FDA Law Blog

AUGUST 16, 2022

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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Bio Pharma Dive

AUGUST 17, 2022

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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Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology.

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World of DTC Marketing

AUGUST 15, 2022

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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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

NPR Health - Shots

AUGUST 18, 2022

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.

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Bio Pharma Dive

AUGUST 16, 2022

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.

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World of DTC Marketing

AUGUST 16, 2022

The new Inflation Bill will not reduce healthcare costs in the U.S. Why? An analysis predicts that by 2030, 48.9% of adults in the United States will be obese, and 24.2% will be severely obese. Annual obesity-related medical care costs in the United States, in 2019 dollars, were estimated to be nearly $173 billion. Annual nationwide productivity costs of obesity-related absenteeism range between $3.38 billion and $6.38 billion.

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STAT News

AUGUST 15, 2022

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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Bio Pharma Dive

AUGUST 16, 2022

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

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Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia in adult and paediatric patients. A custom-made, one-dose gene therapy, Zynteglo is indicated for such patients who need red blood cells (RBCs) transfusions on a regular basis.

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Clinical Supply

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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NPR Health - Shots

AUGUST 15, 2022

Nonprofit RIP Medical Debt buys up unpaid hospital bills plaguing low-income patients and frees them from having to pay.

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Bio Pharma Dive

AUGUST 18, 2022

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.

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Pharmaceutical Technology

AUGUST 18, 2022

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.

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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

Clinical Trials

World of DTC Marketing

AUGUST 18, 2022

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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NPR Health - Shots

AUGUST 16, 2022

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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Bio Pharma Dive

AUGUST 16, 2022

The company has agreed to spend at least $280 million buying back rights to the drug, called Trodelvy, which were sold to Everest Medicines in 2019.

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Pharmaceutical Technology

AUGUST 17, 2022

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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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.

Clinical Trials

World of DTC Marketing

AUGUST 14, 2022

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.

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NPR Health - Shots

AUGUST 14, 2022

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.

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Bio Pharma Dive

AUGUST 16, 2022

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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Pharmaceutical Technology

AUGUST 15, 2022

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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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.

Clinical Research

STAT News

AUGUST 17, 2022

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.

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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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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%.

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Pharmaceutical Technology

AUGUST 16, 2022

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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Clinical Supply

Pharma Times

AUGUST 19, 2022

NICE approval is for first-line treatment of intermediate and advanced renal cell carcinoma

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Rethinking Clinical Trials

AUGUST 18, 2022

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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Bio Pharma Dive

AUGUST 17, 2022

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.

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Pharmaceutical Technology

AUGUST 17, 2022

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

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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.

Clinical Trials