FDA approves first gene therapy for hemophilia B
Bio Pharma Dive
NOVEMBER 22, 2022
The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.
Tue.Nov 22, 2022
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Umoja and IASO partner to develop therapies for haematological malignancies
Pharmaceutical Technology
NOVEMBER 22, 2022
Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.
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GSK to pull blood cancer drug from US market after study failure
Bio Pharma Dive
NOVEMBER 22, 2022
The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.
Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug
Pharmaceutical Technology
NOVEMBER 22, 2022
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. This approval under the emergency regulatory approval system is granted under the Article 14-2-2 of the Pharmaceuticals and Medical Devices Act, the company noted.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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The next era of Greater Boston’s biotech boom
Bio Pharma Dive
NOVEMBER 22, 2022
Over the past two decades, the Cambridge area has become a nerve center for biotech in the U.S. But to stay relevant and accessible, the hub is expanding to the suburbs.
Magazine: What Rishi Sunak can do for the UK pharma industry
Pharmaceutical Technology
NOVEMBER 22, 2022
It's the last issue of Pharmaceutical Technology Focus in 2022, and a lot of changes have occurred over the year, not just in the pharma space, but also from a geopolitical, financial and energy perspective. Most recently, after a tumultuous 45 days, Liz Truss resigned as the UK’s prime minister paving the way for Rishi Sunak to take on the mantle. In this issue, we talk to different stakeholders in the pharmaceutical space to gauge what the sector is hoping Sunak achieves in his tenure when it
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Biotech ObsEva sells drug rights to forestall funding crunch
Bio Pharma Dive
NOVEMBER 22, 2022
In an effort to extend its cash runway and keep its stock listing, ObsEva is offloading rights to an experimental preterm labor drug in a deal with Xoma.
Chinese manufacturers’ transition to innovative pharma requires more investment
Pharmaceutical Technology
NOVEMBER 22, 2022
Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture. China will continue to take steps towards becoming as competitive in high-value innovative pharma as it is in the generics industry, with The Wall Street Journal reportin
Industry hails mandatory QR code on top 300 drug brands from Aug 1, 2023
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 22, 2022
Drug manufacturers have hailed the Drugs (Eighth Amendment) Rules, 2022 mandating barcode or quick response (QR) code on the label of top 300 brands of formulations from August 1, 2023, saying that QR codes will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing. Welcoming […].
Novo Nordisk to boost drug manufacturing in Denmark
Bio Pharma Dive
NOVEMBER 22, 2022
The Danish drugmaker has invested heavily in expanding its production capacity for oral and injectable drugs. A new $744 million project is the latest investment.
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
November 22, 2022: ADAPTABLE Points to Need for Better Integration of Patient-Reported Health Data Into Pragmatic Trials
Rethinking Clinical Trials
NOVEMBER 22, 2022
A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies. Results of the study were published in JAMA Cardiology.
Long-COVID personalized medicine enters Phase 2 trial
BioPharma Reporter
NOVEMBER 22, 2022
GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.
Opinion: A tripledemic hurricane is making landfall. We need masks, not just tent hospitals
STAT News
NOVEMBER 22, 2022
A viral hurricane is making landfall on health care systems battered by three pandemic years. With the official start of winter still weeks away, pediatric hospitals are facing crushing caseloads of children sick with RSV and other viral illnesses. Schools that promised a “return to normal” now report widespread absences and even closures from RSV and flu in many parts of the country , contributing to parents missing work in record numbers.
Experts are concerned Thanksgiving gatherings could accelerate a 'tripledemic'
NPR Health - Shots
NOVEMBER 22, 2022
As the holiday approaches, infectious disease specialists are bracing for the possibility that big family get-togethers and travel will propel the spread of RSV, flu and COVID-19.
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.
Real-world data show updated Covid-19 boosters increase protection against infection
STAT News
NOVEMBER 22, 2022
The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.
States differ on how best to spend $26B from settlement in opioid cases
NPR Health - Shots
NOVEMBER 22, 2022
The cash represents an unprecedented opportunity to derail the opioid epidemic. But with countless groups advocating for a share of the pie, the impact could depend heavily on geography and politics.
STAT+: FDA approves a gene therapy for the inherited bleeding disorder hemophilia B
STAT News
NOVEMBER 22, 2022
The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.
An art exhibit on the National Mall honors health care workers who died of COVID
NPR Health - Shots
NOVEMBER 22, 2022
Art curator Susannah Perlman, who lost her mother to COVID-19, created the Hero Art Project on the National Mall to eternalize the smiles of other health care workers lost to the pandemic.
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.
