FDA approves first microbiota-based treatment
Bio Pharma Dive
DECEMBER 1, 2022
The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.
Thu.Dec 01, 2022
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Liminatus Pharma enters SPAC merger deal with Iris Acquisition
Pharmaceutical Technology
DECEMBER 1, 2022
Liminatus Pharma has entered a definitive business combination agreement with special purpose acquisition company (SPAC) Iris Acquisition to create a business with a pro forma enterprise value of nearly $334m. The new entity is anticipated to receive up to $316m in gross cash proceeds. This includes $276m held in the trust account of Iris and equity private investment in public equity (PIPE) funding of $15m and convertible note financing worth $25m.
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Pfizer, Roivant set up new company around inflammation drug
Bio Pharma Dive
DECEMBER 1, 2022
The drug is currently in mid-stage testing as a treatment for ulcerative colitis. If it continues to advance, it could be the first approved therapy aimed at a protein known as TL1A, a target multiple other companies are pursuing.
Botanical Solution Inc. (BSI) & Croda Pharma Partnership Agreement to Accelerate Production for GMP QS-21
Pharma Mirror
DECEMBER 1, 2022
QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications. Botanical Solution Inc. (BSI), innovator of sustainable, consistent and cost-effective Advanced Botanical Materials (ABM) for agricultural and pharmaceutical applications, has entered into a Partnership Agreement with Croda Pharma to build a robust, scalable and truly sustainable supply chain and deliver kilogram-quantities of QS-21 to the pharmaceutical in
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Lilly’s Alzheimer’s drug bests Aduhelm in plaque clearance study
Bio Pharma Dive
DECEMBER 1, 2022
The company's experimental treatment donanemab reduced amyloid levels in the brain by more than Biogen's approved medicine, but the data’s significance is unclear until Lilly reveals results from a larger study next year.
Medical bills remain inaccessible for many visually impaired Americans
NPR Health - Shots
DECEMBER 1, 2022
When health bills aren't legible — via large-print, Braille or other adaptive technology — blind patients can't know what they owe, and are too often sent to debt collections, an investigation finds.
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STAT+: Gilead wins a key battle with the CDC over patents for its Truvada HIV pill
STAT News
DECEMBER 1, 2022
Gilead Sciences won a key round in its battle with the U.S. government over allegations that the Centers for Disease Control and Prevention breached several contracts and “secretly” obtained patents stemming from research that led to the groundbreaking Truvada pill for preventing HIV. As part of a broader fight with the agency over research and resulting patent rights to the medication, the company had filed a lawsuit in 2020 alleging the CDC violated the terms of a 15-year-old col
SQZ CEO steps down as company restructures, cuts jobs
Bio Pharma Dive
DECEMBER 1, 2022
The biotech will lay off 60% of its staff and reprioritize its research to focus on a "second-generation" approach to the cell therapies it’s been developing.
STAT+: With early data and a possible advantage, Amgen enters the obesity drug race
STAT News
DECEMBER 1, 2022
Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear. The results for the molecule, codenamed AMG133, throw Amgen in a long-gestating race with other major drugmakers that burst into the popular press this year.
Steps to building a more patient-centric industry
pharmaphorum
DECEMBER 1, 2022
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. In 2021, a CISCRIP Perceptions and Insights Study reported more disruption to daily routines compared to previous years, citing length of visits, travel, and diagnostic tests as top burdens
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Opinion: The U.S. doesn’t need a new ‘essential hospital’ designation
STAT News
DECEMBER 1, 2022
A recent essay in Health Affairs, a prominent health care journal, proposed a useful-sounding idea: The government should create a new federal designation for “essential hospitals” — hospitals that, according to their own metrics, serve a safety-net role but aren’t currently recognized as such. But it isn’t useful at all.
Peanuts and herbs and spices may positively impact gut microbiome
Medical Xpress
DECEMBER 1, 2022
Adding a daily ounce of peanuts or about a teaspoon of herbs and spices to your diet may affect the composition of gut bacteria, an indicator of overall health, according to new research from Penn State. In two separate studies, nutritional scientists studied the effects of small changes to the average American diet and found improvements to the gut microbiome.
‘A constant information lag’: The troubled recall of Philips CPAP machines underscores flaws in device oversight
STAT News
DECEMBER 1, 2022
The ongoing recall of millions of breathing devices made by Philips has been botched and belabored at nearly every turn: It took more than a decade after users first reported the soundproofing foam in their CPAP and BPAP machines breaking down for Philips to issue a recall. Even after the recall notice was issued, it failed to reach many patients, and many are still waiting on their promised replacement devices or refunds, some of which had to be recalled themselves.
New study puts gut microbiome at the center of Parkinson's disease pathogenesis
Medical Xpress
DECEMBER 1, 2022
New research from the University of Alabama at Birmingham says the gut microbiome is involved in multiple pathways in the pathogenesis of Parkinson's disease. The findings, published in Nature Communications, show a wide imbalance in microbiome composition in persons with Parkinson's disease. The study is the largest microbiome study conducted at the highest resolution.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Get Set up for Success in the Account Incubator Program
Intouch Solutions
DECEMBER 1, 2022
Finding an agency job after graduating college can feel overwhelming, but it doesn’t have to. Jumpstart your career at EVERSANA INTOUCH and be set up for success as part of our Account Incubator program where you can dip your toes into an Account Services role! The program provides a deep dive into what new-to-the-field pharma marketing professionals need to know, not only to be successful but to be great members of a team.
