Pharma and BioTech Daily

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant shifts and strategies shaping our industry.Novartis’s acquisition of Avidity Biosciences for a staggering $12 billion marks a pivotal moment in the pharmaceutical landscape this year. With this acquisition, Novartis underscores its commitment to bolstering its neuromuscular disease pipeline. Avidity Biosciences has made a name for itself with its cutting-edge RNA therapeutic technologies, particularly its Antibody Oligonucleotide Conjugates (AOCs). This platform uniquely combines monoclonal antibodies with oligonucleotides, enhancing precision in targeting sp...

This week in review covers 5 episodes from October 20 to October 24, featuring major developments in pharmaceutical and biotech industries including strategic acquisitions, regulatory updates, and clinical trial results.
Episodes included:

1. Pharma Innovations: AI's Impact and Strategic Shifts

2. Strategic Acquisitions and AI Revolutionize Pharma Landscape

3. Industry Shifts: Novo Nordisk's Revamp & ADC Breakthroughs

4. Transformative Advances in Precision Oncology and ADCs

5. Transformative Oncology Breakthroughs and Regulatory Shifts

Key topics covered:

- Strategic acquisitions and partnerships

- Regulatory updates and FDA approvals

- Clinical trial...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving deep into a series of significant events that are shaping the future of drug development and patient care.Starting with Merck KGaA, their decision to close the Active Pharmaceutical Ingredient plant in Arklow, Ireland by 2028 marks a pivotal shift in their manufacturing strategy. This move follows a strategic review and is emblematic of broader industry trends where companies reassess their operational strategies for greater efficiency. While this decision may impact the local workforce and supply chain dynamics...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal changes and innovations shaping the industry landscape.Let's begin with a significant acquisition that is resonating across the sector. Alkermes has strategically acquired Avadel Pharmaceuticals for a noteworthy $2.1 billion. This acquisition is primarily aimed at Avadel's long-acting narcolepsy drug, Lumryz. This move not only acts as a growth catalyst for Alkermes but also strategically positions the company to potentially advance its own narcolepsy candidate, Alixorexton. This acquisition highlights a broader trend within...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most significant shifts occurring in these industries, touching on strategic restructuring, regulatory milestones, and groundbreaking scientific advancements that are shaping the future of drug development and patient care.Let's begin with a major corporate shakeup at Novo Nordisk. The company has announced a significant leadership transition as former CEO Lars Rebien Sorensen is set to become the new chairman of the board. This change follows the resignation of seven board members and indicates...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent developments in these industries underscore a period of significant scientific progress, regulatory maneuvers, and strategic investments.One notable event was AstraZeneca and Daiichi Sankyo's success at the European Society for Medical Oncology Congress 2025. Their antibody-drug conjugate, Datroway, demonstrated superior efficacy compared to Gilead's Trodelvy in the first global head-to-head trial involving Trop2-targeted therapies. This reflects the increasing focus on antibody-drug conjugates as precision medicine tools that offer targeted treatment options with potentially improved outcomes over traditional chemotherapy.In...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into a series of remarkable advancements and strategic movements shaping the landscape of healthcare. Let's start with a recent spotlight on the European Society for Medical Oncology Congress 2025, where key clinical trial outcomes have emerged, potentially reshaping future treatment protocols.AstraZeneca made waves with its Phase 3 trial results for Imfinzi, a PD-L1 inhibitor, in high-risk non-muscle invasive bladder cancer. The findings suggest that Imfinzi stands strong against Pfizer's PD-1 candidate, Sasanlimab. This is particularly noteworthy as bladder...

