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.
March 23, 2023: AJOB Calls for Peer Commentaries on Ethics in Pragmatic Trials
Rethinking Clinical Trials
MARCH 23, 2023
The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core. Unlike AJOB ‘s typical Open Peer Commentaries, commentaries for the special issue may be written either in response to the 2 target articles or on the topic of pragmatic trials in general.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
HIV testing and diagnosis severely disrupted in three years of Covid-19 pandemic at AIIMS
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 19, 2023
HIV testing and diagnosis was severely disrupted in the three years of Covid-19 pandemic at All India Institute of Medical Sciences (AIIMS), according to an AIIMS study which covered the documents or records on HIV testing and diagnosis from January 1, 2016 to December 31, 2022.
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: 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.
Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 20, 2023
Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the country.
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.
Biohaven licenses Hangzhou Highlightll’s BHV-8000 to treat brain disorders
Pharmaceutical Technology
MARCH 23, 2023
Biohaven has purchased the exclusive global rights for oral, brain-penetrant dual Tyrosine Kinase 2 (TYK2)/Janus Kinase 1 (JAK1) inhibitor, BHV-8000 (previously TLL-041), which treats immune-mediated brain disorders , from Hangzhou Highlightll Pharmaceutical. The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China.
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.
Centre puts onus on SLAs to take action against e-pharmacies for violation of D&C Act and Rules
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 23, 2023
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
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.
US FDA approves Incyte’s merkel cell carcinoma therapy
Pharmaceutical Technology
MARCH 23, 2023
The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. The regulator granted approval for Zynyz’s Biologics License Application (BLA) under accelerated approval based on the duration of response (DOR) and tumour response rate.
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
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.
Experts advocate decriminalizing existing drugs act without compromising on drug quality and patient safety
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 22, 2023
Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.
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.
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.
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.
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
PCI to extend approval for existing courses for the academic year 2023-24
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 21, 2023
The Pharmacy Council of India (PCI) has decided to extend the approval of existing courses for the academic year 2023-24 for the institutions which are approved by the Council, in the larger interest of the students and to maintain the timeline for the academic session.
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.
Comparison of Humira biosimilars in the US and Europe
Pharmaceutical Technology
MARCH 24, 2023
Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.
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.
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.
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,
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.
Pfizer acquires ADC pioneer Seagen for $43bn
Pharmaceutical Technology
MARCH 23, 2023
Pfizer recently announced an agreement to acquire Seagen, a biotech company based in the US with four marketed oncology therapeutic agents and a rich pipeline. The deal, expected to be completed by the end of 2023, will see Pfizer pay $229 per Seagen share in cash for a total of $43bn, the largest deal for the sector in the past three years. Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio.
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.
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.
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.
MHRA revamps UK clinical trial regulation with the promise of faster timelines
Pharmaceutical Technology
MARCH 23, 2023
This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things. These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21.
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.
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