Tue.Jul 05, 2022

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With $100M AstraZeneca deal, a biotech and its investors engineer another buyout

Bio Pharma Dive

An entity originally known as Teneobio has now been the focus of three acquisition deals with large pharmaceutical companies since 2021, capitalizing on the industry’s growing interest in dual-acting antibody drugs.

Engineer 324
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Getting an Rx does not address health problems

World of DTC Marketing

Imagine a medicine that reduced the death rate of breast cancer and risk of recurrent breast cancer by 50% lowered the risks of colon cancer and type 2 diabetes by two-thirds, and those of heart disease, hypertension, and Alzheimer’s’ disease by 40%. On top of that, it can be as effective as antidepressants or cognitive behavioral therapy in countering depression.

Doctors 200
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Two cancer biotechs merge, raise cash as sector-wide downturn continues

Bio Pharma Dive

Syros Pharmaceuticals and Tyme Technologies, shares of which trade near all-time lows, will combine and raise about $130 million from private investors to stay afloat.

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Sanofi unveils global health brand for medicines supply

Pharmaceutical Technology

Sanofi has unveiled the global health brand, Impact, to make available standard of care treatments for non-profit supply to at-risk populations in low-income countries. Through the Impact brand, which comprises insulin, glibenclamide and oxaliplatin among others, the company will supply its 30 medicines in 40 lower-income countries in the world. The therapies cover a broad range of treatment areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer and are regarded esse

Branding 147
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CureVac sues rival COVID-19 vaccine maker BioNTech for patent infringement

Bio Pharma Dive

The biotech, whose own efforts to develop a COVID-19 vaccine have faltered, claims its inventions were crucial to the development of BioNTech’s top-selling coronavirus shot.

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AstraZeneca signs agreement to acquire TeneoTwo

Pharmaceutical Technology

AstraZeneca has signed an agreement for the acquisition of all outstanding equity of TeneoTwo as well as its CD19/CD3 T-cell engager, TNB-486, in a deal worth up to $1.27bn to bolster the haematological cancer pipeline. As per the deal, AstraZeneca will make an upfront payment of $100m on the closing of the transaction. Furthermore, equity holders of TeneoTwo are entitled to get up to $805m in research and development (R&D)-based milestone payments as well as up to $360m as commercial-relate

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UNC team discovers interactions vital for hepatitis A virus replication

Pharmaceutical Technology

Researchers at the UNC School of Medicine have discovered that hepatitis A virus (HAV) replication needs particular interactions between the human protein ZCCHC14 and TENT4 poly(A) polymerases, a group of enzymes. The team also found that the oral compound, RG7834, developed by Hoffmann-La Roche, hindered replication at a crucial step, preventing the virus from infecting liver cells.

Protein 130
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In 'unusual' move, FDA to reconvene advisers for ALS drug review

Bio Pharma Dive

The drug’s developer, Amylyx Pharmaceuticals, said the meeting is scheduled for Sept. 7 and experts will discuss additional data analyses conducted since the last time the panel met.

Drugs 258
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Filings buzz: tracking the future of work mentions in pharmaceuticals

Pharmaceutical Technology

Mentions of the future of work within the filings of companies in the pharmaceutical industry were 373% higher between April 2021 and March 2022 than in 2016, according to the latest analysis of data from GlobalData. When pharmaceutical companies publish annual and quarterly reports, ESG reports and other filings, GlobalData analyses the text and identifies individual sentences that relate to disruptive forces facing companies in the coming years.

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AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo

pharmaphorum

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

Antibody 124
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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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CureVac files patent infringement lawsuit against BioNTech over COVID-19 vaccine mRNA tech

BioPharma Reporter

CureVac has filed a lawsuit in a German regional court against BioNTech SE: seeking âfair compensation for infringementâ of CureVacâs intellectual property rightsâ regarding tech used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine.

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Ensuring successful digital outreach and retention in atopic dermatitis trials

pharmaphorum

Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Yet evidence from research studies and a survey with 4,000+ atopic dermatitis patients conducted by Clariness shows that this ‘race to recruit’ is actually not the primary reason for the growing discontinuation rate of atopic dermatitis trials.

Trials 113
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Follow-Up Data on Bayer’s Larotrectinib Hints at Potentially Curative Impact

BioSpace

BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients' lives are being affected.

Trials 102
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Astellas teams up with UK biotech Mogrify on hearing loss project

pharmaphorum

Cell therapy specialist Mogrify has struck a deal with Japanese drugmaker Astellas to look at ways to deploy regenerative medicine to treat hearing loss caused by factors such as chronic exposure to loud noises. The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness.

