Sat.Feb 10, 2024 - Fri.Feb 16, 2024

article thumbnail

How Will the Extinction of B/Yamagata Impact Global Flu Vaccination Strategies?

Drug Topics

Drug Topics talked with Gregg Sylvester, MD, chief health officer and vice president of medical affairs at CSL Seqirus, about what can we learn from this unique situation to improve future vaccine development and distribution.

Vaccines 201
article thumbnail

Biosimilars: Are They Delivering the Cost Savings Promised?

Pharmacy Times

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

FDA 152
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Transforming drug development with AI

pharmaphorum

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

FDA 129
article thumbnail

STAT+: In ‘major milestone,’ FDA approves first cell therapy for solid tumors

STAT

Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.

FDA 145
article thumbnail

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

article thumbnail

Fragmented Policy, Insurance Landscape Challenges Newly Approved Vaccines

Drug Topics

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.

Vaccines 184
article thumbnail

Study Shows 40% of Participants Sustain Cognitive Improvement After Surgery-Induced Weight Loss

Pharmacy Times

Sustained cognitive improvement is likely a result of lower inflammation, remission of comorbidities, higher physical activity, and better mood.

153
153

More Trending

article thumbnail

Opinion: Independent doctors like me are becoming an endangered species

STAT

More than 100,000 doctors have  left private practice  and become employees of hospitals and other corporate entities since 2019. Today, nearly  three in four physicians  are employees of larger health care entities or other corporations — a record high. As an independent physician, I know exactly why so many are making that choice.

Hospitals 145
article thumbnail

Patients With Type 1 Diabetes Not Achieving Glycemic Targets Despite Use of New Technology

Drug Topics

Many patients with the condition continue to experience severe hypoglycemic events even with the use of continuous glucose monitors and other disease management tools.

169
169
article thumbnail

FDA Accepts New Drug Application for MDMA-Assisted Therapy for PTSD

Pharmacy Times

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

FDA 153
article thumbnail

MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

Vaccines 142
article thumbnail

Position Your Pharmacy for Expansion

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.

article thumbnail

Ebola vaccine cuts fatality even in people who were infected before the jab, new study shows

STAT

A new study has shown that people vaccinated against Ebola who still developed the disease had a substantially lower risk of dying than people who were not vaccinated, even if they received the vaccine when they were already infected with the virus. It confirms just how major an advancement the Ebola vaccine remains; the study is the first to show that in addition to preventing infections, the vaccine can save some people who are already sick with the often fatal disease.

Vaccines 145
article thumbnail

FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

FDA 139
article thumbnail

Increased Development of RSV Immunoprophylaxis Inhibited by Cost and Acquisition Barriers

Pharmacy Times

Despite the growth in vaccine and antibody development for combatting RSV, lower income countries may not reap the benefits.

Vaccines 149
article thumbnail

Half of rural hospitals are losing money. Rising MA enrollment likely won't help them, Chartis warns

Fierce Healthcare

As more and more rural hospitals find their operations dropping into the red, the rising enrollment of rural residents in Medicare Advantage plans could pull these providers under, healthcare advis | A new analysis found the largest-ever single-year jump in rural hospitals operating in the red and a nearly 50% rise in Medicare Advantage enrollment over the past five years.

Hospitals 138
article thumbnail

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.

article thumbnail

Juul’s internal playbook opens a rare window into influence in Washington

STAT

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government. It’s well documented that Juul spent significant sums on registered lobbyists and political donations back in 2018 and 2019, when the head of the Food and Drug Administration declare

article thumbnail

FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

FDA 139
article thumbnail

Pharmacists Can Help to Optimize the Total Health of Patients with Heart Conditions

Pharmacy Times

Pharmacists can host community events and try different marketing efforts to drive community awareness about heart health and total health.

145
145
article thumbnail

CMS: Providers may now text patient info, orders to care teams

Fierce Healthcare

Providers working in hospitals and critical access hospitals may now text patient information and patient orders among care team members without landing on the wrong side of Medicare’s Conditions o | Texting patient info has been against Medicare's Conditions of Participations for over half a decade, due to concerns of insecure texting platforms.

