// Biotech and Pharma Therapeutics

Drug companies set sights on new Covid medicines to boost depleted arsenal
 December 28, 2022 / COVID / New Drug / AstrZeneca – It was not that long ago that the medical community had a small arsenal of new drugs to prevent and treat COVID-19 in people most susceptible to severe disease. But the arrival of new variants, as well as the loss of two treatments for immunocompromised people, has amped up the urgency to develop a stronger generation of medicines. Read Full Article on STAT News >>
Opus Genetics Announces Acquisition of the Rights to Two Gene Therapy Product Candidates for Inherited Retinal Diseases
 December 28, 2022 / Gene Therapy / Retinal Diseases – Opus Genetics, a patient-first, clinical-stage gene therapy company developing treatments for inherited retinal diseases, today announced it has acquired the rights to two preclinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio. Opus will develop the novel gene therapy candidates to address bestrophin-1 (BEST1)-related inherited retinal diseases and rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), respectively.Read Full Article on Biospace >>
Should Patients Have the Right to Own Their Clinical Trial Data?
 December 28, 2022 / Clinical Trial Data / Clinical Patients / Pharma Companies – Participants in clinical trials donate their health information so researchers can learn more about the risks and benefits of new treatments. During a clinical study, all kinds of personal information are collected: from genetic sequencing to cholesterol measurements, CT scans to IQ results. This data is then analyzed by researchers to answer specific research questions. But what happens to a patient’s individual data? More specifically, do participants have the right to own their own clinical research data? Read Full Article on Med City News >>
Biostage Selects IQVIA to Manage its FDA-Approved Clinical Trial in Severe Esophageal Disease, including Cancer December 28, 2022 / Biostage / FDA / IQVIA – The FDA-approved clinical trial is an open-label trial assessing both safety and efficacy in up to ten patients requiring the removal of up to 6cm of their esophagus for any reason (including cancer, trauma or birth defects) at up to five hospitals in the U.S. The primary endpoint is the establishment of a continuous biological conduit at three months following implantation. Read Full Article on Biospace >>
What Will the Pharma Industry Face in the Year Ahead?
 December 29, 2022 / Pharma Industry / Medical Device / Life Science – Life science organizations faced down an array of daunting challenges during the last three years: a global health crisis, supply chain upheaval, and uncertain economic climate, just to name a few. But if we can say the dust is beginning to settle, we can also look to the future with the knowledge that uncertainty will persist – and that we should be prepared. How can companies prepare for an unpredictable year ahead? Read Full Article on Medcity News >>

// 4th Industrial Revolution

Emergency Drone Can Deliver First Aid Medication by Itself
December 28, 2022 / Drone / First Aid / Medical Emergency – The uFAST relies on a drone — more accurately, an unmanned aerial vehicle (UAV) — to deliver first-aid therapeutics to the scene of an accident or other medical emergency. If there are people already on site, they might not be trained in medical care or drug administration. The system has that covered, as the uFAST is designed to administer medications on its own. It hovers over the patient and releases a weighted canister. When it contacts the patient’s body, the device applies a patch covered with microneedles that are loaded with the required therapeutics. Read Full Article on Health Tech Insider >>
Real-World Study Uses AI to Identify Undiagnosed Dementia in Primary Care
December 28, 2022 / AI / Dementia / Alzheimer / Primary Care Health Insurance – Few primary care practices are designed for the timely detection of Alzheimer’s disease. The limited time that primary care clinicians have to spend with patients, the need to focus on the health problems which brought the patient to the clinic, as well as the stigma of dementia are the major reasons for the lack of recognition of the condition, according to Dr. Boustani. In addition, he notes, there is no demand from the public for dementia diagnoses, most likely driven by the stigma of dementia, lack of public knowledge about the benefits of early recognition of Alzheimer’s, and issues related to health insurance coverage. Full Article on Hit Consultant >>
Smart Belt Monitors Heart Failure Patients
December 27, 2022 / Smart Belt / Cardiovascular / Heart Failure Detection – More than 6 million adult patients in the U.S. have heart failure, a progressive condition that prevents the heart from pumping an adequate supply of blood to the body. Treatment typically includes medication, which must be adjusted as the patient’s condition changes. The sooner that changes can be detected, the sooner adjustments can be made. If adjustments are made early enough, you can avoid potentially life-threatening complications. As a result, constant monitoring can be the key to tracking a patient’s condition. Read Full Article on Health Tech Insider >>
Sound and Light Create 3D Images of Deep Tissues
December 22, 2022 / 3D / Deep Tissue / PPG / University of California San Diego – Blinking lights shining on our skin to make biometric measurements have become commonplace. Photoplethysmography (PPG) is used in fitness trackers, smart rings, and even some earbuds to measure heart rate, blood oxygen levels, and more. But like beauty, the sensitivity of these devices is only skin deep. Their sensors cannot penetrate deeply into the body. Researchers at the University of California San Diego (UCSD) have come up with a possible solution that relies on not just light, but sound as well. Their flexible photoacoustic sensor is designed to diagnose and monitor a range of conditions. One of the key missions is to monitor hemoglobin levels in deep tissues in the body. Tracking blood perfusion or accumulation in a target location can be essential in some circumstances. Read Full Article on Health Tech Insider >>
How Automation Can Cut Into the $500B of Administrative Waste
December 28, 2022 / Automation / Administrative Waste / Data Management – In 2018, David Cutler, a professor of economics at Harvard University, submitted testimony on administrative waste to the U.S. Senate Committee on Health, Education, Labor and Pensions. In his research, Cutler estimated that administrative costs account for twice what the U.S. spends on cardiovascular disease care annually and three times the spend on cancer care.Read Full Article on Med City News >>

