FDA Law Blog

MARCH 13, 2023

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab

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Bio Pharma Dive

MARCH 14, 2023

“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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Containment 321

Pharmaceutical Technology

MARCH 14, 2023

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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Vaccination Vaccine Clinical Trials Clinical Trials 286

Rethinking Clinical Trials

MARCH 15, 2023

IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Demonstration Project, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone! Dr. Christine Goertz, Dr. Adam Goode, Dr. Jon Lurie, and Dr. Rishi Chakraborty Co-led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care.

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Clinical Trials Clinical Trials Trials Doctors 246

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

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

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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Bio Pharma Dive

MARCH 15, 2023

Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb.

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NPR Health - Shots

MARCH 15, 2023

After years of high rates, the country hit a new high during the pandemic, far exceeding rates in other developed nations. Black women are at especially high risk.

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Development 145

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

Researchers have developed a blood test to determine a person’s risk of developing anxiety, while also providing insight into its current severity and best course of treatment.

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Bio Pharma Dive

MARCH 13, 2023

The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.

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Pharmaceutical Technology

MARCH 17, 2023

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health. Ghryvelin is used for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare and serious condition, as well as for Childhood Onset Growth Hormone Deficiency (CGHD), if approved.

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STAT News

MARCH 13, 2023

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 13, 2023

If you needed another reminder of just how important quality sleep is to our health and well-being, a new study has linked three specific sleep problems with a change in risk of developing dementia.

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Bio Pharma Dive

MARCH 15, 2023

Tang Capital’s Concentra Biosciences is offering Jounce investors a competing bid to the biotech’s planned reverse merger with Redx Pharma.

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Pharmaceutical Technology

MARCH 16, 2023

Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.

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NPR Health - Shots

MARCH 16, 2023

A Mississippi woman's life has been transformed by a treatment for sickle cell disease with the gene-editing technique CRISPR. All her symptoms from a disease once thought incurable have disappeared.

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Gene Editing Gene 145

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

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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Bio Pharma Dive

MARCH 17, 2023

The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

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Pharmaceutical Technology

MARCH 17, 2023

The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients. ADCs are designed for targeting cancer cells specifically and selectively provide a highly potent payload that may limit healthy cells’ damage.

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Research Antibody Protein Trials 246

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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.

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NPR Health - Shots

MARCH 14, 2023

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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Pharmacy Research 145

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 13, 2023

The Indian Institute of Science (IISc) researchers from the Department of Organic Chemistry (DOC) and Materials Research Centre (MRC) have shown that surface modifications of two-dimensional molybdenum disulphide (2D-MoS) nanosheets can make them highly effective for applications like delivering drugs to diseased cells.

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Bio Pharma Dive

MARCH 14, 2023

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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Pharmaceutical Technology

MARCH 16, 2023

Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder. It will combine the use of new drug targets for Huntington’s disease from Aitia’s Gemini Digital Twins with the expertise of UCB in preclinical model systems and drug research in neurodeg

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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

NPR Health - Shots

MARCH 11, 2023

A bipartisan group of senators wants to make daylight saving time permanent. But sleep experts say standard time is better, because it saves morning light and is more in sync with our natural rhythms.

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Doctors Doctor 145

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 16, 2023

The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.

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Bio Pharma Dive

MARCH 14, 2023

The regulator’s review of the planned $43 billion deal could reveal how it plans to apply a new philosophy toward drugmaker mergers.

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Regulation 296

Pharmaceutical Technology

MARCH 14, 2023

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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Drugs Research Manufacturing Development 182

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Pharma Times

MARCH 15, 2023

Duo team up for the development of antigen-targeted probes for early cancer detection

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Development 139

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.

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Clinical Trials Clinical Trials Trials Drugs 172

Bio Pharma Dive

MARCH 14, 2023

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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Clinical Trials Clinical Trials Trials Drugs 277

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule. It increased the branching of dendrites and synaptic plasticity signals in animal 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.

Clinical Trials