Sat.Oct 30, 2021 - Fri.Nov 05, 2021

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A three-decade monopoly: How Amgen built a patent thicket around its top-selling drug

Bio Pharma Dive

Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.

Drugs 354
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“Game-changing” obesity drug over-promising?

World of DTC Marketing

SUMMARY: Wegovy is selling so well that it’s hard to get at pharmacies. It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year. In addition, people who lost weight on Wegovy in clinical trials had nutritional counseling and had to stay on a strict diet.

Drugs 271
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Pangolin trafficking: iceberg tip of Nigeria’s illegal trade revealed

Scienmag

Since the first reported pangolin seizure in Nigeria in 2010, the country has seen an explosion in the black market for the world’s most trafficked mammal – becoming Africa’s hub for the criminal export of pangolin products to East Asia. Credit: Charles Emogor Since the first reported pangolin seizure in Nigeria in 2010, the country […].

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Digital therapeutic cuts opioid use disorder care costs, says study

pharmaphorum

A real-world study of digital therapeutic (DTx) for opioid use disorder has found that patient show used it had 46% fewer hospital stays than a control group, saving more than $2,700 over a nine-month period. The study of Pear Therapeutics’ reSET-O found that the total cost of hospital and clinician costs were $11,141 among 64 patients who were prescribed the DTx but didn’t use it, but fell to $8,733 among active users of the 12-week course.

Drugs 131
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer pill for COVID-19 shows dramatic benefit in major study finding

Bio Pharma Dive

The drugmaker, which last week won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.

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DTC forecasts are not really that reliable

World of DTC Marketing

SUMMARY: According to eMarketer, “in 2020, spending on digital advertising in the healthcare and pharma industry will grow by 14.2% to reach $9.53 billion, making it the fastest-growing sector after computing products and consumer electronics (which will grow 18.0% this year). How reliable is this estimate? eMarketer has been wrong more times than I can count.

Doctors 227

More Trending

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Drinking alcohol to stay healthy? That might not work, says new study

Scienmag

Increased mortality risk among current alcohol abstainers might largely be explained by other factors, including previous alcohol or drug problems, daily smoking, and overall poor health, according to a new study publishing November 2nd in PLOS Medicine by Ulrich John of University Medicine Greifswald, Germany, and colleagues. Credit: Alexas_Fotos, CCO ([link] Increased mortality risk among […].

Medicine 114
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Cystic fibrosis group partners with Moderna founder to find better, potentially curative treatments

Bio Pharma Dive

With an initial investment of $20 million, the collaboration will use technologies from various Flagship-backed companies to discover and develop new therapies for the disease.

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Pfizer’s pill cuts COVID deaths and hospitalisations by 90%

pharmaphorum

An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.

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Merck and Synthekine Strike $525 Million Cytokine Therapy Deal

BioSpace

?Under the agreement, Merck can use Synthekine's surrogate cytokine agonist platform to discover, develop, and sell new cytokine-based treatments for up to two cytokine targets.

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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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Advanced breast cancer patients denied opportunities to join clinical trials

Scienmag

Clinicians and the wider research community involved in treating advanced breast cancer (ABC) need to do more to help and encourage patients to join clinical trials, according to a patient advocate who is leading a study that shows only 14% of ABC patients in the UK have been recruited to a trial. Credit: Lesley Stephen […].

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Moderna faces delay in plans to bring coronavirus vaccine to US teenagers, young kids

Bio Pharma Dive

The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S.

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Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia

pharmaphorum

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year were flying under-the-radar of industry watchers, but could potentially develop into blockbusters.

Drugs 113
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Pfizer to Seek EUA for COVID-19 Antiviral with 89% Efficacy

BioSpace

Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.

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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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Digital transformation of clinical research accelerating rapidly: Veeva Systems

Outsourcing Pharma

The cloud software firmâs Digital Clinical Trials Survey Report reveals that the industry is adapting to challenges caused by COVID-19 and other factors.

