December, 2021

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A serial biotech entrepreneur launches his next startup with high-dollar backing

Bio Pharma Dive

Founded and led by Gary Glick, Odyssey Therapeutics has raised $218 million in an initial fundraising round for its cancer and inflammatory disease drug research.

Drugs 352
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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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PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.

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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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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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Pfizer buys immuno-inflammatory firm Arena Pharmaceuticals for $6.7b

Outsourcing Pharma

The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.

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Digital health: the new normal?

pharmaphorum

Personalised and tailored healthcare that utilises patient’s data is rapidly becoming a reality. Ben Hargreaves looks at the concrete steps already being taken by companies in the area. Amongst the many ways in which the pandemic has changed the way in which we live, one of the most common experiences for most people was to revise what it means to have a face-to-face meeting.

Genetics 145

More Trending

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“Patients are only numbers on an Excel spreadsheet”

World of DTC Marketing

LEAD-IN: Yesterday I had a long talk with someone who has been in the industry for over 25 years. She has decided to leave the pharma industry because she said, “patients have been reduced to numbers on an excel spreadsheet” and “I am tired of trying to get coworkers to see them as people with real needs.” According to my WordPress stats, I have over 100 readers a day.

Insulin 259
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In the News: November 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. Voxzogo Approved as a Growth-Improvement Therapy for Children with Dwarfism. Biomarin has obtained FDA accelerated approval for Voxzogo (vosoritide), its first-in-class drug to increase linear growth in pediatric achondroplasia patients over the age of 5 with open epiphyses (growth plates).

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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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Is artificial intelligence the best tool for drug discovery?

Outsourcing Pharma

According to a leader from Cytoreason, AI isnât necessarily the best or only tool suited to discover new and novel therapiesâit might take a human touch.

Drugs 144
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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US pauses distribution of Regeneron, Lilly antibodies over omicron concerns

Bio Pharma Dive

The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.

Antibody 347
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Biogen: This train wreck was due

World of DTC Marketing

MY POINT : Success is always temporary. When all is said and one, the only thing you’ll have left is your character. Right now, I could make a great argument that Biogen’s character is trashed and that they are a company in dire need of authentic leadership. Massive layoffs could be headed to Biogen due to the disappointing rollout of its Alzheimer’s drug Aduhelm that generated only a few million dollars in revenue over the past two quarters.

Drugs 231
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The Composition and Value of a Portfolio Analysis

Camargo

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and e

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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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Will High Vaccination Rates Help Spain Weather Omicron?

NY Times

Spain surpassed others in Europe by avoiding politicized debate about Covid shots. Citizens also largely heeded the health guidance from their leaders.

Vaccine 140
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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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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 140
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A high-profile gene therapy biotech takes aim at Huntington's

Bio Pharma Dive

Passage Bio and the University of Pennsylvania's Gene Therapy Program said they have begun preclinical research aimed at simultaneously developing multiple approaches to treating Huntington's.

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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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Body positive for obesity?

World of DTC Marketing

When obesity has become a national health crisis caused by overeating and lack of exercise, a body positivity website has created free “Don’t Weigh Me” cards for patients who find stepping on the scale at the doctor’s office stressful. The group supports a “Health at Every Size” philosophy, based around the assumption that “the current practice of linking weight to health using BMI (body mass Index) standards is biased and unhelpful.” An analysis p

Doctor 43
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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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Digital health firm Pear goes public, raising $175 million

pharmaphorum

Pear Therapeutics has completed its merger with blank cheque company Thimble Point Acquisition Corp, claiming a Nasdaq listing and raising $175 million in gross proceeds for the digital health specialist. Pear will make its debut on the exchange today after combining with Thimble Point – a special purpose acquisition company (SPAC) – in a deal that sidestepped the conventional initial public offering (IPO) route and has propelled its valuation to around $1.6 billion.

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Cancer clinical trial recruitment drops by 60% during pandemic

Pharma Times

In a new report from The Institute of Cancer Research (ICR), data from cancer trials alongside assessments from clinicians and patients aims to provide guidance on how to improve services

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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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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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Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.

Sales 344
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How much should I spend on an HCP website?

World of DTC Marketing

LEAD-IN- Recent data confirms that health care professionals are using the Internet more and spending less time with drug company reps. How much should you spend on an HCP portal, and how do you measure its success? One of the first questions I often get from potential clients is, “how much does a good HCP website cost?” There is no one answer to that question.

Branding 213
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What Changes To Your Lifestyle Need To Be Done After Bariatric Surgery

Pharma Mirror

Getting bariatric surgery is a lifesaver for many people. It can dramatically improve the quality of life of those that are having problems because of their obesity. It reduces and even eliminates diabetes in many people and seriously reduces the risk of heart disease. The weight loss can be dramatic as well. Starting almost immediately after the surgery, the pounds fall away with ease.

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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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UCB chases after Argenx with FcRN drug for myasthenia gravis

pharmaphorum

UCB has the positive result it was hoping for in its phase 3 trial of anti-neonatal FC receptor (FcRn) antibody rozanolixizumab for autoimmune disease generalised myasthenia gravis (gMG), setting up regulatory filings next year. The MycarinG study met its primary endpoint, demonstrating a “statistically significant and clinically meaningful” improvement from baseline in the myasthenia gravis-activities of daily living (MG-ADL) score, said the Belgian drugmaker.

Drugs 131
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Possible identification of blood clot trigger for AstraZeneca COVID-19 vaccine

Pharma Times

Researchers have identified in those patients experiencing blood clots after vaccination a subsequent condition referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).

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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Moderna vaccine weaker against omicron, but third shot boosts protection

Bio Pharma Dive

As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.

Vaccine 342
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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