Mon.Dec 12, 2022

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Three things to know about the accelerated approval pathway

PhRMA

If you or a loved one were to receive a diagnosis of a serious or life-threatening disease, you would likely want access to a U.S. Food and Drug Administration (FDA) approved safe and effective medicine as soon as possible. That’s precisely why the accelerated approval pathway was created back in 1992 at the urging of patient advocates. Since then, it has been a lifeline for millions of patients.

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Addressing Barriers to MOUDs Faced by People in Incarceration

Drug Topics

Haylea Hannah, MSPH, PhD, discusses her research on the barriers to medications for opioid use disorder that people who are incarcerated can face and what pharmacists can do to address the barriers.

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Dapagliflozin Improves Outcomes in Patients With Chronic Kidney Disease Regardless of Presence of Diabetes

Pharmacy Times

Dapagliflozin (Farxiga) found effective in lowering the risk of hospitalization for patients with chronic kidney disease, with or without a diagnosis of type 2 diabetes, and increased the number of days alive and out of the hospital.

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Examining the Impact of the Roe v Wade Decision on Medication Access

Drug Topics

Investigators set out to evaluate how medication access for certain rheumatic conditions has changed since June 2022.

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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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Covid vaccines averted 3 million deaths in U.S., according to new study

STAT

This Wednesday will mark two years since nurse Sandra Lindsay became the first person in the U.S. to receive a Covid-19 vaccine outside of a clinical trial. A study released Tuesday by the Commonwealth Fund shows that in those two years, the Covid vaccines have averted over 3 million deaths in the U.S. The Centers for Disease Control and Prevention estimates that more than 1 million Americans have died from Covid-19 since the onset of the pandemic.

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Technology Tools for Mental Health Screening

Drug Topics

Online portals are accessible via tablet or computer and can streamline the mental health screening process.

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What’s in a Title?

Drug Topics

When it comes to practicing pharmacy, do titles and degrees actually matter?

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Novel Compounds Show Potential for Treating Anxiety Disorders With Fewer Adverse Effects

Pharmacy Times

Lead compounds may lower the risk of abuse and other adverse effects compared with other drugs currently being evaluated for mental health disorders, such as MDMA.

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House and Senate Dems want CMS to drop ACO REACH members due to fraud concerns

Fierce Healthcare

House and Senate Dems want CMS to drop ACO REACH members due to fraud concerns. rking. Mon, 12/12/2022 - 16:08.

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Revenge of the gaslit patients: Now, as scientists, they’re tackling Ehlers-Danlos syndromes

STAT

Type “Ehlers-Danlos syndromes” into a search engine, and multiple suggestions pop up. Is Ehlers-Danlos an autoimmune disease? Is EDS hereditary? Rare? Then, the algorithm might suggest: Is Ehlers-Danlos syndrome a disease?

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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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Amgen’s AMG-133 shows potential in competing with GLP-1RA obesity therapies

Pharmaceutical Technology

Pipeline therapies within the cardiometabolic space have recently gathered interest following the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference, which took place on 1–3 December. The spotlight was placed on many up-and-coming pharmacotherapies within the space, one of which was Amgen’s obesity therapy, AMG-133, following the company’s announcement of its Phase I therapy results last week, on 1 December.

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Utrogestan accepted as HRT in Scotland

European Pharmaceutical Review

The Scottish Medicines Consortium (SMC) has accepted Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.

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Kite and Arcellx enter partnership for multiple myeloma therapy development

Pharmaceutical Technology

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite.

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Family Supporters Attending Programs Improve Patients’ Management of Diabetes

Pharmacy Times

Relatives who attend low-intensity coaching and monitoring meetings increase individuals’ ability to manage the disease.

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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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Amgen agrees $26bn for Horizon following Sanofi withdrawal

pharmaphorum

In a fresh update, Bloomberg has reported that US biotech Amgen Inc. has agreed to purchase Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26bn), in a deal which could yet see further delays or a breakdown in negotiations. Following Sanofi’s withdrawal from the running, stating that “transaction price expectations do not meet [their] value creation criteria” – for the purposes of Rule 2.12 of the Irish Takeover Rules in response to Horizon’s announcement under Rule 2.4 of the I

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Dapagliflozin approved for heart failure across LVEFs

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency ( MHRA ) has granted a licence extension for FORXIGA (dapagliflozin) in Great Britain for symptomatic chronic heart failure (HF) across the full spectrum of left ventricular ejection fraction (LVEF). The approval means potentially a further 250,000 patients across the full spectrum of LVEF >40 percent, including HF with reduced, mildly reduced, and preserved ejection fraction (HFrEF, HFmrEF, HFpEF) will be eligible for treatment in Engl

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Study Highlights Importance of Zoster Vaccination for Older Adults

Pharmacy Times

Herpes zoster and postherpetic neuralgia can cause a significant health burden among adults 65 years of age and older.

