Tue.Oct 31, 2023

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Second recipient of genetically modified pig heart dies, six weeks after surgery

STAT

Nearly six weeks after his surgery, the world’s second recipient of a genetically modified pig heart has died, the University of Maryland announced Tuesday. Lawrence Faucette, a 58-year-old resident of Frederick, Md., with terminal heart disease, died Monday. He had received the experimental xenotransplant on September 20 at the University of Maryland Medical Center in an eight-hour operation.

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Roche’s $7B Roivant deal was a ‘moment of opportunity,’ CEO says

PharmaVoice

Roivant CEO Matt Gline and Telavant CEO Frank Torti know Roivant’s position as buyers and sellers in the pharma industry, and they’re embracing those opportunities.

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Opinion: I lost my son to OxyContin. ‘The Fall of the House of Usher’ is my Sackler revenge fantasy

STAT

Editor’s note: This essay contains spoilers for the Netflix show “The Fall of the House of Usher.” “W atch “ The Fall of the House of Usher” on Netflix when you can. F**cking Great! Totally based on the Sacklers—Fictional obviously but so damn good!

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Wisp’s ‘bold and unapologetic approach’ to women’s sexual and reproductive health

PharmaVoice

In the role of interim CEO of Wisp, Monica Cepak aims to break down barriers and expand access via telehealth.

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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+: Tracking the FDA advisory panel on the first CRISPR-based treatment for sickle cell disease

STAT

The Food and Drug Administration is convening a meeting of outside experts on Tuesday to review exa-cel, a CRISPR-based treatment for sickle cell disease made by Vertex Pharmaceuticals and CRISPR Therapeutics. Tuesday’s meeting is set up a bit differently than most FDA advisory panels. The agency has not raised any concerns about exa-cel’s efficacy or safety, and there will not be a typical vote at the end of the day on whether the data from exa-cel’s pivotal clinical trial

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Vertex, CRISPR therapy for sickle cell passes FDA panel test

BioPharma Dive

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

BioPharma Dive

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

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STAT+: Eli Lilly to pay $200 million for Beam’s share of drugs from gene-editing firm Verve

STAT

Eli Lilly said Tuesday that it will pay $200 million to gene-editing firm Beam Therapeutics for Beam’s stake in Verve Therapeutics, another gene-editing company focused on treatments for heart disease. The deal, which also includes future milestone payments, is evidence that despite the pressure on biotechnology stocks there is still interest in very early cutting-edge technologies among big pharmaceutical players.

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NHS patients to be offered the opportunity to travel for treatment

Pharma Times

Around 400,000 eligible patients are set to benefit from the travel offer - News - PharmaTimes

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How skeptical should you be of an after-the-fact subgroup analysis in a failed clinical trial?

STAT

This article was adapted from STAT’s latest report , “Subgroup analysis: how to evaluate post hoc tests for significance in failed clinical trials.” C linical trials of newly developed drugs often don’t work out.

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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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GPhC announces new executive appointees

The Pharmacist

A new chief pharmacy officer and deputy registrar has been appointed at the General Pharmaceutical Council (GPhC) to help provide pharmacy leadership across the organisation and ‘influence progress at an exciting and challenging time’ for the profession. Roz Gittins has been announced as the new chief pharmacy officer and deputy registrar of the GPhC, while […] The post GPhC announces new executive appointees appeared first on The Pharmacist.

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New CDC campaign asks health care leaders to take responsibility for reducing burnout

STAT

Often, workplace conversations about burnout put the onus on the individual to take care of their mental health while ignoring management’s role in solving the problem. A new anti-burnout campaign from the Centers for Disease Control and National Institute for Occupational Safety and Health avoids this typical — and often frustrating — tactic, instead imploring leaders to better support health care workers.

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New patent for Astrazeneca drug CALQUENCE

Drug Patent Watch

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

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STAT+: Medicare is urged to consider Amgen patent maneuvers when negotiating the price for a drug

STAT

As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026. At issue is the Enbrel medication sold by Amgen for treating rheumatoid arthritis and other ailments.

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Teamwork for Better Healthcare Solutions: Merging Clinical and Marketing Efforts

PharmExec

In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.

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La ‘paradoja hispana’ intriga a una nueva generación de investigadores decididos a resolverla

STAT

Read in English | Leer en inglés. D urante 40 años, los investigadores han intentado sin éxito explicar –o desacreditar– la “paradoja hispana”, es decir, la constatación de que los hispanoamericanos viven varios años más que los estadounidenses blancos por término medio, a pesar de disponer de ingresos y atención sanitaria mucho menores, y mayores tasas de diabetes y obesidad.

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FIP calls for guidance on optimising skill mix

The Pharmacist

Pharmacy teams in all settings, but particularly those in primary care, need guidance on making the best use of skill mix, the International Pharmaceutical Federation (FIP) has said. It called for tools such as a competency development framework to support the development of ‘a range of progressive roles for pharmacists’, including within preventive healthcare and […] The post FIP calls for guidance on optimising skill mix appeared first on The Pharmacist.

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Opinion: Health care providers need help to treat patients during extreme heat events

STAT

The world’s hottest summer on record is now bleeding into the fall. Instead of enjoying a cool respite from the heat, millions of Americans started September enduring temperatures so high that schools were forced to close across the country. Extreme heat continued into October, leading organizers to cancel the Twin Cities Marathon due to a forecasted high of 91 degrees — 25 degrees higher than normal for Minneapolis and St.

