Sat.Jan 15, 2022 - Fri.Jan 21, 2022

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GSK loses R&D chief Barron to high-powered startup amid investor pressure

Bio Pharma Dive

Hal Barron, a key figure in GSK's efforts to revitalize its drug research, will step down as its top scientist at a time when the company is feeling heat from investors to deliver faster growth.

Scientist 363
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Can pharma really leverage social media?

World of DTC Marketing

A Mediabistro survey showed that social networks influence more than 40% of people’s health choices. Tik-Tok, Instagram, and other social media channels may soon be overwhelmed with pharma companies’ content, but is it a good idea? People between 18 and 24 years of age tend to discuss health and wellness issues on social networks twice as much as those between the ages of 45 and 54 (getpushing.com), and of those between 18 and 24 years of age, 90% say they trust medical informatio

Branding 238
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Botanical Solution Inc. (BSI) Secures $6.1 Million in Series A First Closing

Pharma Mirror

January 17, 2022 (Davis, CA) – Botanical Solution Inc. (BSI), innovator of sustainable, consistent, and cost-effective Advanced Botanical Materials for agricultural and pharmaceutical applications, has successfully closed $6.1 million in a Series A round led by Palo Alto based VC Firm, Otter Capital. This round of funding will enhance BSI’s value proposition by facilitating the geographic expansion of its current botanical-based products and the development of a new product pipeline derive

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Vir Biotechnology and Bill & Melinda Gates Foundation to develop vaccinal antibody tech for tackling HIV and malaria

BioPharma Reporter

Vir Biotechnology and the Bill & Melinda Gates Foundation have partnered up to develop broadly neutralizing antibodies designed to provide a âvaccinal effectâ for the treatment of HIV and prevention of malaria.

Antibody 143
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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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Roche sees cause for optimism with failed Huntington's disease drug. Others aren't so sure.

Bio Pharma Dive

After halting a Phase 3 trial of the drug last year, Roche went digging for more data. What it found led to plans for another trial, but the pharma's hypothesis may rest on shaky ground.

Drugs 340
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The biggest waste of digital media spending in pharma

World of DTC Marketing

Many companies allocate an exponentially more significant percentage of their marketing budget to paid media over organic search. However, many brands are unaware of the waste inherently included in paid media. Organic search delivers results at a lower customer acquisition cost (CAC) than paid search — 87% lower cost, per research. According to Google, organic search also offers double the ROI that paid search does.

Doctors 232

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Scandi pharma: Swede deal for Psyros Diagnostics

Pharma Times

Psyros Diagnostics has signed an agreement to be acquired by the Swedish company, Prolight Diagnostics AB. Psyros’s ground-breaking Point-of-Care (POC) technology enables the measurement of disease-indicating molecules in extremely low concentrations–in ten minutes or less.

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Bluebird faces longer wait for FDA verdict on experimental gene therapies

Bio Pharma Dive

The FDA has extended by three months its review of Bluebird's treatments for beta thalassemia and a rare brain disorder, the latest delay in the company's lengthy road to market in the U.S.

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Horizon pharma’s bad DTC decision

World of DTC Marketing

Thyroid eye disease affects more women than men, although men are more likely to have severe illnesses. The exact prevalence of thyroid eye disease is not known, but is estimated to be 16 per 100,000 women in the general population, and 2.9 per 100,000 men in the general population. So why in the hell is Tepezza running TV ads? Do Millennials know how to market to older consumers?

Marketing 223
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Lab data show Valneva vaccine effective against Omicron

BioPharma Reporter

Valneva announced yesterday that results from a lab study showed three doses of its inactivated COVID-19 vaccine candidate, VLA2001, neutralized the Omicron variant.

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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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CVS Health and Microsoft alliance: an example of an extended partnership

pharmaphorum

Microsoft and CVS Health have announced a new strategic alliance focusing on personalised care and accelerating digital transformation for the benefit of CVS customers and its employees. David Rhew, MD, global chief medical officer and VP of healthcare at Microsoft, tells us, “Using Microsoft technology, CVS Health will develop a more agile, digital-first technology foundation.” Digital innovation and implementation have skyrocketed within healthcare due to the need to adapt quickly

Pharmacy 117
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Top Merck executive to depart company for CEO role at ingredients maker

Bio Pharma Dive

Frank Clyburn, a Merck veteran and head of the company's human health division, will leave next month to run IFF, following the exit of other top leaders at the drugmaker.

