Bio Pharma Dive
AUGUST 19, 2022
A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up by as much as 40%.
World of DTC Marketing
AUGUST 19, 2022
The Inflation Reduction Act’s health insurance subsidies and drug pricing reforms will improve health care affordability for Americans but won’t do a damn thing for our overall healthcare costs, which will keep rising. High drug and health care costs prevent millions of Americans from achieving total health. Nearly 1 in 2 American adults report difficulty affording health care costs.
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Bio Pharma Dive
AUGUST 19, 2022
The biotech startup, which licensed two programs from Novartis, is part of a crowded field of drugmakers trying to develop new hepatitis B treatments.
Pharmaceutical Technology
AUGUST 19, 2022
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has provided interim policy recommendations for the usage of French company Valneva’s Covid-19 vaccine, VLA2001. According to the recommendations, two 0.5ml intramuscular doses of the vaccine are intended to be given as part of the initial dosing regimen. The second dose should be given a minimum of 28 days following the first shot. .
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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
NPR Health - Shots
AUGUST 19, 2022
Missteps and delays have hampered the U.S. effort to vaccinate people against monkeypox. Now state health officials and community members are trying to adapt to a controversial "dose sparing" plan.
Pharmaceutical Technology
AUGUST 19, 2022
The European Commission (EC) has granted approval for Celltrion Healthcare ’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer. Vegzelma (CT-P16) is a bevacizumab biosimilar referencing Genentech’s Avastin, which is approved in the EU.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 19, 2022
The UK National Institute for Health and Care Excellence (NICE) has r ecommended Vifor Fresenius Medical Care Renal Pharma’s Tavneos (avacopan) plus rituximab or cyclophosphamide to treat adults with two ANCA-associated vasculitis (AAV) forms. The treatment is indicated for severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the two forms of AAV.
NPR Health - Shots
AUGUST 19, 2022
A Michigan judge blocked county prosecutors from enforcing the state's 1931 ban on abortion for the foreseeable future. An attorney representing two GOP county prosecutors said an appeal is planned.
STAT News
AUGUST 19, 2022
Sun Pharmaceutical, which is one of the largest purveyors of generic drugs, allegedly falsified various documents that were maintained by employees at one of its plants in India, according to an inspection report issued by the U.S. Food and Drug Administration. During a visit earlier this month to a plant in Mohali, FDA inspectors examined records pertaining to discrepancies in a batch of medicines and found records were allegedly backdated by quality assurance and quality control employees.
NPR Health - Shots
AUGUST 19, 2022
These undiagnosed infections could be a major factor in the rapid transmission of the omicron variant, the researchers said.
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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
STAT News
AUGUST 19, 2022
After a lengthy review, the Food and Drug Administration approved a fast-acting depression treatment from Axsome Therapeutics on Friday, clearing the way for the first new oral therapy for major depressive disorder in decades. The drug, to be sold as Auvelity, had a rapid and significant effect on major depression in a roughly 300-patient trial, outperforming placebo on a measure of depression symptoms after one week and sustaining the effect for another five.
NPR Health - Shots
AUGUST 19, 2022
Now that states can ban abortion after the overturning of Roe v. Wade , experts comment on whether the post- Roe abortion workarounds that have flooded social media are realistic.
STAT News
AUGUST 19, 2022
The sharp decline in routine childhood immunization rates the World Health Organization recently reported is a stark warning that today’s pandemic mistakes and rise of vaccine misinformation could harm generations to come. The enormity of the immunization gap in 2021 is difficult to comprehend: 25 million kids under-vaccinated , with 18 million missing immunizations completely — the highest numbers since 2009.
XTalks
AUGUST 19, 2022
Move over meat and seafood, chocolate might be the next big trend in the cell-based space. Cell-based chocolate is made by growing cells in a similar way to cultured meat and seafood, but the outcome is far different. So, what is cell-based chocolate and who are some of the major players in the burgeoning space? In order to make cell-based chocolate, cells must be sampled through varieties that are selected for their taste, smell, melt and performance.
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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.
STAT News
AUGUST 19, 2022
The Biden administration largely stood firm on its plan for resolving disputes over surprise medical bills, despite vocal opposition from physicians and other providers. In a final rule published late Friday , the government said the entities that are meant to settle disputes between insurance companies and out-of-network providers, must start their considerations with the median in-network payment rate for the service in question.