This Week in Review covers episodes from October 14 to October 17, featuring major developments in the pharmaceutical and biotech industries. Episodes included:

Key topics covered:

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Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into a series of fascinating updates that underscore a period of significant scientific advancement, strategic partnerships, and regulatory developments in the industry.Starting with Dianthus Therapeutics, which has taken a bold step by investing up to $1 billion to license a bifunctional fusion protein from Nanjing Leads Biolabs. This protein targets autoimmune disorders, a field of immense interest due to the unmet medical needs and potential for breakthrough treatments. Such substantial financial commitments highlight the ongoing trend in...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of major advancements and strategic moves that are shaping the future of healthcare.A significant development comes from AstraZeneca, which has committed a substantial $445 million investment to bolster production at its Texas facility for Lokelma, a treatment designed for hyperkalemia. Hyperkalemia is a condition characterized by elevated potassium levels in the blood, posing serious health risks if not managed properly. This investment highlights AstraZeneca's dedication to meeting growing global demand and enhancing patient access...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the rapidly evolving landscape of the pharmaceutical and biotech sectors, where regulatory updates, strategic mergers, and scientific breakthroughs are continually reshaping the industry.Starting with Novo Nordisk's recent challenges, their newly acquired manufacturing facility in Indiana has been flagged by the FDA with an "Official Action Indicated" designation. This classification, being the most severe level of inspection categorization, potentially signals delays in production and collaboration with partners like Regeneron and Scholar Rock. Such regulatory hurdles underscore the...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest news shaping this dynamic industry.Bristol Myers Squibb recently made headlines with their acquisition of Orbital Therapeutics for a remarkable $1.5 billion. This strategic move is aimed at enhancing their in vivo cell therapy capabilities, particularly in treating autoimmune disorders. In vivo cell therapy is a pioneering approach that allows genetic modifications directly within a patient's body, potentially revolutionizing the treatment landscape for numerous conditions. This acquisition underscores Bristol Myers Squibb's commitment to pushing the boundaries...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. ##FDA Approves New Cancer TreatmentThe FDA has approved a new cancer treatment that has shown promising results in clinical trials. This treatment is expected to provide a new option for patients who have not responded well to traditional therapies. ##Drug Company Announces Major Breakthrough in Alzheimer's ResearchA drug company has announced a major breakthrough in Alzheimer's research, with a new drug that has shown significant improvement in cognitive function in patients with the disease. This breakthrough could...

his Week in Review covers 5 episodes from October 06 to October 10, featuring major developments in the pharmaceutical and biotech industries.

Episodes included:

1. Pharma and Biotech Daily: Novo's Acquisition, FDA Breakthroughs, and Industry Updates

2. Pharma and Biotech Daily: Top Stories in the Industry from Zenas to Lilly

3. Pharma and Biotech Daily: Tariff Impact, Promising Trials, and Industry Leaders

4. Pharma and Biotech Daily: The Latest in Cell and Gene Therapy, M&A Activity, and Regulatory Updates

5. The Essential Updates in Pharma and Biotech: Your Daily Dose of What Matters

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world.Novo has recently completed the acquisition of Akero in a deal valued at up to $5.2 billion. This acquisition adds Akero's efruxifermin to Novo's already impressive portfolio. The FDA breakthrough drugs continue to show promise, with nearly three quarters of designated drugs being approved, especially in the rare disease and cancer categories.In other news, there has been a delay in an ACIP meeting, Ferring has announced layoffs of 500 employees, and Pfizer has emerged victorious in a takeover...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Zenas has made a $2 billion bet on autoimmune diseases with Chinese firm InnoCare, focusing on the development of orelabrutinib for multiple sclerosis. Former FDA director Peter Marks has joined Eli Lilly, marking the company's continued push in China. Sanofi's advancements in radiopharma, Boehringer Ingelheim's breakthrough in idiopathic pulmonary fibrosis, and Takeda's exit from cell therapy are also top stories. Cytiva filtration is highlighted as a solution for maintaining product integrity in biopharma.Biospace profiles the five most powerful...

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 survey from CRB shows that most life sciences companies, particularly smaller biotechs, are not planning new investments in response to tariffs. The majority of manufacturing initiatives in the U.S. made in response to tariffs are coming from big pharma companies. Sky Bioscience's CB1 inhibitor, Nimacimab, showed promising weight-loss results when combined with Wegovy despite falling short of expectations in a mid-stage obesity trial. Amgen will offer its lipid-lowering drug Repatha directly to patients at a 60...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Chiesi has entered a $2.1 billion collaboration with Arbor to develop a gene therapy for primary hyperoxaluria type 1. AstraZeneca continues to invest in AI partnerships, FDA lifts clinical hold on Neurizon's ALS drug, and the cell and gene therapy field faces challenges and opportunities at the Meeting on the Mesa event. CDC adopts ACIP recommendations, FDA's manufacturing initiatives progress, and Mythic cuts staff.Industry leaders in the cell and gene therapy space are gathering in Phoenix for a meeting...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Former NIAID director Jeanne Marrazzo was fired after filing a whistleblower report, alleging retaliation. The FDA's new cell and gene therapy guidances have been well-received for streamlining therapies. In other news, CMS has finalized stronger protections for orphan drugs, and Amgen's Repatha has shown positive results in preventing heart disease. Lotte Biologics is highlighted as a multinational CDMO partner, and layoffs at CSL Vifor and Takeda are noted. Trump has delayed pharma tariffs, Pfizer's drug pricing deal with...

