Pharma and BioTech Daily

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Steward, a bankrupt healthcare organization, is set to sell its physician group to a private equity firm for $245 million. Kaiser's operating margin has risen to 3.1% in the second quarter, indicating a strong performance for the nonprofit giant. Stryker is acquiring smart hospital technology firm care.ai to enhance its health IT offering. For-profit health systems have seen an increase in Medicaid supplemental payments in the second quarter, although executives state it is not enough to cover costs. The importance of integrating generative AI in the healthcare landscape is highlighted, with tips on selecting the right vendor for AI solutions. The newsletter also includes insights on using data to improve patient outcomes and transforming healthcare through tailored change management strategies.Transitioning to the next news segment:Lilly has opened a new R&D hub in Boston, while Ovid and Lexicon have laid off staff. Biotech M&A activity is increasing, with Crown Laboratories acquiring Revance Therapeutics. Galderma has received FDA approval for Nemluvio, a competitor to Dupixent for treating prurigo nodularis. Biotech IPOs are crucial for the industry, with Actuate Therapeutics recently pricing its IPO. A journal retracted papers on MDMA-assisted therapy following FDA rejection. Companies like Pfizer and Lilly are focusing on patient-centric commercialization strategies. Key events include a webinar on increasing a drug's chances of reaching the commercial market and company announcements from Procdna, Authenticx, and others.Moving on to the next segment:Atai, a biopharmaceutical company, has seen early success with its psychedelic depression drug in a phase Ib study. This comes after the FDA rejected another company's MDMA-assisted PTSD therapy. Galderma's IL-31 injection has received FDA approval for the skin disorder prurigo nodularis, with potential for use in atopic dermatitis. Novo Nordisk is continuing to pursue its insulin icodec program, aiming to file a combination with semaglutide by the end of the year. Q2 earnings for biopharma companies have been mixed, with some exceeding expectations while others faced challenges due to the COVID-19 pandemic and vaccine issues. The role of Quality Assurance and Regulatory Affairs (QARA) professionals is becoming increasingly important in the biopharma industry, transitioning from the factory floor to the boardroom.Transitioning smoothly to the next news:Gain Therapeutics is making strides in developing a potential treatment for Parkinson's disease that targets alpha synuclein through a small molecule that binds to an enzyme coded by a specific gene. This approach aims to modulate the underlying biology of the disease. The company's chief medical officer, Dr. Jonas Hannestad, emphasized the importance of biomarkers in neurodegenerative drug development to monitor the effectiveness of treatments. Gain Therapeutics faces challenges in financing, but their innovative approach could change how Parkinson's disease is treated.Additionally, an emerging drug candidate for multiple sclerosis from Immunic has shown promising safety and antiviral effects.Transitioning smoothly again:Liquid I.V. is running a multichannel campaign called "Indulge in Hydration" to help consumers beat the summer heat. The campaign includes augmented reality activations, Netflix ad testing, and a Spotify takeover. Oreo and Coca-Cola have partnered to create a drink and cookie combination featuring the iconic brands, with a marketing campaign centered around "besties." LG is boosting its home appliances with a competition show on Prime Video called "Estate of Survival." WPP has downgraded its full-year outlook as it works to modernize its offering.Concluding this episode:This week in biotech news, startup Halda raised $126 million to advance a new type of targeted

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Glaukos, a medical technology company, has received FDA approval for its drug-releasing eye implant to treat glaucoma. This product is expected to revolutionize glaucoma treatment by addressing noncompliance with eye drops. Freenome, another medical technology company, has started a study of a blood test for lung cancer. The test could potentially serve as an alternative to CT imaging, which exposes patients to radiation. Tandem, a diabetes management platform, has completed the US launch of its revamped platform called Tandem Source. The platform combines the features of the company's legacy offerings with new data reports. In the wake of the Philips recall, two US senators are urging a review of FDA medical device oversight. The senators claim that Philips did nothing while patients suffered due to their sleep apnea devices. Medtronic has received approval for its pulsed field ablation (PFA) treatment for atrial fibrillation. PFA is considered a safer alternative to radiofrequency and cryoablation, and other companies like Boston Scientific and Johnson & Johnson are also pursuing the PFA market.The North Carolina Attorney General has sued HCA over degraded care quality at Mission Health. The lawsuit blames HCA for staffing and service shortages at the