Antidote
AUGUST 19, 2022
Celiac disease, an autoimmune disorder that causes a reaction to gluten, is a condition that impacts about 1 in 141 people in the United States. For those with celiac disease, ingesting gluten creates toxins that destroy the villi of the small intestine, which makes it difficult for the body to absorb nutrients from food.
STAT News
AUGUST 19, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Pharma Times
AUGUST 19, 2022
NICE approval is for first-line treatment of intermediate and advanced renal cell carcinoma
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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.
pharmaphorum
AUGUST 19, 2022
US startup Dr B – formed in 2021 to help match patients seeking a COVID-19 vaccine to suppliers with leftover stock – is branching out into antivirals with the help of an $8 million fundraising. The cash injection will be used to launch a telehealth service that promises to provide prescriptions and services to patients regardless of their ability to pay.
NPR Health - Shots
AUGUST 19, 2022
In two New York counties, city health officials have been tackling a worrying trend: polio samples showing up in wastewater. In one county, a young adult became sick and paralyzed from the disease.
Pharma Times
AUGUST 19, 2022
Senior public health figures take unusual step of warning government about energy costs
Drug Channels
AUGUST 19, 2022
Today’s guest post comes from H. John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds. John discusses how a patient-centric technology solution can increase access and affordability for patients. He goes on to describe how human contact and support helps patients understand their disease and their treatment plan, thus increasing adherence.
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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.
Drug Patent Watch
AUGUST 19, 2022
Annual Drug Patent Expirations for TPOXX Tpoxx is a drug marketed by Siga Technologies and is included in two NDAs. It is available from one supplier. There are nine patents…. The post New patent for Siga Technologies drug TPOXX appeared first on DrugPatentWatch - Make Better Decisions.
Intouch Solutions
AUGUST 19, 2022
Here at EVERSANA INTOUCH, we have dozens of boomerangs. No, not the wooden kind – our “boomerangs” are employees who leave, then return to work here. And while we’re happy to list the many benefits, perks, initiatives, and policies that make working here great… our boomerangs often tell the story best. Today, we’re hearing from Andy Cuff, Account Supervisor, EVERSANA INTOUCH Proto.
Olympian Clinical Research
AUGUST 19, 2022
Psoriasis and eczema are both chronic conditions that can affect children and adults alike. While these conditions may be similar, there are some distinguishing characteristics. Knowing the difference between pediatric psoriasis and eczema may help you get the correct diagnosis for your child and help them find relief. While these conditions cannot be cured, there are treatments available that may lessen the symptoms.
Drug Discovery World
AUGUST 19, 2022
Clinical-stage company Respira Technologies has appointed a new Chief Executive Officer (CEO) to the company. . Brian Quigley will take over as CEO after working as Respira’s Chief Operating Officer (COO) for the past two years. . Quigley previously worked at Altria Group for 16 years where he spent seven years as President & CEO at Altria’s Smokeless and Innovative Products/Vapor Businesses. .
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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.
pharmaphorum
AUGUST 19, 2022
The European Commission has approved Oncopeptides’ Pepaxti in combination with dexamethasone for multiple myeloma patients with so-called triple class refractory disease – in other words those who don’t respond to all three of the major classes of treatment for the blood cancer. The approval means that Pepaxti (melphalan flufenamide) can now be used as a rescue therapy for adults with multiple myeloma who have previously failed treatment with at least one proteasome inhibitor, one im
Drug Discovery World
AUGUST 19, 2022
News round-up by DDW Editor Reece Armstrong for 15-19 August. Covid booster approvals, positive results for Malaria vaccines and new CEOs are some of the stories in this week’s news round-up. . MHRA approves Moderna’s bivalent Covid booster . The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine that targets two coronavirus variants.
pharmaphorum
AUGUST 19, 2022
Reeling from the recent failure of its lead product in a pivotal trial, Nordic Nanovector has formally started a restructuring process and called in investment bank Carnegie to help explore its options. The Norwegian biotech was hit hard in July when the PARADIGME study of Betalutin ( 177 Lu lilotomab satetraxetan) – an anti-CD37 antibody radionuclide conjugate being tested as a third-line therapy for patients with follicular lymphoma – was abandoned after being plagued with recruitment issues.
Drug Discovery World
AUGUST 19, 2022
The ability to monitor biologic candidates’ propensity towards self-association is critical for predicting whether a therapeutic is likely to aggregate or become difficult to administer due to viscosity. In this app note, read how Merck KGaA uses light scattering measurements to predict how formulations will behave at clinically relevant concentrations and find the optimal formulation buffer for their biologics candidates.
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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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