Get Updated FDA Tips to Boost Global Response (Bloomberg)
• Regeneron Eyes Earlier FDA Decision on Higher-Dose Eylea (BioSpace) (Reuters) (Fierce)
• Intellia fills gene editing trial outside US after FDA request for preclinical fetal data (Fierce)
• AbbVie, Lundbeck ask FDA to revise draft guidance on migraine drugs (Endpoints)
• US FDA Chief Scientist Wants To Make Advisory Committee Participation Easier (Pink Sheet)
• ‘The First Settlement’: Thermo Fisher Case Could Just Be Start Of The Road For Henrietta Lacks Suits (Pink Sheet) (Endpoints)
• White House drug shortage task force held rare in-person meeting with industry (STAT)
• NIH selects Jeanne Marrazzo to lead infectious diseases institute (Reuters) (Endpoints) (STAT)
• BARDA awards Emergent 10-year, $704M contract for Ebola treatment (Endpoints)
• Sen. Wyden letter to Alvogen on drug quotas for ADHD drugs (Senate)
• US psychiatrists prescribe Wegovy to battle medication-induced weight gain (Reuters)
• Medicare may save $1.8B from four drugs in first year of price negotiations, research finds (Endpoints)

• EU Pharmaceutical Reform: A Delicate Negotiation (Pink Sheet)
• Will Shorter EU Regulatory Timelines Mean Unfeasible Joint Clinical Assessment Timelines? (Pink Sheet)
• EU HTA Regulation: What Comes After The Joint Clinical Assessments? (Pink Sheet)
• England: CSL Undeterred By Draft NICE Rejection Of Its £2.6m Hemophilia B Gene Therapy (Pink Sheet)
• India drug regulator finds counterfeit medicines worth 20 mln rupees in raid (Reuters)
• Ipsen Accuses Government Of Backward Step With Proposed Changes to Statutory Pricing Scheme (Pink Sheet)
• New China Trial Design Rules Stress Patient Needs And Experience (Pink Sheet)
• Vertex faces renewed calls to widen access to its cystic fibrosis medicines in poor countries (STAT)

• Moderna sees up to $8 bln in 2023 COVID vaccine sales on private market hopes (Reuters) (BioSpace)
• U.S. FDA Approves Merck’s ERVEBO® (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older (BioSpace)
• Moderna ramps up R&D spend in RSV, flu and cytomegalovirus (Endpoints)
• Teva CEO says not too late to launch Humira biosimilar in 2024 (Reuters)
• Regeneron rethinks CD28 bispecific R&D plan after 2 patients die (Fierce)
• Steve Jobs' son to lead Emerson Collective's oncology-focused VC firm Yosemite (Endpoints)
• Martin Shkreli's old companies secure $650,000 deal to sell Daraprim amid bankruptcy (Endpoints)
• Merck KGaA suffers CDMO slump after ‘sharp drop; in COVID-related sales, CFO says (Fierce)
• UK drugmaker Hikma raises annual outlook for generics arm (Reuters)
• BridgeBio Pharma Reports Second Quarter 2023 Financial Results and Business Update (BioSpace)
• RS Oncology presents new drug in early clinical development for Mesothelioma and lung cancer patients (BioSpace)
• Israeli biotech offloads CEO and mulls major business shakeup to fund cancer drug into clinic (Fierce)
• Bristol Myers, BeiGene end legacy Celgene deal with settlement years after China ban (Fierce)
• BeiGene's BTK inhibitor brings in $308M, drives Q2 earnings with 46% increase from Q1 (Endpoints)
• Agios looks beyond PK activators with $17.5M deal for Alnylam’s siRNA blood disease program (Fierce)
• Outsourcing company SterRx to shut New York plant and lay off 161 employees due to ‘economic’ reasons (Endpoints)
• Kyverna Therapeutics adds $60M to the bank as it prepares to showcase early CAR-T data in lupus nephritis (Endpoints)

• EU Regulatory Roundup, July 2023: Weighing Up The Impact Of The MDR Amending Regulation (MedTech Insight)
• Baxter recalls infusion pumps for risk of false alarms (MedTech Dive)
• Terumo’s automated blood processing system snag FDA clearance to boost US platelet supply (Fierce) (MedTech Dive)
• BD collects full FDA clearance for ‘tripledemic’ infection test (Fierce)
• FDA broadens green light for Etiometry’s AI algorithm to spot CO2 risk in NICU (Fierce)
• Industry Proposes TCET Timeline, CED Changes During CMS Stakeholder Call (MedTech Insight)
• CMS inpatient final rule will have muted impact on medtech companies, analysts say (MedTech Dive)
• Warning Letters And Close-Outs – July 2023 (MedTech Insight)
• Becton Dickinson beats quarterly profit estimates on strong medical device sales (Reuters)
• Bausch + Lomb's Saunders doesn't expect more big deals in the near term (Reuters)
• JAMA Identifies Challenges For Diagnostic AI (MedTech Insight)

• GSK, Pfizer head into patent duel in high-stakes RSV vaccine war (Endpoints) (Reuters)
• Novo Nordisk, Lilly Sued Over Ozempic, Mounjaro Side Effects (Bloomberg)
• J&J talc cancer plaintiffs want 6-month ban on further bankruptcy filings (Reuters) (Bloomberg)
• Teva Sets Aside $200 Million for Potential DOJ Settlement (Bloomberg)