STAT
MARCH 25, 2024
It’s been four years since Covid-19 emerged, igniting a pandemic that killed millions of people and brought the world to its knees. A key factor in taming the pandemic was the creation of effective vaccines , which have saved millions of lives. You’d think developing a successful vaccine would be an unmitigated win, from a financial perspective.
PharmaVoice
MARCH 25, 2024
As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.
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STAT
MARCH 25, 2024
The health care sector is a notorious laggard when it comes to technology. It was slow to use computers, digitize patient data, and share information electronically. While most of the world instantly interacts via Zoom and Slack, hospitals — even today — are still sending faxes. But something different is happening with generative AI. Health systems, drugmakers, and insurers are racing to build the technology into their operations, aligning themselves with corporate giants such as
PharmaVoice
MARCH 25, 2024
Deborah Reardon is leading a new pillar that asks, ‘Are we looking at this from a patient lens and not from a Boehringer lens?
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
MARCH 25, 2024
WASHINGTON — The Supreme Court on Tuesday will hear opening arguments in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze new drug development. Industry players were initially reluctant to weigh in on the fate of mifepristone , approved by the Food and Drug Administration in 2000 for abortion up to seven weeks of pregnancy.
pharmaphorum
MARCH 25, 2024
Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
BioPharma Dive
MARCH 25, 2024
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
STAT
MARCH 25, 2024
Chick-fil-A, one of the largest fast-food restaurants in the U.S., is easing its commitment to using chickens raised without any antibiotics, a step that was criticized over concerns it could increase the risk of spreading antibiotic resistance among humans. In a statement, the company said it will instead switch to chickens that are raised without the use of antibiotics that are considered important to human health.
The Pharmacist
MARCH 25, 2024
CLINICAL UPDATE How are you getting on with Pharmacy First? GP Dr Toni Hazell presents useful tips for diagnosing and treating uncomplicated UTI in women Most community pharmacies in England are now running the Pharmacy First service which enables them to diagnose and treat seven specific conditions. Under the service, pharmacists can prescribe set medications […] The post Pharmacy First: Tips for diagnosing and treating uncomplicated UTI in women appeared first on The Pharmacist.
STAT
MARCH 25, 2024
LONDON — Novo Nordisk said Monday it would acquire the German firm Cardior Pharmaceuticals in a deal worth up to $1.1 billion, picking up additional drug candidates for its pipeline of cardiometabolic medicines. Cardior focuses on targeting RNA to address the root causes of heart disease. Its lead candidate, known CDR132L, is in Phase 2 development as a treatment for health failure.
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Pharmafile
MARCH 25, 2024
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). This approval follows positive results from the phase 3 CHAMPION-NMOSD trial, which were published in […] The post FDA approves AstraZeneca’s Ultomiris for NMOSD treatment appeared fir
STAT
MARCH 25, 2024
NEW YORK — Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated approval pathway, allowing regulators to speed access to drugs for thousands of dying patients. These days, though, Gonsalves sounds uneasy — if not mournful — of the world he helped build. “We’re approving drugs faster and faster — [the FDA is] one of the fastest regulatory agencies in the world — we know less and less about t
World Pharma News
MARCH 25, 2024
The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
STAT
MARCH 25, 2024
Since the Food and Drug Administration approved methadone for treating opioid use disorder in 1972, its distribution has been strictly regulated. The regulations were put in place to ensure public and patient safety. But they made it hard for people to get the treatment they need. Until recently, most people had to visit a methadone clinic in person for an initial exam and then come in five to six days a week to take their doses under the watchful eye of a health care professional.
pharmaphorum
MARCH 25, 2024
Three digital health technologies (DHTs) used to support patients with psychosis can be used by the NHS while additional evidence of their benefits is gathered.
STAT
MARCH 25, 2024
The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans. Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox.
pharmaphorum
MARCH 25, 2024
FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma
STAT
MARCH 25, 2024
Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or two of stimulation.
The Pharmacist
MARCH 25, 2024
Patients should be asked about any fever or rash in a bid to stop the spread of measles, new guidance from NHS England (NHSE) says. All staff must also know that non-immunised individuals with these symptoms should be isolated on arrival in the building under the advice which notes that ‘measles is highly infectious and […] The post Ask patients about any fever or rash to stop measles, says NHSE appeared first on The Pharmacist.
STAT
MARCH 25, 2024
New biotech newsletter launching this Thursday. Don’t miss out. Hey there. Today, we discuss the implications of the Supreme Court’s forthcoming mifepristone evaluation on the FDA and the biopharma industry. We also examine how Covid-19 vaccine makers are faring today, and more.
Express Pharma
MARCH 25, 2024
Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines.
STAT
MARCH 25, 2024
When Vertex Pharmaceuticals moved from Cambridge to Boston’s Seaport a decade ago, it signaled that what was then a sea of parking lots could be a booming business district, and galvanized a wave of new development. Now, Vertex may be on the move again. With the lease on its two-building campus on Fan Pier set to expire in 2028, the company is reevaluating its real estate options — and considering leaving its prominent headquarters for another spot in the neighborhood.
pharmaphorum
MARCH 25, 2024
The March meeting of the EMA’s human medicines committee saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for rare disease paroxysmal nocturnal haemoglobinuria (PNH) in the EU.
Express Pharma
MARCH 25, 2024
The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved.
European Pharmaceutical Review
MARCH 25, 2024
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria. “Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mo
The Pharmacist
MARCH 25, 2024
An IT functionality that will enable pharmacists to automatically update GP records with Pharmacy First consultations will be rolled out in a ‘phased’ manner from this week. But the speed of the roll-out will largely depend on the readiness of pharmacy IT systems, one GP system provider has suggested. At the time of publishing, one […] The post Automatic records updates from pharmacies to GPs to be phased in from this week appeared first on The Pharmacist.
Pharmaceutical Technology
MARCH 25, 2024
The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.
Outsourcing Pharma
MARCH 25, 2024
Patrick Hughes, co-founder and chief commercial officer of Cluepoints and OSP was able to catch up for an in-person during SCOPE 2024 to find out what developments the company had been working on and how they are benefiting from using AI.
Pharmaceutical Technology
MARCH 25, 2024
Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.
Outsourcing Pharma
MARCH 25, 2024
The Undiagnosed Diseases Network Foundation (UDNF) has successfully co-led a critical discussion on mental health at the 2024 Rare Disease Summit.
Pharmaceutical Technology
MARCH 25, 2024
The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.
Outsourcing Pharma
MARCH 25, 2024
In a significant milestone for pulmonary arterial hypertension (PAH) patients, Johnson & Johnson has announced the approval of OPSYNVI.
BioPharma Dive
MARCH 25, 2024
Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.
Pharmafile
MARCH 25, 2024
Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH). The drug is approved for use in patients who are ‘currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg as separate […] The post FDA approves J&J’s Opsynvi for PAH treatment appeared first on Pharmafile.
The Guardian - Pharmaceutical Industry
MARCH 25, 2024
The medical industry watches with trepidation as mifepristone case could have huge consequences for drug regulation Explainer: the mifepristone case Tell us: have you used an abortion pill in the US? A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.
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