// Business & Markets

Amgen, Merck KGaA add to budding constellation of ADC deals amid the modality’s meteoric rise
December 27, 2022 / Amgen / Merck KGaA / Antibody Drug Conjugates / Licensing – The pool of Big Pharmas competing to develop game-changing antibody-drug conjugates continues to grow, with the water now at a boil after two more sizable licensing pacts. Amgen and Merck KGaA each entered the holiday weekend with separate collaborations aimed at developing the burgeoning cancer-targeting modality, with the deals’ combined value eclipsing $2 billion. Read Full Article on Fierce Biotech >>
Novavax Announces Closing of $175.25 Million Offering of Convertible Senior Notes Due 2027 and $74.75 Million Public Offering of Common Stock
December 28, 2022 / Novavax / Stock – On December 20, 2022, Novavax, Inc. (Nasdaq: NVAX), a biotechnology company (the “Company” or “Novavax”) dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, completed the closing of its previously announced offering of $150 million aggregate amount of 5.00% Senior Convertible Notes due 2027 (the “Notes”), and on December 23, 2022, the Company completed the closing of the initial purchasers’ option to purchase up to an additional $25.25 million aggregate principal amount of the Notes, which was exercised in full. On December 20, 2022, the Company also completed the closing of its previously announced underwritten public offering of 7,475,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase up to an additional 975,000 shares of its common stock (the “Common Stock Offering”) resulting in total gross proceeds of $74.75 million. Total combined gross proceeds to the Company from both the offering of Notes and the Common Stock Offering was $250 million. Read Full Article on Biospace >>
Teleradiology Market Primed to Hit $3.7Bn by 2026 – What’s Driving the Surge in Demand?
December 27, 2022 / Teleradiology / Biotech – 4.7bn diagnostic imaging procedures were performed globally in 2021, representing a strong recovery over 2020. Healthy demand for teleradiology services resulted in the global penetration of teleradiology reads into diagnostic imaging procedures bouncing back to 1.9%, and the overall teleradiology reading services and IT market revenue elevating past its pre-pandemic level to USD $1.7bn. With a projection for the market to reach USD $3.7bn in 2026, here I explore five drivers fueling this period of robust growth. Read Full Article on Hit Consultant >>
A wave of overdoses is hitting an already vulnerable population
December 30, 2022 / Overdose / Epidemic – Francesca Coleman, known to friends as “St. Louis,” has been unhoused since the age of 15. Now 24, Coleman sleeps in Tongva park, across from the famous Santa Monica pier in California. Like many unhoused people in the Los Angeles area, Coleman uses meth in an attempt to ease chronic pain, anxiety, and depression. On a Wednesday morning in July, physician Coley King checked in with Coleman in Tongva Park. King practices street medicine, which means the majority of his patients are unhoused, and Coleman is one of his patients. A routine part of King’s rounds is warning drug users about fentanyl, which has been increasingly tainting other street drugs, and has been a major factor in the U.S.’s accelerating overdose rate. Read Full Article on STAT News >>
Many Women Need Mental Health Services But Aren’t Able To Access Them
December 22, 2022 / Mental Health / Women’s Health – About 50% of women ages 18 to 64 said they needed mental health services in the last two years, but only half of them were able to get an appointment, according to a recent survey. The Kaiser Family Foundation (KFF) survey includes a sample of 5,145 women and 1,225 men between the ages of 18 and 64. It was conducted online between May 10 and June 7. Read Full Article on Med City News>>

