Bio Pharma Dive
JANUARY 25, 2023
The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.
Pharmaceutical Technology
JANUARY 22, 2023
In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow.
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STAT News
JANUARY 27, 2023
After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.
Medical Xpress
JANUARY 23, 2023
An anti-aging gene discovered in a population of centenarians has been shown to rewind the heart's biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Bio Pharma Dive
JANUARY 23, 2023
This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm.
Pharmaceutical Technology
JANUARY 23, 2023
Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JANUARY 27, 2023
Long criticized as discriminatory, the policy has prevented many gay and bisexual men from donating blood. The Food and Drug Administration revealed a draft of its new approach on Friday.
Bio Pharma Dive
JANUARY 23, 2023
A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.
Pharmaceutical Technology
JANUARY 22, 2023
Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.
STAT News
JANUARY 23, 2023
Massachusetts General Hospital is launching a prospective trial of an artificial intelligence tool designed to predict patients’ risk of lung cancer, a crucial area of inquiry amid rising incidence of the disease in never-smokers. The trial, to begin later this year, will test the accuracy and usefulness of an AI system the hospital developed with researchers at the Massachusetts Institute of Technology’s Jameel Clinic.
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.
NPR Health - Shots
JANUARY 22, 2023
An NPR/Ipsos poll finds that most Americans say Supreme Court justices are guided more by their politics than the law, and that lawmakers aren't deciding abortion policy based on public sentiment.
Bio Pharma Dive
JANUARY 24, 2023
The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.
Pharmaceutical Technology
JANUARY 26, 2023
Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.
STAT News
JANUARY 23, 2023
Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Medical Xpress
JANUARY 22, 2023
Scientists have worked out why common anti-depressants cause around half of users to feel emotionally "blunted." In a study published today in Neuropsychopharmacology, they show that the drugs affect reinforcement learning, an important behavioral process that allows people to learn from their environment.
Bio Pharma Dive
JANUARY 23, 2023
Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.
Pharmaceutical Technology
JANUARY 25, 2023
A researchers’ team from the University of Texas at San Antonio’s (UTSA) Department of Chemistry and its partners are developing compounds to treat Glioblastoma multiforme (GBM) tumours. UTSA’s partners include UT Health San Antonio’s Department of Obstetrics and Gynecology and Mays Cancer Center. The National Cancer Institute (NCI) has recently awarded a $3m grant to the researchers’ team.
pharmaphorum
JANUARY 27, 2023
AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
NPR Health - Shots
JANUARY 23, 2023
The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.
Bio Pharma Dive
JANUARY 27, 2023
The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main study supporting its application, taking one Wall Street analyst by surprise.
STAT News
JANUARY 26, 2023
Advisers to the Food and Drug Administration voted Thursday to back a plan whereby all Covid vaccines would move to the formulation used for the updated boosters, a step toward the goal of creating a single annual Covid shot for most Americans. The panel said that a single vaccine would both be more effective and less confusing to both patients and health care workers.
Medical Xpress
JANUARY 21, 2023
Maternal health outcomes continue to worsen in the United States, where maternal and infant mortality rates far exceed rates in European countries and other wealthy nations. Now, a new study led by researchers at Boston University School of Public Health (BUSPH) and Harvard Medical School-affiliated Beth Israel Deaconess Medical Center (BIDMC) is shedding insight on how hospital organizational structures and staffing within US maternity care may affect the birthing process and possibly contribut
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
NPR Health - Shots
JANUARY 22, 2023
The overturning of the Roe v. Wade decision just months ahead of its 50th anniversary has prompted many abortion providers to shift how they serve patients. (Image credit: Rogelio V.
Bio Pharma Dive
JANUARY 24, 2023
The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.
pharmaphorum
JANUARY 26, 2023
2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.
STAT News
JANUARY 27, 2023
When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.
NPR Health - Shots
JANUARY 27, 2023
The defendants allegedly took part in a scam that sold more than 7,600 fraudulent nursing degree diplomas from three Florida-based nursing schools, according to recently unsealed federal indictments. (Image credit: D.A.
Bio Pharma Dive
JANUARY 25, 2023
The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.
Medical Xpress
JANUARY 26, 2023
New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has established a blood-based test that could be used to predict the risk of Alzheimer's disease up to 3.5 years before clinical diagnosis.
STAT News
JANUARY 26, 2023
WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons
NPR Health - Shots
JANUARY 26, 2023
A new study finds that UV dryers for gel nail polish can damage DNA and mutate cells, confirming dermatologists' safety concerns. There are precautions you can take and alternatives to consider.
Bio Pharma Dive
JANUARY 24, 2023
The company blamed a range of factors in its decision, including limited funding, slower-than-anticipated trial enrollment and “broader sector trends.
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