NOVARTIS

Turnstone Biologics to lay off 60% of workforce, focus on cancer cell therapy. FDA approves Roche's Itovebi for breast cancer, competing with Novartis' Piqray. Gritstone bio files for bankruptcy, in talks for potential buyer. Sanofi halts Denali Therapeutics' Phase 2 MS trial after study failure. Pfizer's Talzenna-Xtandi combo extends prostate cancer survival. Paul Parker joins Flagship Pioneering as managing partner. Zealand Pharma's hypoglycemia drug dasiglucagon rejected by FDA again.

FDA approves Roche’s Itovebi (inavolisib) in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex as first-line treatment for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. Itovebi’s sales expected to surpass Novartis’s Piqray, with estimated $1bn in sales by 2030. Positive Phase III INAVO120 trial results showed mean progression-free survival of 15 months for Itovebi combination versus 7.3 months for placebo.

Roche's PI3K inhibitor Itovebi approved by FDA for use in triple therapy for locally advanced or metastatic HR-positive, HER2-negative breast cancer with PIK3CA mutation. Phase 3 INAVO120 study showed progression-free survival more than doubled to 15 months with Itovebi compared to 7.3 months for control group. Roche predicts Itovebi sales could reach CHF 2 billion annually.

Competition authorities are expanding their review of pharmaceutical deals, focusing on whether existing tools for identifying and remedying competition issues are sufficient. The Multilateral Pharmaceutical Merger Task Force explores new enforcement approaches, considering factors like innovation effects, conglomerate effects, and coordinated effects. Authorities in regions like the EU, US, and APAC assess theories of harm, market definitions, and legal standards, with remedies often involving divestitures to ensure market competition.

AstraZeneca to pay $2B to CSPC for a cardiovascular drug, Astellas Pharma licenses gene therapy from AviadoBio, Merck partners with Mestag Therapeutics for fibrosis treatments, Insitro signs three agreements with Eli Lilly for metabolic diseases, MiNK Therapeutics and Autonomous Therapeutics collaborate on metastatic tumors, Bayer and MOMA Therapeutics partner in oncology, Wonderskin names 5W Public Relations as AOR, Eversana signs with Oracle Argus Cloud, Qinotto and Eli Lilly collaborate, Onspire Health acquires Aesthetic Brand Marketing, Reunion Neuroscience partners with Seleni Institute, Danco Laboratories to seek FDA approval for Mifeprex use in miscarriages, Exact Sciences' Cologuard Plus wins FDA approval, Boehringer Ingelheim's survodutide gets Breakthrough Therapy designation, Lunds & Byerlys recalls Lone Star Dip, Kezar Life Sciences' zetomipzomib development halted by FDA, Bayer's elinzanetant NDA accepted by FDA, Biogen's felzartamab gets Breakthrough Therapy Designation, Black Diamond Therapeutics to cut jobs, Upstream Bio targets $182M for IPO, City Therapeutics launches with $135M, Purespring Therapeutics raises $105M, Judo Bio launches with $100M, Orasis Pharmaceuticals raises $78M, CAMP4 Therapeutics targets $67M for IPO, Basecamp Research closes $60M Series B, Arda Therapeutics raises $43M Series A, Crinetics Pharmaceuticals announces public offering, GSK to pay $2.2B to settle Zantac lawsuits, Scholar Rock's SMA drug shows muscle function improvement, CDC to screen travelers due to Marburg virus outbreak in Rwanda, Ad Council, AMA, and CDC launch flu vaccination campaign, Sage Therapeutics' Sage-718 fails in Alzheimer's study, WeightWatchers adds GLP-1 obesity treatments, Gritstone Bio files for Chapter 11, BioPharmCatalyst launches AI-powered chatbot Aiden, Otsuka Precision Health and Amalgam Rx launch Alzheimer's app Elevmi, PatientPoint unveils interactive communication solution, Curia rebrands, Switzerland's COMCO terminates Novartis investigation, Bluebird Bio's Skysona linked to blood cancer in seven children, Solera Health rebrands, HearingLife launches pickleball sweepstakes, Alfasigma launches Morpho brand, Healthy Minds Innovations launches Our World Of Emotions campaign.

Havas Lynx launches global healthcare influencer offering, blending creative and media expertise for effective omnichannel strategies. Utilizing over 50 influencers across 14 therapy areas, the service includes content creation and podcast hosting. Influencer marketing is poised to revolutionize healthcare communications, with 98% of HCPs influenced by earned media and 54% consuming more. Havas Lynx offers tailored influencer marketing solutions for healthcare brands, with successful campaigns for Arena, Novartis, and Teva. A free training session on influencer marketing in healthcare is available for prospective clients.

76% of FDA-approved mAbs have high concentration formulations, necessitated by subcutaneous delivery. High-concentration biologics (over 100g/L) face challenges like increased viscosity and aggregate formation, requiring optimization of TFF parameters and new cassettes. Key biologics include Novartis’s Cosentyx, Genentech/Novartis’s Xolair, and Sanofi/Regeneron’s Dupixent. Selecting the right membrane for filtration is crucial, aiming for high throughput and cost reduction.

GSK’s Benlysta and Aurinia’s Lupkynis have advanced lupus nephritis treatment, but unmet needs persist. Roche’s Gazyva (obinutuzumab) showed potential in Phase III REGENCY trial, addressing key challenges like proteinuria and steroid dependence. Gazyva could become the second biologic for LN, challenging Benlysta’s market dominance. Lupkynis remains a niche option for high proteinuria, but Gazyva’s trial success may shift this dynamic. Future competition from AZ’s Saphnelo and Novartis’ ianalumab is expected post-2025.

GSK’s Benlysta and Aurinia’s Lupkynis have advanced lupus nephritis treatment, but unmet needs remain. Roche’s Gazyva (obinutuzumab) showed significant complete renal response in Phase III REGENCY trial, potentially addressing key challenges like proteinuria and steroid dependence. If approved, Gazyva could rival Benlysta and Lupkynis, with market impact expected before competition from AZ’s Saphnelo and Novartis’ ianalumab.

Recent acquisitions of cancer drug developers RayzeBio and Fusion Pharmaceuticals highlight radiotherapy's resurgence. Oncology sees advancements in genetics, immunology, AI, and personalized treatments. Funding remains robust, with potential for highest corporate rounds since 2021. Combination therapies and AI are crucial, with cancer vaccines and precision treatments offering hope. Despite challenges, progress in treating specific cancers has improved patient outcomes.