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BioSpace: Biotech, Pharmaceutical and Clinical Research NewsBioSpace: Biotech, Pharmaceutical and Clinical Research News News Drug Development FDA Drug Delivery Deals Business Policy Cell and Gene Therapy Weight Loss Rare Disease Cancer Job Trends Artificial Intelligence NextGen Class of 2024 Insights Podcasts Reports Webinars Press Releases All News & Releases Jobs Career Advice Companies Hotbeds More Employer Resources Best Places to Work Post Jobs Talent Solutions Advertise Submit a Press Release SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Drug Delivery Deals Business Policy Cell and Gene Therapy Weight Loss Rare Disease Cancer Job Trends Artificial Intelligence NextGen Class of 2024 Insights Podcasts Reports Webinars Press Releases All News & Releases Jobs Career Advice Companies Hotbeds More Employer Resources Best Places to Work Post Jobs Talent Solutions Advertise Submit a Press Release Search Query Submit Search Schizophrenia FDA Approves First Novel Schizophrenia Drug in 35 Years BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors. September 27, 2024 · 8 min read · Heather McKenzie Psychedelics MDMA Drug Developers Reprioritize Following Lykos Rejection in PTSD September 30, 2024 · 5 min read · Kate Goodwin Regulatory FDA Action Alert: Biofrontera, BMS and Zealand September 30, 2024 · 4 min read · Tristan Manalac Women’s Health IVF Restrictions, Demise of Roe v. Wade Could Endanger Women’s Health Research Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse. September 30, 2024 · 5 min read · Aayushi Pratap Sickle Cell Disease Pfizer’s Oxbryta Withdrawal Leaves Sickle Cell Community Scrambling, Investors Reeling Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess. September 27, 2024 · 7 min read · Annalee Armstrong FDA Sanofi and Regeneron’s Dupixent Snags First Biologic Approval in COPD Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection. September 27, 2024 · 2 min read · Kate Goodwin Editorial Lilly Is Not ‘Feeling the Bern’ on Drug Prices Like Novo: Why the Double Standard? Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair. September 27, 2024 · 3 min read · Greg Slabodkin FDA FDA Adcomm Recommends Limiting Keytruda, Opdivo Use in Stomach, Esophageal Cancer The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks. September 27, 2024 · 4 min read · Heather McKenzie Parkinson’s disease AbbVie’s $8.7B Cerevel Buy Starts to Pay off With Phase III Parkinson’s Win Results from TEMPO-1, which showed that tavapadon significantly improved motor symptoms in patients with Parkinson’s disease, will help AbbVie as it builds a regulatory case for the D1/D5 dopamine receptor agonist. September 27, 2024 · 2 min read · Tristan Manalac More News FEATURED STORIES IRA Cancer and Diabetes Drugs Expected to Dominate 2025 Medicare Negotiations Under IRA Many Big Pharma companies including Pfizer, Merck and BMS make the drugs that some researchers expect to be selected by CMS for next year’s Medicare price negotiations alongside analysts’ top pick, Novo Nordisk’s Ozempic. September 25, 2024 · 2 min read · Greg Slabodkin Deals Lilly and Novo Spend Billions to Expand Obesity Pipelines Beyond GLP-1s Novo Nordisk and Eli Lilly are expected to rule the obesity market for a few more years without much challenge. To ensure they stay there as competition enters, the companies are spending billions in licensing and M&A deals. September 25, 2024 · 10 min read · Annalee Armstrong Drug development Boehringer, Insilico Appear to Break Through Against IPF Clinical trial results shared by Boehringer Ingelheim and Insilico Medicine showed improvement in idiopathic pulmonary fibrosis, an intractable lung disease for which current treatment options fail to stop progression, but the data were limited, leaving experts wanting. September 24, 2024 · 4 min read · Heather McKenzie VIEW ALL FEATURED COMPANIES FROM BIOSPACE INSIGHTS Business The White House, Microsoft, SAS, Foley Hoag & Astellas Offer AI Guidance to Investors. Part Two: The Future As technology continues to evolve, companies should have strategies that incorporate an understand of where they are now, where they want to be, and do they have the talent to get there. September 24, 2024 · 6 min read · Lori Ellis Business The White House, Microsoft, SaS, Foley Hoag & Astellas Offer AI Guidance to Investors. Part One: The Present September 23, 2024 · 10 min read · Lori Ellis Webinar: Embracing Agility: Critical for the role of QARA professional? September 11, 2024 · 1 min read Partnered QARA Professionals Question a Future with Cybersecurity Issues, US Litigation, and the EU AI Act August 12, 2024 · 8 min read · BioSpace Insights FDA FDA CBER Director Dr. Peter Marks Discusses Industry Growth, Collaboration and Communication July 8, 2024 · 1 min read · Lori Ellis Employer Resources With Latest Expansion in Ohio, Resilience Can Best Serve Partners and Patients June 27, 2024 · 5 min read · BioSpace Insights Employer Resources Report: The State of Diversity, Equity, Inclusion and Belonging in Life Sciences May 6, 2024 · 1 min read · BioSpace Insights Read More LATEST PODCASTS Drug Development AI Return on Investment: Just Because We Can, Should We? In this episode, Lori and guests continue their exploratory discussion on AI and focus on the challenges of globalization and return on investment. September 26, 2024 · 1 min read · Lori Ellis Podcast Novo Grilled by Senate, PhRMA’s IRA Win and BMS’ KarXT Awaits Approval New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia. September 25, 2024 · 1 min read · Heather McKenzie Podcast Sickle Cell Gene Therapies Reach Patients, Moderna Cuts, Obesity Pill Race and ESMO 2024 Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more. September 18, 2024 · 1 min read · Heather McKenzie Load More Subscribe to Genepool Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news Email Address   (Required) Submit SPECIAL EDITIONS Obesity Deep Dive: Obesity and Diabetes Markets Explode In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. August 26, 2024 · 3 min read · Heather McKenzie Job Trends 2024 Q2 Job Market Report: More People Competing for Fewer Job Openings For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%. July 11, 2024 · 3 min read · Angela Gabriel Deals Deep Dive: Biopharma M&A Activity Picks Up Steam The pace of mergers and acquisitions has accelerated. In this deep dive, BioSpace takes a closer look at the nature of recent deals and the players involved. June 20, 2024 · 2 min read · Jef Akst Load More DEALS Venture capital ARCH Fuels Up With $3B to Support Next Class of AI Biotechs ARCH Venture Partners is the latest venture capital firm to raise a multi-billion-dollar fund. The cash will be used to support new startups working with AI. September 26, 2024 · 1 min read · Annalee Armstrong Deals Flagship’s AI Company Generate Inks Deal Worth up to $1B With Novartis Flagship Pioneering–backed Generate:Biomedicines has signed its second major Big Pharma partnership, bringing in $65 million upfront to use its AI platform to discover novel protein drug candidates. September 24, 2024 · 2 min read · Annalee Armstrong Deals After Fed Rate Cut, Biotech Stocks Face ‘Anticlimactic’ Reality The drop in interest rate is slightly bigger than anticipated and good news for the biotech industry, but little will change in the near term. September 19, 2024 · 3 min read · Annalee Armstrong M&A Roivant Deals Again, Sending Dermavant to Organon in Sale Worth Up to $1.2B The sale of Dermavant clears the way for Roivant to focus on autoimmune-focused Immunovant and a slate of upcoming pivotal trials. September 18, 2024 · 3 min read · Annalee Armstrong IPO 3 Biotechs Seek Over $700M in Renewed IPO Rush Bicara Therapeutics, Zenas BioPharma and MBX Biosciences are seeking a combined $700 million-plus in IPO filings this week. September 13, 2024 · 2 min read · Annalee Armstrong WEIGHT LOSS Business Novo CEO Reluctantly Agrees to Meet With PBMs on Ozempic, Wegovy Prices In a Tuesday Senate hearing on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs. September 25, 2024 · 3 min read · Greg Slabodkin Podcast Novo Grilled by Senate, PhRMA’s IRA Win and BMS’ KarXT Awaits Approval New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia. September 25, 2024 · 1 min read · Heather McKenzie Policy Novo’s Ozempic Seen as Shoo-In for Next Round of Medicare Price Negotiations Novo Nordisk’s blockbuster type 2 diabetes medication is a sure bet for the list of the next 15 drugs whose Medicare prices will be negotiated in 2025 and go into effect in 2027, according to analysts and academics. September 25, 2024 · 3 min read · Greg Slabodkin Weight Loss New Weight Loss Biotech Metsera Stuns with 7.5% Weight Loss, Few Side Effects Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects. September 24, 2024 · 2 min read · Annalee Armstrong Policy Novo CEO, Sanders to Face Off Over US Prices for Ozempic and Wegovy In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively. September 24, 2024 · 3 min read · Greg Slabodkin