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Omnichannel is irrelevant with the wrong message

World of DTC Marketing

Omnichannel is the latest buzzword-making rounds within pharma, but omnichannel has no relevance if your message is too promotional or is irrelevant to your audience. The channel IS essential but not as important as your message. 68% of HCPs indicate webinars or webcasts as their most preferred channel to receive information. It is evident that HCPs are extremely time constraint and prefer to engage with pharma organizations on their terms regarding channel, content, and type of devices.

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Vaccine manufacturing campus opens in South Africa

BioPharma Reporter

A new vaccine manufacturing plant has been opened in Cape Town by South Africa president Cyril Ramaphosa this week.

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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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Novo Nordisk moves to strengthen obesity efforts

pharmaphorum

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Although specific details of the collaboration are yet to be released, EraCal has confirmed that the duo will utilise its phenotypic drug discovery platform to id

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EQRx builds case for cancer drug it hopes can disrupt market

Bio Pharma Dive

Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.

Drugs 290
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Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias

XTalks

Abbott’s new cardiac mapping platform, EnSite X EP System, has received clearance from the US Food and Drug Administration (FDA) for the treatment of cardiac arrhythmias. The cardiac mapping system incorporates Abbott’s proprietary EnSite Omnipolar Technology (OT), which allows for 360° mapping to generate better and “true” electrograms (EGM) using the Advisor HD Grid Catheter.

Doctors 110
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De-risking cell therapy manufacturing with downstream technology innovation

BioPharma Reporter

Automated cell therapy manufacturing processes could reduce manual intervention and human errors, enabling more robust processes, improved product quality, and lower costs.

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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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Two new drugs added to WHO list of COVID-19 therapies

pharmaphorum

A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal. . Baricitinib, administered with corticosteroids, was strongly recommended as a treatment for patients with severe or critical illness.

Drugs 112
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Roche revives a closely watched Huntington's disease drug

Bio Pharma Dive

Ten months after Roche stopped giving the drug to patients in a Phase 3 trial, the pharma is planning a new study on the belief the medicine may help younger adult patients with less advanced disease.

Drugs 275
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Pharmacist vacancies highlight need for funding booster

Pharma Times

New figures from Health Education England (HEE) show that the pharmacist vacancy rate in community pharmacies across England has doubled to 8% between 2017 and 2021.

Pharmacy 108
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Europe launches initiative to transform clinical trials

BioPharma Reporter

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.

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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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GSK rejects $68.4bn Unilever bid for consumer health

pharmaphorum

GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 billion (£50 billion). The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%.

Marketing 111
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FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

Bio Pharma Dive

AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.

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Beximco Pharma to manufacture molnupiravir for COVID-19

Pharma Times

The drug received conditional marketing authorisation in the UK from the MHRA in November

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FDA accepts GMP plasmid DMF: Andelyn now ‘on track’ to speed up gene therapy development

BioPharma Reporter

Andelyn Biosciences says the FDA's acceptance of its GMP plasmid DNA drug master file (DMF) enables the CDMO to vertically integrate its clientsâ manufacturing process, condensing timelines for developers to begin manufacturing to just three months.

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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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Gilead takes legal action against counterfeit HIV drug network 

pharmaphorum

US pharma giant Gilead Sciences has accused a network of unauthorised suppliers and distributors of selling more than $250 million of counterfeit versions of its HIV medications. According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin.

Drugs 109
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UCB to buy Zogenix for nearly $2B in 'first step' for M&A in 2022

Bio Pharma Dive

The acquisition will give the Belgian pharma access to an epilepsy drug that won U.S. approval in June 2020 but that Zogenix has struggled to sell.

Drugs 296
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Yes, We’re Serious — At Intouch, You Decide Where You Work

Intouch Solutions

Recently, LinkedIn shared the results of a biweekly survey of 5,000 U.S. professionals, and most striking, say the folks at the career-networking site, is “how much the pandemic-influenced worksite choices of 2020 have persisted.” In short, the survey showed that about half of workers are back onsite; about one-third continue to work remotely full time; and nearly one-fifth work using a hybrid approach.

HR 98
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Orgenesis and Johns Hopkins University create Maryland Center for Cell Therapy Manufacturing

BioPharma Reporter

Orgenesis and The Johns Hopkins University will construct a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins.

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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.