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 has once again delayed the imposition of 100% tariffs on pharmaceuticals, with preparations now set to begin on October 1. Halozyme's acquisition of Elektrofi for $900 million has brought two major pharmaceutical partners together, while Takeda is exiting the cell therapy sector and laying off 137 employees. Roche's $3.5 billion takeover of 89bio was driven by the success of Akero's drug, with regulatory documents shedding light on how 89bio's board pushed for the deal. Lotte Biologics is making waves as a...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Pfizer's recent deal with the Trump administration regarding drug pricing has sparked concerns about access to medications, particularly with a focus on commitments to manufacturing in the U.S. and tariff exemptions. The ongoing U.S. government shutdown has had a direct impact on the FDA's ability to accept new drug applications, creating challenges for the industry. Fortress and Sentynl faced hurdles in securing FDA approval due to manufacturing issues, while the third quarter of the year witnessed...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Metsera's mid-stage obesity drug, met-097i, has shown "very encouraging" efficacy, supporting Pfizer's proposed $4.9 billion buyout of the company. The drug's performance is seen as positive by BMO Capital Markets. In other news, drug manufacturers are increasingly utilizing artificial intelligence throughout the drug production process, moving from using AI for specific operations to optimizing the entire production process. Additionally, Crystalys, backed by Novo, has debuted with $205 million to tackle gout with its drug dotinurad. The FDA recently singled...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Genmab has acquired Merus, a rising star in the field of oncology, for $8 billion. The acquisition includes Merus' bispecific antibody, petosemtamab, which targets EGFR and LGR5 and has shown potential for head-and-neck cancer. In other news, GSK CEO Emma Walmsley is stepping down after nine years, with Chief Commercial Officer Luke Miels set to replace her next year. The FDA's decision to disclose complete response letters in real-time has raised questions about transparency and the agency's role. Additionally...

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 has announced a 100% tariff deadline for pharmaceutical companies starting on October 1. However, companies that have already begun construction on manufacturing facilities in the U.S. are exempt from these tariffs. This move is part of the administration's efforts to lower drug prices and improve access to treatments for patients.In other news, Crinetics Pharmaceuticals has received FDA approval for their once-daily treatment for acromegaly, a rare pituitary condition. This approval marks a significant milestone for Crinetics...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.## Immuneering's drug atebimetinib has shown promising results in doubling overall survival in pancreatic cancer patients after nine months. Truist analysts have deemed the results encouraging, although some unknowns remain in the data. Immuneering plans to initiate a registrational trial for atebimetinib later this year. ## In other news, Lilly has halted a mid-stage obesity study for strategic reasons, Harmony has failed a pivotal trial for fragile X syndrome, and the FDA has released guidance to streamline the development...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Uniqure's gene therapy for Huntington's disease, AMT-130, has shown promising results in a 3-year study, slowing disease progression by 75%. If approved, it would be the first genetic treatment for Huntington's. Meanwhile, Acadia Pharmaceuticals has discontinued a Prader-Willi drug after a late-stage failure. Biogen received an unexpected FDA rejection for a high dose of Spinraza, and J&J received a warning letter for violations at a Korean production plant. In the competitive bioscience industry, credentials from Biotility can help...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA has revived a long-dormant drug from GlaxoSmithKline as a potential treatment for autism. The agency also mentioned the potential link between the use of Tylenol and other acetaminophen products during pregnancy and neurological and developmental defects in children. In other news, Scholar Rock's spinal muscular atrophy drug faced manufacturing site issues, while Lexicon's type 1 diabetes drug experienced regulatory delays. Merck's ProQuad vaccine history was examined amid changing vaccine guidelines. Kennedy's criticism of childhood vaccines was also...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a comeback in the obesity market with the acquisition of Metsera for $4.9 billion, rejuvenating its portfolio after facing challenges with three discontinued assets. Meanwhile, Stealth BioTherapeutics has received expedited FDA approval for the first-ever treatment for Barth syndrome, and Sanofi's decision on their oral multiple sclerosis drug has been postponed to December. The ACIP committee has expressed concerns about a lack of knowledge and experience within the reconstituted committee. Biotility offers industry-recognized credentials to advance...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The Advisory Committee on Immunization Practices (ACIP) has changed its recommendations for the MMRV vaccine for children under four, advising that the measles, mumps, rubella (MMR) vaccine be administered separately from the chickenpox vaccine. The committee is also expected to make changes to the childhood schedule for hepatitis B and COVID-19 vaccines. Replimune's stock has crashed after uncertainty surrounding the regulatory path for its tumor destroyer therapy, while a House bill has reignited hope for the FDA's rare...