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Pfizer gene therapy research delayed by trial changes, safety questions

Bio Pharma Dive

Data readouts for Pfizer's hemophilia gene therapies are now expected later than previously forecast, while the company also works through modifying a trial of its Duchenne treatment.

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Lonza invests in exosome category, acquires development and manufacturing capabilities

BioPharma Reporter

Lonza has been investing in developing exosome manufacturing and characterization technologies for the past five years, and this week it ramped up its focus on that category by acquiring two sites.

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Biotech Raises $140 Million to Advance iPSC-based Immunotherapies

BioSpace

Shoreline Biosciences secured $140 million in financing to accelerate the growth of its induced pluripotent stem cells (iPSC)-based immunotherapies and support the expansion of its manufacturing capabilities.

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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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Why and How to Celebrate World Vegan Day 2021

XTalks

Each year, World Vegan Day falls on November 1 as a way to celebrate veganism and appreciate its benefits to humans and the environment. While veganism is far from new, it has gained mass popularity over the last few decades with the advancement of plant-based food technology and a greater push for food sustainability. So, what is the history behind World Vegan Day and how is it being celebrated in 2021?

Branding 105
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Moderna, teaming with a startup, wades further into gene editing

Bio Pharma Dive

The biotech has identified gene editing as a natural fit for the technology it uses to deliver its vaccines and drugs. A deal with Metagenomi, a startup backed by Bayer, will further those ambitions.

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Oral vaccines and novel tech: CEPI announces grants for ‘variant-proof’ COVID-19 vaccine development

BioPharma Reporter

CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.

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Ardelyx Prepares for Battle with FDA Over Rejected CKD Drug

BioSpace

Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.

Drugs 109
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Novartis’ iptacopan hits the mark in rare kidney disease C3G

pharmaphorum

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. A phase 2 trial of iptacopan in patients with the rare kidney disease C3 glomerulopathy (C3G) – which causes progressive kidney failure and has no approved treatments – showed reductions in kidney damage with the drug that Novartis said were “clinically important.” C3G of

Trials 104
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FDA extends review of J&J, Legend's cell therapy for multiple myeloma

Bio Pharma Dive

The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.

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FDA Approves AbbVie’s Vuity as the First Eyedrop for Presbyopia

XTalks

As people get older, many often experience reading problems due to blurriness in their near vision in a condition called presbyopia. Now, instead of reaching for reading glasses, AbbVie’s eyedrop formulation Vuity could offer help in correcting far-sightedness as the US Food and Drug Administration (FDA) granted approval to it late last week. Vuity is a 1.25 percent pilocarpine HCL ophthalmic solution made by AbbVie-owned Allergan.

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Biogen to Present New Aduhelm Data at Upcoming Alzheimer’s Conference

BioSpace

The annual Clinical Trials on Alzheimer’s Disease conference is scheduled for November 9-12, and Biogen plans to present data on its portfolio, including its controversial Aduhelm.

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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.

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Novartis finally sells Roche stake, for almost $21 billion

pharmaphorum

After more than 20 years, Novartis has finally decided to sell its substantial share in fellow Swiss pharma group Roche for $20.7 billion, a decent return on its original $5 billion investment. The agreement will see Novartis lose its one-third voting share stake in Roche, after agreeing to sell 53.3 million Roche bearer shares at their average price over 20 days prior to 2 November, when the deal was agreed.

Sales 104
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Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

Bio Pharma Dive

The biotech has officially filed for an accelerated review of its closely watched ALS drug, an outcome that seemed unlikely just a few months ago.

Drugs 300
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How COVID-19 Gave Rise to Food Delivery Robots

XTalks

Food delivery robots are no longer the stuff of science fiction. The knee-high robots — capable of transporting around four large pizzas — are now making their way around college campuses and large cities in the US, UK and Canada. While they were in the works prior to the COVID-19 pandemic, demand for contactless delivery caused a boom in the number of food delivery robots navigating the streets.

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Flagship Pioneering is All Hands on Deck for Cystic Fibrosis

BioSpace

This first-of-its-kind collaboration will leverage the talent and innovation at companies such as Tessera Therapeutics to advance multiple candidates to human proof of concept.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.