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Zydus acquires LiqMeds Group

Express Pharma

Zydus Lifesciences, through its wholly owned subsidiary Zydus Pharmaceuticals UK, announced the acquisition of the UK headquartered LiqMeds Group of companies which has capabilities and specialisation in development, manufacturing and supply of oral liquid products for global markets, which it currently commercialises through partners. The group’s subsidiary LM Manufacturing, has an oral liquids manufacturing site at Weedon, Northampton, UK, which supplies products to the US and UK markets.

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Sarepta’s disappointing data put the FDA in a difficult spot

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, all. Damian here with disappointing news on a closely watched gene therapy, an interesting deal in genome editing, and the long shadow of biotech’s slump.

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High-performance computing could improve therapy for hard-to-treat cancer

Pharma Times

Researchers reduced 4D-MRI image reconstruction times to 60 seconds - News - PharmaTimes

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STAT+: Pharmalittle: Sarepta Duchenne therapy misses primary endpoint; FDA holds panel for first CRISPR treatment for sickle cell

STAT

Rise and shine, everyone, another busy day is on the way. We can tell by the early hour the official mascots bounded outdoors to chase their breakfast and the increasing volume of traffic passing by the Pharmalot campus. Moreover, some may also note today is when a parade of odd-looking individuals may knock on your door. Beyond the usual cup of stimulation — our choice today is the seasonal pumpkin spice — this calls for a treat or two.

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Weekly injection shows promise for type 1 diabetes

European Pharmaceutical Review

Insulin icodec, a once-weekly basal injection to treat type 1 diabetes, has the potential to be as effective in managing the condition as daily basal insulin treatments, according to results of the year-long ONWARDS 6 Phase IIIa clinical trial, recently published in the Lancet. The study, conducted at 99 sites across 12 countries tested the efficacy and safety of a weekly basal injection of icodec (a long-lasting type of insulin) and compared it to a daily basal injection of insulin degludec in

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Biocon at No. 8 in Science Magazine’s list of best employers in biotech and pharma

Express Pharma

US-based Science magazine has ranked Biocon at No. 8 in 2023 amongst the Top 10 Employers in the global biotech, pharma and biopharma sector. Employees across Biocon and Biocon Biologics participated in the annual Top 20 Employers Survey, which Science magazine has been conducting for over a decade. Biocon has featured on the Science Top Employers list of the world’s pre-eminent pharma, biotech, and biopharma employers for 11 consecutive years, informed a company statement.

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ArriVent’s lung cancer therapy gains FDA breakthrough therapy status 

Pharmaceutical Technology

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

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FDA grants permission for clinical investigations into iOnctura's roginolisib

Outsourcing Pharma

It was announced today (October 31), that the US Food and Drug Administration (FDA) has granted permission to proceed with clinical investigations of small molecule treatment, roginolisib.

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Tackling health inequalities: The need for ‘cultural competence’ in all services

The Pharmacist

Mohammed Omar Sarwar’s pharmacy has only delivered a few contraception service consultations so far – but they have all been to young Caucasian women. ‘We haven't seen any diversity within that service,’ Mr Sarwar tells The Pharmacist, despite the fact that ‘the need for contraception is across the board’. Based in what he describes as […] The post Tackling health inequalities: The need for ‘cultural competence’ in all services appeared first on The Pharmacist.

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Lilly buys out Beam in heart drug alliance with Verve

BioPharma Dive

Already a partner to Verve, the pharma is paying $200 million upfront and investing another $50 million in Beam to acquire option rights to several gene editing programs.

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Drug Channels News Roundup, October 2023: CVS & Humira Biosimilars, GLP-1 G2N Bubble, 340B Abuses, Rite Aid's Endgame, Mark Cuban Update, and an Epic Meetup

Drug Channels

Zoinks! It's time for a super-sized Halloween roundup of wicked Drug Channels ’ tales. This month’s tricks and treats: Spooky! CVS Health frightens all but one Humira biosimilar maker away from its formulary. Creepy! The gross-to-net bubble for anti-obesity GLP-1 drugs walks among us. Grotesque! Penn Medicine gorges on the 340B program. Vampiric!

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M&G’s Catalyst invests $57 million with SkyCell to improve transportation of temperature-controlled medicines

Outsourcing Pharma

M&G Investments has made a $57 million investment with Swiss-based tech firm, SkyCell and says it is seeking to change the face of international pharma supply chains.

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Express Pharma November 2023

Express Pharma

Beyond Manufacturing: Broadening Horizons of CDMOS Click to download: November 2023 Digital Magazine The post Express Pharma November 2023 appeared first on Express Pharma.

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Sygnature Discovery invests £3.75 million in Azenta storage system

Outsourcing Pharma

Integrated drug discovery contract research organization (CRO) Sygnature Discovery has invested Â3.75 million in an Azenta compound management storage system that can also provide customer libraries.

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Epigenetically acting drugs could support cancer immunotherapy

World Pharma News

Epigenetically active drugs enable the cell to read parts oft he genome that were previously blocked and inaccessible. This leads to the formation of new mRNA transcripts and also new proteins, as scientists from the German Cancer Research Center and the University Hospital Tübingen have now published. These "therapy-induced epitopes" could help the immune system recognize cancer cells.

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Pfizer RSV vaccine gets off to fast start on market

BioPharma Dive

The pharma’s shot Abrysvo made over $300 million in sales during the first few months of its launch, and will be an important product to help offset declining COVID vaccine sales.

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Exploring sustainable cooling solutions for freeze dryers

PharmaTech

This article addresses new alternatives in industrial refrigeration systems ready to comply with current and future regulations, applicable for both new and existing freeze

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