Vertex to move non-opioid painkiller into late-stage tests after FDA agreement
Bio Pharma Dive
JULY 22, 2022
Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects.
Sat.Jul 16, 2022 - Fri.Jul 22, 2022
354 
US FDA grants approval to Incyte’s Opzelura cream for vitiligo treatment
Pharmaceutical Technology
JULY 19, 2022
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.
Join 21,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The fairytale of DTC TV ads
World of DTC Marketing
JULY 21, 2022
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.
Coronavirus FAQ: I got it on a family vacay! Can my relatives stay (relatively) safe?
NPR Health - Shots
JULY 22, 2022
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?
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
European regulator recommends Bavarian Nordic's vaccine for monkeypox
Bio Pharma Dive
JULY 22, 2022
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.
Prescribing shift for Pfizer’s Paxlovid expands access but draws questions
Pharmaceutical Technology
JULY 20, 2022
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. .
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
As new variant spreads, a crucial drug to protect the most vulnerable goes vastly underused
STAT News
JULY 22, 2022
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.
FDA approves new vitiligo treatment, bolstering Incyte's dermatology business
Bio Pharma Dive
JULY 19, 2022
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.
Gladstone and UCSF scientists discover BET protein role in Covid-19
Pharmaceutical Technology
JULY 20, 2022
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.
Healthcare doesn’t give a damn about patients
World of DTC Marketing
JULY 20, 2022
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. will raise rates an average of 10% next year, according to a review of rate filings by the Kaiser Family Foundation.
Doubting mainstream medicine, COVID patients find dangerous advice and pills online
NPR Health - Shots
JULY 19, 2022
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.
Vertex, Verve team up to develop a gene editing drug for liver disease
Bio Pharma Dive
JULY 20, 2022
The deal, which is worth $60 million upfront, broadens Vertex’s reach into gene editing and expands Verve’s research beyond heart disease.
Karyopharm receives US and Europe regulatory designations for eltanexor
Pharmaceutical Technology
JULY 21, 2022
Karyopharm Therapeutics has obtained new regulatory designations in the US and Europe for its investigational therapy, eltanexor (KPT-8602), to treat myelodysplastic syndromes (MDS). The company received fast-track designation from the US Food and Drug Administration (FDA) for the eltanexor development programme as a single agent to treat relapsed or refractory intermediate, high or very high-risk MDS patients.
FDA approves first at-home therapy for skin repigmentation in vitiligo patients
STAT News
JULY 18, 2022
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.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
American gun violence has immense costs beyond the death toll, new studies find
NPR Health - Shots
JULY 21, 2022
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.
Biotech downturn hits another startup as Pact Pharma to lay off nearly 100 employees
Bio Pharma Dive
JULY 19, 2022
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.
AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland
Pharmaceutical Technology
JULY 21, 2022
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.
CanSinoBIO developed a highly effective COVID vaccine with an inhalant version
pharmaphorum
JULY 18, 2022
Pierre A. Morgon, PharmD, LL.M, MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical tr
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
In Kabul, a new ritual: Hungry women wait for bread outside bakeries
NPR Health - Shots
JULY 17, 2022
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.
Novartis forecasts improving generic drug business as it weighs unit's future
Bio Pharma Dive
JULY 19, 2022
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.
ASRS conference reveals hopeful outcomes for gene therapy RGX-314 in retinal diseases
Pharmaceutical Technology
JULY 22, 2022
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.
Twill taps YourCoach for DtX-health coaching integration
pharmaphorum
JULY 21, 2022
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.
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.
NICE recommends Rhythm’s Imcivree to help treat obesity and control hunger
Pharma Times
JULY 22, 2022
The treatment has been developed for people aged six years and over will be available for use across the NHS
Drug deals, launches in focus as pharma earnings begin
Bio Pharma Dive
JULY 18, 2022
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.
Filings buzz in pharmaceuticals: 65% increase in cloud computing mentions in Q1 of 2022
Pharmaceutical Technology
JULY 19, 2022
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.
Eggs can survive decades without signs of aging. Now, scientists may know why
STAT News
JULY 20, 2022
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.
The first U.S. case of polio since 2013 has been detected in New York
NPR Health - Shots
JULY 21, 2022
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.
Freeline gives detailed look at hemophilia gene therapy results
Bio Pharma Dive
JULY 21, 2022
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.
ESG Top Trends: Technology trends
Pharmaceutical Technology
JULY 21, 2022
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.
Monkeypox cases prompt governments to order vaccine supply
Pharma Times
JULY 19, 2022
Imvanex is a non-replicating smallpox vaccine developed in collaboration with the US government
The New Age of Decentralized Clinical Trials
Advertisement
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.
Let's personalize your content