Pulse Network

Everything you missed in #Pharma & #Biotech ???? ? Approvals FDA grants accelerated approval for Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii), a HER2-targeting bispecific antibody, for biliary tract cancer with HER2 mutations Syndax Pharmaceuticals’ Revuforj (revumenib) approved by the FDA, the first menin inhibitor for aggressive acute leukemia with specific mutations FDA approves UCB’s Bimzelx (bimekizumab-bkzx) in hidradenitis suppurativa, its fifth indication AbbVie’s antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) receives EU approval for the treatment of ovarian cancer AstraZeneca’s Tagrisso (osimertinib) receives EU CHMP recommendation for use in unresectable lung cancer ?? Deals Novartis acquires Kate Therapeutics to enhance gene therapy pipeline for Duchenne Muscular Dystrophy, facioscapulohumeral dystrophy, and myotonic dystrophy type 1 Kura Oncology, Inc. partners with Kyowa Kirin, Inc.- U.S.?to develop and commercialise oral ziftomenib, an investigational menin inhibitor, to treat acute myeloid leukaemia (AML) and other haematologic malignancies Samsung Biologics signs $668m manufacturing contracts with unnamed European pharma clients Novartis partners with Ratio Therapeutics to develop radiopharmaceuticals targeting SSTR2 for cancer treatment ?? Late-Stage Developments Merck’s Keytruda (pembrolizumab) subcutaneous formulation demonstrates non-inferiority to intravenous version in Ph3 trial for metastatic non-small cell lung cancer Eli Lilly and Company's Mounjaro (tirzepatide) demonstrates reduced risk of worsening heart failure events in adults with heart failure with preserved ejection fraction?(HFpEF) and obesity in Ph3 ?? To Watch REGENXBIO advances gene therapy RGX-202 into pivotal studies for Duchenne muscular dystrophy, challenging Sarepta Therapeutics’s Elevidys (delandistrogene moxeparvovec-rokl), with promising early data showing stable or improved function in treated patients ?? Access Novo Nordisk Wegovy (semaglutide) officially launches in China at a fraction of the US price (1,400 yuan / ~$194) ISPOR—The Professional Society for Health Economics and Outcomes Research's Europe 2024 conference, themed “Generating Evidence Toward Health and Well-Being,” was held from November 17 to 20, 2024, in Barcelona, Spain. Discussions focused on preparedness for the 2025 EU HTA regulation, leveraging real-world evidence, balancing evidence and drug pricing, and advancing digital health for improved patient outcomes. ?? Other President-elect Trump selects Johns Hopkins surgeon Martin Makary to lead FDA FDA releases new draft guidance addressing key questions on the development of cell and gene therapies ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth

Everything you missed in #Pharma & #Biotech ???? ? Approvals FDA approves Autolus Therapeutics'?Aucatzyl, new CAR-T competitor to Gilead Sciences's Tecartus After re-examination, EMA’s CHMP recommends Biogen's Leqembi (lecanemab) for treating early Alzheimer's disease Philips’ spectral CT scanner for radiotherapy receives FDA approval, enhancing oncology imaging ?? Deals BioNTech IMFS to acquire Chinese biotech company Biotheus Inc. for $800 million upfront, gaining global rights to dual-targeting drug for oncology Merck gains rights to LaNova’s PD-1/VEGF LM-299 in agreement worth over $3.2bn Flare Therapeutics collaborates with Roche to develop small molecule cancer therapies Femasys Inc. partners with Boston IVF to enhance access to its fertility treatments GSK partners with Vesalius Therapeutics, investing $80M to develop treatments for Parkinson's and other neurodegenerative diseases ?? Late-Stage Developments AstraZeneca and Merck's Koselugo achieves a phase 3 trial success in adults with neurofibromatosis type 1 (NF1) Curium Pharma’s 177Lu-PSMA-I&T radiotherapy meets Phase 3 endpoint for castration-resistant prostate cancer GSK shares survival data for Blenrep (belantamab mafodotin) in multiple myeloma, challenging Johnson & Johnson's Darzalex (daratumumab) ?? Access Johnson & Johnson and Eli Lilly and Company sue the U.S. government, challenging the rejection of their proposed changes to the 340B drug discount program NICE - National Institute for Health and Care Excellence final menopause guidelines prioritize HRT as first-line treatment for menopause symptoms over CBT, addressing criticism of previous drafts ?? Other President-elect Trump nominates vaccine skeptic Robert F. Kennedy Jr. as Secretary of Health and Human Services Noom, specializing in weight loss and wellness, introduces an AI body scan to track body composition changes Sanofi, Formation Bio, and OpenAI unveil Muse, an AI tool aimed at expediting clinical trial recruitment ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth

?? LAST PLACES available for our ???????????????? 21 event in Paris! Come experience "?????????? ??????????????????????????," a speed-networking exercise where we will explore: ??????????? ?????? ?????? ?????????????? ?????????????????? ?????? ?????????????????? ?????? ???????????????????? ???? ???? ?????????? 2025? Our attendees appreciate the diversity of sectors from the #lifesciences and fruitful connections and with other #thoughtleaders. ?? Register your interest to attend using the link in comments. #TryPulse #Networking #BioPharmaLeaders #LifeSciences #PulseIntersections Hannah Kurth

Excited to see so many people already registered to our Nov 21 event, "?????????? I????????????????????????," a speed-networking exercise where we will explore: ? ??? ???????? ?????? ?????? ?????????????? ?????????????????? ?????? ?????????????????? ?????? ???????????????????? ???? ???? ?????????? 2025? ? If you haven't yet pre-registered, please do so asap at https://lnkd.in/eBZSMQ4K to take advantage of our "regular" ticket rates (which end this week). #PulseIntersections #Biopharma2025 #HealthtechHorizon #BigIdeasOnly #NetworkAndInnovate #FutureOfHealth #CuriousMinds

Do you have a digital health solution that is working to eliminate racial, economic, and regional disparities in health outcomes? The Massachusetts eHealth Institute (MeHI), a division of the Massachusetts Technology Collaborative (MassTech), is seeking startups and entrepreneurs to compete for prizes worth a total of $250,000 in the third Digital Health Sandbox Challenge. ?? Link to detailed info in comments #MassDigitalHealth #Healthcare #digitalhealth

Everything you missed in #Pharma & #Biotech ???? ? Approvals Caris Life Sciences receives FDA approval for multicancer companion diagnostic LumiThera, Inc. gains FDA clearance for light-based therapy targeting dry age-related macular degeneration Regeneron and Sanofi expand Dupixent’s European label to treat pediatric eosinophilic esophagitis ?? Deals Novo Nordisk partners with Ascendis Pharma, with up to $285M in payments, to develop long-acting GLP-1 and metabolic drugs NLS Pharmaceutics AG and Kadimastem Ltd. merge to focus on cell therapies for diabetes and ALS Advent International explores selling Zentiva for €5B ($5.4B) NeuroReality is acquired by XRHealth, expanding therapeutic virtual reality (VR) and extended reality (XR) technology offerings Avid Bioservices goes private via a $1.1B acquisition by GHO Capital and Ampersand ?? Late-stage Developments ImPact Biotech releases positive Phase 3 interim data for Padeliporfin VTP in urothelial cancer Beam Therapeutics reports sickle cell patient death in gene editing trial, with the incident attributed to busulfan chemotherapy used for conditioning ?? To Watch Trump is re-elected, signaling a potential shift toward market-driven healthcare reforms including measures to lower prescription drug prices, Medicare/Medicaid reform, and deregulation to expedite drug approvals Pfizer announces plans to invest over $1B in China over the next five years J.P. Morgan launches a new life sciences fund targeting late-stage biotech companies ?? Access NICE - National Institute for Health and Care Excellence revises submission requirements, eliminating Document A for Technology Appraisals and Highly Specialised Technologies submissions from November 1, 2024 The French National Health Authority (Haute Autorité de Santé) opens consultation to enhance patient-reported outcomes (PROs) in health tech assessments, with submissions due by December 1, 2024 Zentiva warns that EU regulations linked to the Urban Wastewater Treatment Directive could cause future drug shortages ?? Other Ascletis Pharma Inc. Pharma shares promising Phase 1 results for ASC47, an obesity treatment focused on muscle preservation Juntendo University and Metagen Therapeutics, Inc. initiate a collaboration on Fecal Microbiota Transplantation for Parkinson’s disease ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth Patricia Machado Tamsin Lacourte Alexandra SILVAIN