hospital.CMS has sent a letter to health plans and pharmacy benefit managers (PBMs) urging them to ease up on independent pharmacies. The letter asks payers to implement special payment arrangements with pharmacies before a new policy takes effect that could reduce upfront payments to pharmacies.CVS, Geisinger, and other healthcare organizations have signed a pledge committing to responsible use of artificial intelligence (AI) in healthcare.Nasdaq has ruled that Veradigm will not be delisted from the exchange as long as it complies with financial reporting requirements.Biogen receives positive recommendation from European regulators for its gene editing treatment Casgevy, while the clearance for Biogen's Skyclarys is uncertain.Novartis veteran Jay Bradner joins Amgen as its new chief scientific officer and head of R&D.The FDA expands the use of cancer drug Welireg to treat advanced kidney cancer.Fewer biotech companies are going public after a record run, but Fractyl Health becomes the first company in nearly a month to join the IPO queue.Moderna's cancer vaccine data leads to a share rally, with speculation that the company and partner Merck could seek approval before completing phase 3 testing.Patent protection will expire for many multibillion-dollar medicines this decade, prompting large pharma companies to find new products and markets.European regulators push for approval of CRISPR drugs.AstraZeneca and AbbVie are criticized by Elizabeth

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Amazon has partnered with Talkspace to expand its digital health benefits program, which also includes Omada Health. Community Health Systems (CHS) subsidiary is acquiring 10 urgent care centers, following in the footsteps of other for-profit health systems. Steward Health Care auctioned off Glenwood Regional Medical Center for $500,000, but there are concerns about the continued involvement of hospital landlord Medical Properties Trust in operations. The text also includes sponsored content on safeguarding healthcare against ransomware and cybercrime, as well as information on trends in telehealth and strategies for improving provider data accuracy for payers. Healthcare Dive provides news and insights for healthcare leaders and is a publication operated by Industry Dive.Roivant's subsidiary, Dermavant, is being acquired by Organon, giving Organon access to a psoriasis and eczema cream called Vtama. This acquisition will provide Roivant with additional cash to fund its research and development plans. Meanwhile, biotech M&A activity has plateaued, with private company acquisitions continuing while public company acquisitions have slowed down. One biotech, Ratio Therapeutics, backed by Bristol Myers Squibb, is optimistic about the boom in radiopharma and the pharmaceutical industry's shift towards targeted radiation drugs. In other news, Novartis' Kisqali has received expanded FDA approval which could double its market for breast cancer treatment. Additionally, Express Scripts is suing the FTC over a report critical of pharmacy benefit manager business practices. The industry is also exploring new ways to deliver genetic therapies and improve clinical trial execution through systems thinking. Overall, the biopharma industry is experiencing exciting times with various developments and advancements in drug development and healthcare technology.Zimmer has decided to pull its hip implant off the market due to fracture risk, with plans to phase out its use by December. Merit Medical has acquired Cook's lead management business for $210 million, adding devices used in heart rhythm device procedures to its portfolio. Synchron has connected brain-computer interface technology to Amazon Alexa, allowing patients to control various functions without using their hands or voice. Senseonics has received FDA clearance for a one-year continuous glucose monitoring system, and Boston Scientific has closed its acquisition of Silk Road Medical. The wearables market is expected to grow by 13% annually between 2024 and 2030, highlighting the importance of adhesives in wearable device development. AI is increasingly influencing the value chain of medical device companies, and manufacturers are exploring ways to utilize AI throughout the product lifecycle. These developments reflect the ongoing innovation and evolution within the medtech industry.Roivant has sold Dermavant to Organon in a deal worth up to $1.2 billion, allowing Roivant to focus on their autoimmune-focused Immunovant and upcoming trials. Summit Therapeutics' bispecific for non-small cell lung cancer has shown promise against Keytruda but still needs more data. Other news includes the FDA approving Keytruda for pleural mesothelioma, Bernie Sanders claiming generics companies can offer a cheaper alternative to Ozempic, Novartis expanding Kisqali's use in breast cancer, and HRSA threatening sanctions against J&J. In the world of enzyme development, SignalChem Biotech offers tailored services. Additionally, new gene therapies for sickle cell disease are reaching patients, and the race for an obesity pill is heating up among companies like Novo, Roche, and Terns.The FDA is facing challenges with conducting overseas drug manufacturing inspections, with 42% of registered plants overdue for inspections. Indian drugmaker Zydus Lifesciences received a warnin

