Sat.Aug 13, 2022 - Fri.Aug 19, 2022

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FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)

FDA Law Blog

By Douglas B. Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the Sea conference when Douglas Throckmorton, Deputy Director for Regulatory Programs at FDA’s Center for Drug Evaluation and Research, stated that domestic FDA inspections of facilities have been performed

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Bluebird gene therapy approved by FDA for rare blood disease

Bio Pharma Dive

The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.

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What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money. However, some pharma companies are having problems filling open positions, and when they do, they often find it wasn’t a good fit. Here are some things to consider to ensure you’re hiring good people.

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Atomwise and Sanofi partner for drug discovery using AI

Pharmaceutical Technology

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally. The approach of Atomwise makes the process of drug discovery more logical and efficient by moving away from serendipitous discovery and toward a search that is structure-based.

Drugs 246
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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August 18, 2022: Rural and Remote Populations Are Focus of Funding Opportunity From NIH HEAL Initiative

Rethinking Clinical Trials

The NIH HEAL Initiative?, or Helping to End Addiction Long-Term Initiative?, announced its intent to publish a new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and efficiently implementing effective interventions and evidence-based pain m

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‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

Bio Pharma Dive

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields.

More Trending

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IN FOCUS: Northgate Technologies

Pharmaceutical Technology

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The Verdict. Northgate Technologies Inc. (NTI) is a Illinois based producer of medical devices and technologies for the healthcare sector, with a particular focus on surgical environments. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories.

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What's behind the FDA's controversial strategy for evaluating new COVID boosters

NPR Health - Shots

Some scientists are alarmed that the agency plans to evaluate the next generation of boosters by reviewing mouse studies alone. Others say there's no time to waste waiting for human trials.

Scientist 145
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Schrödinger names longtime biotech analyst Porges its CFO and top dealmaker

Bio Pharma Dive

Geoffrey Porges, who has spent nearly two decades researching biotechs at SVB Securities and AllianceBernstein, will now oversee and seek to grow the drug discovery specialist's network of partnerships.

Drugs 300
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Millennium hits a home run with DTC

World of DTC Marketing

Millennium Pharma’s ad and website for ENTYVIO touch all the bases with targeted patients. It shows that the team understands what it’s like for patients with severe ulcerative colitis. This is the kind of DTC that can help patients seek treatment. Empathy. Understanding what it’s like to live with health problems is the key to developing great DTC.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group.

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States with the toughest abortion laws have the weakest maternal supports, data shows

NPR Health - Shots

Many of the states that are moving to ban abortion tend to have less access to health care, worse maternal and infant health care outcomes and weaker social supports for children and families.

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Merck pays startup Orna $150M as ‘circular RNA’ attracts industry interest

Bio Pharma Dive

The pharmaceutical company has formed an alliance with Orna and invested $100 million in its Series B round, hoping the young biotech’s approach could lead to multiple new vaccines and drugs.

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Can we be serious about telehealth?

World of DTC Marketing

If you follow the hype around telehealth, you would think it will save healthcare. Telehealth does have a future as PART of healthcare, but it won’t replace the benefit of seeing a patient in person and being able to diagnose a health problem. There it is again. According to Healthcare Transformers, “ use of telehealth climbed more than 154% in late March 2020, compared with the year before, and a 2020 survey found 76% of patients would be interested in using it.

Doctors 154
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Pack

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Parents and clinicians say private equity’s profit fixation is short-changing kids with autism

STAT News

ATLANTA — When a new person comes into his living room, a giggly “E” smiles and passes a balloon her way. His fifth birthday was a few weeks ago, and these half-filled remnants still loiter around his suburban house. Suddenly, E darts upstairs for a moment alone, his wispy brown hair bouncing with each step.   There, in his room, is a corner with a tiny armchair, a short bookshelf, and a stuffed octopus.

