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.

342

342

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.

HR 321

HR Trials Engineer Clinical Trials 321

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, […].

Clinical Trials 246

Clinical Trials Clinical Trials Clinical Research Trials 246

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

Vaccine 145

Vaccine Vaccination 145

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

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.

Gene Therapy 363

Gene Therapy Gene Drugs 363

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).

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

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.

Trials 145

Trials Clinical Trials Clinical Trials Production 145

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.

357

357

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.

Vaccine 246

Vaccine Vaccination Clinical Trials Clinical Trials 246

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 […].

FDA Approval 241

FDA Approval Drugs Clinical Trials Clinical Trials 241

Advertisement

Clinical Supply

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.

Scientist 145

Scientist Research 145

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.

Gene Therapy 352

Gene Therapy Gene 352

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.

Insulin 246

Insulin FDA Approval Research Development 246

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 […].

Clinical Trials 207

Clinical Trials Clinical Trials Clinical Research Trials 207

Advertisement

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

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

Research 145

Research 145

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.

Medicine 337

Medicine Drugs 337

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.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

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 […].

Clinical Trials 187

Clinical Trials Clinical Trials Trials Drugs 187

Advertisement

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

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.

Pharmacy 145

Pharmacy 145

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.

Drugs 331

Drugs 331

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).

Clinical Trials 243

Clinical Trials Clinical Trials Clinical Development Development 243

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 […].

Research 187

Research Clinical Trials Clinical Trials Clinical Research 187

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

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

Production 144

Production Marketing 144

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.

FDA Approval 325

FDA Approval Drugs Sales Medicine 325

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.

Development 173

Development Manufacturing Vaccine Vaccination 173

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 […].

Regulation 183

Regulation Clinical Trials Clinical Trials Clinical Research 183

Advertisement

Clinical Supply

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.

Doctor 143

Doctor Doctors 143

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.

322

322

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.

Gene Therapy 147

Gene Therapy Gene Development Licensing 147

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 […].

Packaging 181

Packaging Packaging Pharmacy Pharma Companies 181

Advertisement

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