STAT
MAY 4, 2023
For Darren Orbach, a pediatric neurointerventionalist at Boston Children’s Hospital, the first-of-its-kind procedure to fix a potentially deadly vascular malformation in the brain of a fetus was an “exhilarating” experience, despite the sobering potential consequences. For the expectant parents, it was an exercise in hope.
PharmaVoice
MAY 4, 2023
With leaders at the biggest biopharma companies bringing in millions, the CEO of Corvus Pharmaceuticals opted for a pay cut to pour more funds into science.
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STAT
MAY 4, 2023
In the beginning, Conner Curran ran up the stairs. It was a miraculous moment for him and his parents, Jess and Chris Curran. Just months before, contractors were in their New York home to install a motorized lift, while Jess tearfully explained that it wasn’t for a grandparent but for their 7-year-old son, who suffered from Duchenne muscular dystrophy and could barely haul himself up the steps.
LifeProNow
MAY 4, 2023
May 4, 2023 : “Sandoz, a global leader in generic pharmaceuticals and biosimilars, announced that it has signed a distribution and collaboration agreement with Adalvo for exclusive Sandoz rights to commercialize six products in the US across key therapeutic areas, including antifungal/antibiotic, oncology and pulmonary. “Sandoz is putting patients first by securing the rights to bring more affordable, equally effective treatments for a range of disorders that collectively affect millions o
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
STAT
MAY 4, 2023
If you want a large pharmaceutical company to invent a new drug, your best bet is probably AstraZeneca. But if you have a medicine you’d like to get to market — and you want to see it generate revenue — you might be better off with Pfizer. That’s the message from the 12th edition of the Pharmaceutical Innovation and Invention Index, produced by the consultancy Idea Pharma, which was released Thursday at the STAT Breakthrough Summit.
LifeProNow
MAY 4, 2023
May 02, 2023: “The U.S. FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
PharmaVoice
MAY 4, 2023
A number of biopharma companies slashed their workforces this year and as market anxieties persist, more challenges could be looming.
STAT
MAY 4, 2023
An April 28 article in JAMA Internal Medicine , “Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum,” generated a great deal of discussion — much of it horrified. In particular, people are focusing on the study’s conclusions: that “chatbot responses were longer than physician responses, and the study’s health care professional evaluators preferred chatbot-generated responses over p
BioPharma Dive
MAY 4, 2023
After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.
STAT
MAY 4, 2023
SAN FRANCISCO — About a decade ago, David Fajgenbaum thought his life was over. He was a young, bright physician hoping to work in oncology in remembrance of his mother, who died of brain cancer a few years earlier. Fajgenbaum was having his last rites read to him, and his family braced for his death from Castleman disease, a rare inflammatory illness that impacts the lymph nodes and can severely damage other organs.
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Pharmaceutical Technology
MAY 4, 2023
Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.
STAT
MAY 4, 2023
Gilead Sciences is famous — or perhaps, notorious — for its cure for hepatitis C. But the pharma giant believes the foundation of its company will continue to be its HIV franchise, particularly the pre-exposure prophylaxis (PrEP) drugs that help prevent the infection. “It’s extraordinary that in this day and age, you still have the incidence of HIV increasing around the world, and even in this country,” CEO Daniel O’Day said Thursday at the STAT Breakthr
BioPharma Dive
MAY 4, 2023
The $540 million offering adds to a small, but growing body of evidence suggesting young drugmakers may need to be well into clinical testing before going public.
STAT
MAY 4, 2023
WASHINGTON — Juul executives wrote personal checks to the head of the House Oversight Committee, Rep. James Comer (R-Ky.), right as he launched a critical probe of the FDA’s regulation of e-cigarettes. On March 28, Comer sent a sharply worded letter to FDA commissioner Robert Califf questioning whether the agency’s decisions on authorizing certain vapes “have been influenced by political concerns rather than scientific evidence.
The Pharmacist
MAY 4, 2023
A survey by charity Melanoma Focus has found that 32% of British people rarely or never use sunscreen when in the UK, raising concerns over the risk of melanoma skin cancer among the population. While 11% of respondents told the survey that they always use sunscreen, male respondents in particular emerged as reluctant to protect […] The post Concerns UK public ‘ignoring’ skin cancer risks appeared first on The Pharmacist.
STAT
MAY 4, 2023
The National Institutes of Health may be the largest public funder of biomedical research in the U.S., but its contributions to drug development are not well understood or recognized by most Americans. And a new analysis finds a key reason may be most institutions and researchers that receive NIH support fail to fully or correctly disclose this information when applying for patents.
Pharmaceutical Technology
MAY 4, 2023
Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.