HIPAA 133
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

Stem cell study offers clue to South Asians’ increased risk of cardiovascular disease

STAT

A growing body of data show that South Asians are at greater risk of developing heart disease than white people, and they tend to get complications at younger ages, but it’s not been fully clear what explains this disparity. A new study suggests one potential reason is that South Asians have a decreased ability to repair blood vessels that get injured from cardiovascular problems.

145
145
article thumbnail

'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

137
137
article thumbnail

Common Osteoporosis Treatment May Reduce Risk of Incident Diabetes

Pharmacy Times

Continued doses of denosumab reduced the incidence of diabetes by more than 1000 patients compared to an initial dose alone.

145
145
article thumbnail

'New set of digital table stakes': Most executives see tech as worthy investment, EY survey finds

Fierce Healthcare

Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals. | Nearly all healthcare executives believe technology is worth the cost, even though they have yet to see a financial return from it, according to a new survey from EY. Most believe in its power to reduce costs and boost provider credibility.

132
132
article thumbnail

STAT+: A flurry of research misconduct cases has universities scrambling to protect themselves

STAT

There was a time when an allegation of data mishandling, scientific misconduct, or just a technical error felt like a crisis to Barrett Rollins, an oncologist and research integrity officer at Dana-Farber Cancer Institute. Now, it’s a Tuesday. The renowned cancer treatment and research center is in the midst of a lengthy review of possible discrepancies involving around 60 papers co-authored by four of its top researchers over a period of over 15 years, including CEO Laurie Glimcher and C

145
145
article thumbnail

Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'

Fierce Pharma

While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.

130
130
article thumbnail

FDA Approves Omalizumab to Reduce Food-Based Allergic Reactions in Adult and Pediatric Patients

Pharmacy Times

This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.

FDA 144
article thumbnail

Kaiser Permanente reports $4.1B profit, exceeds $100B operating revenues in 2023

Fierce Healthcare

Kaiser Permanente wrapped up its fiscal year with $329 million of operating income (0.3% operating income), net income of $4.1 billion and more than $100 billion in both operating revenues and expe | The California-based nonprofit noted cost pressures, labor challenges and membership declines but still logged a 0.3% operating income in the wake of 2022's losses.

131
131
article thumbnail

Smoking impairs immune response, even after quitting, new study says

STAT

Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought. The study , published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.

article thumbnail

J&J consumer health spinoff Kenvue telegraphs 100-plus layoffs in California, New Jersey

Fierce Pharma

While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.

129
129
article thumbnail

Pharmacy Focus: Policy Editions - February 2024 Rx Roundup

Pharmacy Times

The meeting provided a brief overview of California's new Stop Dangerous Pharmacies Act, the benefits of e-prescribing for improving patient safety and outcomes, and New Jersey's pilot program for anonymous dispensing of opioid antidotes from pharmacies.

144
144
article thumbnail

Hospital violence isn't confined to EDs, often rising during COVID-19 surges, full moons, data show

Fierce Healthcare

Most alarms triggered by hospital staff’s wearable safety alert systems occurred outside of the emergency department and more often during weekdays, non-holidays, surges of COVID-19 and even during | Aggregate data from 200,000 workers' wearable duress systems suggest emerging or active violent incidents occur "throughout every part of the hospital," and are more frequent during weekdays, COVID-19 surges and full moons.

Hospitals 128
article thumbnail

Lyme disease cases rise, but largely due to a change in data collection

STAT

A new report released Thursday by the Centers for Disease Control and Prevention appears to show that Lyme disease cases in the United States rose by 69% in 2022 over previous years. But in reality, the sharp increase is likely due to a new way of doing surveillance for the disease, not an explosion of cases. The change, an attempt to lift a crushing reporting burden off the shoulders of states where Lyme disease infections are common, went into effect in 2022.

143
143
article thumbnail

Women’s health is a priority not a charity

pharmaphorum

Investing in women's health research and funding is not a charity, but a priority. Discover the importance of allocating resources and supporting initiatives that promote women's health and well-being.

127
127
article thumbnail

FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis

Pharmacy Times

The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.

FDA 145