Thu.Aug 17, 2023

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STAT+: Health care CEOs hauled in $4 billion last year as inflation pinched workers, analysis shows

STAT

The health care industry didn’t just provide a safe haven for jittery stock investors in 2022, a year defined by inflation and higher interest rates. It also provided a stable stream of wealth for top executives, who collectively pocketed billions of dollars in what was otherwise a rough patch for the economy. By almost every measure, 2022 was a bad year for the stock market.

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How an AstraZeneca exec is leading the charge in the next immuno-oncology era

PharmaVoice

The pharma giant’s head of immuno-oncology is now charging toward the next step in the cancer fight with long-term survival and precision.

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Trending Sources

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New definition of a human embryo proposed amid rapid scientific advances

STAT

When someone says the word embryo, what do you think of? Probably that picture you’ve seen a thousand times on a thousand different news articles: a translucent orb swelling with cytoplasm being prodded by a microinjection needle under the light of a microscope. The mainstreaming of IVF, or in vitro fertilization, has familiarized new generations of people with what the earliest stages of human development entails.

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Gilead antibody drug shows signs of potential in early lung cancer

BioPharma Dive

A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.

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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+: South Africa ordered to disclose contracts with Pfizer, J&J, and other Covid-19 vaccine suppliers

STAT

A South African court ruled the government must disclose contracts signed with pharmaceutical companies for Covid-19 vaccines, a victory for advocates who alleged that authorities may have overpaid for the shots and that the lack of transparency masked pharmaceutical profits at the public’s expense. At issue are contracts signed by the South African government with several companies — including Johnson & Johnson and Pfizer — that provided millions of Covid-19 vaccines du

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New patent for Bracco drug LUMASON

Drug Patent Watch

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

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NICE gives go ahead to digital platforms for weight loss services

The Pharmacist

NICE has recommended four digital platforms to be used by NHS weight management services to help assess patients and prescribe weight-loss medication for obesity. Draft guidance has proposed the use of platforms that can help clinicians support patients psychologically, provide monitoring, and even allow prescription. The platforms put forward – Liva, Oviva, Roczen, and Second Nature […] The post NICE gives go ahead to digital platforms for weight loss services appeared first on The Pharma

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Opinion: Medicare beneficiaries deserve access to genetic counselors

STAT

Precision medicine driven by genetic health care is knocking on the door. It offers hope that, sooner than later, we can address health problems like Alzheimer’s disease, cancer, and heart disease that affect the lives of so many Americans. For many patients, the first step will be genetic testing and counseling by a board-certified genetic counselor.

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LPC 175 CONCLAVE TO BE HELD IN MUMBAI

Express Pharma

Event: LPC 175 Conclave: Mumbai Organiser: Live Pharma Coalition Theme: Future of Pharma: Challenges & Opportunities Date: September 3, 2023 Time: 09:00 am – 05:30 pm Venue: Auditorium, SIES School of Business Studies, Nerul, Navi Mumbai Speakers Yogesh Kaushal, President, Alkem Laboratories OP Singh, Global CEO, Akums Drugs Venugopal Vijayendran, President, Intas Pharma Shahbaz Alam, President, Pharma Ratna Manoj Saxena, MD, Bayer India & SE Asia Dilip Singh Rathore, President India Bus

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Listen: Racing for gene therapy, a pioneering approval, & startups in the lurch

STAT

What difference does a day make? Who gets to have gene therapy? And are biotech startups OK? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Jason Mast joins us to explain how the approval of a landmark gene therapy for Duchenne muscular dystrophy set in motion a frantic race to get children treated before their 6th birthdays.

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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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NICE gives green light for MSD's Keytruda

Pharma Times

The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study - News - PharmaTimes

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Opinion: The definition of clinical trial diversity must include disabled people

STAT

There are people in your life who influence and shape how you see the world. For me, one of these people is Terry Moakley, a warm and welcoming family friend, a veteran of the Vietnam War, and a fervent advocate for people with disabilities. After he became a quadriplegic as a result of an injury, he began a decades-long career dedicated to improving disability access.

