Sat.May 20, 2023 - Fri.May 26, 2023

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J&J antibody drug combination shows promise in multiple myeloma

Bio Pharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

Antibody 357
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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.

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It’s Official: Artificial Sweeteners Don’t Work For Weight Loss, WHO Says

AuroBlog - Aurous Healthcare Clinical Trials blog

This week, the World Health Organization (WHO) advised that “non-sugar sweeteners should not be used as a means of achieving weight control or reducing the risk of noncommunicable diseases” such as diabetes and heart disease.

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Johnson & Johnson cites rebates and discounts for drug price increases

Fierce Pharma

Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36

Drugs 143
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Bio Pharma Dive

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

Antibody 316
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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights

Drug Patent Watch

Introducing DrugChatter.com: Empowering Access to Biopharmaceutical Drug Insights through AI Chat We are pleased to introduce DrugChatter.com, a groundbreaking platform that redefines the way professionals obtain concise, cited information on… The post DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 105
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Bristol Myers data make case for earlier use of bone marrow disease drug

Bio Pharma Dive

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

Drugs 312
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Immuno-oncology market set to grow in billions, but access concerns remain

Pharmaceutical Technology

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.

Marketing 264
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To bring food & drugs under one controller, TN govt appoints an IAS officer R Lalvena as director of DCA

AuroBlog - Aurous Healthcare Clinical Trials blog

With an intention to bring both the administrations of the food safety department and the drug control under one controller, the Government of Tamil Nadu has given the charge of director of drugs control administration (DCA) to the commissioner of food safety, R Lalvena, an IAS officer.

Drugs 202
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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FDA delays decision on Duchenne gene therapy and considers narrower approval

Bio Pharma Dive

The agency will extend its review of Sarepta’s treatment by roughly one month as it weighs limiting an initial OK only to children with Duchenne aged 4 to 5 years old.

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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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A Popular Sweetener Had A Worrying Impact on Generations Of Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Could the sweetened drinks we knock back make us feel a little more anxious? A 2022 study that looked at the effects of the artificial sweetener aspartame on mice suggested that it’s a possibility that’s worth investigating further.

Drugs 200
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How Machine Learning Drives Clinical Trial Efficiency

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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Delivery pivotal as UK life sciences plan takes shape

Pharma Times

Life Sciences Council meeting hosted by chancellor Jeremy Hunt has unfolded in Downing Street

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Novartis buys rare disease gene therapy from Avrobio

Bio Pharma Dive

The pharma will pay nearly $90 million to acquire Avrobio’s treatment for cystinosis, an inherited condition caused by the toxic buildup of an amino acid.

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Appili Therapeutics receives US patent for ATI-1501

Pharmaceutical Technology

Appili Therapeutics has received a US patent for ATI-1501 , a liquid oral reformulation of metronidazole. The patent claims for ATI-1501 were published by the US patent and trademark office under US application no. 18/072,154, filed on 30 November 2022. It covers the composition and preparation methods for ATI-1501 until 2039. Metronidazole is a widely used frontline oral treatment for parasitic and anaerobic bacterial infections.

Marketing 264
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Long COVID Seems to Make Distinct Changes to The Immune System

AuroBlog - Aurous Healthcare Clinical Trials blog

Long COVID has more than 200 potential symptoms and can affect almost every organ in the body. With more than 65 million people now estimated to live with this often-disabling condition worldwide, and numbers growing daily, there is a desperate need to understand the underlying biology driving it.

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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.

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Positive opinion for Novo Nordisk’s Sogroya

Pharma Times

Therapy has been developed for use among children and adolescents with growth hormone deficiency

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FDA approves new antibiotic for hospital-acquired pneumonia

Bio Pharma Dive

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

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Clover collaborates with Kyuan Trade to launch AdimFlu-S (QIS) in China

Pharmaceutical Technology

Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The China National Medical Products Administration approved AdimFlu-S (QIS) in January 2022 for individuals aged three years and above.

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A Popular New Weight-Loss Drug May Help Prevent Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

Over 55 million people worldwide have dementia. This mind-robbing condition has a huge impact on society and the economy, so scientists are working hard to find ways to treat or prevent it. One of the avenues being explored is the new weight-loss jab, Wegovy.

Scientist 194
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Priority review granted by FDA for 'landscape changing' colorectal cancer drug

Outsourcing Pharma

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

Drugs 98
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PTC lays off staff, fires CFO as neuromuscular drug study fails

Bio Pharma Dive

The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.

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Avrobio to sell cystinosis gene therapy to Novartis for $87.5m

Pharmaceutical Technology

Avrobio has announced a deal to sell its investigational haematopoietic stem cell (HSC) gene therapy programme , designed to treat cystinosis, to Novartis in an all-cash deal valued at $87.5m. Novartis will receive an exclusive licence for intellectual property related to the gene therapy platform of Avrobio for use in cystinosis and for other assets.

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DoP floats tender to appoint consultant for valuation of BPCL

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department of Pharmaceuticals (DoP) is initiating processes for valuation of the assets of Bengal Chemicals & Pharmaceuticals Ltd (BCPL) – a public sector undertaking which has shown resilience to overcome its financial troubles to turn around to profit – as part of the Central government’s divestment plans.

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The New Age of Decentralized Clinical Trials

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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Delivering the Sales Interaction of the Future

Intouch Solutions

Even as some of the effects of COVID-19 have begun to wane, it’s a challenging time to be a life-sciences sales representative. Survey after survey indicates that rep access remains a challenge. “No-see” policies, live-meeting reluctance from healthcare professionals (HCPs) and the time crunch HCPs face all represent barriers that reps must overcome.

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Ironwood to buy rare disease drugmaker in billion-dollar deal

Bio Pharma Dive

The acquisition would give Ironwood a drug in late-stage testing for a condition known as short bowel syndrome, further building out the company’s gastrointestinal-focused research.

Drugs 260
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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The precision therapy has been designed for potently and selectively inhibiting KIT D816V, which is the main underlying driver of the disease. It received FDA approval to treat ISM, advanced SM, including SM with an associated haematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and aggr

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Teleconsultation positions itself as viable alternative to offset low doctor-to-population ratio & specialists shortage

AuroBlog - Aurous Healthcare Clinical Trials blog

Teleconsultation is seen as a viable alternative with low doctor-to-population ratio and shortage of specialists doctors. In fact, teleconsultation is seen to bridge this gap by allowing patients in remote areas to receive earlier diagnosis and treatment with low cost and faster follow-up check-ups. We have seen teleconsultation has become an essential solution in India.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.