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 for the pharmaceutical industry, offering highly customized solutions for sterile drug production. Additionally, the American pharma industry is facing challenges with tariffs and policy changes. Several upcoming webinars and job opportunities in the pharmaceutical industry are also highlighted in the newsletter.

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 Academy of Pediatrics is recommending the COVID-19 vaccine for kids, and there are updates on various biotech developments. Opinion pieces discuss drug pricing and the viability of high-dose peptides.The American pharmaceutical industry has lost the trust of the people, with many viewing them as the 'bad guys' despite producing drugs in the U.S. for Americans. The industry faces challenges such as competition and changing regulations, with the Trump administration's trade policies adding to the confusion. Some companies are taking a platform strategy approach to drug development, using one molecule to target multiple diseases. Despite these challenges, there are opportunities for innovation and growth in the industry. Additionally, conflicts of interest in vaccine committees have been decreasing, and companies are making strategic moves such as forming partnerships and restructuring to adapt to the changing landscape. The industry continues to navigate uncertainty and seek ways to improve drug development and access for patients.

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 the pharmaceutical industry, and Vantai is in talks with Halda for a potential proteomics partnership. ## Other news includes conflicts of interest in vaccine committees declining, RegenxBio facing a delay in their gene therapy approval, and Genentech ending a partnership with Adaptive Biotechnologies. Kriya raises $313 million for gene therapy, Merck KGaA invests in RNA-targeting technology, and Novo Nordisk receives approval for Wegovy.

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 not succeed in Phase III trials, while gene therapy company Kriya has raised an impressive $313 million. Kennedy has shown support for mRNA vaccines in cancer treatment. Bausch Health has closed a facility, Precigen has received FDA approval for an immunotherapy drug, and Eli Lilly has partnered with Superluminal in the obesity pipeline. Stay tuned for more industry news and developments.

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 for obesity treatments. Trump delays tariffs, and upcoming webinars focus on AI in research, integrated supply chain strategies, and data lakes. Job opportunities include positions at Utro Biopharma, BioMarin Pharmaceutical, and AbbVie.

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. Other news includes Vedanta downsizing, Abata shutting down.

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 drugs Mounjaro and Zepbound, leading to a new lawsuit. Genscript is entering a new era of innovation and trust, offering exclusive promos and events. Additionally, Tang Capital is on a buyout binge in the biotech industry, while a top ARPA-H official has departed in protest of cuts to mRNA funding. The biotech industry continues to see contractions with companies like AbSci, Fate, and Oric downsizing. In career advice, loyalty is seen as a flawed strategy that can cost individuals opportunities.Arrowhead, a biotech company, has emerged as a savior in the RNA interference (RNAi) pipeline after Sarepta faced troubles unrelated to Arrowhead's assets. Concentra Biosciences, a biotech shell company, has been on a buying spree, acquiring four biotechs in the past month and seven so far this year. President Trump's most favored nation drug pricing policy is seen as unfavorable for all parties involved. Novo Nordisk experienced a rapid rise and fall due to the success of ozempic and wegovy. Lilly is facing drug pricing pressure while defending its injectable GLP-1 empire. Novartis is rumored to be considering acquiring RNA specialist Avidity. Despite safety concerns, Sarepta beat Q2 estimates, but not due to sales of its product Elevidys. Various biotech companies are downsizing while others are receiving significant investments.

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 surround obesity leaders defending their injectable GLP-1 empires, recent layoffs at Merck, and the hurdles faced by oral obesity drugs. Opinion pieces delve into the skepticism towards mRNA technology and the potential repercussions of dismissing the head maha implementor following an mRNA purge. Stay tuned for more updates on upcoming events and job opportunities in the industry.

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 AAV gene therapy technology following patient deaths related to Sarepta Therapeutics' platform. There is a push for improvement in the technology, while some are looking to move on to other options. The article also highlights the importance of mRNA technology in cancer research and the need for continued investment in this area. Additionally, it mentions the FDA's decision on Biogen and Eisai's Alzheimer's drug, as well as five oral obesity drugs that could rival Lilly's Orforglipron. Other topics covered include cancer drug developments, gene therapy news, and upcoming industry events.Stay tuned for more updates on the latest news in the pharmaceutical and biotechnology industries.

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 and meeting the needs of various stakeholders. This unexpected turn of events has generated interest and optimism among industry insiders.Gilead remains positive about the prospects of its HIV prevention drug, despite uncertainties surrounding recommendations from the U.S. Preventive Services Task Force. The FDA has launched a new program to help pharmaceutical companies lower regulatory barriers to manufacturing in the U.S. Other news includes Dewpoint Therapeutics slashing headcount, Novartis rumored to be taking over RNA specialist Avidity, and Trilink Biotechnologies offering process development services for nucleic acid therapeutic development. Lotte Biologics is expanding its global manufacturing bases, while other companies like Bicycle, Tune, and Iovance are downsizing to conserve cash. The FDA is in flux, Pfizer is discussing pricing with Trump, and Merck is cutting jobs. Vertex's next-generation pain drug failed in trials despite strong Q2 earnings. Thank you for listening to Pharma and Biotech daily: your source for quick updates on the latest news in the pharmaceutical and biotechnology industries.