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Amgen's obesity candidate, maritide, faced new safety concerns related to bone density, causing a drop in the company's stock. Biogen's shares have also plummeted due to issues such as a slow launch for their Alzheimer's medicine and a lackluster pipeline. Meanwhile, the biotech company Metsera raised significant funds for their long-acting GLP-1 drug despite competition in the weight loss space. Additionally, Kezar's autoimmune drug faced a second FDA clinical hold, and Syros experienced a significant drop in stock value due to a late-stage MDS failure. Novo's deal with Catalent is seen as a significant moment for the CDMO sector. These developments indicate ongoing challenges and opportunities in the biotech industry.Biogen's shares have dropped by 36% in 2024 due to factors such as a slow launch for Alzheimer's medicine Leqembi and a lackluster pipeline. The Novo-Catalent deal is seen as a defining moment for the CDMO industry, with concerns about consolidation limiting competition but also providing opportunities for smaller-scale CDMDs to find new partners. Other news includes Amgen facing bone density safety concerns for Maritide, AbbVie shares plummeting due to a failed schizophrenia asset, and Bayer's CEO admitting that their earnings are not looking good. In the biopharma job market, positions such as Executive Director of Biologics Analytical Research and Development at Merck & Co. and Vice President of Global Program Head - Ophthalmology at Regeneron Pharmaceuticals are available.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. In today's episode, we have several news updates in the biopharma industry. Let's dive in:## News 1: Uniqure's gene therapy setbackUniqure's gene therapy for Huntington's disease faced a setback as the company's share price fell over 10% following the release of more data from a small study. This news highlights the challenges in developing effective therapies for genetic diseases.## News 2: Novo Nordisk's investment in vaccine researchThe foundation behind Novo Nordisk plans to invest $260 million in vaccine research and development. The initiative will focus on developing vaccines for tuberculosis, influenza, and group A streptococcus. This investment reflects the commitment to improving public health and addressing global health challenges.## News 3: Biogen's market monopoly for TecfideraBiogen's multiple sclerosis medicine, Tecfidera, will maintain its market monopoly in Europe until early 2025 after European regulators revoked approvals for five generic versions of the drug. This decision ensures continued access to this important medication for patients with multiple sclerosis.## News 4: Merck's new pneumococcal vaccineMerck has received an FDA decision date for its new pneumococcal vaccine, which targets 21 strains of pneumococcal bacteria and would compete with Pfizer's Prevner 20 if approved. This development brings hope for improved prevention of pneumococcal infections.## News 5: Fewer biotech companies going publicFewer biotech companies are going public after a record run, and the article discusses how these companies are performing in the market. This trend suggests a shift in the biotech industry and raises questions about future growth and innovation.## News 6: Structure's obesity pill falls shortStructure shares plummeted as results from a phase 2 trial for their obesity pill fell short of expectations. This outcome highlights the challenges of developing effective treatments for obesity, a prevalent and complex health issue.Moving on to our next set of news:## News 7: FTC and DOJ finalize merger guidelinesThe Federal Trade Commission (FTC) and the Department of Justice (DOJ) have finalized merger guidelines that could make it more difficult for healthcare mergers and acquisitions to proceed. These new guidelines aim to ensure fair competition and protect consumers' interests.## News 8: Biden administration's call for action on child Medicaid enrollmentThe Biden administration is urging nine states to address high disenrollment rates in child Medicaid and Children's Health Insurance Program (CHIP). These nine states account for around 60% of the decline in enrollment in these programs between March and September. The administration is taking steps to address this issue and improve access to healthcare for children.## News 9: John Muir Health and Tenet Healthcare deal collapsesThe deal between John Muir Health and Tenet Healthcare for the acquisition of a California medical center has collapsed following a lawsuit from the FTC. The regulators sued to block the deal over concerns that it could lead to increased healthcare costs in the region. This turn of events highlights the importance of regulatory oversight in healthcare mergers and acquisitions.## News 10: Molina Healthcare lowers sale priceMolina Healthcare has agreed to lower the sale price of Bright Health's California Medicare Advantage unit. The original sale price was $510 million, but it has been lowered to $425 million. This adjustment reflects the changing dynamics of