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Incorrect cuff size can significantly impact BP readings

The Pharmacist

Using the incorrect cuff size when taking blood pressure measurements can lead to significant over and under-estimations, according to the findings of a randomised trial by US researchers. Although clinical practice guidelines recommend the selection of an appropriately sized cuff based on mid-arm circumference before taking a blood pressure (BP) reading, the extent to which miscuffing […] The post Incorrect cuff size can significantly impact BP readings appeared first on The Pharmacist.

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STAT+: Blue Shield of California overhauls drug pricing operation — by adding more vendors

STAT

Blue Shield of California, a health insurance company that covers almost 5 million people, is restructuring how it will pay for prescription drugs by dividing the work up among five different vendors — two of which include Amazon and Mark Cuban’s pharmacy company. Starting in 2024, Blue Shield will rely less on CVS Health’s pharmacy benefit manager, CVS Caremark, a move that led Wall Street to sell off CVS’ stock by more than 9%.

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Hikal gets Brazilian GMP certification and US FDA EIR for Bangalore and Panoli facilities

Express Pharma

Hikal announced the receipt of two certifications – the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) confirming the NAI status and the Good Manufacturing Practice (GMP) Certification known as Certificado de Boas Práticas de Fabricação (CBPF) by the Regulatory Authority of Brazil, Agência Nacional de Vigilância Sanitária (ANVISA).

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STAT+: ActiGraph executives on why getting digital endpoints approved for drug trials matters

STAT

As drugmakers wade into using digital health technologies, ActiGraph has made its mission to become the wearable of choice for the industry. The Pensacola, Fla.-based company creates  devices and software explicitly designed for clinical trials by focusing on features that matter to sponsors, like bulletproof reliability, access to raw sensor data, and 30-day battery life so that trial participants never have to worry about charging devices.

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CDMO to manufacture SARS-CoV-2 intranasal vaccine

European Pharmaceutical Review

The National Institutes of Health (NIH) has chosen contract development, and manufacturing organisation (CDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19. As an alternative drug delivery method to traditional injected vaccines, live, replicating, intranasal vaccines have potential for effectively interrupting transmission of COVID-19 by inducing the development of immunity in the respiratory tract.

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STAT+: ViiV Healthcare and Doctors Without Borders tussle over contract terms for an HIV drug

STAT

A feud has erupted between ViiV Healthcare and Doctors Without Borders over a deal to allow the relief organization to purchase an injectable HIV prevention drug, the latest fracas involving the company and efforts to distribute its medication to mostly poor locations around the world. The dispute hinges on a move by the ViiV, which is largely controlled by GSK, to add certain last-minute conditions to a procurement agreement, according to Doctors Without Borders.

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Venus Remedies launches its flagship R&D drug Elores in Oman

Express Pharma

Venus Remedies has launched its R&D drug, Elores, in Oman. Elores is effective against bacterial strains resistant to the last-resort carbapenem class of antibiotics. It is clinically proven to be effective against ICU infections caused by multidrug-resistant extended spectrum beta lactamase (ESBL) and metallo beta lactamase (MBL) -producing gram negative bacteria.

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STAT+: Pharmalittle: U.S. appeals court upholds limits to abortion pill; ‘knock-off’ Ozempic thrives on ‘bogus’ website

STAT

Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation. But this is to be expected at this time of year, yes? Our choice today, by the way, is pumpkin spice. In any event, there is work to be done, so as always, we have assembled a few items of interest for you.