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Healthcare companies' default risk steadily rising, with most owned by private equity: Moody's

Fierce Healthcare

Healthcare companies' default risk steadily rising, with most owned by private equity: Moody's. hlandi. Mon, 12/12/2022 - 22:05.

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SABCS: Pharmas show their working in HR+/HER2- breast cancer

pharmaphorum

The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. Along with data from its antibody-drug conjugates and oral selective oestrogen receptor degrader (SERD) camizestrant reported earlier, AZ presented results of the CAPItello trial of AKT inhibitor capivasertib in combination with injectable SERD Faslodex (fulvestrant) in

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Opinion: Responsibly expanding access to methadone for people with opioid use disorder will save lives

STAT

The overdose epidemic continues to ravage communities across the country. In Washington state, where I live and work, more than 2,000 people died from a drug overdoses in 2021; country-wide, the death toll was more than 107,000. Each loss of life is a preventable tragedy, as well as a missed opportunity for the U.S. health care system to treat addiction and save lives.

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Mark Cuban Cost Plus Drug Company partners with EmsanaRx

Drug Store News

The EmsanaRx Plus supplemental drug discount product represents a transition for Cost Plus Drugs from operating exclusively in the direct-to-consumer market into the employer market.

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Utrogestan approved as HRT in Scotland

European Pharmaceutical Review

The Scottish Medicines Consortium (SMC) has approved Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.

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Empowering MSLs to be the kings of Pharma’s New Frontier

pharmaphorum

The demand for high-calibre, sharply-focussed clinical knowledge and data is increasing as HCPs streamline and recalibrate their engagements with the pharmaceutical sector. But, although open opportunities are diminishing and time slots are being squeezed, MSLs are emerging as the ideal ambassadors to ensure the science and data reaches the right targets and makes connections.

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STAT+: Coming soon: Permanent Covid-19 safety rules for health care workers

STAT

​​The federal agency that oversees workplace safety is moving forward with making certain Covid-19 protections for health care workers permanent, and not everyone is happy about it. The Occupational Safety and Health Administration has been working since last year on rules governing masks and vaccination requirements in hospitals. After putting out proposed standards and then gathering hundreds of comments from hospitals, clinicians, unions, and others, it sent a final version of t

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Proof of Delivery is Key to Maximizing Pharmacy Reimbursement, Defending Audits and Preventing Costly Write-Offs

Pharmacy Times

Five crucial steps pharmacies can take to enhance patient engagement and lower operational costs.

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Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war

Fierce Pharma

Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war. esagonowsky. Mon, 12/12/2022 - 08:18.

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Are viral TikTok food trends influencing grocery purchases?

Drug Store News

Instacart analyzed its own purchase data to find out how much of the viral #FoodTok content and its ingredients are making it into consumers’ grocery carts.

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ASH: CSL, uniQure's gene therapy Hemgenix shows durable protection in hemophilia B

Fierce Pharma

ASH: CSL, uniQure's gene therapy Hemgenix shows durable protection in hemophilia B. kdunleavy. Mon, 12/12/2022 - 14:25.

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STAT+: The Covid-19 test maker that pivoted to being a health insurance company

STAT

Curative rose to prominence during the throes of the pandemic, as people and governments across the country used its Covid-19 tests. But that business is now firmly in the past, and the company has switched to an even more regulated industry: health insurance. Last year, Curative had a cloud hanging over its head. It got into trouble with the Food and Drug Administration and states, which said the company’s tests led to too many false negatives, meaning the tests may have told patients th

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Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati

Fierce Pharma

Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati. aliu. Mon, 12/12/2022 - 18:14.

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New blood cancer treatment appears successful for most trial patients

Pharmafile

A new and experimental immunotherapy treatment has appeared successful in treating patients with multiple myeloma in an ongoing phase 1/2 clinical trial. The blood cancer treatment has seen successful response rates in 73% of patients, and an application has been submitted to the FDA to bring the drug to market. read more.

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STAT+: Amid fears of superbugs, sales of antibiotics used in food-producing livestock barely declined last year

STAT

Amid fears of superbugs, the sale of medically important antibiotics given to food-producing livestock declined by less than 1% overall in the U.S. in 2021, a small change that prompted advocates to complain that not enough is being done to thwart antibiotic resistance. In particular, the sale and distribution of tetracycline, which accounted for 65% of the medically important antibiotics, fell by only 1%, according to the latest annual report from the Food and Drug Administration.

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ED docs offer better care than nurse practitioners, research finds

Fierce Healthcare

ED docs offer better care than nurse practitioners, research finds. fdiamond. Mon, 12/12/2022 - 16:05.

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STAT+: Mirati wins FDA approval for KRAS-blocking lung cancer drug, but blockbuster sales hopes have dimmed

STAT

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results. The new medicine, a pill called Krazati, was cleared to treat patients with advanced non-small cell lung cancer containing a specific type of KRAS alteration called G12C.

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