In-Vivo 106
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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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Return of Research Results to Study Participants

Advarra

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Empirical research into participant views and experiences has consistently shown participants desire to learn the results of research to which they’ve contributed.

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The post-Covid New Normal: a golden opportunity for the NHS?

pharmaphorum

I recently had the pleasure of attending the PING Conference 2022 , which had the tagline of ‘The Golden Age for Life Sciences Innovation’. In part, this was due to it being held at The Old Palace at Hatfield House, a location steeped in history and formerly the residence of Queen Elizabeth I, with whom ‘a golden age’ is often associated. However, it also reflected the optimistic tone of the event, organised by VWV , which aimed to present some rays of light for the future as we (hopefully) emer

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New patent for AMRYT drug MYCAPSSA

Drug Patent Watch

Annual Drug Patent Expirations for MYCAPSSA Mycapssa is a drug marketed by Amryt and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent for AMRYT drug MYCAPSSA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
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AlzeCure’s Alzheimer’s candidate shows promise

Pharma Times

Treatment abstract focuses on results from a multiple ascending dose study in healthy volunteers

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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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New patent for Hope Pharms drug SODIUM NITRITE

Drug Patent Watch

Annual Drug Patent Expirations for SODIUM+NITRITE Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Hope Pharms drug SODIUM NITRITE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 96
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Natural gas is key to WVU engineer’s vision for clean hydrogen energy

Scienmag

More than 50 years after scientists first coined the term “hydrogen economy,” the movement to make hydrogen a predominant global fuel source could be gaining traction, thanks to research led by one West Virginia University engineer. Credit: (WVU Photo/Paige Nesbit) More than 50 years after scientists first coined the term “hydrogen economy,” the movement to make […].

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Veru, Immunome Tout Positive Data for COVID-19 Therapeutics

BioSpace

Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.

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NTU Singapore and poultry firm Leong Hup Singapore collaborate to create Singapore’s first ‘zero waste’ poultry processing facility

Scienmag

Nanyang Technological University, Singapore (NTU Singapore) and poultry producer Leong Hup Singapore Pte Ltd have jointly developed processes to repurpose waste materials from poultry farming. Credit: NTU Singapore Nanyang Technological University, Singapore (NTU Singapore) and poultry producer Leong Hup Singapore Pte Ltd have jointly developed processes to repurpose waste materials from poultry farming.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Boehringer, Evotec and bioMérieux Recognize AMR Threat and More Deals

BioSpace

Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.

RNA 92
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FSU researchers expand understanding of vortex spread in superfluids

Scienmag

An international team of scientists featuring Florida State University researchers has developed a model that predicts the spread of vortices in so-called superfluids, work that provides new insight into the physics that govern turbulence in quantum fluid systems such as superfluid neutron stars. Credit: Courtesy of Wei Guo/FAMU-FSU College of Engineering An international team of […].

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Researchers Explain Risks of COVID-19 Re-Infection

BioSpace

Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.

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A good simulation of heatwave frequency variation by a machine-learning model

Scienmag

Against the background of global warming, the European region has experienced several severe extreme heatwave events in recent decades, which have had a huge socioeconomic and environmental impacts. It is therefore important for governments to improve the ability of climate models to predict heatwave events. However, the ability of most climate models in this regard […].

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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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Sarepta, Roche Tout Promising Data for Muscular Dystrophy Gene Therapy

BioSpace

Sarepta Therapeutics and its partner, Roche, presented promising functional data from several trials of its gene therapy for Duchenne muscular dystrophy.

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Adolescent childbirth remains linked to poor outcomes for both mother and child in Cote d’Ivoire

Scienmag

According to the 2014 general population census for Cote d’Ivoire, one in four of the country’s women aged 20–24 years gave birth to at least one child before they reached 18 years. A retrospective study of teenage childbirth in the west African country has found that these adolescent births are often associated with a range […].

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Otsuka-Partnered Mindset Wins Patent Allowance for Psychedelic CNS Assets

BioSpace

Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.

Drugs 85
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Inhalable COVID-19 vaccine shows promise in rodent model

Scienmag

Researchers have created an inhalable COVID-19 vaccine that is shelf stable at room temperature for up to three months, targets the lungs specifically and effectively, and allows for self-administration via an inhaler. The researchers also found that the delivery mechanism for this vaccine – a lung-derived exosome called LSC-Exo – is more effective at evading […].

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.