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, alleging that Health Secretary Robert F. Kennedy Jr. accused CDC employees of "killing children." In other news, Roivant and Pfizer's therapy shows promise in a rare inflammatory condition, BMS...

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 their GLP-1 weight loss drugs in advertising, particularly during a prime time special with Oprah Winfrey. Lilly is also investing in...

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 despite safety concerns, and new members have been appointed to the ACIP panel. Stealth Biotherapeutics is awaiting a verdict on...

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 other news, AstraZeneca has suspended its $270 million commitment in the UK, the FDA has flip-flopped on scrapping advisory committee meetings, and Sino Biological has developed...

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 R&D work. AbbVie has extended exclusivity for its drug Rinvoq until 2037 with a generics settlement. Novo's headcount has increased by 81% in five years...

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 considering restrictions on Chinese licensing deals in the pharmaceutical industry. ## Lilly is seeking individuals willing to challenge the status quo of...

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 Susan Monarez will testify in front of the Senate, and a recent report from the Maha commission emphasizes chronic diseases and potential vaccine reform...

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, putting over $17 billion into deals this year. The biotech industry is also seeing some activity, with LB filing for a $228 million IPO to support its phase III...

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 stock value after positive mid-stage data for its epilepsy pill, and the FDA opted for a consumer "green list" instead of addressing compounded versions of...

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 advisory panel with "antivaccine rhetoric." Hengrui Pharmaceuticals signed lucrative deals with Merck and GSK, while the FDA promised to release future Complete Response Letters promptly. In other news...

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 downsized and refocused its pipeline, while Kennedy proposed adding seven new vaccine advisors to the ACIP. Other news included successful RNA editing...

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 freeze. Gene therapy, with its potential to cure deadly diseases, is still facing challenges in terms of insurance coverage in the U.S. The industry is seeing...

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 the subcutaneous maintenance formulation of Leqvembi. Arrowhead Pharmaceuticals has secured a commitment of up to $2 billion from Novartis for an siRNA Parkinson's program. The FDA's new radiopharma...

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 announced plans to merge with another company in the industry. This merger is expected to create a powerhouse in the pharmaceutical world, with the...

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 vaccine mandates during the COVID-19 pandemic, citing concerns about limiting medical choice. However, the FDA, under their leadership, has now approved...

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 rates of brain swelling in Phase I testing. Novo Nordisk is collaborating with other companies on cardiometabolic treatments. The pharma industry is facing...

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 losing its edge in biopharma innovation to China. Additionally, a drug program for a rare neurodegenerative disorder has been discontinued...

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 seeing success in AI-driven manufacturing. The White House has denied rumors of a potential ban on COVID-19 vaccines, as the pharmaceutical industry continues to...

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 chikungunya shot from the market due to safety concerns, and several obesity drugs have failed to make it to market. Meanwhile, Arnatar is working on advancing RNA...

