October, 2022

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Boston University researchers’ testing of lab-made version of Covid virus draws government scrutiny

STAT

Research at Boston University that involved testing a lab-made hybrid version of the SARS-CoV-2 virus is garnering heated headlines alleging the scientists involved could have unleashed a new pathogen. There is no evidence the work, performed under biosecurity level 3 precautions in BU’s National Emerging Infectious Diseases Laboratories, was conducted improperly or unsafely.

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A longtime believer in mRNA, Strand Therapeutics’ co-founder is now pushing the tech to the next level

PharmaVoice

The company’s co-founder and head of R&D on how it’s using synthetic mRNA to create “smarter” therapies that could provide cures for cancer and more.

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Meet Florence, WHO’s AI-powered digital health worker

pharmaphorum

An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.

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Robotic capsule could replace injected biologics

European Pharmaceutical Review

Scientists at MIT have demonstrated that a novel robotic capsule could potentially replace conventional biologic injection methods by tunnelling through the intestinal mucus barrier to deliver insulin. The research, published in the journal Science Robotics described how the new drug delivery system can transport large protein and small-molecule drugs, like vancomycin, an antibiotic peptide.

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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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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

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Thérèse Coffey criticised for giving leftover antibiotics to a friend

The Guardian - Pharmaceutical Industry

Health secretary accused of ‘monumental stupidity’ for saying she had shared a prescribed medication Doctors have rounded on the health secretary, Thérèse Coffey, after she admitted to sharing prescription medicines with others, actions the British Medical Association described as both dangerous and against the law. Coffey told civil servants in a meeting last month that she had given leftover antibiotics to a poorly friend, an admission that came as the discussion on how to alleviate pressures

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The digital therapeutics revolution is happening and Big Pharma is buying in — with caution

PharmaVoice

Companies like Pfizer, Novartis, Sanofi and BMS are diving into the world of digital therapeutics while recognizing the limitations of the young field.

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Verge Genomics takes AI-sourced drug for ALS into clinic

pharmaphorum

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

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Novel cancer therapeutic synthesised by Stanford researchers

European Pharmaceutical Review

Research published in the journal Nature Chemistry , shows how researchers from Stanford University in the US uncovered a promising new method to synthetically manufacture the compound tigilanol tiglate, named EBC-46, which could offer targeted medicine for cancer and other diseases. Natural sources of the compound can only be found in a small section of the Northeastern Australia rainforest, in fruit seeds from the blushwood tree ( Fontainea picrosperma ).

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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

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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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PDUFA and BsUFA reauthorizations are wins for patients

PhRMA

America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) are both great news for biopharmaceutical innovation and for patients. With these programs reauthorized for another five years, the FDA can continue doing its vital work reviewing medicines.

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Opinion: Messaging — the unrecognized coefficient in pandemic control — matters

STAT

A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.

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Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

PharmaVoice

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

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Janssen leads effort to cut waste in digital health devices

pharmaphorum

A consortium of industry and academic groups – led by Johnson & Johnson’s pharma division Janssen – has been set up to tackle the environmental impact of digital health products, specifically aimed at minimising waste that could end up in landfill. The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” The programme

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Tackling immune-mediated disease with CAR Tregs

European Pharmaceutical Review

In recent years there has been significant development within the cell therapy field, as chimeric antigen receptor (CAR) T-cell therapy demonstrated an ability to transform the treatment of patients with haematological malignancies. Recognising the potential of CAR T cells to act as highly targeted therapeutics, several biotechnology companies – including Sangamo Therapeutics – have established development pipelines of CAR T regulatory cells (Tregs) that aim to tackle immune?

Immunity 124
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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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Identifying and addressing health disparities: PhRMA's first chart pack on health equity

PhRMA

PhRMA is proud to announce the release of its first ever chart pack on health equity. This chart pack contains information on health equity in three sections: (1) A Snapshot of Health Disparities in America, (2) Inequities in Access to Screenings and Medicines Allow Health Disparities to Persist, and (3) PhRMA’s Commitment to Building a More Equitable Health Care System for All.