FDA FDA AstraZeneca Expands Tagrisso’s Reach in NSCLC; Second NPC Approval In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024. September 26, 2024 · 185 min read · Heather McKenzie Regulatory FDA Considers Narrowing Label of PD-1 Drugs in Stomach Cancer Ahead of Adcomm Meeting If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression. September 25, 2024 · 2 min read · Tristan Manalac Approvals IntraBio Wins FDA Nod for Ultra-Rare Neurodegenerative Disease on Heels of Competitor’s Approval IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa. September 25, 2024 · 2 min read · Tristan Manalac Approvals Sanofi Secures First-Line Nod for Sarclisa in Multiple Myeloma, Tees Up Competition With J&J With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year. September 23, 2024 · 2 min read · Tristan Manalac Complete response letters Vanda Contests FDA Rejection of Gastroparesis Drug, Slams ‘Delayed’ Decision Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act. September 19, 2024 · 2 min read · Tristan Manalac CAREER HUB Career Advice Telling the Right Story: Overselling, Underselling Can Hurt Your Candidacy During the job application and interview process, candidates who lie to prospective employers and those who don’t properly highlight their accomplishments can find it difficult to land—or keep—their next role. We asked experts how to sell yourself positively and honestly. September 26, 2024 · 5 min read · Angela Gabriel Career Advice How to Deal With a Toxic Co-Worker September 25, 2024 · 5 min read · Alina Zahid Career Advice Evaluating Job Security in a Tough Biopharma Market September 19, 2024 · 5 min read · Angela Gabriel Career Advice 11 Signs of Good Company Culture Good company culture is a crucial aspect of professional life. Look at these 11 important indications of good workplace culture before accepting a job offer or use them to evaluate your new employer. September 19, 2024 · 4 min read · Editorial Staff Opinion Opinion: A Small Pharma Mindset Can Reshape Big Pharma and Improve Patient Care An appreciation for practicality, independent thinking and patient care can help disrupt the bureaucracy of Big Pharma. September 12, 2024 · 3 min read · Jill Marie Drury Job Search Strategy Career Coach: Why Fall Is Prime Time for Your Biotech Job Hunt Plus, learn about what to expect in initial interviews and how to time your post-Ph.D. job search for maximum success. September 11, 2024 · 5 min read · Carina Clingman Career Advice The Top 12 Companies Hiring in Biopharma Now Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you. September 5, 2024 · 1 min read · Angela Gabriel Career Advice Manager’s Toolbox: How to Have Difficult Conversations Having difficult conversations with the right mindset can build trust and further develop your relationship with your team. September 4, 2024 · 6 min read · Bruce Wu Management Stuck in the Middle: How Millennial Managers Can Bridge Generational Gaps Getting caught between younger team members and older bosses can be stressful for millennial managers. A leadership expert and millennial manager share tips for bridging the gap between these groups. September 4, 2024 · 4 min read · Angela Gabriel MORE CAREER ADVICE HOTBEDS Biotech Bay Biotech Beach Genetown Pharm Country BioMidwest BioForest BioCapital Bio NC Lone Star Bio Best Places to Work Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year. May 23, 2024 View 2024 Winners IN CASE YOU MISSED IT Drug Development AI Return on Investment: Just Because We Can, Should We? In this episode, Lori and guests continue their exploratory discussion on AI and focus on the challenges of globalization and return on investment. September 26, 2024 · 1 min read · Lori Ellis Collaboration Novo, Evotec Ink Stem Cell Partnership as Drugmaker Looks to Expand Pipeline September 26, 2024 · 2 min read · Tristan Manalac Sickle cell disease Pfizer Takes Sickle Cell Drug Oxbryta Off Global Market, Cites Risk of Death September 26, 2024 · 2 min read · Tristan Manalac REPORTS Job Trends Report: 2024 Job Market Trends, H2 Update This report investigates anticipated job search activity and hiring outlook for the remainder of 2024. July 24, 2024 · 1 min read · BioSpace Insights Employer Resources Report: The State of Diversity, Equity, Inclusion and Belonging in Life Sciences BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives. May 6, 2024 · 1 min read · BioSpace Insights Job Trends Report: 2024 U.S. Life Sciences Salary Trends BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals. March 