ABPI responds to rebooted MHRA clinical trials framework
Pharma Times
MARCH 22, 2023
Measures include a requirement to publicly register studies and share results among research participants
Sat.Mar 18, 2023 - Fri.Mar 24, 2023
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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders
Bio Pharma Dive
MARCH 22, 2023
Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.
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InvisiShield and Gladstone partner to develop intranasal preventatives
Pharmaceutical Technology
MARCH 21, 2023
Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.
Opinion: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything
STAT News
MARCH 24, 2023
I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.
Private opulence, public squalor: How the U.S. helps the rich and hurts the poor
NPR Health - Shots
MARCH 21, 2023
Poverty, by America author Matthew Desmond says if the top 1% of Americans paid the taxes they owed, it would raise $175 billion each year: "That is just about enough to pull everyone out of poverty.
Biotech startups face ‘Series A cliff’ as venture capital stays cautious
Bio Pharma Dive
MARCH 24, 2023
Series A rounds have been easy to secure in the last few years, but industry watchers say they haven't seen a corresponding increase in Series B's as startups struggle to recruit new investors.
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Opinion: There is no epidemic of autism. It’s an epidemic of need
STAT News
MARCH 23, 2023
On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.
FDA gives 2nd safety nod to cultivated meat, produced without slaughtering animals
NPR Health - Shots
MARCH 21, 2023
GOOD Meat, which grows chicken and other meat from animal cells in a production facility, is the second company to cross this hurdle. The move brings no-kill meat closer to sale in the U.S. (Image credit: Brian L. Frank for NPR/Brian L.
Sanofi, Regeneron surge as Dupixent scores in COPD trial
Bio Pharma Dive
MARCH 23, 2023
The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.
RVAC and University of Pennsylvania to develop mRNA vaccines
Pharmaceutical Technology
MARCH 20, 2023
RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The collaboration, under a sponsored research agreement, will focus on mRNA vaccines that can help in modulating the normal immune response of the body for the treatment of certain autoimmune diseases as well as allergic conditions.
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
Marburg fever outbreak in Equatorial Guinea widens, WHO reports
STAT News
MARCH 22, 2023
The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a
Getting around muscle aging by modulating the function of immune cells
Medical Xpress
MARCH 23, 2023
Muscle is able to regenerate through a process that involves multiple steps and players, including the immune system. As our organism ages, the muscles lose the capacity to regenerate.
Novo partners with Dewpoint to mine an emerging field for new drugs
Bio Pharma Dive
MARCH 22, 2023
The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.
The CDC is investigating recalled eyedrops after infections cause death and blindness
NPR Health - Shots
MARCH 22, 2023
Infections from drug-resistant bacteria have caused death and illness in 68 patients across the U.S., the CDC says. The strain has been linked to recalled eyedrops like EzriCare Artificial Tears.
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.
Tuberculosis cases nearly back to pre-pandemic levels, data show
STAT News
MARCH 23, 2023
Early in the Covid-19 pandemic, new diagnoses of tuberculosis dropped like a stone in the United States. Data released Thursday by the Centers for Disease Control and Prevention suggest the pandemic effect has pretty much worn off; TB is nearly back to pre-2020 levels. “We’re getting … close to where we were pre-pandemic; not quite back yet with increases in cases in the last two years,” Philip LoBue, director of the CDC’s division of tuberculosis elimination,
Study recommends using age, not weight, to screen for diabetes
Medical Xpress
MARCH 23, 2023
Researchers should focus on age, not weight, to capture the greatest number of people in all racial and ethnic groups with prediabetes and diabetes, recommends a new Northwestern Medicine study.
FDA staff signal support for Biogen ALS drug, but highlight data hurdles
Bio Pharma Dive
MARCH 20, 2023
In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of its benefit could be difficult, however.
Georgia governor signs bill banning most gender-affirming care for trans children
NPR Health - Shots
MARCH 23, 2023
The state will ban most gender-affirming surgeries and hormone replacement therapies for transgender people under 18 with a new bill signed into law by Gov. Brian Kemp.
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.
Tanzania reports a Marburg outbreak, Africa’s second this year
STAT News
MARCH 21, 2023
Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.
Hidden 'super spreaders' spur dengue fever transmission, finds study
Medical Xpress
MARCH 22, 2023
For mosquito-borne diseases such as dengue fever, the abundance of the insects in places where people gather has long served as the main barometer for infection risk. A new study, however, suggests that the number of "hidden" infections tied to a place, or cases of infected people who show no symptoms, is the key indicator for dengue risk.
Moderna CEO defends price of COVID shot at Senate hearing
Bio Pharma Dive
MARCH 22, 2023
Stéphane Bancel said his company's planned price hike covers the higher costs of commercial sales. Sen. Bernie Sanders called it part of industry’s “unprecedented level of corporate greed.
80-hour weeks and roaches near your cot? More medical residents unionize
NPR Health - Shots
MARCH 23, 2023
Part of a national trend, medical residents at Penn Medicine in Philadelphia push to form a union to demand better working conditions and higher wages. Child care is an important issue for many.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
‘That scares me’: New childhood obesity guidelines still face a long road to consensus
STAT News
MARCH 20, 2023
This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. The rise of childhood obesity in the United States did not happen quickly. But, to medicine, “it sort of cropped up overnight,” says Bob Siegel, a pediatric obesity specialist at Cincinnati Children’s.
What to know about new research on coffee and heart risks
Medical Xpress
MARCH 23, 2023
Coffee lovers—and their doctors—have long wondered whether a jolt of java can affect the heart. New research published Wednesday finds that drinking caffeinated coffee did not significantly affect one kind of heart hiccup that can feel like a skipped beat.
Karuna’s schizophrenia drug succeeds in a second late-stage trial
Bio Pharma Dive
MARCH 20, 2023
The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.
California enters a contract to make its own affordable insulin
NPR Health - Shots
MARCH 19, 2023
Under the $50 million deal, the state is partnering with drugmaker Civica to start making the new generic insulin later this year, Gov. Gavin Newsom said.
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.
Opinion: Will there be any emergency doctors to see you in the future?
STAT News
MARCH 20, 2023
In the emergency room today, everyone is suffering. Many emergency medicine physicians are struggling to provide quality care amid staffing shortages, increased pressure to meet productivity metrics, and frustrated patients battling prolonged wait times. Their situation is compounded by a sense that they have been abandoned by hospital leadership, leading to increasing levels of physician burnout and attrition.
A higher dose of magnesium each day keeps dementia at bay
Medical Xpress
MARCH 23, 2023
More magnesium in our daily diet leads to better brain health as we age, according to scientists from the Neuroimaging and Brain Lab at The Australian National University (ANU).
Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data
Bio Pharma Dive
MARCH 18, 2023
The eagerly anticipated results from a Phase 2 study in psoriasis show why the pharma paid $4 billion to buy the drug from startup Nimbus Therapeutics last year.
A new Arkansas law allows an anti-abortion monument at the state Capitol
NPR Health - Shots
MARCH 19, 2023
Arkansas Gov. Sarah Huckabee Sanders has signed a law to allow a monument near the state Capitol marking the number of abortions performed in Arkansas before Roe v. Wade was overturned. (Image credit: Phelan M.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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