New potential mechanism for vision loss discovered
Medical Xpress
DECEMBER 1, 2022
Visual cells in the human retina may not simply die in some diseases, but are mechanically transported out of the retina beforehand. Scientists from the Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) and the Center for Regenerative Therapies Dresden (CRTD) at TU Dresden have now discovered this.
STAT+: Afraid of pharma pushback, a health data broker puts up a barrier to drug pricing information
STAT News
DECEMBER 1, 2022
At a time when many Americans are clamoring for more transparency into prescription drug pricing, one key provider of that data is making it harder to access the information. A new venture called Merative — which was formed recently from the ashes of IBM’s Watson Health division — has decided it will no longer provide the media with pricing changes for specific medicines.
Residue from rinse agents used in commercial dishwashers found to destroy protective layer in gut
Medical Xpress
DECEMBER 1, 2022
Residue from rinse agents is left behind on dishes after they are cleaned in professional-grade dishwashers. This damages the natural protective layer in the gut and can contribute to the onset of chronic diseases, as demonstrated by researchers working with organoids at the Swiss Institute of Allergy and Asthma Research.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
STAT+: Pharmalittle: Roche Alzheimer’s drug didn’t clear enough amyloid; startup to seek approval of nasal swab version of naloxone
STAT News
DECEMBER 1, 2022
Good morning, Jason Mast here filling in for Ed. There are many types of coffee in this world and I must admit to you that I, preternaturally lazy and languorous, have become partial to instant. Don’t tell Ed, as I’m sure he will find it heresy. But I would point out that much of the world is on my side. Anyway, here’s some news.
mRNA vaccines offer one-two punch to combat malaria
Medical Xpress
DECEMBER 1, 2022
Malaria is found in more than 90 countries around the world, causing 241 million cases and an estimated 627,000 deaths every year. Vaccines are one intervention that could help eliminate this deadly disease, yet a highly effective vaccine remains elusive. Recent technological advances in vaccine development–such as the mRNA vaccines for SARS-CoV2–could lead to a new generation of malaria vaccines.
Listen: Whither PhRMA, Alzheimer’s treatment data revealed, and the first fecal microbiome drug approval
STAT News
DECEMBER 1, 2022
A big Alzheimer’s treatment data reveal. The first FDA-approved fecal microbiome drug. And a stinging defeat for Big Pharma’s lobbying arm. We cover all these topics and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. STAT Washington correspondent Rachel Cohrs joins us to explain how PhRMA, the all-powerful lobbying group, lost its edge in a fight over drug-pricing negotiation.
Few Americans are aware of links between alcohol and cancer risk
Medical Xpress
DECEMBER 1, 2022
Despite conclusive research that shows that all alcoholic beverages, including wine, increase the risk of many types of cancer, Americans demonstrated low awareness of this risk, and some perceived alcohol as having health benefits, according to results published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Can VR technology make physical therapy fun? – the pharmaphorum podcast
pharmaphorum
DECEMBER 1, 2022
In the newest episode of the pharmaphorum podcast, editor in chief Jonah Comstock chats with Gita Barry, EVP and GM of Immersive Healthcare at Penumbra, a therapeutic VR company. Penumbra uses VR to improve the physical therapy experience – both making it more fun for patients and delivering certain types of therapy, like mirror therapy, more effectively than traditional PT methods.
Fitness levels can be accurately predicted using wearable devices—no exercise required
Medical Xpress
DECEMBER 1, 2022
Cambridge researchers have developed a method for measuring overall fitness accurately on wearable devices—and more robustly than current consumer smartwatches and fitness monitors—without the wearer needing to exercise.
Respiratory vaccination candidate tested in German hospitals
Pharma Times
DECEMBER 1, 2022
Novel tuberculosis vaccine tested in a large phase 3 trial against severe respiratory infection disease
Long-term benefit of wearing masks for endemic diseases depend on the biology of transmission and immunity
Medical Xpress
DECEMBER 1, 2022
Masking—along with social distancing, hand washing, and other so-called "non-pharmaceutical interventions" (NPIs)—proved very effective at limiting the spread of COVID-19, and simultaneously drove down rates of endemic diseases like colds, flu, RSV and others. This prompted infectious disease researchers to ask whether longer-term implementation could reduce flu and RSV outbreak over the long term.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Eli Lilly dumps Innovent's PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug
Fierce Pharma
DECEMBER 1, 2022
Eli Lilly dumps Innovent's PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug. aliu. Thu, 12/01/2022 - 15:03.
Prevalence of 'meth' heart failure now seen in a wide range of socioeconomic and racial groups
Medical Xpress
DECEMBER 1, 2022
Rates of heart failure associated with the growing illicit use of the stimulant drug methamphetamine, or meth for short, are rising worldwide and now affect a wide range of socio-economic and racial groups, finds a review of the available evidence, published online in the journal Heart.
FDA Clears First IND for a Multiplex-Base Edited Investigational Therapy
BioSpace
DECEMBER 1, 2022
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
Hot weather associated with increased stroke risk in older people
Medical Xpress
DECEMBER 1, 2022
Emergency visits for stroke are elevated after a heatwave, according to research presented today at ESC Asia, a scientific congress organized by the European Society of Cardiology (ESC), the Asian Pacific Society of Cardiology (APSC), and the Asean Federation of Cardiology (AFC).
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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