Mon.Jun 20, 2022

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Uniqueness if pharma DTC

World of DTC Marketing

Pharma DTC marketing is unique, and drug marketers need to think more about the journey from awareness to requesting an Rx. In addition, the patient journey is different for each product category and audience. Some will lead to more online research, while others may not. The hottest pharma product is Lilly’s diabetes drug, hyped by the media as helping patients lose weight.

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Lilly’s Verzenios gets NICE blessing for early-stage breast cancer

pharmaphorum

Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE backed use of the drug after surgery for early-stage tumours. The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the

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FDA, HHS Sued by Doctors Over Controversial Drug Ivermectin

BioSpace

Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.

Doctors 109
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Is Merck planning a $30bn-plus move for Seagen?

pharmaphorum

Speculation that Merck & Co may be preparing a $30 billion takeover bid for Seagen – bolstering its oncology ambitions – has the biopharma community aflutter. The rumour was first published in the Wall Street Journal, which suggests that a takeover is just one option on the table, along with a marketing deal that would bind the two companies together without the risk of antitrust issues holding up or blocking a merger.

Sales 105
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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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Europe looks to next wave of COVID with coordinated supply plan

BioPharma Reporter

Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.

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Rain Targets Normal p53 Expression with Possible Pan-Cancer Therapeutic

BioSpace

In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.

Trials 101

More Trending

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Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

XTalks

Alnylam Pharmaceuticals, a leading RNA interference (RNAi) therapeutics biopharmaceutical company, announced it received approval from the US Food and Drug Administration (FDA) for its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults. Hereditary ATTR amyloidosis is a rare, rapidly progressive condition that causes serious nerve damage, affecting approximately 50,000 people worldwide.

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Pharma industry slams WTO move on TRIPS waiver

BioPharma Reporter

Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.

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PTC Ready to Take Another Shot at FDA Approval of DMD Drug

BioSpace

For years, PTC Therapeutics has attempted to win regulatory approval for its DMD drug, Translarna. Now, the company believes it has data that will support another filing for FDA approval.

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New collaboration to accelerate advancements in gene therapies for dementia

BioPharma Reporter

The Cell and Gene Therapy Catapult (CGT Catapult) and the UK Dementia Research Institute (UK DRI) have announced a collaboration to accelerate clinical development of adeno-associated virus (AAV) based gene therapies for dementia.

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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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Pfizer takes stake in French Lyme disease jab partner Valneva

pharmaphorum

Pfizer has acquired an 8.1% stake in French vaccines developer Valneva at a cost of €90.5 million (around $95 million) and rejigged the terms of their alliance to develop a shot for Lyme disease. The deal gives Valneva a cash injection that it will be able to use to advance Lyme disease candidate VLA15 towards the market, but the revised licensing terms means that the French biotech will shoulder more of the financial cost of the development programme.

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How to Navigate a Career Change From Pharma to Biotech

BioSpace

If you’re considering a career change from pharma to biotech, you’ll be happy to hear that according to industry experts, the transition is more common than you might think.

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Blood vessel breakthrough is major step towards Alzheimer’s treatment

Pharma Times

The discovery may lead to development of drugs that halt disease progression and stop memory loss

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Retracted Studies Continue to Spur Funding for Cardiac Stem Cell Research

BioSpace

Despite the refutation of research articles by Piero Anversa, they continue to serve as a basis for funding requests from scientists who hope to prove that the heart can regenerate cardiac muscle.

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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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Melting Arctic ice could transform international shipping routes, study finds

Scienmag

PROVIDENCE, R.I. [Brown University] — With climate change rapidly warming the world’s oceans, the future of the Arctic Ocean looks grim. Climate models show that parts of the Arctic that were once covered in ice year-round are warming so quickly that they will be reliably ice-free for months on end in as few as two […].

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AstraZeneca and Ionis Look to Carve Out Slice of ATTR Market

BioSpace

AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.

Marketing 100
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Nanoparticles control flow of light like road signs direct traffic

Scienmag

Physicists at The Australian National University (ANU) have developed tiny translucent slides capable of producing two very different images by manipulating the direction in which light travels through them. Credit: Credit: Ella Maru Studio Physicists at The Australian National University (ANU) have developed tiny translucent slides capable of producing two very different images by […].

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Merck, Emergent, Affinivax and Ocugen Level Up in Vaccine Development

BioSpace

???????The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.

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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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The greening ashore

Scienmag

A team led by evolutionary biologist Prof. Dr. Sven Gould of Heinrich Heine University Düsseldorf (HHU) has been studying the current state of research on the plant colonisation of land that occurred some 500 million years ago. The findings from this illustrated overview study published by Dr. Mona Schreiber as lead author have now appeared […].

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Can Olema Oncology Prevail Where Other SERDs have Recently Failed?

BioSpace

Olema president and CEO Sean Bohen spoke with BioSpace about why he believes his company's approach with a SERD and ER antagonist can successfully treat an advanced form of breast cancer.

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A rare discovery of long-term memory in wild frog-eating bats

Scienmag

COLUMBUS, Ohio – Frog-eating bats trained by researchers to associate a phone ringtone with a tasty treat were able to remember what they learned for up to four years in the wild, new research has found. Credit: Photo by Marcos Guerra COLUMBUS, Ohio – Frog-eating bats trained by researchers to associate a phone ringtone with […].

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Therorna, Carbon Reel in Combined $80M in Series A Financing

BioSpace

Therorna brought in $42 million to advance its circular RNA platform, while Carbon Biosciences banked $38 million to develop therapies for genetic diseases, beginning with cystic fibrosis.

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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.

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New membrane improves reversibility of zinc-air batteries

Scienmag

The long-standing challenges to the practical implementation of rechargeable zinc-air batteries (ZABs) are the electrochemical irreversibility of the Zn anode and degradation of the air cathodes in alkaline electrolyte, which eventually results in poor cycle life and low cell voltage. Credit: Image by ZHANG Xinbo The long-standing challenges to the practical implementation of rechargeable zinc-air […].

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Manufacturing Issues Trip up Acer, Relief in NDA Quest

BioSpace

Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.

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Who benefits from brain training and why?

Scienmag

RIVERSIDE, Calif. — If you are skilled at playing puzzles on your smartphone or tablet, what does it say about how fast you learn new puzzles, or, more broadly, how well you can focus, say, in school or at work? Or, in the language of psychologists, does “near transfer” predict “far transfer”? Credit: Audrey Carrillo, […].

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RMI’s COVID-19 vaccine partnership with Acacium proves a success

Pharma Times

The joint aim of the companies was to provide vaccines to vulnerable communities

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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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Fifth of global food-related emissions due to transport: research

Scienmag

In 2007, ‘locavore’ – a person who only eats food grown or produced within a 100-mile (161km) radius – was the Oxford Word of the Year. Now, 15 years later, University of Sydney researchers urge it to trend once more. They have found that 19 percent of global food system greenhouse gas emissions are caused […].

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Mark Cuban's Pharmacy Touts "Safe, Affordable Medicines"

BioSpace

Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.

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What makes blood vessels grow?

Scienmag

Joint press release by the Max Delbrück Center for Molecular Medicine and the Berlin Institute of Health at Charité Credit: Michael Potente, MDC Joint press release by the Max Delbrück Center for Molecular Medicine and the Berlin Institute of Health at Charité Blood vessels run throughout the human body and ensure that our organs get […].

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Disappointing Results End 9 Meters' Phase III Trial for Celiac Treatment

BioSpace

9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.