Tue.Aug 22, 2023

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Medical illustrations neglect people with dark skin. A Nigerian doctor-to-be is working to change that

STAT

Medical illustration is both an art and a science. But it can have a huge cultural impact, too, as medical student and illustrator Chidiebere Ibe discovered when his illustration of a pregnant Black woman and her fetus went viral in 2021. The image was groundbreaking precisely because it shouldn’t have been. People have a wide range of skin colors, and everyone develops medical conditions; it’s common sense that medical illustrations should feature a diverse range of bodies.

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A rare disease research aims to tackle disability discrimination in new lawsuit

PharmaVoice

How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

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Opinion: The hospice industry needs major reforms. It should start with apologies

STAT

“How has the clinical work you do affected you personally?” We’d come to the Q&A part of the evening in an historic church in eastern Pennsylvania. I had traveled there at the request of a local hospice to talk about my perspective as a doctor with a long career of caring for seriously ill and dying patients. I smiled at the casually dressed older man who asked the question.

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Foundery, a new biotech venture firm, sets out to speed early immune drug research

BioPharma Dive

Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.

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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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Opinion: How to take care of trans patients in hospice

STAT

In the United States, more than 1.6 million people identify as transgender. Of these, more than one-fifth are over the age of 65 , the vast majority of whom transitioned in the latter part of their lives. Transgender Americans are both living and dying among us: precisely why we health care providers must improve our approaches to ensuring dignified and respectful care for transgender elders, especially at the end of life.

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Academic Pharmacy Fellowships: Is it the defined path into Academia?

Pulses

By : Victoria L. Williams, PharmD, BCCCP “Dr. Williams, what do I have to do if I want to pursue a career in academia? ” a curious student asked me after class. As a clinical faculty member with 50% of my appointment dedicated to direct patient care and the other 50% to teaching, research/scholarship, and service, my answer started off strong with tried-and-true advice on pursuing residency training to prepare for the practice component of my role.

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Industry examining FDA guidance on nitrosamines

Quality Matters

Industry examining FDA guidance on nitrosamines Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S.

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How the first Native Hawaiian psychiatrist set a course for diversifying medicine

STAT

Benjamin Young didn’t set out to be the first Native Hawaiian psychiatrist. Nor did he go looking to be the first physician on board what would become a landmark epic voyage from Tahiti to Hawaii back in 1976, using only the stars, sun, moon, and cloud and wave patterns as guides. And Young had no clue that, toward the beginning of his career, he would be called on to start up a first-of-its-kind program at the University of Hawaii to diversify the number of Pacific Islanders and other un

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EC grants CMA to Janssen’s Talvey for multiple myeloma

Pharmaceutical Business Review

These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in adults who received at least four prior lines of therapy. It is a bispecific antibody that targets T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D).

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STAT+: Eli Lilly CEO donates big to Mike Pence presidential super PAC

STAT

WASHINGTON — David Ricks, who leads Eli Lilly, made a major early donation to a super PAC in support of former vice president Mike Pence — one of the first big 2024 donations from a major player in the pharmaceutical industry. Ricks in June donated $25,000 to a special political action committee called Committed to America, which was founded to support Pence.

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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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Boehringer sues to block US drug price program

BioPharma Dive

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

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STAT+: FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device

STAT

An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious. The committee will evaluate data from two companies vying for market approval: ReCor Medical, a startup owned by Japanese company Otsuka Medical Devices, and device giant

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Shiva Pharmachem files DRHP for Rs 900 cr IPO

Express Pharma

Vadodara-based Shiva Pharmachem, a manufacturer of acid and alkyl chlorides, has filed its Draft Red Herring prospectus (DRHP) with capital market regulator SEBI to raise funds through for its initial public offering (IPO). The IPO with a face value of Rs 2 each is entirely an offer for sale (OFS) of up to Rs 900 crore by Promoter and Promoter Group Selling Shareholders.

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STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

STAT

Good morning, one and all. Damian Garde here, filling in for Ed Silverman once more on another day of aberrant weather and out-of-office autoreplies. Here’s hoping yours ends with fewer open browser tabs than it began. Below find a few items to get you started, and, as always, let us know if you hear anything interesting out there. The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us.

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Improving Medicare Star Ratings & Outcomes: MTM's Growing Importance

cureatr

Medication Therapy Management (MTM) has always been an important component of the Medicare Advantage Part D plan structure. Potential changes to Part D would not only significantly increase the number of Medicare beneficiaries eligible for MTM enrollment, but they could also adversely impact Medicare star ratings and member outcomes if MTM programs can’t appropriately scale to meet demand.

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NICE recommends Amryt’s Filsuvez for rare skin disorder

Pharma Times

Around 670 people in England with epidermolysis bullosa will benefit from the treatment - News - PharmaTimes

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Fulcrum rejoins sickle cell drug race as FDA lifts study hold

BioPharma Dive

The biotech, which aims to develop an alternative to existing medicines and emerging gene-based treatments, will focus further testing on sicker patients.

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Twitter to 'X' and the Evolving Social Media Landscape for Marketers: Q&A with Mikaela Walker, Marketing and Social Manager at Greater Than One

PharmExec

Amid Twitter's transformation into "X", social media expert Mikaela Walker weighs in on the rebrand's impact for pharma marketing, assesses ongoing brand safety risks, and highlights established social platforms and those gaining traction.

