Sat.Apr 16, 2022 - Fri.Apr 22, 2022

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GSK goes for gold as FDA starts review of daprodustat

pharmaphorum

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and showed that the drug offered an oral alternative to injectable erythropoietin stimulating agents (ESAs) for anaemia, without sacrificing efficacy.

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DNA analysis uncovers new cancer treatment clues

Pharma Times

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

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Clinical trial evolution, innovation center of Oracle Health Sciences event

Outsourcing Pharma

The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.

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Five Takeaways from the Big Three PBMs’ 2022 Formulary Exclusions (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies.

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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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US study finds high rates of unneeded antibiotic prescribing

pharmaphorum

A study has found that there is still a very high level of inappropriate antibiotic prescribing to patients in the US, particularly to older and Black patients. Sifting through data from around seven billion outpatient visits to doctor’s offices, hospital clinics and emergency departments over a seven-year period, the researchers found that almost three-quarters (74%) of antibiotics prescribed to patients aged 65 years or older, and two thirds (64%) to Black patients, were unnecessary.

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New study reveals emotional and psychological impact of infertility

Pharma Times

Infertility is estimated to affect one in seven couples across the UK and can have a profound effect on mental health

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More Trending

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Four Reasons Why PBMs Gain As Maximizers Overtake Copay Accumulators (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from February 2022. More than four years ago, I warned about the emerging trend of copay accumulators and outlined the costly consequences for patients. The latest data reveal that copay accumulator adjustment programs are now in the word list for a growing share of pharmacy benefit designs.

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Ampio slumps as FDA delivers knee osteoarthritis shock

pharmaphorum

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. Shares in the US biotech have fallen sharply after it revealed that the regulator did not accept changes to a phase 3 trial of the drug – called Ampion – that the company put forward in order to make it serve as a confirmatory pivotal study.

Immunity 103
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NICE releases revised guidelines on antidepressants

Pharma Times

The new guidelines focus on key areas of prescription, management of withdrawal and severity of withdrawal symptoms

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Tech Innovations: April 2022

Outsourcing Pharma

The latest news on expansions, innovations, awards, and more includes items from Eversana, DHL Supply Chain, X-Chem, Medidata, and other notable companies.

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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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Follow the Vial: The Buy-and-Bill System for Distributing and Reimbursing Provider-Administered Outpatient Drugs (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from October 2021. By reader request, we present below a channel flow chart illustrating the buy-and-bill process for provider-administered drugs. This chart complements Follow the Dollar: The U.S.

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FDA starts speedy review of Enhertu in lung cancer

pharmaphorum

AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year.

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New coalition formed to raise awareness of sight loss

Pharma Times

‘The Eyes Have It’ partnership will highlight the importance of eye health

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Covid Drugs Save Lives, but Americans Can’t Get Them

NY Times

Once again, a dysfunctional health care system has hindered our pandemic response.

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Why PBMs and Payers Are Embracing Insulin Biosimilars with Higher Prices—And What That Means for Humira (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from November 2021. An ironic postcript: Less than two months after my article was published, Cigna CEO David Cordani bragged about the cost savings from "aggressive adoption" of biosimilars.

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Astellas takes $170m charge as it drops DMD gene therapies

pharmaphorum

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for rare disease X-linked myotubular myopathy (XLMTM), which was placed on clinical hold by the FDA last year after four patient deaths liked to pos

Labelling 102
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Oncomatryx announces 15m euros funding to conduct clinical trials

Pharma Times

Company at the forefront of developing personalised treatments against invasive cancer has raised 15m euros to conduct clinical trials

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Ohio Doctor Is Acquitted of Killing Patients With Fentanyl

NY Times

The doctor, William Husel, had faced 14 counts of murder after his patients overdosed on fentanyl, the powerful opioid.

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Break Through Cancer announces $50m to power research collaboration

Outsourcing Pharma

The one-year-old organization is giving $50m USD in grants to encourage scientists from five cancer research centers to work together on cancer solutions.

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The largest pharma company in Europe calls for interoperability

pharmaphorum

Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare system. COVID spotlighted the vulnerability of the healthcare system and the need for structural and technological change to help manage such as crisis. Though some regions have started to make the necessary changes, Youssef says Europe is lagging. “In general, there is a good progression in almost every country.

