Sat.May 29, 2021 - Fri.Jun 04, 2021

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An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Bio Pharma Dive

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it.

Genetics 356
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Personal responsibility in the obesity epidemic

World of DTC Marketing

SUMMARY: The U.S. is one of the wealthiest countries in the world and accordingly has high obesity rates; one-third of the population has obesity plus another third is overweight. The cost of doing nothing is not an option. Yes, there are root causes for obesity that can’t be fixed quickly, but among the causes that we can try and change is our personal responsibility to live a healthier life.

Genetics 207
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Janssen’s myeloma CAR T therapy cilta-cel demonstrates ‘sustained efficacy’

Pharma Times

Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months

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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

pharmaphorum

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.

Trials 138
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Bayer buys a biotech and its offshoot in bet on radiopharmaceuticals

Bio Pharma Dive

The German drugmaker will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.

Medicine 336
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The Future of Health Care

World of DTC Marketing

IN SHORT : Out-of-control health care spending exact an enormous and growing toll on Americans. The scale of the broken US health care system reveals itself in tragic ways. Fraud accounts for about $300 billion of annual US health care spending. Many employers no longer try to contain health care spending, but many more are fighting back. The Future of Health Care is Local, Open, and Independent.

Pharmacy 198

More Trending

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In the News: May 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair.

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Biotech venture capital still booming as venBio raises another $550M

Bio Pharma Dive

VenBio has previously invested in a range of treatment areas and technologies, including cell and gene editing companies like Precision Bio and Artiva.

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Disruption my ass! Tech companies want healthcare dollars

World of DTC Marketing

SUMMARY: Amazon has set its sights on healthcare as it smells another profit opportunity. Google has signed an agreement with the Mayo clinic to help analyze data as they want a slice of healthcare dollars but what’s missing from these tech companies is “the human touch” that patients want. Via The New Republic “whether it believes its own rhetoric—or just smells another profit opportunity—the tech industry shows little sign of slowing its march into the world of commerci

Pharmacy 198
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FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

Pharma Times

Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021

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

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Avantor Acquires RIM Bio; Expands Bioproduction Footprint into China

Pharma Mirror

Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies & applied materials industries, announced today that it has acquired RIM Bio, a leading China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications.

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Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy

Bio Pharma Dive

Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.

Drugs 328
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Biogen’s Alzheimer’s drug: What’s the price tag on hope?

World of DTC Marketing

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?

Drugs 187
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Novartis reports 'clinically relevant' survival data for Lutathera

Pharma Times

The radioligand therapy was linked with a significant increase in progression-free survival and a clinically relevant increase in overall survival in patients with midgut neuroendocrine tumours

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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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ASPA and Messe Frankfurt India to unite experts to discuss ideas for securing the pharmaceutical supply chain

Pharma Mirror

Increasing instances of substandard, falsified and counterfeit medical products continue to pose a major challenge to the global healthcare system which is already suffering from the dire impact of COVID-19. To address this issue, ASPA and Messe Frankfurt India will unite leading experts from the pharmaceutical segment for a live panel discussion on 11 June 2021.

Medicine 130
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Amgen pays $400M for an eczema drug, putting faith in an old partner

Bio Pharma Dive

A deal with Kyowa Kirin gives Amgen rights to an experimental treatment aimed at an autoimmune target that has drawn interest from multiple drugmakers.

Drugs 325
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Communicating with HCPs via email

World of DTC Marketing

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. That should, however, not discourage the use of email to HCPs. If you follow some basic testing, email can be an effective tool for communicating information. 100 percent of U.S. pharma marketers use email marketing, and research shows that 73 percent of in-house marketers believe email m

Doctor 180
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'Indian' variant of coronavirus now dominant strain in the UK

Pharma Times

Officials warned that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to the Alpha (Kent) strain

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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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SIRIO’s Nutra-Innovation Team tackles global surge in demand for novel mood and stress health formulations

Pharma Mirror

SIRIO Group’s global Nutra-Innovation Team is rapidly intensifying efforts to create new formulations in different delivery formats for mood and stress relief. The team’s focus follows a year of global lockdowns in which consumers faced significant challenges. This has led to a rise in demand for products that enhance personal health and wellness – mind and body – with formulations that boost mood and reduce stress in strong demand.

Scientist 130
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MorphoSys to buy Constellation in $1.7B deal, aided by unusual funding

Bio Pharma Dive

Royalty Pharma will effectively fund MorphoSys' acquisition of the cancer biotech through a separate agreement to buy MorphoSys' shares of royalties on several marketed and experimental medicines.

Medicine 307
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FDA grants swift approval to Cognoa’s digital device for autism diagnosis

pharmaphorum

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence.

Doctor 114
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J&J’s Tremfya shows significant improvements for post-TNFi psoriatic arthritis patients

Pharma Times

IL-23 inhibitor helped patients achieve complete skin clearance and joint symptom improvement

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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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Ketamine as a Depression Treatment Saved Me

NY Times

I tried everything to treat my depression. Ketamine is the one thing that worked.

Drugs 112
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Alexion, AstraZeneca executives switch roles amid $39B buyout

Bio Pharma Dive

Marc Dunoyer, the U.K. drugmaker's longtime finance chief, will move over to a strategy role and run Alexion as a rare disease unit within AstraZeneca.

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UK is talking to AstraZeneca about beta variant COVID jab

pharmaphorum

The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta variant – also known as B.1.351 – which is estimated to be around 50% more transmissible than earlier strains.

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Amgen and Kyowa Kirin agree to jointly develop eczema med

Pharma Times

KHK4083 is an anti-OX40, fully human monoclonal antibody in development for the treatment of atopic dermatitis

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Female-Founded and Funded Capsida Taps Swati Tole as Chief Medical Officer

BioSpace

Newly entrenched in a leadership role within one of the most complex therapeutic spaces, Tole discussed the complexities of being both a woman and a woman of color in the biotech industry.

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Alkermes prepares for uncertain launch as FDA finally clears schizophrenia drug

Bio Pharma Dive

Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.

Drugs 214
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New French consortium wants to boost number of cancer focused startups

BioPharma Reporter

OncoSTART sees 12 expert partners join forces to combine networks to promote entrepreneurial innovation to tackle cancer head on.

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WHO authorises Sinovac’s COVID-19 vaccine for emergency use

Pharma Times

A WHO emergency use listing (EUL) is issued when a product meets international standards for safety, efficacy and manufacturing

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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.