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Human neurons implanted in a rodent’s brain lead a rat to water — and make it drink

STAT

The scientist flicked on a laser, filling the rat’s brain with blue light. The rodent, true to its past two weeks of training, scampered across its glass box to a tiny spout, where it was duly rewarded with a drink of water. From the outside, this would appear to be a pretty run-of-the-mill neuroscience experiment, except for the fact that the neurons directing the rat to its thirst-quenching reward didn’t contain any rat DNA.

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Woman of the Week: HBA’s Nikki Jones

PharmaVoice

As the Healthcare Businesswomen’s Association’s first chief people and DEI officer, Jones is poised to tackle pay gap inequity, systemic gender bias and leadership barriers impeding women of color.

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Positive in vitro results for Imutex’s FLU-v

Pharma Times

Data further supports the continued development of FLU-v as a broad-spectrum influenza vaccine

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CHMP recommends Pluvicto® for treating advanced prostate cancer

European Pharmaceutical Review

Novartis announced that The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Pluvicto ® radioligand therapy for treatment of patients with prostate cancer. Pluvicto combines a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope (in this case lutetium-177).

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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Merck’s Lagevrio ‘no better than placebo’ in COVID hospitalisations

pharmaphorum

A UK study has found that Merck & Co’s oral COVID-19 therapy Lagevrio was unable to reduce hospitalisations compared to placebo in patients at higher risk from the virus, adding fuel to assertions in some quarters that its authorisation was premature. The 25,000-subject PANORAMIC trial conducted by researchers at Oxford University looked at the addition of a five-day course of Lagevrio (molnupiravir) to standard care in people aged over 50, or adults aged 18 and over with conditions th

Vaccines 116
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Which diet and health habits are backed by science? Now there’s a tool for that

STAT

Does eating red meat increase one’s risk of heart disease? Would eating more vegetables help? Is leaving high blood pressure untreated really a death wish? The answers might vary, depending on who a person asks, which friend or TikTok nurse, and when. Researchers at the University of Washington want to make it easier to find current, evidence-based health advice.

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J&J reveals just how much economic turbulence is affecting Big Pharma

PharmaVoice

The healthcare giant showed pharmaceutical gains, but that's no thanks to the economic environment of persistent inflation and a strong U.S. dollar.

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‘Junk’ DNA may hold the key to neurological disorders

Pharma Times

University of Lincoln and the University of Sheffield are researching how DNA could be repaired

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Growth in Cell and Gene Therapy Market

PharmaTech

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

Vaccines 115
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Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

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Nobel Prize in medicine awarded for research into the evolutionary history of humankind

STAT

A Swedish scientist won the 2022 Nobel Prize in medicine or physiology on Monday for his groundbreaking research into the evolutionary history of humankind. Svante Pääbo, of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, accomplished something widely believed to be impossible: recovering and reading DNA from 40,000-year-old bones.

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Backed by celebrity interest, Novo is finding new success in weight loss — while staying true to its roots

PharmaVoice

The company's head of U.S. and Canadian operations explains how the company is evolving its game plan after 100 years in the insulin space.

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FlyPharma: airea

Pharma Times

The Airport Region in Central Germany’ presents itself as an attractive location for the international pharmaceutical industry

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RemeGen receives ODD for myasthenia gravis treatment

European Pharmaceutical Review

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallisable

Immunity 113
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Pfizer acquires Global Blood Therapeutics for $5.4bn

Pharmaceutical Technology

Pfizer has acquired all the outstanding shares of the common stock of biopharmaceutical firm Global Blood Therapeutics (GBT) in a deal worth nearly $5.4bn. The total enterprise value comprised debt and the net of cash acquired. With the latest acquisition, GBT became a wholly-owned Pfizer subsidiary. GBT discovers and develops life-changing therapies for ailments with an initial focus on sickle cell disease (SCD).

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Novartis drops presbyopia drug acquired with Encore Vision

pharmaphorum

Novartis has abandoned development of its drug to treat presbyopia, a common age-related loss of near distance vision, after it failed a phase 2b trial. The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision for $375 million upfront in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.

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