Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

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Bio Pharma Dive

NOVEMBER 14, 2022

The deal, which could carry a total value of roughly $145 million, is in large part focused on a nasal formulation of the opioid overdose drug nalmefene.

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Development Drugs 359

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 15, 2022

Scientists from the Dana-Farber Cancer Institute have found some male cancer cells, those with X and Y chromosomes, show signs of having their X chromosome silenced. In normal mammal cells, the X chromosome is only muted when a female cell has a pair of Xs to choose from. Randomly turning off an extra X is […].

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Rethinking Clinical Trials

NOVEMBER 16, 2022

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Stephanie Morain, PhD, MPH. Assistant Professor. Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health. Kayte Spector-Bagdady, JD, MBioethics. Associate Director, Center for Bioethics & Social Sciences in Medicine. Assistant Professor of Obstetrics & Gynecology.

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Clinical Trials Clinical Trials Trials Research 189

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

NOVEMBER 17, 2022

The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update. This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike.

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Hormones Compliance Research 257

Bio Pharma Dive

NOVEMBER 16, 2022

Tricida, Harpoon, Freeline and three other small drug developers have this week announced plans to cut staff or to reprioritize their drug development.

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Research Development Drugs 347

Worldwide Clinical Trials

NOVEMBER 14, 2022

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

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Pharmaceutical Technology

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. It is claimed to be the first and only immunomodulatory treatment for T1D and is provided as a sterile, preservative-free, clear, and colourless solution in a

FDA Approval 246

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Bio Pharma Dive

NOVEMBER 16, 2022

The U.K. biotech will sell its German unit and lay off staff to save cash as it focuses on therapies for Gaucher and Fabry diseases.

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Gene Therapy Gene 344

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 16, 2022

Electric shocks to the brain took away the cravings of two patients with binge eating disorder for at least six months, a small study said. The two patients were fitted with a brain implant to zap the part of the brain linked to cravings. They told The New York Times that after the surgery they […].

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NPR Health - Shots

NOVEMBER 16, 2022

NPR spoke with 26 people who were involved with more than 200 executions across the country. Most said their health suffered and they had little support to help them cope with their unusual jobs.

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Pharmaceutical Technology

NOVEMBER 16, 2022

ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic.

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Bio Pharma Dive

NOVEMBER 15, 2022

Acrivon is the 20th biotech company to go public this year, roughly a fifth of last year’s total at this time, and had to sell more shares at a lower price to complete the deal.

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Drugs 338

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 16, 2022

In a bid to bring transparency in clinical trial costs which will in turn increase equity in the biomedical R&D ecosystem, Médecins Sans Frontières (MSF), a global medical non-governmental organization, has approved and published its first Clinical Trial Transparency Policy (CTTP). This policy is a commitment to publishing research protocols, registering clinical trials on appropriate […].

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Clinical Trials Clinical Trials Trials Research 189

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STAT News

NOVEMBER 18, 2022

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

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Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly.

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Antibody FDA Approval Clinical Trials Clinical Trials 246

Bio Pharma Dive

NOVEMBER 18, 2022

Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen.

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FDA Approval Drugs 328

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 17, 2022

The Department of Pharmaceuticals (DoP) has issued a notification amending the Drugs (Prices Control) Order, 2013, in order to replace the previous version of National List of Essential Medicines (NLEM) with NLEM, 2022, which was launched in September, this year by the Union health minister Dr Mansukh Mandaviya. The Drugs (Prices Control) Amendment Order, 2022, […].

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Medicine Drugs Clinical Trials Clinical Trials 182

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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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STAT News

NOVEMBER 15, 2022

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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Vaccine Vaccination Engineer Clinical Trials 145

Pharmaceutical Technology

NOVEMBER 15, 2022

Two weeks ago, the US Centers for Disease Control and Prevention (CDC) director Rochelle Walensky became the latest high-profile individual to report a case of Paxlovid rebound. Similar cases have been in the news for several months as the antiviral’s use increases, but the cause of such effects has remained mostly unknown. However, a recent study in the Journal of American Medical Association suggests that Paxlovid may not be the sole cause for this relapse in Covid-19 symptoms.

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Bio Pharma Dive

NOVEMBER 15, 2022

Only a small fraction of the companies Lilly evaluates get into its incubator, according to Gilmore. Here’s how the big pharma selects them.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 15, 2022

The Union ministry of health and family welfare (MoHFW) has notified inclusion of Coronary Stents in the National List of Essential Medicines (NLEM), 2022, with immediate effect based on the recommendations by the expert committee constituted to review and revise the list based on requirement. The Standing National Committee on Medicines (SNCM), on November 6 […].

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Medicine Clinical Trials Clinical Trials Clinical Research 173

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

NOVEMBER 14, 2022

The meat of the future may be cultured directly from animal cells without slaughtering livestock. It's not yet sold in the U.S., but NPR got a tour of a leading start-up and a taste of their chicken. (Image credit: Brian L.

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Pharmaceutical Technology

NOVEMBER 14, 2022

BioNTech’s Singapore affiliate BioNTech Pharmaceuticals Asia Pacific has signed an agreement with Novartis Singapore Pharmaceutical Manufacturing to acquire a GMP-certified manufacturing site in the country. . The latest development is part of the expansion plans of BioNTech to boost its international footprint in Asia. . Backed by the Singapore Economic Development Board (EDB), the site will become completely operational late next year.

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Manufacturing Vaccine Vaccination Production 162

Bio Pharma Dive

NOVEMBER 15, 2022

Backed by the same investors and team as an immunotherapy biotech Roche bought in September, Bonum Therapeutics plans to develop “conditionally” active cancer medicines.

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Medicine Development 322

STAT News

NOVEMBER 16, 2022

BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone , a key drug used to treat opioid use disorder. American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday.

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Research Doctor Doctors Drugs 144

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NPR Health - Shots

NOVEMBER 17, 2022

Some credit cards advertised by hospitals lure in patients with rosy promises of convenient, low-interest payments on big bills. But interest rates soar if you can't quickly pay off the loan.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Indivior has signed a definitive agreement to acquire all outstanding shares of Opiant Pharmaceuticals for an upfront payment of $20 for each share in cash or a deal totalling nearly $145m. In addition to the upfront consideration, Opiant is entitled to get up to $8 for a share in contingent value rights (CVRs). . This amount is payable on meeting specific net revenue milestones during the applicable seven-year period following the approval and launch of Opiant’s lead asset, OPNT003.

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Clinical Trials Clinical Trials Production Development 147

Bio Pharma Dive

NOVEMBER 15, 2022

The company secured $157 million between its second partnership agreement with Roche and a Series C round.

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Medical Xpress

NOVEMBER 14, 2022

A new study published in Diabetologia finds that outdoor artificial light at night (LAN) is associated with impaired blood glucose control and an increased risk of diabetes, with more than 9 million cases of the disease in Chinese adults being attributed to LAN exposure. The study is by Dr. Yu Xu and colleagues at the Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

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Medicine 136

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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