Curious about Pulse Network? ?? Don't miss our ???????????????? 21 event in Paris! Come experience "?????????? ??????????????????????????," a speed-networking exercise where we will explore: ??????????? ?????? ?????? ?????????????? ?????????????????? ?????? ?????????????????? ?????? ???????????????????? ???? ???? ?????????? 2025? Our attendees appreciate the diversity of sectors from the #lifesciences and the open, relaxed atmosphere that cultivates meaningful connections with other #thoughtleaders. ?? Register your interest to attend using the link in comments. #TryPulse #Networking #BioPharmaLeaders #LifeSciences #PulseIntersections

Everything you missed in #Pharma & #Biotech ???? ? Approvals Novartis’ Scemblix (asciminib) granted accelerated approval by FDA in chronic myeloid leukemia Distalmotion receives FDA de novo clearance for its Dexter surgical robot, enabling its use in outpatient hernia repair procedures ?? Deals Sanofi acquires equity in Resalis Therapeutics to support Ph2 POC for obesity medication, RES-010 AbbVie acquires neuroscience biotech Aliada Therapeutics for $1.4 billion Boston Scientific to acquire Cortex medtech specializing in diagnostic mapping for atrial fibrillation (AF) Novartis partners with Monte Rosa Therapeutics to advance molecular glue degraders for immune-mediated conditions, with potential milestone payments totaling $2.1B Boehringer Ingelheim collaborates with Circle Pharma, Inc., investing up to $607M in precision oncology with Circle’s peptide macrocycle platform Pfizer and Acepodia enter partnership to develop antibody-cell conjugate therapies aimed at autoimmune disease treatment Sanofi teams with Radiomedix, Inc. and Orano Med, committing up to €320M to advance radioligand therapies in oncology Jade Biosciences merges with Aerovate Therapeutics, Inc., raising $300M Crescent Biopharma merges with GlycoMimetics, securing $200M to develop advanced cancer immunotherapy aimed at surpassing Keytruda GSK licenses potential lupus treatment from Chimagen Biosciences for $300M, focusing on T cell engagers ?? Late-stage Developments Novo Nordisk shares positive Ph3 results for semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) Biofrontera Inc.’s Ameluz + photodynamic therapy meets primary and secondary endpoints in Ph3 Bristol Myers Squibb Myers announces positive topline results from Phase 3 open-label trials evaluating COBENFY (xanomeline and trospium chloride) in adult schizophrenia Roche's Elecsys Amyloid Plasma Panel shows high accuracy in ruling out Alzheimer's disease-related amyloid pathology ?? To Watch FDA is reassessing the necessity of boxed warnings regarding the risk of secondary cancers on CAR-T cell therapies ?? Access The French National Health Authority (Haute Autorité de Santé) initiates a 12-month pilot project to streamline real-world data (RWD) collection for early access medicines by extracting data from the national health data system (SNDS), aiming to reduce the burden on healthcare professionals and enhance data quality ?? Other A recent survey of 2000 Americans reveals that while 80% of Americans own at least one medical device, many are unaware of the full range of such devices and their benefits Compass Pathways lays of 30% of staff to focus on advancing lead program, COMP360, in treatment-resistant depression ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth Patricia Machado Tamsin Lacourte Alexandra SILVAIN

