5 questions facing emerging biotech in 2023
Bio Pharma Dive
JANUARY 10, 2023
Investors expect another lackluster year in IPOs, while company restructurings look set to continue as biotech executives try to conserve cash.
Sat.Jan 07, 2023 - Fri.Jan 13, 2023
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Health Canada gives approval to Enhertu for breast cancer treatment
Pharmaceutical Technology
JANUARY 13, 2023
Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.
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COVID Autopsies Reveal The Virus Spreading Through The ‘Entire Body’
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 12, 2023
COVID-19 is defined as a respiratory infection, but the effects of the novel coronavirus are certainly not confined to any one organ. Dozens of recent autopsies show persistent evidence of SARS-CoV-2 throughout the body, including in the lungs, the heart, the spleen, the kidneys, the liver, the colon, the thorax, muscles, nerves, the reproductive tract, […].
Routine vaccinations drop among U.S. kindergartners for the third year in a row
STAT News
JANUARY 12, 2023
The percentage of U.S. kindergartners who’ve received standard childhood vaccines took a small but notable dip into the 2021-2022 school year, health officials said Thursday, amid disruptions related to Covid-19 and fears that anti-vaccine sentiment stirred up by the pandemic could be spreading to other shots. Vaccinations among children remain high, but the trend — with coverage dropping from about 95% in the 2019-2020 school year to 94% in 2020-2021 to 93% in 2021-2022, according
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
5 FDA decisions to watch in the first quarter
Bio Pharma Dive
JANUARY 9, 2023
An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.
Are we entering the era of biologics for COPD?
Pharmaceutical Technology
JANUARY 8, 2023
In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Approaches like bronchodilator inhalers focus on treating both asthma and chronic obstructive pulmonary disease (COPD).
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The FDA no longer requires all drugs to be tested on animals before human trials
NPR Health - Shots
JANUARY 12, 2023
In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.
JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas
Bio Pharma Dive
JANUARY 10, 2023
The FDA commissioner shared advice for drugmakers at the J.P. Morgan Healthcare conference, while venture investors cautioned of a coming funding crunch for young biotechs.
BARDA awards contract for Sabin’s Ebola Sudan and Marburg virus vaccines
Pharmaceutical Technology
JANUARY 13, 2023
The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) of the US Department of Health and Human Services, will initially invest around $35m for the production of up to 100,000 doses of the Ebola Sudan virus (ChAd3-SUDV) vaccine.
FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 10, 2023
The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report […].
For most mild infections, long Covid symptoms clear after a year, large study finds
STAT News
JANUARY 11, 2023
Since long Covid emerged, how best to define it, predict it, and treat it has been up for debate, but perhaps the most urgent question for patients and providers alike has been how long it lasts. A new study analyzing nearly 2 million patient records in Israel concludes that for most people, the troubling symptoms that persist after a mild Covid infection fade away after about a year.
5 questions facing gene therapy in 2023
Bio Pharma Dive
JANUARY 12, 2023
Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.
Provention’s Tzield can delay type 1 diabetes. But will it reach all patients?
Pharmaceutical Technology
JANUARY 10, 2023
On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). Providing an early-treatment strategy allows people to manage a lifelong condition while maximizing their quality of life, and it is a potential first step to tackling inequity. However, without fair and equal access to testing for T1D, it is difficult for people to obtain a diagnosis and access treatment.
Our Mental Picture of Space Seems to Expand Like The Universe
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 11, 2023
Inside your brain there is a map of every bedroom you’ve slept in. Every kitchen you’ve cooked in. Every city you’ve worked in, every country you’ve holidayed in. There’s even a threadbare map of every Universe you’ve dreamt in. Squeezing this vast trove of detailed information into a small tapestry of neurons is possible thanks […].
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
Medical schools are missing the mark on artificial intelligence
STAT News
JANUARY 12, 2023
Ready or not, health care is undergoing a massive transformation driven by artificial intelligence. But medical schools have barely started to teach about AI and machine learning — creating knowledge gaps that could compound the damage caused by flawed algorithms and biased decision-support systems. “We’re going to be at a point where we’re not going to be able to catch up and be able to call out the technology defects or flaws,” said Erkin Ötleş, a
JPM23: Takeda tests Bristol Myers, Prime weighs spinoffs and Sanofi faces down a competitor
Bio Pharma Dive
JANUARY 11, 2023
Executives at the two pharmas talked up their rival autoimmune disease drugs at the J.P. Morgan Healthcare Conference, while Prime Medicine’s CEO pondered a busy future.