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King’s College London explore COVID-19 technology as heart attack cure

Pharma Times

Protein technology could dramatically improve prospects of heart attack victims by proliferating organ cells

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Scientists Question Data Behind an Experimental Alzheimer’s Drug

NY Times

Studies linked to Cassava Sciences, once a stock market favorite, have been retracted or challenged by medical journals.

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New patent for Purdue Pharma drug OXYCONTIN

Drug Patent Watch

Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from eight suppliers. There are nineteen…. The post New patent for Purdue Pharma drug OXYCONTIN appeared first on DrugPatentWatch - Make Better Decisions.

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Digital therapy for osteoarthritis tops other methods, says study

pharmaphorum

A meta-analysis of published studies looking at web- app- or telehealth-based therapy for osteoarthritis has concluded that they outperform standard approaches to care. The study – published in the journal Osteoarthritis and Cartilage – focused on patients with osteoarthritis of the hip or knee, and compared the digitally-delivered exercises to standard approaches such as in-person physiotherapy, other forms of care, waitlisting and patient education.

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Shionogi and NEC collaborate on hepatitis B vaccine

Pharma Times

High unmet need in the area of hepatitis B therapies will see companies share responsibilities to develop the vaccine

Vaccines 112
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Save America’s Patent System

NY Times

It needs to promote innovation, not reward legal trickery.

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New patent expiration for Novartis drug LEQVIO

Drug Patent Watch

Annual Drug Patent Expirations for LEQVIO Leqvio is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nineteen patents protecting…. The post New patent expiration for Novartis drug LEQVIO appeared first on DrugPatentWatch - Make Better Decisions.

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Sarepta DMD rival PepGen files $115m IPO

pharmaphorum

Just days after dosing its first patient in a Duchenne muscular dystrophy trial, US biotech PepGen has pushed the button on an initial public offering (IPO). The Boston-based company has filed with the US Securities and Exchange Commission to raise up to $115 million from the IPO, according to a Renaissance Capital report. The funding will be used to continue the clinical development of lead oligonucleotide PGN-EDO51 for DMD, as well as two other oligo drugs PGN-EDODM1 for myotonic dystrophy ty

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Leeds health chief issues warning about the risks of missing MMR vaccinations

Pharma Times

The civil servant drew attention to vaccinations falling to lowest level in a decade

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Why Provider Status for Pharmacists Should Be the New Normal

EnlivenHealth

The words “provider status” have been a fixture of pharmacy industry discussions for years. But with the onset of the COVID-19 pandemic (now entering its third year), those discussions started to ramp up. How do you get medical resources like testing, treatment, and vaccinations to more people, including those in medically underserved areas?

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New patent for Pacira Pharms drug EXPAREL

Drug Patent Watch

Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.

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Teva’s long-acting schizophrenia drug rejected by FDA

pharmaphorum

Teva’s long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company’s long-acting formulation of schizophrenia drug risperidone. The US regulator issued a complete response letter (CRL) for the MedinCell-partnered drug, and the companies haven’t been forthcoming on the reasons behind the rejection, saying merely that they would work with the FDA to try to get the programme back on track.

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How Can I Earn CME Credits?

Board Vitals - Pharmacist

Completing your CME requirements does not have to be stressful or time consuming. No matter how many hours you are due to complete this year, there are a number of options to help you through the process without impacting your busy schedule. Here are some of the top ways to earn CME quickly and easily. . Live CME Conferences . Events sponsored by an accredited CME provider include national, regional, or local conferences, workshops, seminars, journal clubs, simulation labs, and live webinars.

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Launching your medical device: A strategy and execution cross-functional guide

Definitive Healthcare

Launching your medical device: A strategy and execution cross-functional guide mgathers Thu, 04/21/2022 - 15:45 Teaser Image Launching your medical device-A strategy and execution cross-functional guide.png Teaser Content This comprehensive eBook captures the total cross-functional alignment needed to launch your medical device by outlining the tactical and strategic considerations for each functional area.

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New patent for Almatica drug LOREEV XR

Drug Patent Watch

Annual Drug Patent Expirations for LOREEV+XR Loreev Xr is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Almatica drug LOREEV XR appeared first on DrugPatentWatch - Make Better Decisions.

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