Everything you missed in #Pharma & #Biotech ???? ? Approvals BeiGene's Tevimbra (tislelizumab) gains EU recommendation for gastric and esophageal cancers FDA approves Novocure's Optune Lua (tumor-treating fields) for advanced lung cancer FDA approves Astellas Pharma' VYLOY (zolbetuximab-clzb)?for advanced gastric or gastroesophageal junction cancer Merck's Keytruda (pembrolizumab) secures its 29th and 30th European approvals, broadening its use in endometrial and cervical cancers FDA expands Pfizer's RSV vaccine Abrysvo (RSVpreF) for adults 18-59 AbbVie wins FDA approval for Parkinson's drug Vyalev (foslevodopa-foscarbidopa) after prior rejections DBV Technologies receives FDA accelerated guidance for Viaskin peanut patch (peanut protein allergen) EMA recommends Novo Nordisk's Alhemo (concizumab) to treat hemophilia A and B ?? Deals Merck acquires Modifi Bio with $30M upfront, potential for $1.3B Lumos Pharma goes private via merger with Double Point Ventures Samsung Biologics signs $1.24B production deal with an Asian pharma TEVOGEN BIO joins Microsoft’s program to advance AI for drug development Eli Lilly and Company invests ￡279M in UK for Gateway Labs, backing biotech and obesity prevention Novartis licenses cancer drug from Chengdu Baiyu Pharmaceutical for $70M upfront, $1.1B in milestones SIGA Technologies in-licenses mAb library from Vanderbilt for smallpox/mpox Editas Medicine teams up with Genevant Sciences for a gene-editing platform Recursion expands collaboration with Google Cloud to enhance AI-driven drug discovery processes Monopar Therapeutics Inc. licenses Wilson disease drug ALXN-1840 (bis-choline tetrathiomolybdate) after Ph3 success ?? Late-stage developments Marinus Pharma's ganaxolone fails Ph3 trial in tuberous sclerosis Zhaoke Ophthalmology announces positive Ph3 for NVK002 in myopia GSK’s Arexvy shows positive results in Phase 3b trials for RSV prevention in younger adults, broadening its potential impact beyond senior populations Regeneron and Sanofi's Dupilumab (dupilumab) shown effective for Chronic Spontaneous Urticaria ?? Other Industry-sponsored clinical trials in Europe now 12% of global share Women's Brain Foundation reveals critical sex and gender disparities in Alzheimer’s research #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth Patricia Machado Tamsin Lacourte Alexandra SILVAIN

Everything you missed in?#Pharma?&?#Biotech????? ? Approvals Roche's new breast cancer drug Itovebi (inavolisib), a targeted therapy for patients with hormone receptor-positive, HER2-negative advanced breast cancer, approved by the FDA FDA approves Pfizer’s HYMPAVZI (marstacimab), once-weekly treatment for adults and adolescents with hemophilia A or B without inhibitors ?? Deals Paris-based Qantev, an AI-driven solution supporting health insurers, raises €30 million in Series B Purespring Therapeutics raises $80-105 million in Series B financing to advance gene therapies aimed at transforming the treatment of kidney diseases Lundbeck acquires US company Longboard Pharmaceuticals for $2.6bn AstraZeneca commits up to $2bil in deal with CSPC Pharmaceutical Group to develop preclinical heart disease drug, YS2302018, aimed at disrupting lipoprotein(a) to treat cardiovascular conditions Judo Bio debuts with $100M and a plan to take RNA drugs to the kidney ??Late-stage developments Boehringer Ingelheim?receives breakthrough therapy designation for survodutide as a treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis GSK's RSV vaccine Arexvy shows strong efficacy in preventing lower respiratory disease in older adults across three RSV seasons in Phase 3 Scholar Rock's apitegromab meets primary endpoint, demonstrating improvements in motor function for patients with spinal muscular atrophy ?? Access An analysis by IQVIA Institute for Human Data Science confirms that the first round of Medicare drug price negotiations under the IRA is unlikely to lead to significant cost reductions for most patients. While government claims suggest savings for Medicare, patient out-of-pocket expenses are expected to remain largely unchanged, particularly for those already benefiting from low fixed co-pays or low-income subsidies. Additionally, changes in insurance plan designs and drug formularies may even increase costs for some patients. ?? Other The 2024 Nobel Prize in Chemistry was awarded for AI breakthroughs in predicting protein structures, revolutionizing drug discovery and biology The 2024 Nobel Prize in Medicine was awarded to Victor Ambros and Gary Ruvkun for their discovery of microRNAs, small molecules essential in regulating gene expression and playing a critical role in various disease processes ? Melinda French Gates announces $250 million fund, "Action for Women's Health," aimed at improving women's healthcare globally bluebird bio's Skysona gene therapy trials report seven cases of blood cancer in gene therapy trials Microsoft launches new AI tools to streamline healthcare, including an AI agent for automating tasks like nurse documentation and enhanced models for medical imaging ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds #healthtech Hannah Kurth Patricia Machado Tamsin Lacourte Alexandra SILVAIN