Tue.Mar 14, 2023

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SVB’s failure was contained. Its effects on biotech could still linger.

Bio Pharma Dive

“A generation of founders is now scarred,” one biotech CEO said, as small drugmakers grapple with the longer-lasting effects of SVB’s stunning collapse.

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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Novo Nordisk follows Lilly in sharply cutting price of insulin drugs

Bio Pharma Dive

Responding to policy changes and pressure over high drug costs, the pharma is reducing the sticker price of four branded diabetes medicines by up to 75%.

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The FDA Just Approved The First Fast-Acting Nasal Spray For Migraines

AuroBlog - Aurous Healthcare Clinical Trials blog

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday. ​Pfizer said it expected the drug, marketed under the name Zavzpret, to be available in pharmacies in July 2023.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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VA to cover Leqembi for veterans with early Alzheimer’s

Bio Pharma Dive

The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.

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Innovation in targeted therapies: Leading companies in photodynamic cancer therapy drugs

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Photodynamic canc

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Cingulate partners with Indegene for ADHD therapy

Pharmaceutical Technology

Biopharmaceutical firm Cingulate and life sciences commercialisation firm Indegene have entered into a joint commercialisation deal for the former’s attention-deficit/hyperactivity disorder (ADHD) therapy CTx-1301 (dexmethylphenidate). The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval.

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IPC to run series of SDPs to enhance pharmacovigilance knowledge & skills of healthcare professionals

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Pharmacopoeia Commission (IPC) will run a series of skill development programmes (SDPs) on pharmacovigilance (PV) of medical products in May, August and November 2023. One SDP is scheduled between May 15 and May 19 with the other two scheduled between August 7 and August 11 and between November 20 and November 24, 2023.

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Pfizer signs agreement to buy Seagen for $43bn

Pharmaceutical Technology

Pfizer has entered a definitive merger agreement to buy biotechnology firm Seagen in a deal valued at $43bn. Under the deal, the company would pay $229 per Seagen share in cash. Both companies’ Board of Directors have unanimously approved the transaction. Seagen discovers, develops, and commercialises transformative cancer medicines. It is a pioneer in antibody-drug conjugates (ADCs) technology.

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Switch Therapeutics launches with $52M to capitalize on RNA medicine ‘era’

Bio Pharma Dive

The company’s name comes from its goal of developing drugs that only “switch” on in target cells, potentially enabling more precise therapies.

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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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Innovation in chemotherapy: Leading companies in platinum-based cancer drug compositions

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Platinum-based ca

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Mexican pharmacies are selling pills to U.S.travelers laced with deadly fentanyl

NPR Health - Shots

Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.

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Innovation in chemotherapy: Leading companies in purine derivatives-based cancer drug compositions

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Purine derivative

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Podcast February 28, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Rethinking Clinical Trials

This podcast continues the discussion with Dr. Michael Gibson as he discusses a new paradigm in conducting virtual clinical trials. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 44: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials NIH Pragmatic Trials Collaboratory · Podcast 43: Ethical Considerations for Vulnerable Populations in Pragmatic Clinical Trials Want to hear more?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Nordisk will cut some U.S. insulin prices by up to 75% starting next year

NPR Health - Shots

The Danish drugmaker's move follows a similar announcement by rival Eli Lilly earlier this month. More than 8 million Americans use insulin, according to the American Diabetes Association.

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‘This is a nonpartisan issue’: Planned Parenthood’s Alexis McGill Johnson on fighting for reproductive rights

STAT News

In the wake of the Supreme Court’s decision to overturn Roe v. Wade, the news has been full of stories about patients crossing state lines in order to access reproductive care. What often gets left out is the accompanying confusion created by abortion restrictions. “I had a patient travel all the way from Mississippi,” said Sarah Traxler, an OB-GYN in Minnesota, “only for me to have to say, ‘It’s not safe for me to see you here in this clinic.

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Neurotech could connect our brains to computers. What could go wrong, right?

NPR Health - Shots

Connecting our brains to computers may sound like something from a science fiction movie, but it turns out the future is already here. One expert argues it's a slippery slope.

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UK boosts cell and gene therapy manufacturing with new facility

BioPharma Reporter

The new Clinical Biotechnology Centre (CBC) in Bristol will expand the UKâs ability to make clinical grade products for the research and development of new cell and gene therapies.

