Pharmaceutical Technology

JUNE 12, 2023

On 9 May, National Fentanyl Awareness Day was observed in recognition of the US opioid crisis. Accordingly, the development of non-opioid painkillers is experiencing a surge in activity and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favourites to replace opioid-related medications. The North American opioid epidemic highlights limitations in opioid use, such as the potential for drug abuse and overdose.

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Bio Pharma Dive

JUNE 15, 2023

Lilly will pay the genetic medicine specialist $60 million upfront to work together on a treatment targeting a risk factor known as Lp(a).

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Gene Editing Gene Genetics Medicine 325

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 14, 2023

It starts with an innocent bite from a tsetse fly – an all too common occurrence in sub-Saharan Africa. Before a person knows it, tiny microscopic parasites known as Trypanosoma are swimming in their bloodstream, playing “hide and seek” with their immune system.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). This will allow the Swiss company to begin ramping up its drug substance manufacturing process with its sister company FinVector Oy in Kuopio, Finland ahead of its planned product launch.

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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

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. While this process is essential, it’s also slow, expensive and unpredictable. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money.

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Bio Pharma Dive

JUNE 14, 2023

The FDA last year turned back an approval request from the drug’s former developer, Levo Therapeutics. That biotech is now owned by Acadia, which will run a new study designed to boost its odds of success.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 11, 2023

People who took a cheap diabetes drug after testing positive for COVID-19 had a 40 percent lower risk of getting long COVID, a US-based study said Friday.

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BioSpace

JUNE 12, 2023

The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

Switching to a diet full of fresh veggies and low in processed foods could do wonders for your brain’s biological age, new research shows.

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Bio Pharma Dive

JUNE 12, 2023

DeSouza is departing unrepentant about his decision to close the Grail deal, telling colleagues his belief in the merger “remains unshakeable.

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Clinical Supply

Pharmaceutical Technology

JUNE 16, 2023

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials.

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Vaccine Vaccination Trials Immune Response 246

Fierce Pharma

JUNE 12, 2023

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

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Vaccine Vaccination 143

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 13, 2023

A group of researchers at the Kolkata-based S N Bose National Centre for Basic Sciences has developed non-invasive method of recognising breath patterns that can help rapid, one-step diagnosis and classification of various gastric disorders like dyspepsia, gastritis, and gastroesophageal reflux disease (GERD).

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Bio Pharma Dive

JUNE 12, 2023

Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.

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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

Clinical Trials

Pharmaceutical Technology

JUNE 15, 2023

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. Following underwhelming topline results from the Phase II trial (NCT04135495) announced in late 2022, Eloxx recalculated the results using the change in ppFEV1 (a secondary outcome) from day 1 instead of from baseline.

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Fierce Pharma

JUNE 12, 2023

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

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Sales Drugs 141

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 15, 2023

The Tamil Nadu Pharma Traders Association (TN PTA), a registered body of 30,000 pharmaceutical wholesalers and retailers working in the 30 districts of the state, has approached the director-in-charge of the drugs control administration (DCA) with a request to the DTAB and the DCC under the union health ministry to allow three months time for […]

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Bio Pharma Dive

JUNE 13, 2023

In a sign of the impact the downturn has had on young biotechs, Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is “substantial doubt” it can survive.

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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.

Clinical Trials

Pharmaceutical Technology

JUNE 13, 2023

Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.

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Gene Therapy Gene Trials Clinical Trials 246

Fierce Pharma

JUNE 16, 2023

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.

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Drugs 138

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

The Multidisciplinary Committee (MDC) of Experts has recommended the prices of various fixed dose combinations (FDCs) containing dapagliflozin, sitagliptin, vildagliptin, pioglitazone, among others in tune with the recent amendments made by the Department of Pharmaceuticals (DoP) in the Drugs (Prices Control) Order (DPCO), 2013 related to fixing prices of drugs with off patented molecules.

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Bio Pharma Dive

JUNE 12, 2023

The company said the spending will help it manufacture future treatments for chronic diseases, adding to a string of recent plant investments.

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Production Manufacturing Drugs 208

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

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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Fierce Pharma

JUNE 16, 2023

In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 15, 2023

Scientists have discovered not only that animals age more quickly when they don’t have enough of the amino acid taurine in the body, but that oral taurine supplements can delay aging and increase a healthy lifespan.

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Bio Pharma Dive

JUNE 15, 2023

The biosimilar developer’s plans to set steep discounts on its copycat version of AbbVie’s Humira set off a legal back-and-forth between the companies.

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Development 195

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Clinical Supply

Pharmaceutical Technology

JUNE 12, 2023

Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceutical products, orphan drugs and other life-saving medicines.

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Fierce Pharma

JUNE 16, 2023

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.

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FDA Approval 131

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 14, 2023

The Union health ministry will soon amend the Recruitment Rules for the post of Assistant Drugs Inspector (Medical Devices) in Central Drugs Standard Control Organization (CDSCO). The ministry has now invited suggestions on the proposed amendment. The Ministry is also examining the proposal for amendment of Recruitment Rules towards making the provision.

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Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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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