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Parexel, Partex announce alliance to leverage AI, Big Data to accelerate drug discovery and development

Express Pharma

Parexel and Partex announced a preferred strategic alliance designed to leverage artificial intelligence (AI)-powered solutions to accelerate drug discovery and development for biopharma customers worldwide. Parexel’s expertise across Phase I to IV clinical development combined with Partex’s big data and AI capabilities is expected to further advance the efforts of drug developers working to understand the probability of clinical success of assets in their portfolio and recommend oth

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Immunotherapy combo could overcome melanoma anti-PD-1 resistance

European Pharmaceutical Review

Use of the immune checkpoint inhibitor immunotherapy drug ipilimumab plus nivolumab has been shown to be effective as second-line therapy in metastatic melanoma that is resistant to PD-1 inhibitors. In a Phase II clinical trial, the anti-cancer treatment extended progression-free survival (PFS) by 37 percent compared to participants who received ipilimumab alone.

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New appointments: Who are the movers and shakers in pharma?

Outsourcing Pharma

BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers and shakers in the pharma industry. From Karuna Therapeutics to IO Biotech, we break down the key changes on the pharmaceutical job ladder.

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AbbVie gains EU migraine treatment approval

European Pharmaceutical Review

Recent EU approval means adults who have four or more migraine days per month can now access the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant). Authorisation of AbbVie’s AQUIPTA ® (atogepant) by the European Commission (EC) is based on two Phase III studies which demonstrated that “AQUIPTA provides significant and sustained reduction of mean monthly migraine days [for both chronic and episodic migraines ],” stated Dr Patricia Pozo-

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Elfabrio receives vital MHRA authorisation

Pharma Times

The therapy involves long-term enzyme replacement therapy for aduls with Fabry disease - News - PharmaTimes

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Amicus CEO 'proud of relentless commitment' to make Pompe disease treatment available

Outsourcing Pharma

The UKâs Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombliti + Opfolda, a two-component therapy to treat Pompe disease.

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Covid booster jabs to be approved for sale to UK public

The Guardian - Pharmaceutical Industry

Health officials support proposal for private provision of vaccines after age limit on NHS booster programme raised to 65 Covid booster vaccines are expected to become available for the UK public to buy for the first time after health officials supported the proposal. Pharmacists and private clinics will be allowed to offer jabs for sale on the high street, as they do with the flu vaccine.

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Raw Materials Testing for Cell & Gene Therapy Manufacturing (Aug 2023)

PharmaTech

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

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CPHI Milan to be hosted at Fiera Milano and Lombardy Pharma Region for 2024

Express Pharma

CPHI, the global pharma exhibition, organised by Informa, will be held in Fiera Milano (Rho) from October 8-10, 2024. It will be hosted in the city of Milan for the second time in three years in recognition of the massive pharma ingredients and manufacturing industry in the region. Italy is one of Europe’s largest producers and exporters of ingredients – around 85 per cent are exported to North America, the EU and Japan – with the Milan region at the centre of its pharma base.

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Adherence to a Mediterranean lifestyle associated with lower risk of all-cause and cancer mortality

World Pharma News

People who adhere to a Mediterranean lifestyle - which includes a diet rich in fruits, vegetables, and whole grains; healthy eating habits like limiting added salts and sugars; and habits promoting adequate rest, physical activity, and socialization - have a lower risk of all-cause and cancer mortality, according to a new study led by La Universidad Autónoma de Madrid and Harvard T.H.

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UK sets aside £210m for antimicrobial resistance project

pharmaphorum

UK sets aside £210m for antimicrobial resistance project Phil.

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Further investment for BDD Pharma after £2M funding round

Outsourcing Pharma

Integrated drug formulation and clinical trials company, BDD Pharma, will be expanding its phase appropriate development, manufacturing, and clinical testing services after a Â2 million ($1.3 million) investment.

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Unlocking superpower status: The crucial role of space in scaling up

pharmaphorum

Unlocking superpower status: The crucial role of space in scaling up Mike.

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Further Discussion on Plasmids to Establish Release Specifications Using a Risk-Based Approach to Manage Supply (Aug 2023)

PharmaTech

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

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Changing Faces: Pharma and biotech hires from July 2023

pharmaphorum

Changing Faces: Pharma and biotech hires from July 2023 Mike.

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