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

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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.

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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. With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval.

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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. According to a 2019 study from Kantar , a whopping 70 percent of consumers say they see the same ads over and over again.

Marketing 266
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Coronavirus FAQ: I got it on a family vacay! Can my relatives stay (relatively) safe?

NPR Health - Shots

It's a common dilemma in this summer of surging travel and surging COVID. If one member of a vacation party comes down with the virus, what steps can be taken to reduce the risk to others?

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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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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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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

A key factor of Pfizer’s Covid-19 antiviral Paxlovid efficacy has been early intervention, but getting it in time has proven to be a challenge. On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .

Pharmacy 278

More Trending

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As new variant spreads, a crucial drug to protect the most vulnerable goes vastly underused

STAT News

Jennifer Padgett has spent 2 1/2 years terrified for her immunocompromised daughter, Hannah. Hannah catches pneumonia like mosquito bites; what could Covid wreak? Their whole family locked down in the early days, rushed to get vaccines when they became available and kept masking and avoiding indoor dining in their small southern town even after the Centers for Disease Control and Prevention loosened restrictions.

Doctors 145
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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.

Trials 354
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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. . The research also found that BET proteins play two distinct roles in affecting how the SARS-CoV-2 virus interacts with human cells. . They provide the virus with a pathway into cells while aiding cells to defend themselves.

Protein 278
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Doubting mainstream medicine, COVID patients find dangerous advice and pills online

NPR Health - Shots

A 75-year-old woman became enmeshed in conspiracy theories about COVID. After she got infected, she rejected effective treatments and sought out black market drugs instead.

Medicine 145
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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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FDA approves first at-home therapy for skin repigmentation in vitiligo patients

STAT News

Patients with vitiligo will now have access to the first ever at-home therapy for skin repigmentation approved by the Food and Drug Administration. The FDA announced the approval of Incyte’s ruxolitinib cream on Monday   based on data collected from two duplicate Phase 3 clinical trials that found 30% of patients using the cream regained 75% or more skin repigmentation on the face and roughly 20% of patients regained at least 50% or more repigmentation on their body after 24 weeks.

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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.

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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. Tixagevimab and cilgavimab are two long-acting antibodies (LAABs) obtained from the B-cells of patients convalescing following Covid-19.

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In Kabul, a new ritual: Hungry women wait for bread outside bakeries

NPR Health - Shots

Since the Taliban came to power, food insecurity has risen. Women in blue burqas sit in front of the city's upscale bakeries, silently waiting for charitable passersby to purchase bread for them.

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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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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. “Digital therapy has been around for a really long time,” YourCoach Cofounder and CEO Marina Borukhovich told pharmaphorum.

Doctors 137
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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.

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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. The spotlight was placed on many up-and-coming pharmacotherapies for retinal diseases, one of which was AbbVie’s/Regenxbio’s gene therapy RGX-314.

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American gun violence has immense costs beyond the death toll, new studies find

NPR Health - Shots

Two new studies outline the massive financial, social and health care costs of America's gun violence epidemic on victims and the large pool of often forgotten survivors.

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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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Eggs can survive decades without signs of aging. Now, scientists may know why

STAT News

In a high-stakes evolutionary gambit, female mammals are born with a finite supply of immature eggs. Propagating future generations depends on this reserve of pre-egg cells, or “primordial oocytes,” staying alive and out of the way of harmful, mutation-causing molecules — sometimes for decades — so they can give rise to mature eggs capable of producing healthy offspring.

Scientist 134
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Drug deals, launches in focus as pharma earnings begin

Bio Pharma Dive

Second quarter reports could bring questions on a reportedly forthcoming $40 billion takeover, GSK’s new slimmed-down look and market uptake for expected blockbusters-to-be from Lilly and Bristol Myers.

Drugs 299
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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. In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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A floating abortion clinic is in the planning stage, and people are already on board

NPR Health - Shots

Dr. Meg Autry is raising money to buy and retrofit a vessel that would operate as a reproductive health clinic in federal waters off the Gulf of Mexico, providing services including surgical abortion.

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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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Biotech employees cash in health care’s largest salaries, while people working at providers sit near the bottom

STAT News

It pays to be in the lab. It pays way less to be at the patient’s bedside. People who work at biotechs, life sciences firms, and pharmaceutical companies pull in the largest salaries of anyone in health care — usually more than $100,000 per year, and frequently above $250,000, according to a STAT analysis of the median pay for employees at more than 200 publicly traded health care companies.

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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.

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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. Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData.

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The first U.S. case of polio since 2013 has been detected in New York

NPR Health - Shots

The patient, who has developed paralysis but is no longer contagious according to the AP, may have contracted the virus overseas. The CDC says no cases of polio have originated in the U.S. since 1979.

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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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With monkeypox spreading globally, many experts believe the virus can’t be contained

STAT News

It has been a mere nine weeks since the United Kingdom announced it had detected four cases of monkeypox, a virus endemic only in West and Central Africa. In that time, the number of cases has mushroomed to nearly 13,000 in over 60 countries throughout Europe, North and South America, the Middle East, new parts of Africa, South Asia, and Australia. The growth in cases and the geographic spread has been rapid and relentless.

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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.

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Roche CEO Severin Schwan to stand down after 14 years

pharmaphorum

Long-serving Roche chief executive Severin Schwan is stepping down, to be replaced next March by Thomas Schinecker, currently head of diagnostics at the Swiss group. Schwan (pictured above) has been nominated as chair of Roche’s board of directors however, to succeed Christoph Franz will not seek re-election after more than eight years in the role, so will still be intimately involved in the company’s affairs.

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The first U.S. polio case was discovered in nearly a decade. Should you worry?

NPR Health - Shots

The CDC confirmed that a patient in New York has contracted polio, the first U.S. case since 2013. But most people shouldn't be concerned about contracting the virus because of high vaccination rates.

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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.