Thu.May 04, 2023

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New resource underscores the importance of small molecule medicines

PhRMA

A small molecule medicine is what most people think of when they imagine a medicine. These medicines typically come in the form of a tablet or capsule and are usually taken by mouth. These medicines play essential roles in the treatment of different diseases and are indispensable in providing patients, caregivers and health care providers with the tools necessary to achieve improved health outcomes.

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New Narcolepsy Medication to Be Priced Competitively, Manufacturer Says

Drug Topics

Despite having a highly differentiated clinical value proposition compared to branded, twice-nightly oxybates, Avadel is pricing Lumryz at $64.67 per gram or around $177,034 annually, which is on par with twice-nightly oxybate products that require chronic, middle-of-the-night awakening.

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Trending Sources

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4 Things to know about PhRMA’s new 50-state poll

PhRMA

When it comes to health care, Americans are concerned about innovation and affordability.

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Provider Recommendation Influences Rate of Pneumococcal Vaccination in High-Risk Patients

Pharmacy Times

Study sheds light on the importance of the source of vaccine information and other factors that prevent lifesaving influenza or pneumococcal vaccination.

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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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VMS Frequency Reduced Considerably by Drug Elinzanetant

Drug Topics

A recent clinical trial showed positive results from the selective neurokinin-1,3 receptor antagonist elinzanetant (Bayer) against menopausal vasomotor symptoms.

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Combination CRISPR, Antiretroviral Therapies Could Eliminate 100% of HIV

Pharmacy Times

At least 58% of mice treated with combined CRISPR therapies showed signs of complete HIV-1 viral elimination.

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FDA Approves Ivacaftor for Eligible Infants Ages 1 Month and Older With Cystic Fibrosis

Pharmacy Times

Ivacaftor is now the first and only cystic fibrosis transmembrane conductance regulator modulator approved for this age group.

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STAT+: Gilead foresees more growth in its HIV drugs

STAT

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

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Study: Women With Breast Cancer in Racially, Ethically Diverse Neighborhoods Have Worse Cancer-Specific Survival Outcomes

Pharmacy Times

Study examines association between breast cancer survival and neighborhood-level measures such as socioeconomic status.

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STAT+: NIH grant recipients often fail to disclose agency support in patent applications

STAT

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.

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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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Forge Biologics and Labcorp partner for gene therapies development

Pharmaceutical Technology

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.

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STAT+: New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

STAT

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.

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Biosimilars Now Look Like a Surer Thing After Initial Skepticism

Drug Topics

The Inflation Reduction Act boosted the Medicare payment for biosimilars from the standard average sales price plus 6% to 8%.

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12,000 diseases lack treatments. One doctor thinks generics could yield cures

STAT

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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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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Morning Rx: May 4, 2023

Drug Topics

Lawmakers take on harm reduction, in-flight medical emergency kits are under review, and a new Alzheimer drug shows promise.

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In a first, a potentially fatal rare blood vessel disorder is treated in the womb

STAT

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.

Hospitals 101
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What’s the rarest blood type?

The Checkup by Singlecare

Do you know your blood type? If you do not, you are like most people. If you’re ever in a life-threatening situation requiring a blood transfusion, your blood type will always be checked. That’s because if you’re given an incompatible blood donation, your immune system will attack the donor blood by forming antibodies to destroy the unrecognized “foreign invaders.

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STAT+: A new list ranks large pharmaceutical companies by research and development

STAT

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.

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Vertex secures FDA clearance for infants’ cystic fibrosis therapy

Pharmaceutical Technology

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.

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Covid and mpox are here to stay, but the WHO’s emergencies may be nearing an end

STAT

Over the next week or so, the World Health Organization may declare a formal end to two long-running global health emergencies, Covid-19 and the mpox outbreak, after independent expert panels meet to assess whether these health events still merit being called Public Health Emergencies of International Concern. What the panels will recommend, and what WHO Director-General Tedros Adhanom Ghebreyesus will ultimately decide, remains to be seen.

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Amiodarone alternatives: What can I take instead of amiodarone?

The Checkup by Singlecare

Compare amiodarone alternatives | Multaq | Betapace | Tikosyn | Tambocor | Rythmol SR | Natural alternatives | How to switch meds Amiodarone is a prescription drug used to treat severe heart arrhythmias (irregular heartbeats). It is approved to treat life-threatening ventricular tachycardia or ventricular fibrillation. However, it’s commonly used off-label to treat atrial fibrillation (Afib).

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Opinion: Why a chatbot might seem more empathetic than a human physician

STAT

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

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J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year

Fierce Pharma

J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58

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STAT+: Gene therapy has helped boys like Conner walk. Scientists are trying to keep it that way

STAT

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.

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Transforming oncology with antibody therapeutics

European Pharmaceutical Review

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.

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STAT+: Juul execs shower House Oversight chair with campaign cash, just as he launches probe into FDA’s moves on e-cigarettes

STAT

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.

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Low-dose combination antihypertensives effective first-line treatment

Hospital Pharmacy Europe

Using a low-dose combination of antihypertensive medicines appears to be effective and well-tolerated as a first-line therapeutic option A study of nearly 27,000 hypertensive patients identified that roughly a third (32.5%) of patients had uncontrolled disease. Therapy guidelines recommend monotherapy as a first-line approach to treatment, only adding other agents where this fails to control blood pressure (BP).

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‘Are we better off with the information?’: Experts spar over the benefits of liquid biopsy to catch cancer

STAT

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?

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Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations

Fierce Pharma

Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations aliu Thu, 05/04/2023 - 10:02

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Amid booming demand, Novo to hold back some doses of obesity drug Wegovy for new U.S. patients

STAT

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.

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Pneumococcal Vaccination Rates Have Risen in Patients With Rheumatic Diseases

Pharmacy Times

It is possible that the pandemic had a positive impact on influenza vaccination rates.

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STAT+: Option Care takes over Amedisys in ‘perplexing’ $3.6 billion home care deal

STAT

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.

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Teva Pharmaceuticals, collaborators team up to donate behavioral health meds to free clinics, pharmacies

Fierce Healthcare

Teva Pharmaceuticals, collaborators team up to donate behavioral health meds to free clinics, pharmacies agliadkovskaya Thu, 05/04/2023 - 14:30

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STAT+: NIH systems for non-human primate research fall short, threatening biomedical research

STAT

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.

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