Sat.May 01, 2021 - Fri.May 07, 2021

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Janssen seeks EU approval for first CAR-T therapy cilta-cel

Pharma Times

Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma

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Biden Backs Suspending Patents on Covid Vaccines

NY Times

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

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Why relationships are key in rare disease patient engagement

pharmaphorum

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards. It is difficult to get data on rare diseases and the people who live with them by their very nature. But these patients face unique challenges in their everyday lives that pharma needs to account for when developing treatments, and understanding these challenges requires strong real-world

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Explore vital drug delivery innovations at online event

Outsourcing Pharma

On May 5, a panel of experienced industry experts will discuss recent developments during Innovations in Drug Delivery, a free one-hour industry webinar.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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AZ' Tagrisso first to win MHRA approval under Project Orbis

Pharma Times

Decision brings the innovative treatment to early-stage lung cancer patients, helping to address unmet need in this setting

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After a Decade Without Executions, South Carolina’s Solution: Bring Out the Firing Squad

NY Times

State lawmakers have voted to add the firing squad as an alternative to the electric chair or lethal injection, with the drugs used for capital punishment in short supply.

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CPhI survey: pharma leaders optimistic about the future

Outsourcing Pharma

According to a recent survey of executives conducted by CPhI, COVID-19âs impact is driving manufacturing and CDMOs are fueling industry growth.

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Vectura, Inspira team up to develop inhaled COVID-19 drug

Pharma Times

The deal will see Vectura test Inspira's inhaled IPX formulation candidates

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Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine

NY Times

The company said its vaccine generated $3.5 billion in revenue in the first three months of this year.

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Hidden compliance risks for life sciences companies

pharmaphorum

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target for regulators.

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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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New patent for Teva Pharm drug ARMONAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are nineteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

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Preliminary NICE 'no' for Merck's Bavencio

Pharma Times

The cost regulator has rejecting funding the drug as maintenance treatment of advanced/metastatic urothelial cancer

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Pfizer Seeks Full FDA Approval for Its Covid-19 Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months.

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MDMA on track for 2023 approval as PTSD therapy, says developer

pharmaphorum

A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it. . The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) is leading the development of MDMA and has just reported top-line results from a phase 3 trial of the drug combined with psychotherapy that it says could form the basis of a marketing application to the US reg

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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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New patent expiration for Gilead Sciences drug ATRIPLA

Drug Patent Watch

Annual Drug Patent Expirations for ATRIPLA Atripla is a drug marketed by Gilead Sciences and is included in one NDA. It is available from two suppliers. There are nine patents…. The post New patent expiration for Gilead Sciences drug ATRIPLA appeared first on DrugPatentWatch - Make Better Decisions.

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Researchers identify new genetic target for acute myeloid leukaemia

Pharma Times

Targeting a specific mutation in the CUX1 gene may offer a ‘new therapy avenue’ for AML patients

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W.H.O. Approves China’s Sinopharm Vaccine for Emergency Use

NY Times

Sinopharm is the first Chinese shot to be classified as safe and effective by the World Health Organization, allowing the vaccine to be more widely distributed to poor and middle-income nations.

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Silence Tx uses game to raise thalassaemia awareness

pharmaphorum

UK biotech Silence Therapeutics has launched an online game to raise the profile of the rare blood disorder thalassaemia, and one of its most common symptoms. . Blood Run Beta can be played online at www.bloodrunbeta.game and has been launched in the build-up to International Thalassaemia Day on Saturday 8 May. It aims to help players learn more about the daily impact of thalassemia and in particular fatigue, which can have a significant impact on patients’ daily lives.

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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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Which pharmaceutical companies have the most SPCs in France?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in France. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in France? appeared first on DrugPatentWatch - Make Better Decisions.

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AZ’s Farxiga scores US approval in chronic kidney disease

Pharma Times

SGLT2 inhibitor approved for high-risk patients with and without type 2 diabetes

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Pfizer Seeks Full F.D.A. Approval for Its Covid Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months.

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Pfizer shares slump as support grows for COVID-19 vaccine patent waiver

pharmaphorum

Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost global supplies of the life-saving shots. Waiving the patent on proprietary knowledge would allow it to be shared with other manufacturers and the matter is being discussed by the World Trade Organization’s General Council today.

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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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Finding the right partners key to decentralized trials: Illingworth

Outsourcing Pharma

A leader from the mobile research nursing specialist offers advice on what to look for in a service provider, and why finding the right one is vital.

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UK launch for progressive multiple sclerosis mega-trial

Pharma Times

It is hoped that the multi-armed Octopus trial will rapidly speed up development of new treatments

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Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

NY Times

Millions of doses of Johnson & Johnson’s Covid-19 vaccine produced by Emergent BioSolutions have been held back in Europe, South Africa and Canada as a precaution.

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Small Pharma stock market launch funds DMT-based depression drug trial

pharmaphorum

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to develop medicines based on N,N-dimethyltriptylene (DMT) to treat depression. Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries.

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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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People on the Move: May 2021

Outsourcing Pharma

This monthâs roundup of new hires, investment funding, partnerships, and other industry news includes key firms such as Clinical Ink, Medable, CPhI, and Sterling Pharma.

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NICE expands access for SMA drug Spinraza

Pharma Times

Managed access agreement treatment eligibility criteria extended following review

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Taking ‘Extraordinary Measures,’ Biden Backs Suspending Patents on Vaccines

NY Times

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

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Roche’s Tecentriq gets fourth European lung cancer indication

pharmaphorum

Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). Tecentriq (atezolizumab) has now been used in Europe for adults with metastatic NSCLC whose tumours have high PD-L1 expression. The tumours must also have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

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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.