Sat.Jul 16, 2022 - Fri.Jul 22, 2022

Vertex to move non-opioid painkiller into late-stage tests after FDA agreement

Bio Pharma Dive

Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects

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The fairytale of DTC TV ads

World of DTC Marketing

The pandemic is changing consumer behavior, and there is zero chance they will return to their carefree spending ways. Using the same ads to advertise prescription drugs repeatedly is a waste of money and doesn’t lead to sales.

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US FDA grants approval to Incyte’s Opzelura cream for vitiligo treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

Is FDA Going to Get A Little Help From Its Friends at the PTO?

FDA Law Blog

By Sara W. Koblitz — Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “ gamesmanship ” allowing brand companies to keep drug prices high. Yet, as long as FDA and FTC have been trying to address anticompetitive behavior, the U.S.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

European regulator recommends Bavarian Nordic's vaccine for monkeypox

Bio Pharma Dive

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines

Reprehensible!

World of DTC Marketing

According to a STAT analysis of hundreds of financial filings, the CEOs of approximately 300 health care companies collectively took home more than $4.5 billion in 2021. Regeneron Pharmaceuticals CEO Leonard Schleifer represented 10% of that total on his own, pulling in an astounding $453 million.

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Sky-High Prices Are Only Part of the Problem

NY Times

Inflation has unmasked the depths of our affordability crisis. United States Economy Prices (Fares, Fees and Rates) Drugs (Pharmaceuticals) Liberalism (US Politics) United States Politics and Government Center for Economic and Policy Research Republican Party Democratic Party

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FDA approves new vitiligo treatment, bolstering Incyte's dermatology business

Bio Pharma Dive

The cream, known as Opzelura, is now the only treatment approved in the U.S. to repigment skin in patients with the most common form of vitiligo

Are new weight loss drugs an answer or problem?

World of DTC Marketing

Worldwide obesity rates have tripled since 1975, with 650 million adults obese in 2016, according to the World Health Organization. In 2019, the OECD declared that developed countries’ plans to tackle the problem largely failed.

Gladstone and UCSF scientists discover BET protein role in Covid-19

Pharmaceutical Technology

Researchers at Gladstone Institutes and UC San Francisco (UCSF) have discovered in a study that bromodomain and extraterminal (BET) proteins are vital for the body to fight Covid-19 infection. .

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Free One-on-one Legal & Financial Help for the Cancer Community

Triage Cancer

You’ve looked through our free materials and resources, and attended events, but you still have questions. Now what? There is one free resource you may have missed!

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Vertex, Verve team up to develop a gene editing drug for liver disease

Bio Pharma Dive

The deal, which is worth $60 million upfront, broadens Vertex’s reach into gene editing and expands Verve’s research beyond heart disease

Healthcare doesn’t give a damn about patients

World of DTC Marketing

A new analysis released Wednesday by Patients for Affordable Drugs estimates that pharmaceutical companies in the U.S. have raised drug prices 1,186 times so far this year. But they’re not alone. Health insurers in individual marketplaces across 13 states and Washington D.C.

AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Pfizer, Flynn Pharma slapped with £70 million fine for massive price hike on epilepsy drug

Fierce Pharma

Pfizer, Flynn Pharma slapped with £70 million fine for massive price hike on epilepsy drug. zbecker. Thu, 07/21/2022 - 10:19

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Biotech downturn hits another startup as Pact Pharma to lay off nearly 100 employees

Bio Pharma Dive

The cancer drugmaker, which was formed in early 2017 by a group that includes Nobel Prize winner David Baltimore, is one of dozens of biotechs to cut staff this year

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COVID shield: spray coating to shield surfaces from viruses, bacteria

Scienmag

A first-of-its-kind sprayable coating that can prevent the surface spread of infection from bacteria and viruses – including COVID-19 – over a sustained period –– has been developed by a team of Australian researchers.

Karyopharm receives US and Europe regulatory designations for eltanexor

Pharmaceutical Technology

Karyopharm Therapeutics has obtained new regulatory designations in the US and Europe for its investigational therapy, eltanexor (KPT-8602), to treat myelodysplastic syndromes (MDS).

Lilly taps Triastek to use 3D printing for gut-targeted drug delivery

Fierce Pharma

Lilly taps Triastek to use 3D printing for gut-targeted drug delivery. ntaylor. Mon, 07/18/2022 - 06:46

Novartis forecasts improving generic drug business as it weighs unit's future

Bio Pharma Dive

The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year

Introducing a protocol for using robotic pets in memory care

Scienmag

You might think it was a typical therapy session at a long-term care facility. In a quiet room, a therapist sets down a pet carrier, brings out a cat, and sets it on a resident’s lap.

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ASRS conference reveals hopeful outcomes for gene therapy RGX-314 in retinal diseases

Pharmaceutical Technology

Pipeline therapies within the diabetic macular oedema (DME) space have recently gathered interest following the American Society of Retina Specialists (ASRS) Annual Meeting, which took place on 13–16 July.

Twill taps YourCoach for DtX-health coaching integration

pharmaphorum

Health coaching ecosystem YourCoach Health and digital therapeutics company Twill (formerly Happify Health ) are teaming up to offer access to YourCoach’s cross-specialty health coaches via Twill’s Duet platform, the companies announced today.

Roche digs deeper into gene therapy for the eye

Bio Pharma Dive

The Swiss drugmaker, which already owns rights to a marketed gene therapy for inherited vision loss, will work with startup Avista Therapeutics to develop better delivery tools for the complex treatments

New discovery in cancer progression paves way to combat cancer

Scienmag

Filings buzz in pharmaceuticals: 65% increase in cloud computing mentions in Q1 of 2022

Pharmaceutical Technology

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022.

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How patient organization partnerships can tackle the most common patient recruitment barriers

Clairnes

The post How patient organization partnerships can tackle the most common patient recruitment barriers appeared first on Clinical Trial Recruitment & Management Services.

Freeline gives detailed look at hemophilia gene therapy results

Bio Pharma Dive

The London-based drugmaker is currently seeking a partner to continue development of the hemophilia B treatment, which has shown promise in testing but trails a rival therapy from CSL Behring and UniQure

Improving serious illness communication for patients with advanced cancer

Scienmag

LEBANON, NH – Patients with advanced cancer want and need to partner with their care team to make treatment decisions that reflect their own values and align with what matters most.

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Moderna’s Covid-19 shot gets Australian TGA provisional approval for kids

Pharmaceutical Technology

Moderna has received provisional registration from the Australian Therapeutic Goods Administration (TGA) for its messenger RNA (mRNA) Covid-19 vaccine, Spikevax, for kids aged six months to five years.

FDA puts the microscope on 2 more cancer accelerated approvals without voluntary withdrawals

Fierce Pharma

FDA puts the microscope on 2 more cancer accelerated approvals without voluntary withdrawals. Fri, 07/22/2022 - 11:22

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CDC backs Novavax's protein-based vaccine for COVID-19

Bio Pharma Dive

Health officials argue a new type of shot could help to persuade unvaccinated people, although some surveys suggest that might not be the case

Discovery of molecular signatures of immature neurons in the human brain throughout life provide new insights into brain plasticity and other functions, according to Penn Medicine researchers

Scienmag

PHILADELPHIA – A team led by researchers at the Perelman School of Medicine at the University of Pennsylvania has used advanced techniques to show that, in a key memory region of the brain called the hippocampus, immature, plastic neurons are present in significant numbers throughout the human lifespan.

ESG Top Trends: Technology trends

Pharmaceutical Technology

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. Overcoming these challenges requires collaborative, proactive steps to achieve sustainability goals and turn the reputation of this industry around.