Why doesn’t the U.S. have at-home flu tests?
STAT News
NOVEMBER 22, 2022
Flu season is underway. RSV is putting record numbers of children in hospitals. And health professionals are gearing up for another Covid winter. With so many potential viruses in play, it would be helpful if Americans had a way to distinguish between different ailments at home. And when it comes to the flu in particular, at-home testing could help telehealth doctors decide when it makes sense to prescribe treatments like Paxlovid and Tamiflu, which need to be administered within a specific time
Doctors who would like to defy abortion laws say it's too risky
NPR Health - Shots
NOVEMBER 22, 2022
Doctors in states with abortion bans can face prison time and lose their licenses if they violate the laws. Some are calling on doctors to openly defy the bans.
GSK will pull Blenrep from US market after failed trial
pharmaphorum
NOVEMBER 22, 2022
GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. Some patients will be able to continue to receive the drug via a compassionate use programme.
A simple screening question could help millions of women prevent cardiovascular disease. Why aren’t we using it?
STAT News
NOVEMBER 22, 2022
Early one afternoon in 2000, Monique Shields, just a few weeks shy of her 30th birthday, left her busy day as an executive assistant at Starbucks’ corporate headquarters to go to her routine prenatal checkup. Feeling healthy, as she had throughout her 34 weeks of pregnancy, she stopped by her home outside of Seattle, changed into her flip-flops, and drove the five minutes to the appointment at her obstetrician’s office.
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.
Researchers discover that vitamin C improves health for children of pregnant smokers
Medical Xpress
NOVEMBER 22, 2022
Researchers at Oregon Health & Science University have found that vitamin C supplementation to pregnant women unable to quit smoking significantly improves airway function and respiratory health in their offspring at 5 years of age.
U.K. analysis shows one dose of monkeypox vaccine yields strong protection
STAT News
NOVEMBER 22, 2022
An analysis released Tuesday by U.K. health officials indicates that even one dose of the monkeypox vaccine provides strong protection against the virus. Researchers at the U.K. Health Security Agency estimated that one dose of the vaccine was 78% effective at protecting against infection 14 or more days after vaccination.
Chronic disorder occurring only in low, middle income countries prompts study to understand it at molecular level
Medical Xpress
NOVEMBER 22, 2022
A study of patients with a chronic intestinal condition has helped demystify—but not totally solve—a puzzling disorder that is widespread in low-and middle-income countries, but is largely unseen in wealthier regions of the world.
One-third of U.S. labs have stopped using race-based equations to diagnose kidney disease
STAT News
NOVEMBER 22, 2022
Even as a child, La’Tonzia Adams was interested in diagnosing disease. One day, when she noticed a bump on her chest, she decided to look up “chicken pox” in the Webster’s dictionary at her grandmother’s house to figure out if her symptoms matched the illness. “I remember I scratched it, and it was watery,” said Adams.
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.
How antibiotic resistant gut bacteria cause lung infections
Drug Discovery World
NOVEMBER 22, 2022
An Oxford University study has provided the first evidence that antibiotic resistant bacteria can travel from the gut to the lung, increasing the risk of deadly infections. . The findings coincide with World Antimicrobial Awareness Week and shed light on how antimicrobial resistance (AMR) arises and persists. . The study, which has been published in Nature Communications highlights the importance of preventing pathogenic bacteria from translocating from the gut to other organs where they can
STAT+: ‘Digital health is late to the party’: Can telehealth help hospitals mitigate their carbon footprints?
STAT News
NOVEMBER 22, 2022
As the world stares down the barrel of climate change, the health care system — which is responsible for about 9% of all U.S. greenhouse gas emissions — is finally starting to take action. Hospitals, in particular, are working to stem their impact, and have held up telehealth as a prime strategy to cut down on carbon, by eliminating millions of miles of travel to and from health care centers.
Patients with PTSD are less likely to survive COVID than those without, finds new research
Medical Xpress
NOVEMBER 22, 2022
A new study shows that patients with COVID-19 who also had post-traumatic stress disorder (PTSD) were more likely to die or be hospitalized than those without a psychiatric disorder. For patients with other mental illnesses, the risks were substantially higher.
STAT+: GSK to withdraw blood cancer drug from U.S. market following confirmatory study setback
STAT News
NOVEMBER 22, 2022
British pharma giant GSK said Tuesday that it will withdraw its blood cancer drug Blenrep from the U.S. market, following a request from the Food and Drug Administration. Blenrep’s removal is another sign that U.S. regulators are taking a more aggressive stance toward cancer drugs approved based on preliminary evidence of efficacy.
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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