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New report sets out clear steps pharma cos to curb AMR risk in antibiotic production

Express Pharma

A new report from the Access to Medicine Foundation, an independent non-profit organisation, zeroes in on responsible manufacturing, setting out three clear areas pharma companies can focus on to ensure they limit AMR risk when manufacturing their antibiotics. Since the first AMR Benchmark in 2018, the Foundation has been assessing how some of the world’s leading producers of antibiotics perform on limiting AMR risk from manufacturing.

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UK medicines manufacturing to get innovation boost

European Pharmaceutical Review

According to UK Research and Innovation ( UKRI ), £13 million is set to fund medicine manufacturing in the UK, through a focus on innovation in intracellular drug delivery, digitalisation and automation and nucleic acid medicines. The investment aims to improve vaccines and shorten the time it takes to produce medicines. Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing.

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Pilot sites in every ICB to test how pharmacist prescribing could be used

The Pharmacist

NHS England (NHSE) has launched its independent prescribing pathfinder programme to explore how independent prescribing could be used in community pharmacy. The programme could include up to 210 community pharmacies across each of the 42 Integrated Care Boards (ICBs) in England. Each ICB will be able to determine the scope of their sites, which will […] The post Pilot sites in every ICB to test how pharmacist prescribing could be used appeared first on The Pharmacist.

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Marksans receives USFDA approval for Guaifenesin ER Tablets (OTC)

Express Pharma

Marksans Pharma has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC). The Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC) are bioequivalent to the reference listed drug (RLD), Mucinex Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC.

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Mahana Therapeutics signs agreement with Consumer Health division of Bayer to commercialize digital therapeutics

World Pharma News

Mahana Therapeutics, a leading provider of prescription digital therapeutics, announced today that the company has entered into a multi-million-dollar distribution and marketing partnership with the Consumer Health division of Bayer to commercialize digital therapeutics. Earlier this year, Bayer announced the launch of a new business unit focused on delivering new digitally enabled precision health products to market.

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Pfizer maternal RSV vaccine approved

European Pharmaceutical Review

Abrysvo is approved for pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants. The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. It is approved for use at 32 through to 36 weeks pregnancy gestation.

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Top 20 global biopharma companies report 2.3 per cent market cap growth in Q2 2023: GlobalData

Express Pharma

Despite the continued inflationary pressures, the second quarter (Q2) of 2023 yielded promising outcomes for the leading 20 biopharma giants. The aggregate market capitalisation demonstrated a resilient upswing of 2.3 per cent, surging from $3.49 trillion during the first quarter (Q1) of 2023 to an impressive $3.56 trillion in Q2 2023, reveals GlobalData.

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Research shows new technique could cut time to detect polio in half

Pharma Times

This is the first time that this type of scientific method has been used to detect polio - News - PharmaTimes

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Elevating Health Through Medication Adherence

assurecare

In my previous blog, I expressed my profound passion for medication adherence and my dedication to helping people improve their lives. Proper medication adherence is essential, as it can significantly enhance the well-being of numerous individuals. As a refresher, let's define adherence again based on the U.S. Food and Drug Administration (FDA) definition: "Medication adherence, or taking medications correctly, refers to the extent to which patients follow their doctors' prescribed medication re

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Actimed secures extra £4.75M funding towards 'first globally approved product' treating cancer cachexia

Outsourcing Pharma

Actimed Therapeutics Ltd will put some of its additional funding of Â4.75 million ($6 million) towards its attempt to provide the worldâs first cure for cancer cachexia.

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FDA’s OPDP Issues Third Letter of 2023

Eye on FDA

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came in the form of an Untitled Letter (NOV) sent to a company regarding a paid social media posting. Enforcement this year was non-existent until June when the agency posted its first letter in a year.

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A Reality Check on That Blue Shield of California Announcement

Drug Channels

Last week, Anna Matthews of The Wall Street Journal scored a market-moving scoop with her story about Blue Cross of California’s decision to ditch CVS Health’s Caremark pharmacy benefit manager (PBM) in favor of five separate vendors. ICYMI: A Big Health Insurer Is Ripping Up the Playbook on Drug Pricing I commend Blue Shield of California for undertaking a noble experiment to unbundle the PBM business model.

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Hope for patients 'burdened by their ITP disease' in China after Hutchmed positive trial results

Outsourcing Pharma

Hutchmed is planning to submit a New Drug Application (NDA) for treatment of primary immune thrombocytopenia (ITP) in China.

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How Aizon Helps Leading Biotech Company Use AI to Improve Yield

PharmaTech

This case study shares why a leading biotech company reached out to Aizon to identify how artificial intelligence (AI) could be used to further optimize yield. The team was able to analyze five years of historical batch data to discover a direct correlation between hold up volume and time between process operations as well as generating millions of additional recovered revenue.

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Bios Health Group enters life sciences offering multiple solutions to pharma industry

Outsourcing Pharma

Those in the life sciences industry needing some creative input can now turn to Bios Health Group who have recently launched into the space.

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Supporting Bone Health with Metagenics Bone Builder: What You Need to Know

Welltopia Pharmacy

Looking for a reliable bone health supplement? Explore the benefits of Metagenics Bone Builder and its potential impact on your overall well-being. Get the facts before you make a decision.

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QuantHealth says pharma ‘on brink of major crisis’ and $15M funding for AI will help

Outsourcing Pharma

QuantHealth announced it has raised a $15 million series A funding round today (August 22) for its clinical simulator that can predict how a patient will respond to treatment in a clinical trial.

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