Tue.May 02, 2023

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FDA Approves Two Medications for Treatment of Schizophrenia 

Drug Topics

Otsuka America Pharmaceutical and Lundbeck’s Alify Asimtufii (aripiprazole) also was approved for maintenance monotherapy treatment of bipolar I disorder in adults.

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Taking your biotech global? Here’s how you can navigate cultural norms

PharmaVoice

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

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Risk Factors Associated with TRD

Drug Topics

Medical experts discuss the risk factors associated with TRD.

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From science to strategy, this exec is painting Genmab’s bigger picture into the next decade

PharmaVoice

Martine van Vugt, recently named Genmab’s chief strategy officer and executive vice president, aims to usher in the company’s next wave of "knock your socks off" antibodies.

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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

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Treatment Landscape Surrounding TRD

Drug Topics

Key opinion leaders illustrate treatment strategies for patients diagnosed with TRD.

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Food Insecurity is a Leading Health-Related Social Need Among Patients With Diabetes

Pharmacy Times

Screening tools are becoming widely used to help clinicians address the needs of patients with diabetes to improve health outcomes.

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CVS closes $10.6B acquisition of Oak Street Health to expand primary care footprint

Fierce Healthcare

CVS closes $10.

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New Drug Pricing Policies Under Inflation Reduction Act Put More Liability on Payers, Manufacturers

Drug Topics

At the 2023 Asembia Specialty Pharmacy Summit, panelists discussed how inflation rebates and a redesign of Medicare Part D plans will impact payers and manufacturers.

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Opinion: Long waits to see a doctor are a public health crisis

STAT

In 2004, the physician search firm Merritt Hawkins first issued their Survey of Physician Appointment Wait Times. That year, the national average wait to get in to see a new physician was 21 days, an unacceptable amount of time to wait to access care. But that number has only gotten worse. In their 2022 survey , the wait for a new patient appointment increased to an average of 26 days.

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Merck entitled to $1.4B in cyberattack case after court rejects insurers' 'warlike action' claim

Fierce Pharma

Merck entitled to $1.

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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+: What to know about the upcoming readout of Eli Lilly’s experimental Alzheimer’s therapy

STAT

Eli Lilly is nearing the readout from a pivotal study of its experimental treatment for Alzheimer’s disease. The approval of a similar medicine earlier this year has wrung risk from the outcome, but for the same reason, expectations for strong results are higher. The Lilly drug, called donanemab, is an antibody that targets accumulated plaques in the brain called amyloid.

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FDA Accepted sBLA for Luspatercept-aamt to Treat Anemia in Patients With Blood Cancer

Pharmacy Times

The treatment showed significant improvement in patients in patients who require frequent blood transfusions and are at risk of infection.

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Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

Fierce Pharma

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27

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Study: Ingredient found in salad bowls and burger wrappers less safe than previously thought

STAT

A compostable salad bowl seems like an Earth-friendly way to enjoy a healthy lunch. But the toxic chemicals used in containers like molded-fiber salad bowls, sandwich wrappers, and French fry pouches may be leaching into food despite efforts to make those materials safer, according to the results of a study published in March in the journal Environmental Science and Technology.

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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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DiGiorno caters to thick, thin pizza crust preferences

Drug Store News

New from the brand are Loaded Ultra-Thin and Detroit Style pizzas.

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Report on medical access finds one-third of Black Americans live in ‘cardiology deserts’

STAT

Many Black Americans would have to travel across county lines just to find an open spot with a cardiologist, a new analysis found. About 16.8 million Black Americans — roughly 1 in 3 — live in counties with little or no access to heart specialists, according to a report from GoodRx, a telehealth company that provides drug discounts and also researches health trends.

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FDA revokes EUAs of Pfizer/BioNTech’s and Moderna’s original Covid-19 vaccines

Pharmaceutical Technology

The FDA recently announced the expansion of the emergency use authorizations (EUAs) of both Pfizer/BioNTech’s and Moderna’s bivalent original/Omicron BA.4/5 Covid-19 messenger RNA (mRNA) vaccines. The expanded EUAs state that these current bivalent vaccines are now to be used for all primary and booster doses administered to individuals ages six months of age and older.

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Ritual enters skin care space with HyaCera

Drug Store News

HyaCera is formulated with ingredients that hydrate the skin after 90 days of use and also help minimize fine lines and wrinkles, the company said.