// Legal & Regulatory

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development
December 26, 2022 / Animal Testing / Modernization Act / FDA / Drug Development – Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal testing in drug development. This will allow drug companies the option to use alternative safety-testing models when making new drug submissions. This is important because the Federal Food, Drug and Cosmetics Act of 1938, which is still in force, mandates animal testing for every new drug development protocol. Advocates of non-animal experimentation have argued that the cost of animal research is high—in dollars, in time, and in delays in approvals of beneficial drugs for human use. They also maintain that some drugs that were deemed safe by animal studies went on to cause harm in human subjects in clinical testing, although this last position is poorly quantified. Read Full Article on Med City News >>
Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma
December 27, 2022 / Roche / Genentech / Lunsumio / Follicular Lymphoma – Upon the FDA approval for its bispecific antibody Lunsumio (mosunetuzumab) as a third-line therapy for follicular lymphoma, Roche was quick to point out that its treatment was an “off-the-shelf, accessible” option. The reference, of course, was to the competition Lunsumio now faces as it takes on Novartis’ Kymriah, Bristol Myers Squibb’s Breyanzi and Gilead’s Yescarta. Read on Fierce Pharma >>
Smart Insulin Pen Device Gets New FDA Clearance
December 26, 2022 / Smart Insulin Pen / FDA / Clearance – Mallya is coming to America. The U.S. Food and Drug Administration (FDA) recently granted clearance to the smart medical device from the French manufacturer Biocorp. First launched in French pharmacies in spring 2021, Mallya is an add-on that fits atop a range of disposable insulin pens to transmit injection data via Bluetooth to companion software in real time. According to its makers, Mallya is the first system approved for use in the United States that can automatically connect different kinds of insulin and GLP-1 medications that lower blood glucose levels. Read on Health Tech Insider >>
MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
December 29, 2022 / MediWound / FDA / NexoBrid / Thermal Burns – “We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said Ofer Gonen, Chief Executive Officer of MediWound. “We appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement. We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S. This U.S. FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023.” Read on Biospace >>
After FDA’s Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena
December 29, 2022 / TG Therapeutics / Multiple Sclerosis / US Sclerosis / US FDA / FDA Approval – Half a year after the FDA snatched back an approval for TG Therapeutics’ first-in-class lymphoma med Ukoniq, the company has landed a regulatory win. Wednesday, TG snared U.S. approval for its monoclonal antibody ublituximab in the crowded relapsing multiple sclerosis field. Now christened Briumvi, TG’s CD20-targeting drug will rely on its twice-a-year dosing to provide a potential convenience edge against a host of competitors like Roche’s Ocrevus, Novartis’ Kesimpta and Biogen’s Tecfidera.Read on Fierce Pharma >>