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CSL says drug for rare swelling disorder succeeds in late-stage study

Bio Pharma Dive

The company plans to soon seek approval of a once-monthly preventive drug for hereditary angioedema, a disease other drugmakers are targeting with gene editing and RNA medicines.

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Scotland becomes the first country to offer tampons and pads for free, officials say

NPR Health - Shots

Studies have shown that a significant number of people struggle to afford menstrual products, and going without can cause people to miss school or work. (Image credit: Jeff J.

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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.

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Merck and Orna partner for RNA technology-based vaccines and therapies

Pharmaceutical Technology

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas. By self-circularisation, Orna’s oRNA technology makes circular ribonucleic acids (oRNAs) from linear RNAs. oRNA molecules have been demonstrated to possess increased stability in vivo compared to linear mRNA an

RNA 147
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Risk of ‘brain fog’ and other conditions persists up to two years after Covid infection

STAT News

Among the many worrying consequences of Covid-19, neuropsychiatric conditions rank high. A year ago researchers from Oxford University reported that 1 in 3 patients experienced mood disorders, strokes, or dementia six months after Covid infection. Now the same group is back with a longer-term analysis of 1.25 million Covid patient records, including what they believe is the first large-scale look at children and at new variants.

Research 132
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Axsome rebounds to win FDA approval of depression drug

Bio Pharma Dive

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%.

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Scholars confirm what itsy bitsy babies around the world already know

NPR Health - Shots

Studies have long shown that Western parents speak a singsongy high-pitched language to babies. Now researchers have gone to the Amazon, to the Hadza people and more to see if it's a global thing.

Research 139
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The New Age of Decentralized Clinical Trials

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.

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More big wins for the AstraZeneca-Daiichi Sankyo collaboration

Pharmaceutical Technology

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. This was followed by a further deal for the global development and commercialisation of another ADC, datopotamab deruxtecan (DS-1062) in 2020, with a deal value of up to $6bn.

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Opinion: As a pediatric cancer researcher, I admired the FDA. Then I got ALS

STAT News

Amyotrophic lateral sclerosis (ALS), as I have unfortunately come to learn, is a terrible disease with no cure. Some exciting treatments are on the horizon, but the Food and Drug Administration’s Office of Neuroscience , which has the task of overseeing the development of new ALS drugs in the U.S., has repeatedly failed to take aggressive steps to greenlight these experimental therapies.

Research 126
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Amid market turbulence, a Flagship startup pushes off an IPO with a new fundraise

Bio Pharma Dive

Senda Biosciences decided to raise a $123 million Series C round rather than test public markets with an initial offering, its top executive said.

Marketing 300
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Long uncertain, young people's access to abortion is more complicated than ever

NPR Health - Shots

As more states restrict abortion, the obstacles for minors who need the procedure are growing. Abortion-rights advocates warn the legal upheaval is leaving young people confused and without options.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Novavax’s Covid-19 vaccine gets approval in South Korea for adolescents

Pharmaceutical Technology

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. The vaccine is indicated for active immunisation for the prevention of Covid-19 in people of this age group.

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‘A poster child’ for diversity in science: Black engineers work to fix long-ignored bias in oxygen readings

STAT News

Like many people who are Black, Kimani Toussaint was concerned when he learned that the pulse oximeters relied on so heavily by physicians to treat and monitor Covid-19 patients didn’t work as well on darker-skinned patients. Unlike many people who are Black, he could do something about it. Toussaint is an optics expert whose lab at Brown University creates precision techniques to image and assess biological tissues.

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US plans shift to private market sales of COVID-19 vaccines, drugs

Bio Pharma Dive

The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their shots and therapeutics.

Sales 269
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Buy a rural hospital for $100? Investors pick up struggling institutions for pennies

NPR Health - Shots

Some rural hospitals are in such bad shape, they're selling for next to nothing. One company is snapping several distressed or closed hospitals in rural Tennessee, hoping to turn a profit.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.