The Intricacies of the Pharma Cold Chain
Pharmaceutical Commerce
OCTOBER 14, 2022
How to navigate the ongoing temperature challenges surrounding storage & distribution.
Sat.Oct 08, 2022 - Fri.Oct 14, 2022
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‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy
Bio Pharma Dive
OCTOBER 13, 2022
Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference.
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Merck and Moderna partner to develop and sell cancer vaccine
Pharmaceutical Technology
OCTOBER 14, 2022
German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.
Researchers Track an Ultra-Rare Disease That Turns Muscle to Bone
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 10, 2022
A three-year-long study has tracked dozens of patients with an ultra-rare disorder that gradually turns muscle, tendons, and ligaments to bone. The lifelong, irreversible condition is known as fibrodysplasia ossificans progressiva (FOP). While estimates on its prevalence vary, confirmed cases occur in roughly one out of every 1 to 2 million births. Only about 800 […].
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
'Where is humanity?' ask the helpless doctors of Ethiopia's embattled Tigray region
NPR Health - Shots
OCTOBER 14, 2022
Civil war has blockaded the country's northern region and decimated a hospital system that serves nearly 7 million people. Without basic supplies, power and medicine, thousands are needlessly dying.
BIO’s McMurry-Heath steps down as head of biotech lobby
Bio Pharma Dive
OCTOBER 11, 2022
Her exit from the role follows reported disagreements over the group’s direction. Former GlycoMimetics CEO Rachel King will serve as interim CEO during the search for a successor.
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Pollen Can Trigger ‘Thunderstorm Asthma’, Even if You Typically Don’t Have Asthma
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2022
Climate change has caused melting icebergs, flooding, and landslides. It can also bring about an increase in pollen levels, prolong the duration of pollen season, and cause more pollen-related health problems. Pollen grains landing on the moist membranes of the nose or eyes cause “hay fever” (allergic rhinitis) in one in five people. This often […].
Opinion: Maternity care in the U.S. is in crisis. It’s time to call the midwife
STAT News
OCTOBER 12, 2022
After pushing for several hours, my patient looks exhausted but happy, clutching her seconds-old newborn to her chest. As I help her put her baby to breast for the first time, she isn’t thinking about anything other than the tiny human blinking up at her. As well she shouldn’t.
Brain disease startup Neumora draws more funding for ambitious research plan
Bio Pharma Dive
OCTOBER 11, 2022
Launched last year to change how drugs for brain diseases are made, the biotech has now raised about $650 million to build a pipeline that includes two clinical-stage medicines.
Novo Nordisk submitting once-weekly insulin to FDA following Phase III success
Pharmaceutical Technology
OCTOBER 12, 2022
Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin mar
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
Commerce ministry begins anti-dumping probe against antibiotic metronidazole imported from China
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2022
The Union ministry of commerce and industry has initiated an anti-dumping investigation against antibiotic metronidazole imported from China following a complaint filed by Aarti Drugs Limited. Metronidazole is used in treatment of bacterial infections and parasitic infections. It is used in cases of amoebiasis (amoebic dysentery), trichomoniasis (STD), giardiasis (beaver fever), gingivitis (gum inflammation), acute […].
A parents' lawsuit accuses Amazon of selling suicide kits to teenagers
NPR Health - Shots
OCTOBER 9, 2022
Amazon sold the food preservative sodium nitrite, which lawyers say has no household use at high purity levels, to people who later killed themselves using the substance, the suit claims. (Image credit: Patrick T.
Merck cardiovascular drug succeeds in study, validating $11B buyout bet
Bio Pharma Dive
OCTOBER 10, 2022
Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH. The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire.
Inceptor Bio and Avectas partner for CAR-T cell therapies development
Pharmaceutical Technology
OCTOBER 13, 2022
Inceptor Bio has partnered with cell engineering technology company Avectas to improve CAR-T cell therapies’ development and manufacturing to treat solid tumours. Under the collaboration deal, Inceptor Bio will use the Solupore technology from Avectas instead of electroporation for engineering T cells to yield a healthier T cell. This non-viral technology is well suited to the CAR-T cell process of Inceptor Bio.
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.
Human neurons implanted in a rodent’s brain lead a rat to water — and make it drink
STAT News
OCTOBER 12, 2022
The scientist flicked on a laser, filling the rat’s brain with blue light. The rodent, true to its past two weeks of training, scampered across its glass box to a tiny spout, where it was duly rewarded with a drink of water. From the outside, this would appear to be a pretty run-of-the-mill neuroscience experiment, except for the fact that the neurons directing the rat to its thirst-quenching reward didn’t contain any rat DNA.
Artificial intelligence could soon diagnose illness based on the sound of your voice
NPR Health - Shots
OCTOBER 10, 2022
Everything from your vocal cord vibrations to breathing patterns when you speak offers potential information about your health. Researchers are collecting voice data to one day use in an app.