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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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GSK staffers kick off series of strikes in UK for the first time in drugmaker's history

Fierce Pharma

GSK staffers kick off series of strikes in UK for the first time in drugmaker's history aliu Tue, 05/02/2023 - 14:22

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STAT+: A battle between Gilead and the U.S. government over patents on HIV prevention pills goes to trial

STAT

After years of sparring, the federal government and Gilead Sciences will square off in a Delaware courtroom this week in a bid to settle dueling claims over the rights to a pair of groundbreaking and lucrative HIV prevention pills. The case has drawn attention because a central theme is the extent to which taxpayer-funded research may be used by a pharmaceutical company to reap enormous profits, and whether the prices charged for any resulting medicine are out of reach for many Americans.

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How long does it take antidepressants to work?

The Checkup by Singlecare

If you’ve been prescribed an antidepressant, it’s probably because you’ve been experiencing levels of anxiety or depression that are interfering with your daily function or quality of life. This can be scary, frustrating, and exhausting, so chances are that once you begin taking an antidepressant , you want it to start working right away. Unfortunately, there is a waiting period when you start taking an antidepressant: While some take less time than others to work, you won’t be feeling the full

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For Spanish-speaking Latinas, language gaps — real or perceived — tied to discrimination during labor

STAT

The research question that pursued Jessica Valdez, an OB-GYN resident physician at the University of California, San Francisco, stemmed from her mother’s womb: How important is it to a birthing woman’s experience to be seen by health care providers who share her primary language? Valdez’s mother was 17 when she immigrated to California from Mexico in the 1970s.

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Industry Voices—Adding context to the 'weight-loss drug' debate

Fierce Healthcare

Industry Voices—Adding context to the 'weight-loss drug' debate hlandi Tue, 05/02/2023 - 12:39

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STAT+: Tobacco control groups oppose a bill targeting disposable vapes — because they worry RJ Reynolds is behind it

STAT

WASHINGTON — There’s a new bill in Congress meant to crack down on the cheap disposable vapes, like Puff Bar, that are increasingly popular with kids. But nearly all of the leading tobacco-control groups don’t want anything to do with it. They say the bill is being pushed by the makers of competing vapes, namely RJ Reynolds, the maker of Vuse e-cigarettes, to take attention off of its products’ growing popularity, and to push competition out of business.

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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

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Walgreens expands commitment to improving mental health, well-being

Drug Store News

Walgreens and Mental Health America are collaborating to address youth mental health, bringing much-needed resources to local schools.

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STAT+: Legal battle between Apple and Masimo over trade secrets ends in mistrial

STAT

A California jury was unable to reach a verdict in a messy, drawn-out legal battle between Apple and patient-monitoring company Masimo. James Selna, the judge presiding, announced the case a mistrial on Monday. “While we are disappointed that the jury was unable to reach a verdict, we intend to retry the case and continue to pursue legal redress against Apple,” Masimo told STAT in a statement.

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Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing

ISPE

Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Trudy Patterson Tue, 05/02/2023 - 13:42 iSpeak Blog iSpeak Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Lisa J. Graham, PhD, PE 2 May 2023 The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it.

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STAT+: Disagreements and digs upend an otherwise bipartisan hearing on PBM reform

STAT

WASHINGTON — The first Senate health committee markup under Chair Bernie Sanders (I-Vt.) and ranking Republican Bill Cassidy (La.) was rocky from the start — and it only went downhill from there. The committee was supposed to consider several bills to reform drug middlemen practices and make changes to laws governing generic drugs. But the markup was marred by procedural disagreements and ultimately adjourned unexpectedly, over Sanders’ efforts to continue.

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Astellas Reaches Agreement to Obtain Iveric Bio

PharmExec

Acquisition expected to support pharmaceutical’s blindness regeneration campaign.

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STAT+: Pharmalittle: Senate delays PBM-reform bill effective date; Gilead and HHS square off in court over HIV patents

STAT

Good morning, everyone, and how are you today? Steely skies are hovering this morning over the Pharmalot campus, which is exceedingly quiet now that the official mascot has finished his daily jog around the grounds and is happily snoozing in a nearby corner. As for us, we are going about the usual routine, brewing cups of stimulation — our choice today is roasted coconut — and foraging for interesting subject matter.

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FDA releases draft guidance for decentralised clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The publication includes recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

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Albertsons kicks off PSA campaign to address food insecurity

Drug Store News

Under its charitable program Nourishing Neighbors, the message encourages communities and people to come together to help more than 30 million people in the U.S. who are food insecure.

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