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 patients who have been waiting for a treatment for this debilitating condition.##Positive results from Phase 3 clinical trialIn other news, a pharmaceutical company...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. HHS employees have accused RFK Jr. of spreading public mistrust against the CDC after a shooting at their headquarters. They have asked him to stop spreading health misinformation, especially about vaccines and infectious diseases. In other news, Johnson & Johnson has added $2 billion to their US manufacturing commitment amid Trump's tariff threats. Regeneron's Eylea HD decisions have been delayed, and Stealth Biotherapeutics' rejected Barth drug is returning to the FDA for review. Fedegari is now a one-stop solution provider...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The FDA is pushing new guidelines for cancer trials, recommending overall survival as a primary endpoint. Capricor Therapeutics is asking the FDA to reconsider their rejection of a treatment for DMD cardiomyopathy with the return of Vinay Prasad. Rocket Pharmaceuticals' phase II trial has resumed after a patient death, and the Trump administration's tariffs and drug pricing policies are causing confusion in the pharmaceutical industry. Fedegari is now offering customized solutions for the bio/pharmaceutical industry. The American...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Viking Therapeutics' oral obesity pill, VK2735, achieved over 12% weight loss in a clinical trial, causing their stock to plummet due to safety concerns. The pending approval of oral Wegovy has also brought attention to high-dose peptides.## Meanwhile, leaked information reveals a proposed overhaul of vaccine strategies and access to novel therapies. The FDA rejected PTC Therapeutics' drug for Friedreich's ataxia, and Novo Nordisk reassured investors of their capacity to supply oral semaglutide. Fedegari now offers customized solutions for...

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 received approval for label expansion, potentially boosting its market performance. Tonix has also secured approval for a new fibromyalgia medication. Additionally, Novo has teamed up with GoodRx to provide lower prices for its drugs. Merck KGaA has made a significant investment of $2 billion in RNA-targeting technology through a collaboration with Skyhawk Therapeutics. On the sterilization front, Fedegari now offers tailored solutions for the pharmaceutical sector. In other updates, Pfizer's sickle cell therapy did...

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 plans to raise drug prices in Europe in response to Trump's Most Favored Nation policy. RFK Jr. has expressed support for mRNA cancer vaccines after cutting mRNA BARDA contracts. Precigen wins FDA approval for an immunotherapy for recurrent respiratory papillomatosis, while Kennedy revives a childhood vaccine safety group and suggests mRNA vaccines could be effective for cancer. Genscript announces a new era of innovation, Bausch Health closes a California site, and Eli Lilly partners with Superluminal...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Eli Lilly has invested $1.3 billion in a partnership with Superluminal, an AI/ML startup focusing on endocrine and cardiometabolic diseases to develop new small molecule obesity medications. Schrodinger has discontinued the development of an early-stage blood cancer drug after two patient deaths. Trump has delayed pharma tariffs citing other priorities. RFK Jr. has been criticized for canceling Barda contracts related to mRNA vaccine research, leading to more vaccine misinformation. Genscript announces a new era of innovation and trust...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sarepta has released new safety data for their gene therapy Elevidys, showing zero ambulatory deaths in patients with Duchenne muscular dystrophy. This data confirms the therapy's positive risk/benefit profile. Meanwhile, Novo Nordisk's rapid rise and fall was driven by GLP-1s like Ozempic and Wegovy, leading to a plummet in stock value. Insmed has received FDA approval for the first bronchiectasis drug and DPP1 blocker, Brinsupri. Texas has accused Eli Lilly of "bribing" prescribers to push their...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Bayer has secured a $1.3 billion deal with Kumquat Biosciences for exclusive access to their small-molecule KRAS G12D blocker. Meanwhile, Arrowhead has navigated through the Sarepta storm and experienced a drop in stock prices, despite having no direct ties to Sarepta's issues. In other news, a medical journal stands firm in refusing to retract a vaccine study, HHS has put a freeze on Vaxart's oral COVID-19 vaccine, and GenScript is celebrating a new era of innovation.## Additionally, discussions...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Vinay Prasad has returned to his position as director of the Center for Biologics Evaluation and Research at the FDA after a sudden exit less than two weeks ago. The FDA has restricted the patient pool for bluebird's Skysona gene therapy due to safety concerns, and Sarepta's AAV gene therapy platform has come under scrutiny following patient deaths from liver injuries. Genscript is celebrating a new era of innovation and trust.The text discusses the scrutiny faced by...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Vinay Prasad has returned to the FDA as the Chief of the Center for Biologics Evaluation and Research, just 10 days after his mysterious departure. His return comes after a short "vacation" in California, and it is believed that the regulator convinced him to come back. Some speculate that Prasad's time away may have helped him gain a better understanding of the complexities involved in decision-making at the FDA, especially when it comes to ensuring the safety of patients...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Eli Lilly is facing significant drug pricing pressure, with issues ranging from the pricing of their weight loss pill Orfoglipron to market battles with competitors like Novo Nordisk. Despite the challenges, Lilly's executives see opportunities for their products in the real world. Jazz Pharmaceuticals received FDA approval for Dordaviprone, making it the first new treatment for an ultra-rare brain tumor. In other news, Sarepta beat Q2 estimates despite not holding an investor call, and Trilink Biotechnologies is offering...

