February, 2024

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'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.

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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.

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Stealing With Our Eyes Open

Drug Topics

How much longer can independent pharmacists survive with the current method of reimbursement?

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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.

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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.

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STAT+: Here are the cancer drugs Pfizer thinks could reignite investors’ interest

STAT

Pfizer spent more than four hours Thursday laying out its oncology program to investors. But the company also spent some time talking about the effects of the Inflation Reduction Act on its pipeline. The drug giant, which is facing investor dissatisfaction after a year in which its stock dropped 44%, said it would be focusing on drugs that are based on proteins, not small molecule pills as it has traditionally developed.

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Denied care: Trans men often struggle for inclusive gynecologic healthcare

Fierce Healthcare

When Joseph Schneier, a transgender man then in his early 40s, started experiencing unusual spotting and elevated progesterone levels in 2021, his partner urged him to get checked out. | When Joseph Schneier, a transgender man in his early 40s, started experiencing unusual spotting and elevated progesterone levels in 2021, his partner urged him to get checked out.

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More Trending

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The opportunities and challenges facing rare disease therapies developers

pharmaphorum

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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Repeat Dosing Study Demonstrates Positive Data for Neffy Epinephrine Nasal Spray

Drug Topics

Manufacturer ARS Pharma will submit the data as part of a response to a CRL received in 2023.

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Maternal Vitamin D, Multivitamin Supplementation May Reduce Risk of Autism in Offspring

Pharmacy Times

Supplementation during pregnancy also reduced communication warning behaviors in children who developed autism compared to the children of women who did not take supplements.

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STAT+: Change Healthcare cyber attack outage could persist for weeks, UnitedHealth Group executive suggests

STAT

The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT. UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline.

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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.

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As AI adoption in healthcare grows, Senate lawmakers weigh regulation, payment approaches

Fierce Healthcare

As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for strong | As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for stronger regulation.

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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.

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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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.

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California Passes First-in-Nation Law to Reduce Medication Errors, Address Pharmacy Staffing Concerns

Pharmacy Times

California's Stop Dangerous Pharmacies Act aims to improve patient safety by establishing new pharmacy staffing regulations and a medication error reporting system, arising from understaffed conditions.

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STAT+: A ‘vaccine-like’ version of Wegovy is on the drawing board at Novo Nordisk

STAT

LEXINGTON, Mass. — New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine? That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.

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Abridge clinches $150M to build out generative AI for medical documentation

Fierce Healthcare

Investors continue to pour money into generative AI startups and Abridge is riding this wave as it rapidly scales its technology across U.S. health systems. | Along with the funding round, Abridge also announced an enterprise agreement with Connecticut-based Yale New Haven Health System to give thousands of clinicians access to its AI-powered clinical documentation technology.

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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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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.

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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.

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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.

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CDC advisory panel says people 65 and older should get a Covid spring booster shot

STAT

An expert panel advising the Centers for Disease Control and Prevention on vaccines on Wednesday recommended that people 65 and older should get an additional Covid-19 vaccine shot this spring. The recommendation was approved by CDC Director Mandy Cohen, allowing the United States to join Canada and the United Kingdom in offering a spring booster this year to people at high risk of severe disease if they contract Covid.

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Optum's Change Healthcare responding to 'cybersecurity issue'

Fierce Healthcare

Change Healthcare is mitigating a "cybersecurity issue" that began Wednesday, and details remain scant. | Change Healthcare is mitigating a "cybersecurity issue" that began Wednesday, and details remain scant.

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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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Data science in healthcare

pharmaphorum

Data science in healthcare is transforming the industry, from drug discovery to patient care. Learn about the role of data, artificial intelligence (AI), and the impact of initiatives like the NHS Datastore in revolutionising healthcare outcomes.

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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Hyperbaric Oxygen Therapy May Be the First, Only Clinically Effective Treatment for Long COVID

Pharmacy Times

“I’m better than I was before I had long COVID, and in so many ways,” said a patient in an interview with Pharmacy Times.

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‘Brain fog’ is one of Covid-19’s most daunting symptoms. A new study measures its impact

STAT

Of all the lingering symptoms of long Covid , difficulty focusing and thinking, known as brain fog , may be the most frightening and baffling. A new study published Wednesday in the New England Journal of Medicine, which looks at how much cognition is impaired in the months after a coronavirus infection, shows that Covid-19’s impact can be measured in the equivalent of IQ points.

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Virta Health champions its nutrition therapy as an effective GLP-1 off-ramp. Here's why

Fierce Healthcare

Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in | A new study in Diabetes Therapy from Virta Health says the company's carbohydrate restricted nutrition therapy allows patients who no longer want a GLP-1 prescription to still keep the weight off.

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AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

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Roche’s Xolair is first medicine for food allergy in US

pharmaphorum

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.

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Alvotech, Teva obtain FDA OK for Humira biosimilar

Drug Store News

Simlandi is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the United States.

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All Pharmacies Are Not the Same: Community Pharmacy Quality

Pharmacy Times

Patients and other stakeholders need to be able to compare pharmacies based on standardized, transparent metrics with a measurement system to make informed decisions.

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STAT+: White House to hold a listening session on reforming pharmacy benefit managers

STAT

In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers , according to people familiar with the plans. The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters.

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