US FDA approves Eisai-Biogen’s antibody for Alzheimer’s
Pharmaceutical Technology
JANUARY 9, 2023
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials.
NPPA looks into fixation of retail price of drugs under phase IV clinical trials
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 10, 2023
The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form. The Authority deliberated the issue of retail price fixation […].
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.
Drugstores make slow headway on staffing problems
STAT News
JANUARY 7, 2023
Joan Cohrs missed her chance to grab a prescription at her usual drugstore by about 30 seconds. Cohrs walked up to the counter of an Indianapolis CVS pharmacy shortly after a metal curtain descended, closing it for lunch. She didn’t mind. The 60-year-old said she feels compassion for people in health care.
5 questions facing the pharma industry in 2023
Bio Pharma Dive
JANUARY 9, 2023
Drug price reforms and regulatory scrutiny present challenges for large drugmakers, although successes in Alzheimer’s and obesity have brought new opportunities, too.
AstraZeneca to buy US-based CinCor Pharma for $1.8bn
Pharmaceutical Technology
JANUARY 10, 2023
AstraZeneca has signed a definitive agreement to buy US-based biopharmaceutical company CinCor Pharma in a deal valued at about $1.8bn. Under the deal, the company will initiate a tender offer to purchase all the outstanding shares of CinCor Pharma for $26 per share in cash. The transaction also includes a non-tradable contingent value right of $10 per share in cash which will be paid after a specified regulatory submission of CinCor’s lead drug candidate, baxdrostat (CIN-107).
DBT to open eProMIS to accept proposals from researchers on Chronic & Lifestyle Disease Programme
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 9, 2023
The Department of Biotechnology (DBT) will shortly be opening its electronic project management information system (eProMIS) to accept proposals from eligible researchers under its Chronic and Lifestyle Disease Programme. The Programne supports research on chronic diseases with major thrust on metabolic disorders. It aims to support basic, clinical, translational and interdisciplinary research in focused high […].
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.
STAT+: Oscar Health’s CEO on post-hype health insurance and finally turning a profit
STAT News
JANUARY 13, 2023
Oscar Health has excelled at one thing in particular since its inception a decade ago: burning cash. The health insurance company did not plan to be profitable immediately. It was staking its future on the new Affordable Care Act marketplaces and had to grow quickly to compete with larger insurance carriers. Oscar organized its health insurance product through an app, promoted virtual care, advertised on New York subways, and then low-balled prices in certain markets to attract young, healthy pe
AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma
Bio Pharma Dive
JANUARY 11, 2023
Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.
BioNTech to buy UK-based AI company InstaDeep
Pharmaceutical Technology
JANUARY 11, 2023
BioNTech has signed an agreement to buy UK-based artificial intelligence (AI) and machine learning (ML)-based products developer InstaDeep in a deal valued at about $440m (£362m) in cash and shares. InstaDeep shareholders will also receive up to $243.1m (£200m) in additional performance-based future milestone payments. The latest move follows an initial equity investment made by BioNTech as part of the Series B financing round of InstaDeep in January last year.
CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 11, 2023
Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities. This is taking a long time to progress, according to Dr. Arvind Lal, chairman, Dr. Lal PathLabs while revealing the fact that the country only […].
Jill Biden had three skin lesions removed
NPR Health - Shots
JANUARY 11, 2023
When first lady Jill Biden went for routine surgery for a small lesion above her right eye, doctors found two more lesions, and removed them, too, the White House said.
Sanofi tops off venture arm, bringing fund to $750M
Bio Pharma Dive
JANUARY 12, 2023
The pharma is rolling out a multi-year capital commitment to its biotech investment group, which this week backed biotech NextPoint Therapeutics.
AbbVie and Anima partner for mRNA biology modulators
Pharmaceutical Technology
JANUARY 11, 2023
AbbVie has collaborated with Anima Biotech for the discovery and development of mRNA biology modulators against three oncology and immunology targets. The collaboration will use the mRNA Lightning platform from Anima and AbbVie’s oncology and immunology expertise to discover new mRNA biology modulators against the targets. AbbVie will get exclusive rights to license and develop and market the programmes.
Indian pharma sees immense importance in US FDA guidance on aluminum content and labelling in parenteral nutrition
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 12, 2023
Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products. There are also exports for the same. The global regulatory authority noted […].
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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