
The Pharma and Biotech Daily: Your Essential Dose of Industry Breakthroughs
12/18/23 • 2 min
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Pharma and Biotech Daily: Your Morning Dose of Industry Breakthroughs
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
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Pharma and Biotech Daily: Industry Updates and Strategic Shifts
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have several developments in the industry to discuss.First, Structure, a biotech company focused on obesity treatments, experienced a setback. The results from a phase 2 trial of their obesity pill fell short of expectations, causing the company's shares to plummet. Similarly, Radiopharma's drug for prostate cancer did not meet analysts' predictions for its benefit, which could accelerate a planned takeover by Eli Lilly.In other news, Illumina has decided to part ways with Grail, ending their battle with regulators. Activist investor Carl Icahn, who is suing Illumina over its acquisition of Grail, continues to push for the removal of several board members. Additionally, Pivotal Life Sciences has reloaded with $389 million and is now hunting for deals in a downturn, tracking startups in the biotechnology sector that need fresh funds to move their programs forward.Moving on, Zimvie is selling its spine business to H.I.G. Capital for $375 million. This strategic move allows Zimvie to focus on its dental business and reduce its debt. BTIG analysts are optimistic that the medtech industry will rebound in 2024 after a "string of rough years," despite rising interest rates and concerns about the impact of GLP-1 drugs and supply chain issues.Glaukos has received FDA approval for its drug-releasing eye implant to treat glaucoma. This product has the potential to revolutionize glaucoma treatment by addressing noncompliance with eye drops. Freenome has also started a 20,000-subject study of its lung cancer blood test, which could provide an alternative to CT imaging and reduce radiation exposure.Moving on to the healthcare industry, Elevance and Blue Cross Blue Shield of Louisiana (BCBSLA) are reviving their proposed $2.5 billion merger after addressing regulatory concerns. The No Surprises Act's dispute portal has reopened as the CMS faces challenges in rolling out the policy. A lawsuit has been filed in New Jersey alleging that the state's telehealth licensure rules hinder access to care, especially for patients with rare conditions.Cybersecurity concerns remain as connected devices used in telemedicine enable real-time patient monitoring and advanced care. CMS has sent a letter urging health plans and PBMs to ease up on independent pharmacies before a new policy goes into effect.In the biopharmaceutical sector, Roivant has faced setbacks but remains focused on expanding its pipeline. Babson Diagnostics has received FDA clearance for its blood testing technology, bringing us closer to Theranos-like blood testing.Overall, these developments highlight the challenges and strategic decisions made by companies in the Pharma and Biotech industry. Stay tuned for more updates in our next episode. Thank you for listening to Pharma and Biotech Daily.
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