Odyssey recruits news investors to fund precision drug research
Bio Pharma Dive
OCTOBER 13, 2022
A $168 million Series B round brings Odyssey’s total funding to date near $400 million, helping the startup support a growing pipeline of cancer and immune disease drug candidates.
UK approves prescription-only melatonin drug for childhood ADHD
Pharmaceutical Technology
OCTOBER 13, 2022
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). The therapeutic is meant for youth with ADHD aged 6-17 years who found sleep hygiene measures inadequate.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Which diet and health habits are backed by science? Now there’s a tool for that
STAT News
OCTOBER 10, 2022
Does eating red meat increase one’s risk of heart disease? Would eating more vegetables help? Is leaving high blood pressure untreated really a death wish? The answers might vary, depending on who a person asks, which friend or TikTok nurse, and when. Researchers at the University of Washington want to make it easier to find current, evidence-based health advice.
Is 'rainbow fentanyl' a threat to your kids this Halloween? Experts say no
NPR Health - Shots
OCTOBER 11, 2022
The Drug Enforcement Administration is warning that drug dealers are marketing rainbow-colored fentanyl to kids. Many drug experts say that's likely not happening.
Merck pays $250M to license Moderna cancer vaccine
Bio Pharma Dive
OCTOBER 12, 2022
The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release.
Neumora raises funds for precision neuro therapies development
Pharmaceutical Technology
OCTOBER 12, 2022
Neumora Therapeutics has raised $112m in a Series B financing round to advance its new precision medicine candidates pipeline for neuropsychiatric disorders and neurodegenerative diseases. New and existing investors including F-Prime Capital, Altitude Life Science Ventures, Mubadala Capital, Amgen, Exor Ventures, ARCH Venture Partners, Invus, Abu Dhabi Growth Fund (ADG), Newpath Partners, Polaris Partners, as well as other undisclosed investors have participated in the financing round.
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.
‘It still prevented cancers’: Experts discuss furor over colonoscopy study and dissect the nuances
STAT News
OCTOBER 14, 2022
On Sunday, the New England Journal of Medicine published the interim results of a landmark trial examining the effect of inviting people to colonoscopy screening. The paper, which STAT covered , exploded across medical media and ignited debate over the trial’s results, how to interpret those results, and the popular coverage of the study. The frenzy resulted over the trial’s main finding — which is that offering colonoscopies to people did not reduce cancer deaths within a 1
On #dementia TikTok, family caregivers find support and bring the disease to light
NPR Health - Shots
OCTOBER 11, 2022
On TikTok, the hashtag "dementia" has 3 billion views. Caregivers of people with Alzheimer's and other dementias have been using the site to swap tips and share the burdens of life with dementia.
Relmada shares collapse after fast-acting depression drug fails first test
Bio Pharma Dive
OCTOBER 13, 2022
The company blamed a higher-than-expected placebo response for the negative outcome, and is now pinning its hopes on two other trials that are currently underway.
Stalicla signs licence deal for Evgen Pharma’s lead asset SFX-01
Pharmaceutical Technology
OCTOBER 11, 2022
Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. Under the deal, Stalicla will gain the global rights of SFX-01 as a potential treatment for autism spectrum disorder (ASD), while Evgen will retain SFX-01’s worldwide rights for all other indications.
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.
Faster brain imaging technique seems to overcome limitations of current MRI scans
STAT News
OCTOBER 13, 2022
Research often proceeds in a logical progression, new studies building upon a detailed understanding of the underlying processes revealed by earlier work. But a new brain imaging technique that can directly track the activity of neurons emerged from one of academics’ favorite questions: “What would happen if we tried doing it this way?
The FDA has officially declared a shortage of Adderall
NPR Health - Shots
OCTOBER 14, 2022
The FDA has confirmed the nation is experiencing a shortage of Adderall after many pharmacies around the country have been unable to fill prescriptions and keep up with demand.
Covalent drugs take the stage — again — in Atlas Venture’s latest startup
Bio Pharma Dive
OCTOBER 14, 2022
A decade after Celgene bought the Atlas-backed Avila Therapeutics, the venture firm is building Matchpoint Therapeutics to develop covalent medicines for autoimmune diseases.
Health Canada approves Pfizer-BioNTech’s Covid-19 booster
Pharmaceutical Technology
OCTOBER 10, 2022
Health Canada has approved Pfizer ’s subsidiary Pfizer Canada and BioNTech’s bivalent Covid-19 vaccine, Comirnaty, as a 30?g booster shot for 12 years and above aged individuals. The regulatory approval for Comirnaty Original & Omicron BA.4/BA.5 booster dose is based on the clinical data obtained from the companies’ monovalent, Omicron BA.1-adapted bivalent vaccine.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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