Tue.Dec 17, 2024

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STAT+: FDA deputy commissioner Namandjé Bumpus to leave agency

STAT

Namandjé Bumpus, principal deputy commissioner of the Food and Drug Administration, is leaving the agency. Commissioner Robert Califf shared the news with staff Tuesday morning, according to an email reviewed by STAT.

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Maternal mortality trends remain dire — and researchers face an uphill battle to solve them

PharmaVoice

Rising maternal mortality, particularly among vulnerable populations, stems in part from a lack of research in pregnant women.

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STAT+: PBMs face scrutiny from all sides, and analyzing Marty Makary’s road to the FDA

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Congress nears spending deal with long-awaited PBM reforms Congress is on the edge of a deal that would reshape pharmacy benefit managers, extend telehealth access, and renew certain public health authorities.

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A biotech’s race to tackle the most severe hepatitis

PharmaVoice

Bluejay Therapeutics is one of just a handful of companies developing treatments for hepatitis D.

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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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Half of adults struggle to access trusted health information

The Pharmacist

Around half of adults in the UK struggle to access trusted health information, according to a new report. The study, published by the Patient Information Forum (PIF) and Ipsos,called Knowledge is Power, found that 53% of people felt they could trust the health information they found offline, with 45% saying they could trust the information […] The post Half of adults struggle to access trusted health information appeared first on The Pharmacist.

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Sanofi, Teva say study results show gut disease drug could be ‘best in class’

BioPharma Dive

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

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More Trending

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B&R drives adaptive manufacturing solutions in pharma production

Express Pharma

Revolutionising pharma the adaptive way Pharmaceutical manufacturing is undergoing a transformative development, driven by innovative technologies that enable right-first time (RFT) production and adaptive scaling to meet changing demands. By embracing smart manufacturing, the industry is addressing numerous challenges, allowing consumers to receive life-saving drugs more quickly and sustainably.

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GPhC November pass rate drops again to 2022 levels

The Pharmacist

Just 58% of trainee pharmacists passed the General Pharmaceutical Council (GPhC)'s national registration assessment this November, the regulator has announced. This brings the pass rates back down almost to November 2022 levels of 56%, following a 10% rise to 66% in November 2023. And it comes as summer pass rates have seen a steady decline […] The post GPhC November pass rate drops again to 2022 levels appeared first on The Pharmacist.

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German cancer centre treats first patient with Elekta Evo

Pharma Times

New CT-guided radiotherapy system offers personalised cancer treatment

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Merck targets 2025 RSV season with antibody now under FDA review

BioPharma Dive

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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MindMed begins phase 3 study of MM120 for anxiety disorder

Pharma Times

First patient dosed in landmark trial for GAD treatment

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FDA dents J&J's blockbuster hopes for Rybrevant

pharmaphorum

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Novo Nordisk invests $1.2bn in new Denmark facility

Pharmaceutical Technology

Construction has already begun on the Ozempic-producers new Denmark production facility and 40,000m2 warehouse.

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Yugal Sikri outlines 3 key trends defining India’s pharma growth in 2025

Express Pharma

India’s pharmaceutical industry, a global leader in generics, is poised for exponential growth. The sector is targeting a remarkable $130 billion by 2030 and a visionary $450 billion by 2047. Several key trends are shaping the industrys trajectory: Market consolidation: Strategic mergers and acquisitions, primarily backed by private equity, are reshaping the industry landscape.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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CTO Europe 2024: keep the burden of trials away from patients, say experts

Pharmaceutical Technology

The two-day event included talks on subjects ranging from how to best utilise AI to how to build a stable CRO.

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Schizophrenia market to reach $17 billion in 7MM by 2031, forecasts GlobalData

Express Pharma

The schizophrenia market across the seven major markets (7MM*) is poised to grow at a compound annual growth rate (CAGR) of 7.4 per cent from $8.4 billion in 2021 to $17.0 billion in 2031, driven by the anticipated introduction of 11 late-stage pipeline products during the forecast period, according to GlobalData. GlobalDatas latest report, Schizophrenia: Seven-Market Drug Forecast and Market Analysis Update, reveals that the late-stage pipeline products are expected to capture a significant po

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Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year

BioPharma Dive

Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.

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China NMPA approves MSD’s KEYTRUDA for stages of NSCLC

Pharmaceutical Technology

China National Medical Products Administration (NMPA) has approved MSDs KEYTRUDA for treating certain non-small cell lung cancer (NSCLC).

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Pfizer predicts stability, to Wall Street’s relief

BioPharma Dive

The company forecast revenue next year will grow slightly versus this year, when excluding certain factors. “The uncertainty caused by COVID [is] mostly resolved,” its CFO said.

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Biotech bounces back as venture funding grows $3.8m from 2023 to 2024YTD

Pharmaceutical Technology

However, caution persists:166 of 785 US venture-backed companies with an innovator drug in development have not raised capital since 2021.

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Teva, Sanofi score well with anti-TL1A drug in IBD test

pharmaphorum

Phase 2b results with Sanofi and Teva's duvakitug are exciting and warrant a swift move to phase 3 in inflammatory bowel disease, say the companies.

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GSK’s lung cancer therapy gains EMA PRIME designation

Pharmaceutical Technology

GSKs GSK227 has gained Priority Medicines (PRIME) designation from the EMA for the treatment of relapsed ES-SCLC.

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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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Granules Pharmaceuticals gains U.S. FDA approval for Lisdexamfetamine Dimesylate chewable tablets

Express Pharma

Granules India, through its wholly-owned foreign subsidiary Granules Pharmaceuticals (GPI), has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The product, available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, is bioequivalent to Vyvanse Chewable Tablets by Takeda Pharmaceuticals USA.

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Bavarian Nordic signs mpox vax deal with Serum Institute of India

Pharmaceutical Technology

Bavarian Nordic has signed a licence and manufacturing agreement with the Serum Institute of India (SII) for its mpox vaccine, MVA-BN.

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AbbVie acquires Roche immune drug spinout in $200 million deal

Outsourcing Pharma

AbbVie acquires Nimble Therapeutics in $200M deal to advance oral peptide therapies for autoimmune diseases.

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The Importance of CDMO Flexibility: Adapting to the Ever-Changing Pharmaceutical Landscape

Drug Patent Watch

Flexibility has become more than just a buzzword it’s a necessity. Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. But what exactly makes flexibility so important for CDMOs, and how can they cultivate this essential trait? Let’s dive into the world of pharmaceutical outsourcing and explore why adaptability is the key to success.

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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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Study backs Closed Loop's drug+digital blood pressure plan

pharmaphorum

Closed Loop Medicine's smartphone app for blood pressure monitoring has shown proof-of-concept in the Cure-19 study.

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Maternal mortality trends are dire — and reversing them remain an uphill battle

BioPharma Dive

Rising maternal mortality, particularly among vulnerable groups, has roots in insufficient research involving pregnant women.

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6 PioneerRx Features to Promote Customer Retention

PioneerRx

In todays day and age, its essential to have modern and adaptable pharmacy technology. Your pharmacy software plays an integral role in its success.

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Pharma’s ‘Best-Kept Secret’

PharmExec

Margaret Keegan, the new CEO of Precision Medicine Group, is eager to elevate the profile of the expert-rich service provider and build it into an industry leader in next-gen drug development and commercialization support.

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Trade & Channel Strategies 2024: Boosting Patient Support & Engagement Across Care Settings

Pharmaceutical Commerce

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, discusses "Enhancing Patient Access and Support Through Technology: A Comprehensive Assessment," and upcoming industry challenges.

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