18, 2024 · 1 min read · BioSpace Insights Load More CANCER Cancer Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study Merck follows in the footsteps of Bristol Myers Squibb, which in December 2023 also failed to secure a late-stage victory for its combo regimen of a PD-1 blocker and an anti-LAG-3 antibody. September 25, 2024 · 2 min read · Tristan Manalac Antibody-drug conjugate (ADC) AstraZeneca, Daiichi Sankyo’s ADC Flops in Phase III Breast Cancer on Heels of Lung Cancer Stumble Monday’s failure to improve overall survival in breast cancer “further dents belief” in the companies’ Dato-DXd and “likely complicates regulatory discussions for approval of this indication,” Jefferies analyst Peter Welford wrote in a note to investors. September 23, 2024 · 3 min read · Tristan Manalac Cancer ADCs, Bispecifics and Radiopharma Take Center Stage at ESMO24 The European Society for Medical Oncology’s annual meeting this week featured the hottest emergent areas of cancer treatment—antibody-drug conjugates, bispecifics and radiopharmaceuticals—while anti-TIGIT therapies made a bit of a comeback. September 20, 2024 · 3 min read · Greg Slabodkin Lung cancer Despite Win Over Keytruda, Summit’s NSCLC Bispecific Still Has Something to Prove Summit Therapeutics’ ivonescimab has the potential to challenge Merck’s blockbuster checkpoint inhibitor in non-small cell lung cancer, but experts stress the need for diverse and overall survival data. September 18, 2024 · 5 min read · Kate Goodwin Regulatory FDA Approves Merck’s Keytruda for First-Line Treatment of Pleural Mesothelioma The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group. September 18, 2024 · 2 min read · Tristan Manalac NEUROSCIENCE Alzheimer’s disease Cassava Agrees to Pay $40M Fine to Resolve SEC Probe as Company Hit With New Lawsuit Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate. September 27, 2024 · 2 min read · Tristan Manalac Multiple sclerosis Study Casts Doubt on Benefit of Anti-CD20 Therapies in Multiple Sclerosis New research has found that MS patients treated with anti-CD20 antibodies, such as Roche’s Ocrevus, do not experience significantly slower progression of disability. September 26, 2024 · 2 min read · Tristan Manalac Neurodegenerative disease Biohaven Sets Stage for Comeback With Pivotal Study Results in Spinocerebellar Ataxia The FDA previously refused to review Biohaven’s candidate in the indication due to a failed late-stage trial. However, the company is now planning to file an NDA in the fourth quarter of 2024. September 24, 2024 · 2 min read · Tristan Manalac Schizophrenia 5 Schizophrenia Candidates Chasing BMS’ KarXT As the FDA prepares to render a verdict on BMS’ closely watched schizophrenia drug, BioSpace takes a closer look at the late-stage pipeline for this neuropsychiatric disorder. September 23, 2024 · 6 min read · Heather McKenzie Multiple sclerosis Sanofi’s Tolebrutinib Delays MS Progression in Phase III Study Following Earlier Flops The positive readout in patients with non-relapsing secondary progressive multiple sclerosis comes on the heels of back-to-back failures in which tolebrutinib was unable to improve relapse rates in patients with relapsing MS. September 20, 2024 · 2 min read · Tristan Manalac CELL AND GENE THERAPY Gene therapy 4DMT’S Gene Therapy for AMD Clears Phase II, Heads to Late-Stage Studies 4D Molecular Therapeutics reported its experimental gene therapy demonstrated a nearly 90% reduction in the need for annualized standard-of-care injections in patients with wet age-related macular degeneration. September 19, 2024 · 2 min read · Tristan Manalac Gene Therapy Patients At Last Begin Receiving Vertex-CRISPR and Bluebird Sickle Cell Gene Therapies Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia. September 17, 2024 · 2 min read · Annalee Armstrong Business BridgeBio Grows Up, Trims Pipeline as It Leans Into Late-Stage Assets As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline. September 12, 2024 · 4 min read · Heather McKenzie Gene Therapy Vertex, CRISPR’s Casgevy Highlights Complex Path to Gene Therapy Profitability No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general. September 11, 2024 · 7 min read · Annalee Armstrong Business BioMarin Rolls Out $4B Revenue Expectations, as Analysts Wonder About Pipeline BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting. September 5, 2024 · 7 min read · Annalee Armstrong ALL NEWS BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe. 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