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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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Why Medicare is suddenly under debate again

NPR Health - Shots

As the White House and Republicans in Congress gear up for negotiations over the U.S. debt ceiling, how to pay for senior health care could be a sticking point, even if cuts are "off the table.

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High blood caffeine level might curb amount of body fat and type 2 diabetes risk

Medical Xpress

A high blood caffeine level might curb the amount of body fat a person carries and their risk of type 2 diabetes, suggests research published in the open access journal BMJ Medicine.

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STAT+: Novo Nordisk to lower insulin prices by up to 75% amid growing pressure

STAT News

Under mounting pressure, Novo Nordisk plans to cut U.S. list prices for several insulin products by up to 75%, the latest big drugmaker to take such a step in response to a years-long outcry over the cost of the diabetes treatments. The company plans to cut the list price of its NovoLog insulin by 75%, and the prices for Novolin and Levemir by 65% starting in January 2024.

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Mediterranean diet cuts women's cardiovascular disease and death risk by nearly 25%, finds study

Medical Xpress

Sticking closely to a Mediterranean diet cuts a woman's risks of cardiovascular disease and death by nearly 25%, finds a pooled data analysis of the available evidence—the first of its kind—published online in the journal Heart.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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EPA announces proposed drinking water limits for six ‘forever chemicals’

STAT News

The Environmental Protection Agency for the first time on Tuesday proposed enforceable regulations for “forever chemicals,” also called PFAS, in Americans’ drinking water. The six PFAS are the first new contaminants to be regulated under the Safe Drinking Water Act’s 1996 amendments. The EPA set a threshold of 4 nanograms per liter for the chemicals PFOA and PFOS in drinking water.

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How neuroimaging can be better utilized to yield diagnostic information about individuals

Medical Xpress

Since the development of functional magnetic resonance imaging in the 1990s, the reliance on neuroimaging has skyrocketed as researchers investigate how fMRI data from the brain at rest, and anatomical brain structure itself, can be used to predict individual traits, such as depression, cognitive decline, and brain disorders.

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National Academies calls for transforming use of racial and ethnic labels in genetics research

STAT News

Saying genetics researchers inconsistently and inappropriately use racial and ethnic labels that fail to capture the complex patterns of human genetic variation, the National Academies of Sciences, Engineering, and Medicine issued a report Tuesday calling for a transformation in how such descriptors are used. Outdated methods of grouping people may result in poor scientific results and misguided interpretations, said the report.

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Biological network in cells helps body adapt to stresses on health

Medical Xpress

Every minute of every day, our body adapts to meet the needs of each moment. When we binge on carbs, exercise, or become sick, chemical reactions inside our cells switch on, slow down, or shift strategy so that we have the energy and strength we need.

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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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Opinion: NRC: be straight about when clinicians need to report errors that lead to radiation exposure

STAT News

A recent action by the U.S. Nuclear Regulatory Commission (NRC) should have protected patients who are inadvertently exposed to potentially high doses of radiation due to faulty injections or infusions. But it instead preferentially protects the nuclear medicine practitioners who are subject to its regulations and oversight. At issue is the NRC’s policy that exempts practitioners of nuclear medicine — clinicians who use radioactive pharmaceuticals to diagnose or treat disease

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Gene essential to making DNA appears to be a good target in minimizing pulmonary hypertension

Medical Xpress

The vascular smooth muscle cells that normally give blood vessel walls strength and flexibility proliferate and become destructive in pulmonary hypertension, a typically rapidly progressing condition that makes it hard to get blood inside our lungs and oxygen to our bodies.

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STAT+: PhRMA chief dings health insurers over drug prices at their own conference

STAT News

WASHINGTON — The head of the brand drug lobby used an in-person health insurance industry conference to blame insurers for making people pay too much for drugs. America’s Health Insurance Plans CEO Matt Eyles, interviewing PhRMA President Stephen Ubl, asked for examples of policies that would benefit both industries. Ubl responded by suggesting that insurers lower cost sharing for drugs.

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Industry calls on UK Government to support biotech SMEs

Drug Discovery World

Ahead of the UK’s Spring Budget, the UK BioIndustry Association (BIA) is calling on the Treasury to provide additional support through the R&D tax relief scheme to R&D intensive SMEs. These companies are the most at risk from the R&D tax relief rate cut announced at the Autumn Statement, due to their high R&D investment and lack of other revenue sources.

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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.