2024

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These microscopic tunnels are a goldmine for new medicines

Bio Pharma Dive

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Medicine 342
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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

Drugs 144
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Experimental Parkinson’s Treatment Elicits Antibodies Against Toxic Protein in Phase I

BioSpace

Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.

Protein 134
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA settles ivermectin lawsuit, removes contentious COVID-19 posts

BioPharma Reporter

The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.

Doctors 145
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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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Researchers combine herpes virus with cancer vaccine to treat brain cancer in children

Pharma Times

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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2024 predictions: Experts comment on AI, ML and automation

Drug Discovery World

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. This is part of a series of predictions based on different themes. Here, experts weigh in on the impact of artificial intelligence (AI), machine learning (ML) and automation in the sector. Updesh Dosanjh, Practice Leader for Pharmacovigilance Technology Solutions, IQVIA “In 2024, the traditional pain points of the pharmacovigilance (PV) space will not disappear.

Genome 139
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What to know about endometrial cancer

Antidote

Also known as endometrial carcinoma or uterine cancer, endometrial cancer occurs when the cells that line the uterus begin growing uncontrollably. Though the mortality rates are relatively low due to the high rate of early detection, it is a cancer that impacts nearly 70,000 people every year.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

Bio Pharma Dive

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Trials 347
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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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Duchenne approval exposes FDA rift over Sarepta gene therapy

Bio Pharma Dive

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

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Investors put $400M into biotech licensing obesity drugs from China

Bio Pharma Dive

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing 355
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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

Bio Pharma Dive

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

Drugs 331
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Patient dies in Pfizer study of Duchenne gene therapy

Bio Pharma Dive

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

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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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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

Bio Pharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

Bio Pharma Dive

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

Trials 353
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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

Bio Pharma Dive

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Psychiatry drugs finally have pharma’s attention. Can they keep it?

Bio Pharma Dive

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

Medicine 340
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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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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

Bio Pharma Dive

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

Drugs 322
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[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Bio Pharma Dive

How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Amylyx ALS drug fails crucial study, putting company’s future in doubt

Bio Pharma Dive

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

Drugs 340
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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

Bio Pharma Dive

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

Hormones 303
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10 clinical trials to watch in the first half of 2024

Bio Pharma Dive

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

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Drug patents protect pharma profits. Track when they’ll expire here.

Bio Pharma Dive

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

Drugs 326
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

Bio Pharma Dive

Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!