Sat.Dec 11, 2021 - Fri.Dec 17, 2021

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CAR-T therapy trials show promise for earlier use in lymphoma

Bio Pharma Dive

Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer.

Trials 342
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You can’t afford to get cancer

World of DTC Marketing

OPENING: American cancer patients spent more than $21 billion on their care in 2019. That $21.09 billion included out-of-pocket costs of $16.22 billion and patient time costs of $4.87 billion. As cancer survival rates rise, so do the price tags of life-saving treatments. Monthly drugs costs may reach $100,000, causing many Americans to struggle with the physical and emotional effects of high out-of-pocket medical costs.

Drugs 55
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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.

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Judge Overturns Purdue Pharma’s Opioids Settlement

NY Times

The ruling said the company’s owners, members of the Sackler family, could not receive protection from civil lawsuits in return for a $4.5 billion contribution.

Drugs 145
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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J&J's coronavirus vaccine faces new US limits

Bio Pharma Dive

Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's.

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Pharma’s big lie is about greed

World of DTC Marketing

The public has been told that pharma needs money to develop new drugs, but unfortunately, that’s a huge lie. As biopharmadive recently, “some of the biggest pharmaceutical companies, sitting on large and growing sums of cash, are funneling those funds into major share buyback programs and acquisitions of smaller biotech companies. On Thursday, Swiss drug-making giant Novartis announced plans to buy back up to $15 billion worth of its shares by end of 2023, a program it will fund wi

Sales 209

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Firms Push for Over-the-Counter Access to Birth-Control Pills

NY Times

Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.

Drugs 145
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Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Bio Pharma Dive

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

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From patient engagement to patient centricity

pharmaphorum

Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.

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New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

BioPharma Reporter

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Antibody 143
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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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Insilico Medicine launches trial for AI-discovered drug

Outsourcing Pharma

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

Trials 141
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Two cancer cell therapy studies succeeded. Why did a third fail?

Bio Pharma Dive

Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences.

Drugs 327
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SMC approves first immunotherapy combination for advanced bowel cancer patients with rare mutation

Pharma Times

Nivolumab plus ipilmumab has been accepted as a treatment option for adult patients by NHS Scotland for patients who have previously failed fluoropyrimidine-based chemotherapy.

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Now scientists can efficiently screen billions of chemical compounds to find effective new drug therapies

Scienmag

Key takeaways: Credit: USC Dornsife/Yekaterina Kadyshevskaya Key takeaways: New technology called “V-SYNTHES” uncovers more effective drug candidates in a fraction of the time other algorithms need. The method screens virtual chemical components that can be “clicked” together to build a drug. Scientists tested V-SYNTHES on the protein receptors affected by the active ingredient in marijuana, […].

Scientist 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Prescription Drugs and Their Role in D.U.I. Incidents

Pharma Mirror

Impaired driving due to prescription medication is often given less attention than driving under the influence of illegal drugs. Yet, prescription drugs are just as dangerous, if not more dangerous, because many people are either not aware of the drug’s influence on their driving or assume prescribed medication is “safe.” Some medication, however, significantly increases the risk of car crashes.

Drugs 130
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Arena, completing its turnaround, sells to Pfizer for nearly $7 billion

Bio Pharma Dive

Pfizer will pay $100 per share to acquire Arena and the portfolio of inflammatory disease medicines it developed in the wake of a disappointing drug launch.

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Vaccines still provide ‘significant protection’ against severe COVID-19

Pharma Times

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines.

Vaccine 130
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Merck’s Covid Pill Might Pose Risks for Pregnant Women

NY Times

Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children.

DNA 129
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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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Why the Next Generation of Drugs Can’t Depend on Legacy Drug Packaging

Pharma Mirror

By Christopher Weikart, Chief Scientist at SiO2 Materials Science Why is an incredibly innovative and forward-thinking industry like pharmaceuticals being held back by the products that haven’t changed in over a century? The glass used to package, store, and deliver drugs today was created in 1881 — just 16 years after the Civil War ended — and has changed very little since then, and it’s these vials that drug companies, who are creating ever-evolving, more complex drugs, are beholde

Packaging 130
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Bristol Myers returns to Immatics for a dual-targeting cancer drug

Bio Pharma Dive

The pharma has expanded an alliance with a German biotech by paying $150 million for a drug candidate that executives hope can have "cell therapy-like efficacy" for solid tumors.

Drugs 319
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Study finds Omicron multiplies 70 times faster than Delta, UK COVID-19 cases exceed 75,000

Pharma Times

A warning has been issued to UK MPs from the head of NHS England that hospitalisations could exceed numbers recorded in January 2021.

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Michael J. Fox Foundation significantly expands Parkinson’s study

BioPharma Reporter

The Parkinsonâs Progression Markers Initiative, built using Evidation Healthâs research platform, aims to triple enrollment and recruit online participants.

Research 126
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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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FDA sets April date for verdict on Incyte’s vitiligo drug

pharmaphorum

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year.

Drugs 111
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Flush with cash, large drugmakers turn to share buybacks, deals

Bio Pharma Dive

Novartis is using funds gained from the recent sale of its stake in Roche to buy back $15 billion worth of its own shares, while Pfizer is signaling more dealmaking could follow its buyout of Arena.

Sales 307
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Needle free COVID-19 vaccine trialled in UK

Pharma Times

The DIOSvax technology produced by the University of Southampton aims to predict how the virus could mutate.

Vaccine 129
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Moderna to build mRNA vaccine manufacturing facility in Australia

BioPharma Reporter

Moderna and the Australian Government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.

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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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Abbott, Howard University join to boost research diversity

Outsourcing Pharma

The pharma firm has gifted $1m USD to form a scholarship fund for students headed toward careers in clinical research, with the aim of increasing diversity.

Research 107
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In final analysis, Pfizer's COVID-19 pill remains highly effective

Bio Pharma Dive

Full study results show Paxlovid cut the risk of COVID-19 hospitalization or death by about 90% among high-risk adults, matching the interim findings Pfizer disclosed last month.

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Kineret receives positive CHMP opinion for treatment of COVID-19 pneumonia

Pharma Times

The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.

Medicine 127
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Citrus greening disease can infect an entire tree weeks before symptoms appear

Scienmag

For the first time ever, scientists have been able to measure the speed of a bacterium that causes the incurable citrus greening disease. Citrus greening disease (also known as Huanglongbing) is the most devastating citrus disease in the world. Afflicted trees grow yellow leaves and low-quality fruit and eventually stop producing altogether, resulting in enormous […].

Bacterium 107
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time