STAT
MAY 4, 2023
New technologies are making it possible to detect cancer earlier than ever — but the field is still fiercely divided on whether these liquid biopsy tests are yet ready for prime time. Those tensions are tangible among experts who continue to spar over the question of whether the cancer screening technology is actually beneficial. Among the most contentious points of debate: Do studies of liquid biopsies need to prove they can reduce mortality rates?
Pharma Times
MAY 4, 2023
The treatment is a small molecule that activates endogenous retinal stem and progenitor cells
STAT
MAY 4, 2023
Novo Nordisk, the maker of the wildly popular obesity drug Wegovy, said Thursday it would temporarily limit some “starter” doses for new patients in the United States to ensure a steady supply for people already on the medication. The company will cut the supply of lower-strength doses available that new patients start with, it said.
EMCrit Project
MAY 4, 2023
My attempt to model my empirical experience with Burnout EMCrit Project by Scott Weingart, MD FCCM.
STAT
MAY 4, 2023
Option Care Health is buying Amedisys in an all-stock merger valued at $3.6 billion, creating a national company that specializes in almost all types of home care that can be provided from cradle to grave. Health insurance companies, providers, and patients have pushed for more care to be handled at home instead of a hospital or post-acute facility, under the idea that quality home care saves money and is what patients want.
Pharma Times
MAY 4, 2023
Patent will allow the development of an industrial biomarker analysis kit which could be available worldwide
STAT
MAY 4, 2023
A worsening shortage of non-human primates and an inadequate government response threatens to undermine biomedical research in the U.S. and hamper the ability to respond to public health emergencies, a sweeping new report warns. Non-human primates represent just 0.5% of the animals used in biomedical research, but can be very valuable due to their similarities to humans on genetic, anatomic, physiologic, and behavioral levels.
European Pharmaceutical Review
MAY 4, 2023
Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy.
STAT
MAY 4, 2023
Rise and shine, another busy day is on the way. We can tell by the volume of email arriving this morning and the cacophony of vehicular sounds outside our window. Since we are on the road, however, finding acceptable cups of stimulation is more challenging than we would like, so we will soon attempt to forage about this foreign land for something suitable.
Express Pharma
MAY 4, 2023
CORONA Remedies has entered into an agreement with Ferring Pharmaceuticals to commercialise unique and innovative products in the field of maternal health and urology. “We are delighted to partner with Ferring, a research-driven, specialty biopharma group to bring world-class medicines to patients in India. This partnership is in sync with our purpose and commitment of *#GoodHealthForAll*,” said Nirav Mehta, Promoter & Executive Director of CORONA.
STAT
MAY 4, 2023
WASHINGTON — Eli Lilly’s latest anti-amyloid Alzheimer’s treatment seems to slow the disease, the company announced this week — news that adds even more pressure on Medicare’s unprecedented restrictions on coverage. Medicare has so far held firm on its plans to require patient registries for the entire class of anti-amyloid Alzheimer’s drugs, even after they are fully approved.
The Pharmacist
MAY 4, 2023
The National Pharmacy Association (NPA) has set out 10 principles for transforming the Community Pharmacy Contractual Framework in England. It follows a meeting of the new NPA board, elected in April, and as the organisation continues to raise concerns about the current framework, which it said is ‘failing’ the sector, patients, the NHS and the […] The post NPA sets out new contractual framework principles ahead of negotiations appeared first on The Pharmacist.
STAT
MAY 4, 2023
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Pulses
MAY 4, 2023
By: Kaley Shepard, PharmD I find myself reminiscing on my childhood—summer nights, building castles out of tattered blankets. Though unimpressive to the adult eye, I saw worlds of possibility, creating new tales each night. I didn’t realize the imaginary creation of castles and unique storylines would be a critical aspect of my professional development.
STAT
MAY 4, 2023
What’s the future of Alzheimer’s disease treatment? How do you pivot from a pandemic? And how successful can Wegovy get? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Eli Lilly’s investigational medicine for Alzheimer’s met its goals in an all-important clinical trial, and we explain the results, their implications, and the backstory of what could be a blockbuster drug.
Express Pharma
MAY 4, 2023
Mankind Pharma’s successful IPO raises hope for IPO-wannabes but the real hard work starts after the IPO party ends. Most companies face an IPO hangover, with share prices dipping post the IPO as they struggle to meet raised investor expectations. Will Mankind Pharma buck this trend? Mankind Pharma’s IPO was oversubscribed 15.32 times, thanks largely to qualified institutional buyers (QIBs).
The Honest Apothecary
MAY 4, 2023
Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. I might throw in a something off-topic from time to time which I found while wandering throughout the endless hallways and corridors of the internet. All article shared will be free to read and not locked behind an annoying paywall.
World Pharma News
MAY 4, 2023
The U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
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