Ted W. Love, MD’s Post

Shares of biopharmaceutical company #KarunaTherapeutics skyrocketed more than 47% Friday morning after giant #BristolMyersSquibb Co (NYSE:BMY, ETR:RM, OTC:BMYMP) announced a deal to acquire the company for $14 billion in cash.  The agreement valued Karuna at $330 per share. Karuna stock traded at $316.51 early Friday afternoon. Bristol Myers shares climbed 2.7%.  For Bristol Myers, the move expands its drug pipeline. That’s significant, particularly after demand for its blood cancer medication Revlimid dropped in recent months due to competition from a generic version.  Karuna’s primary development focus is treatments for neurological and psychiatric conditions. Its flagship drug, KarXT, is an antipsychotic for patients with schizophrenia.  More at #Proactive #ProactiveInvestors #NYSE #ETR #OTC #BMY #RM #BMYMP http://ow.ly/Hhh21056Cr6

OTO-313 failed as a cure for tinnitus. Here’s why: It was a pharmaceutical drug developed by Otonomy, a San Diego-based biopharmaceutical company. OTO-313 was a liquid compound administered via needle injection, past the eardrum, near the cochlea. (The cochlea is known as the ‘hearing organ’ — its corresponding cochlear nerve carries bio-electric signals up to the auditory cortex, which is how the brain processes sound.) Now, more specifically… OTO-313 is a compound by the name of gacyclidine. Otonomy researchers believed gacyclidine could reduce the severity of tinnitus-related symptoms by strengthening the auditory nerve fibers within the cochlea. So, the drug was promising. But after going through multiple clinical trials, it failed. Trial #1 took place during July of 2020. It included participants with moderate-to-severe unilateral tinnitus (tinnitus in one ear). The trial produced a positive clinical response via the Tinnitus Functional Index (TFI). The TFI is what we use to measure progress (or lack thereof) in treatments, such as loudness and annoyance. The first research trial showed promise, with a positive clinical response to many participants after only a single injection. Trial #2 continued in August of 2022, which unfortunately ended in failure. In other words, there was an insufficient percentage of those reporting reduced symptoms vs the placebo. So, the study was shut down. Still, I applaud the researchers’ efforts. And while this wasn’t an outright success… It did help expand our knowledge as to what is and isn’t working. Especially as it pertains to studies using a placebo. So many research studies in tinnitus, including my own, have not utilized a true double-blind study design, which makes it hard to come to a clear yes-no decision on whether a treatment works or not. That’s why there’s a long history of tinnitus treatment companies slowly fading away, and eventually ending production of their product. Thank you to the researchers for Otonomy for giving this treatment a shot. And thanks to the scientific method for allowing us to put this one to rest. ______________________________________ I'm Ben Thompson, AuD, leading tinnitus specialist, YouTuber and Founder of Treble Health. ➡️ Follow me for: ✔ the latest news and tinnitus-related developments ✔ tips for tinnitus prevention, management and treatment ✔ stories and advice from a telehealth company founder

BioXcel receives European patent for method of treating agitation in dementia using sublingual dexmedetomidine

𝗙𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝘀 𝘀𝗲𝗰𝗼𝗻𝗱 𝗵𝗶𝗴𝗵𝗲𝘀𝘁 𝗻𝘂𝗺𝗯𝗲𝗿 𝗼𝗳 𝗻𝗼𝘃𝗲𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 𝗶𝗻 𝟯𝟬 𝘆𝗲𝗮𝗿𝘀! The FDA greenlit 55 new drugs in 2023, an impressive surge of nearly 50% compared to the previous year. This included a substantial uptick in small molecules and biologics, and featured several groundbreaking first-in-class or disease-specific approvals. In this article, we give an overview of the noteworthy developments and highlights of 2023. We also explore potential trends and pivotal events to anticipate in the dynamic landscape of drug approvals, as we look ahead at 2024. Find out more: https://okt.to/Ar4pLj #FDAApproval #DrugAproval #pharma #DrugDiscovery #ScienceForASaferWorld

Patent Expirations: Large bio/pharmaceutical companies are facing a significant revenue threat due to the upcoming biologics patent cliff, which could jeopardize an estimated $300 billion–$350 billion in revenue over the next three years. FinBio estimates that between 2023 and 2030 over 5,000 drug patents will expire, with Oncology products representing ~20% of the total. Leading Products w/Patent Expiry by Revenues: #1 KEYTRUDA® (pembrolizumab) HCP Merck #2 Buy Eliquis 5mg online US to US Delivery 7*24Bristol Myers Squibb Elizabeth Rosario One major pressing question remains: Will Keytruda be able to successfully extend its patent expiry date from 2028?

SRNE StockTwits: Insights into Sorrento Therapeutics Inc SRNE StockTwits emerges as a comprehensive platform for investors, traders, and enthusiasts interested in Sorrento Therapeutics Inc. It not only facilitates real-time discussions and analysis of SRNE’s stock performance but also serves as an educational resource hub and community-building platform. By fostering collaboration, sharing insights, and providing valuable market commentary, SRNE StockTwits enriches the investment experience and contributes to informed decision-making within the biopharmaceutical investment landscape. #srne_stock_stocktwits #srnestocktwits #stocktwits_srne https://lnkd.in/d9JphDCD

Biopharmaceutical companies that develop cancer treatments bring hope to millions of patients, and often profit handsomely along the way. However, while shareholders are eager for positive news about a company’s prospects, misrepresenting regulatory statements in the pharmaceutical industry—where lives are on the line—is exceedingly dangerous. Pomerantz recently achieved a $19.65 million settlement in a shareholder suit against Y-mAbs Therapeutics, Inc., a clinical biopharmaceutical company specializing in antibody-based therapies. According to the complaint, Y-mAbs misrepresented the FDA’s concerns about certain data in the company’s approval application for its neuroblastoma treatment, omburtamab, misleading investors into believing that omburtamab was on track for approval when in fact the FDA had identified serious issues with the data used as a control group in a study of the drug’s efficacy. When the FDA denied approval for omburtamab, the company's stock price sharply declined, resulting in significant losses for investors. #MedicalInnovation #PharmaceuticalIndustry #InstitutionalInvestors #SecuritiesLitigation #ClassAction

The successful submission of an Investigational New Drug (IND) application to the FDA marks a crucial milestone for biopharmaceutical companies intending to conduct clinical trials on innovative RNA therapeutics. This guide aims to assist in streamlining and fortifying the IND filing process for novel nanomedicines, facilitating their expedited progression through regulatory channels. #RNAtherapeutics #INDapplication #fdaapproval

As part of Global Biosimilars Week, CSI are sharing key educational insights into the evolution of biosimilars. The development of biosimilars has had a significant impact on costs for clinical trials, helping to bring safe and effective drugs to market at an affordable price. Clinical Services International (CSI) specialises in sourcing both biologics and biosimilars and has supplied them to more than 700 oncology studies globally. Find out more about these revolutionising biopharmaceuticals and how CSI can provide cost savings for your trial: https://hubs.ly/Q028ckzM0 #GlobalBiosimilarsWeek #ComparatorSourcing

🧠 Neurogenesis, the process of generating new neurons, has garnered significant interest in the pharmaceutical industry. Pharmaceutical companies are actively exploring compounds and therapies that stimulate neurogenesis as potential treatments for these conditions. #BrainAcademy #Procrastination #ShortTermVsLongTerm #DopamineDrive #Neuroplasticty #Neurogenesis