// Research & Development

ML Model Accurately Predicts Need for Massive Transfusion During Surgery
December 29, 2022 / Surgery / High-risk Patients / Heart Failure – Published in JAMA Network Open, a recent study described how adding preoperative data and intraoperative hemodynamic monitoring data to a machine learning (ML)-based prediction model led to accurate real-time predictions of the need for massive transfusion during surgery. Many healthcare providers are using predictive analytics to improve the timeliness and quality of treatment while reining in costs. For example, a study published in December found that a disease management outreach program supported by predictive analytics effectively reduced medical spending among chronic heart failure patients. Read Full Article on Health IT Analytics>>
Pfizer says hemophilia B gene therapy controlled bleeding in key study
December 29, 2022 / Hemophilia B / Pfizer / Key Study / Drugmakers – Drugmakers have long studied hemophilia gene therapies, seeking to replace the infusions that people with the disease take for life to control their bleeding. In recent years, their research has delivered clinical successes in both the “A” and “B” forms of the disease and, in 2022, the first regulatory approvals. Health authorities in Europe in August authorized BioMarin Pharmaceutical’s gene therapy for hemophilia A, while last month the Food and Drug Administration approved CSL and UniQure’s gene therapy for hemophilia B. Read Full Article on Biopharma Dive >>
Pfizer’s hemophilia B gene therapy is better than standard of care in phase 3 trial
December 29, 2022 / Pfizer / Gene Therapy / Cell & Gene Therapy / Spark Therapeutics – Pfizer’s gene therapy for severe hemophilia B has not only matched standard of care but beat it in a phase 3 study testing whether the treatment can help patients make the protein responsible for blood clotting on their own. Fidanacogene elaparvovec, which Pfizer licensed from Spark Therapeutics, was being tested in the late-stage trial with 45 male patients who have moderately severe or severe hemophilia B. The pharma giant is developing the gene therapy as a one-time treatment to help patients develop the Factor IX protein needed to clot blood. The current standard of care for these patients is a recurrent Factor IX regimen to prevent and control bleeding. Read Full Article on Fierce Biotech >>
Despite missing the mark in a phase 2, Lexicon is standing by its neuropathic pain therapy
December 22, 2022 / Lexicon Pharmaceutical / Postherpetic Neuralgia / Neuropathic Pain / Clinical Data – Lexicon Pharmaceuticals has missed the mark in a phase 2 aiming to treat a common complication of shingles known as postherpetic neuralgia. However, the Texas biotech is standing by its therapy, saying the trial still demonstrates “clear evidence of effect.” Read Full Article on Fierce Biotech >>
Researchers Develop ML Tool for Studying Characteristics of Single Cells
December 23, 2022 / Single Cell / New Study / Machine Learning / RNA / Proteins – Researchers from the Children’s Hospital of Philadelphia (CHOP) and the New Jersey Institute of Technology (NJIT) developed new machine-learning (ML) software to analyze multiple characteristics of a single cell, which may lead to insights into the causes of genetic disease. The press release states that the tool enables researchers to perform single-cell sequencing, which helps them see how one change in a cell can lead to several others and how specific aspects of a cell impact its interaction within its microenvironment. Using single-cell sequencing, researchers can study gene expression, messenger RNA, proteins, and organelles within the cells in much greater detail than previously possible. Read Full Article on Health IT Analytics >>

// Politics

‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol
December 29, 2022 / FDA / Congress / Biogen / Drugmakers – The Food and Drug Administration’s review and approval of a controversial Alzheimer’s drug was “rife with irregularities,” including dozens of undisclosed calls and emails with Biogen and an “inappropriate” level of coordination between the drugmaker and regulators, a congressional investigation concluded. Read Full Article on STAT News >>
Biogen, FDA’s inappropriate Aduhelm coordination detailed in blistering congressional report
December 29, 2022 / Biogen / Aduhelm / FDA / Congress – A scathing congressional report has detailed communications described as “inappropriate” and “atypical” between Biogen and the FDA regarding the approval of Alzheimer’s disease drug Aduhelm plus the decision-making behind the pricing and marketing of the now-benched medicine. Read Full Article on Fierce Pharma >>
FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation
December 29, 2022 / FDA / Biogen / Alzheimer’s / Congress – Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how it went from what was supposed to be the biggest drug launch in history to a financial catastrophe. Read Full Article on STAT News>>
Justice Dept. Sues AmerisourceBergen Over Role in Opioid Crisis
December 29, 2022 / AmerisourceBergen / Opioid Crisi / Justice Department – The Justice Department filed a lawsuit on Thursday against AmerisourceBergen, one of the country’s largest pharmaceutical distributors, accusing the company of knowingly distributing opioids that were later resold illegally. Read Full Article on New York Times >>