Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has made a significant move in the pharmaceutical industry by acquiring 89bio for $3.5 billion, with a contingent value right of $6 per share. The acquisition includes pegozafermin, an analog in late-stage development for metabolic dysfunction-associated steatohepatitis. Meanwhile, former CDC director Susan Monarez spoke to the Senate about her firing, allegin...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eli Lilly's oral weight loss pill, orfoglipron, has faced challenges in meeting expectations, possibly due to an over-representation of males and Hispanic patients in the phase III study. The company is now presenting detailed late-stage data to paint a competitive profile for the drug. Meanwhile, the FDA has targeted Lilly and Novo Nordisk for downplaying risks of th...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo's amylin analog drug, cagrilintide, has shown a significant 11.8% weight loss in a phase III trial, with improved safety data to address past tolerability issues. The FDA is set to make a decision on the drug, with significant stakes for the company and the Barth Syndrome community. Additionally, Sarepta's DMD gene therapy is still being prescribed by doctors ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novartis and Monte Rosa have entered into their second molecular glue deal worth up to $5.7 billion, with Novartis putting $120 million upfront for more of the biotech's AI-discovered degraders. The myasthenia gravis market, once sparse, is now flourishing with new treatments approved and promising late-stage trial results from companies like Argenx and Regeneron. In ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump is considering exempting certain "non-patented" pharmaceuticals from tariffs, although specific guidelines have not yet been released. The Intercept has withdrawn a liver drug from the US market, and Ocaliva, approved for primary biliary cholangitis in 2016, did not receive full approval last year. Merck is cutting 125 employees in the UK as it ends ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Capsida has reported a patient death in a gene therapy trial for epilepsy, but the exact cause of death has not been disclosed. The patient had received the gene therapy cap-002. ## The FDA is looking to streamline the development of non-opioid painkillers, while Avidity has seen functional improvements in their DMD therapy. ## The White House is reportedly consi...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novo Nordisk has cut 9,000 jobs worldwide and reduced its 2025 profit growth guidance. The new CEO is fulfilling a cost reallocation promise, leading to a decrease in operating profit growth projection from 10% to 16% down to 4% to 10%. The company's restructuring efforts are aimed at increasing efficiency and reducing costs. In other news, the ousted CDC director Sus...
Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Novartis recently acquired Tourmaline for $1.4 billion, continuing its investment in cardiovascular treatments. The company has also made other partnerships in the cardiovascular space this year. Biogen is preparing to release new data on its lupus treatments, with analysts praising the company's pipeline. Novartis has been active in mergers and acquisitions, p...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.A new data release shows that Summit's Keytruda competitor, Ivonescimab, had better overall survival rates in Asian patients compared to those in North America and Europe. Despite this, the drug narrowly missed the statistical significance threshold required by the FDA for approval in Western countries. Meanwhile, Rapport Therapeutics saw a 180% increase in its stoc...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. During a Senate hearing, Robert F. Kennedy Jr. faced criticism for spreading anti-vaccine views and breaking promises regarding vaccines. The FDA released rejection letters for companies like Lykos Therapeutics, Stealth Biotherapeutics, and Regeneron. Ousted CDC director Susan Monarez accused Kennedy of firing her for not supporting Covid-19 recommendations from an...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Robert F. Kennedy Jr. faced the Senate Finance Committee in a tense hearing amidst calls for the removal of the health secretary. The committee questioned Kennedy on his recent actions, including the firing of CDC director Susan Monarez. Meanwhile, the FDA's new rare disease pathway received mixed reactions, with some questioning its tangible impacts. AC Immune dow...
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novartis has increased its commitment to its partnership with Argo BioPharma by an additional $5.2 billion, focusing on RNAi agreements targeting cardiovascular diseases. This highlights the ongoing advancements and challenges in the biopharmaceutical industry. Biotechs are turning to special purpose acquisition companies (SPACs) as a way to go public amid the IPO f...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk's drug Wegovy has successfully reduced cardiovascular risk by 57% compared to tirzepatide. Eli Lilly has terminated two mid-stage trials for a second obesity asset, while Vertex Pharmaceuticals and Enlaza Therapeutics have formed a potential $2 billion partnership to develop drugs for autoimmune diseases. Biogen and Eisai have received FDA approval for...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ##FDA approves new drug for rare genetic disorderThe FDA has recently approved a new drug for the treatment of a rare genetic disorder. This drug has shown promising results in clinical trials and is expected to provide much-needed relief for patients suffering from this condition. ##Major pharmaceutical company announces mergerA major pharmaceutical company has an...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Health Secretary Robert F. Kennedy Jr. is set to testify before the Senate Finance Committee on September 4. This comes after the removal of CDC Director Susan Monarez and the appointment of HHS Deputy Secretary Jim O'Neill as her interim replacement. Kennedy, along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad, had previously been vocal against...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. CDC Director Monarez was fired after less than a month due to internal unrest over new COVID-19 vaccine policies. Novo Nordisk is investing over $500 million in RNA obesity treatments. The FDA has approved updated COVID-19 shots from Pfizer, Moderna, and Novavax with restrictions, causing concern among some groups. Prothena's Alzheimer's drug, PRX012, has shown high ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Regeneron's experimental drug for myasthenia gravis, cemdisiran, has shown promising results in a Phase III trial and the company is aiming to file for FDA approval by 2026. Pharmaceutical spending in China has reached record levels, with more than $48 billion spent in the first half of the year. Former FDA Commissioner Scott Gottlieb has raised concerns about the US ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Lilly's new oral obesity drug is progressing towards FDA approval in 2025 after positive results from the second phase III trial for Orfoglipron. Analysts are optimistic about the potential for a "double-digit billion dollar opportunity" due to a manufacturing advantage.Arginex is looking to expand the label for Vyvgart in myasthenia gravis, while drugmakers are seein...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.AbbVie has acquired Gilgamesh Pharmaceuticals for $1.2 billion, focusing on neurology and depression treatments. This move follows AbbVie's previous failure with Emraclidine in schizophrenia treatment. The biotech industry's IPO stalemate appears to be ending, with Lb Pharma planning an IPO to fund a phase III-ready schizophrenia asset. The FDA has pulled Valneva's ...
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##New drug approval for rare genetic disorderToday, the FDA announced the approval of a new drug for a rare genetic disorder that affects approximately 1 in every 50,000 people. This drug has shown promising results in clinical trials, with patients experiencing significant improvements in their symptoms. This approval is a major milestone for the company and for pa...