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's new CEO, Maziar Mike Doustdar, is focusing on developing more drugs for obesity and diabetes while trimming the company's pipeline. The Department of Health and Human Services is terminating around $500 million in contracts for mRNA vaccine development, affecting companies like Moderna and Pfizer. Chinese biotechs are turning to big pharma for partnerships to survive, while Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. Other top stories include biopharma CEOs being pulled into policy...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##Breaking News: Pfizer announces successful COVID-19 vaccine trialsIn a groundbreaking announcement, Pfizer revealed that their COVID-19 vaccine candidate has shown to be over 90% effective in preventing the virus. This news brings hope to the world as we continue to battle the global pandemic.##FDA approves new treatment for Alzheimer's diseaseThe FDA has approved a new treatment for Alzheimer's disease, marking a significant advancement in the fight against this debilitating condition. This approval could potentially change the lives of...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. BioNTech is focusing on infectious diseases as vaccine rates drop, with expectations that the US COVID-19 vaccination rate will decrease slightly. Glioblastoma research is seeing increased funding and interest from companies like Merck and Jazz Pharmaceuticals. The FDA's rejection of Replimmune's melanoma drug, despite staff consensus, has caused a drop in the company's stock. Sarepta and Capricor learned of regulatory decisions through media leaks, causing confusion for patients and families. Trilink Biotechnologies offers process development services for nucleic...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna CEO Stephane Bancel has stated that the company is not interested in pursuing mergers and acquisitions, preferring to focus on research and development partnerships instead. Former President Trump has threatened 17 big pharmaceutical companies with a deadline to lower drug prices or face government intervention. Regeneron faces regulatory issues affecting decision dates for high-dose Eylea, while Moderna has won a UK patent battle against Pfizer and BioNTech. After the removal of FDA chief Dr. Prasad, Dr. Makary is...

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Biogen's sales of the partnered Alzheimer's drug Leqembi have climbed 20% in the second quarter, while CEO Chris Viehbacher dismisses rumors of disagreements with Eisai. Moderna has cut 10% of its global workforce as part of cost-cutting measures. AbbVie is celebrating the success of Skyrizi and Rinvoq, Lilly's Mounjaro shows promise in a cardiovascular trial, and there is optimism around Sarnas for therapeutic breakthroughs. Amidst industry challenges, many biopharma professionals are looking for new job opportunities.

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Vinay Prasad's departure from CBER has analysts anticipating a more traditional successor, while GSK streamlines its pipeline and pledges billions in US investments. Susan Monarez is now the confirmed CDC director, and the top biopharma venture capital raises of H1 2025 are summarized. Despite challenges like layoffs and market fluctuations, GSK remains committed to investing in the US despite tariffs. Other headlines include Madrigal's potential $2 billion investment, Biogen and Eisai's Alzheimer's drug update, and Novo Nordisk's new leadership. Trilink...

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 announced Maziar Mike Doustdar as its new CEO, along with a 5% reduction in its 2025 sales guidance. This decision comes as a response to the slowed growth of its semaglutide franchise in the U.S. Senate Democrats are currently looking into HHS Secretary RFK Jr.'s controversial move to dismiss all 17 members of the CDC's vaccine advisory committee. Astrazeneca CEO Pascal Soriot emphasized the importance of global collaboration in pharmaceutical research and development. Merck has allocated $3...