STAT

AUGUST 22, 2024

WASHINGTON — U.S. regulators approved  updated Covid-19 vaccines  on Thursday, shots designed to more closely target recent virus strains — and hopefully whatever variants cause trouble this winter, too. With the Food and Drug Administration’s clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its updated vaccine version to be available a little later.

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Vaccines 362

PharmaVoice

AUGUST 22, 2024

Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.

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STAT

AUGUST 22, 2024

If you’d told Jim Wilson three years ago that he’d be stepping down as director of the University of Pennsylvania’s storied Gene Therapy Program, he wouldn’t have believed you. And yet he’s now doing exactly that. Wilson, a gene therapy pioneer who has spent decades devising ways to deliver functional copies of missing or defective genes to patients, recently announced that he’s leaving Penn to found a pair of companies focused on developing gene therapi

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Drug Development 355

PharmaVoice

AUGUST 22, 2024

There’s no link between revenue and R&D from smaller biotechs, and that’s where most innovation comes from, according to new studies.

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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.

STAT

AUGUST 22, 2024

LONDON — Leqembi, the Alzheimer’s treatment from Eisai and Biogen, has hit another roadblock reaching patients in Europe.  In draft guidance, the U.K.’s cost-effectiveness watchdog on Thursday said that the limited benefits of the drug, also called lecanemab , do not justify its costs, citing not just the price of the treatment but the related expenses of administering it and monitoring for side effects.

Drug Development 357

Drug Development 357

BioPharma Dive

AUGUST 22, 2024

The approval of both reformulated messenger RNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.

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Vaccines 113

Pharmaceutical Commerce

AUGUST 22, 2024

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

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STAT

AUGUST 22, 2024

The pharmaceutical industry has long operated on a one-size-fits-all model, developing drugs primarily tested on, and thus best suited for, people of European descent. This approach ignores — and potentially harms — the billions of people of color on the planet. Lack of diversity occurs at all levels of the pharmaceutical ecosystem, from the makeup of C-suite and research staffs to participation in clinical trials.

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Drug Development 315

Express Pharma

AUGUST 22, 2024

India’s healthcare sector is undergoing a surge in digital transformation, driven by a strong digital infrastructure and a growing economy. According to the latest ‘SME Digital Insights’ study by Tata Tele Business Services (TTBS) in collaboration with Cyber Media Research (CMR), 33 per cent of healthcare SMEs recognise the potential of big data analytics to enhance diagnostics, while 31 per cent see artificial intelligence (AI) as a valuable tool for streamlining operations and accelerating dr

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Communication Pharmaceutical Companies Pharmaceutical Companies 105

STAT

AUGUST 22, 2024

Over a year after Pear Therapeutics filed for bankruptcy and shut down, its smartphone apps for people with substance use disorder and opioid use disorder are again available to patients.  After acquiring Pear’s Food and Drug Administration-cleared apps, called reSET and reSET-O,in December 2023 , virtual addiction treatment company PursueCare this month began offering them to its patients.

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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.

Outsourcing Pharma

AUGUST 22, 2024

H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.

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STAT

AUGUST 22, 2024

Good morning, Pharmalittle fans! Adam Feuerstein here, filling in for Ed. I drink my morning coffee from a heavy, thick diner mug. I suggest you do the same. Here’s some news for your Thursday morning. … Eisai and Biogen secured approval in the U.K. for their Alzheimer’s treatment, Leqembi, but at the same time, the U.K.’s cost-effectiveness watchdog agency issued draft guidance that said the drug’s limited benefits do not justify its costs, STAT reports.

Vaccines 267

Vaccines 267

pharmaphorum

AUGUST 22, 2024

Discover how digital therapeutics (DTx) have evolved in the wake of COVID-19, and how they are changing the landscape of healthcare. Explore the fall and rise of DTx and their potential impact on patient care.

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STAT

AUGUST 22, 2024

What does the hiring of a well-known industry dealmaker mean for the future of BioMarin Pharmaceuticals? Can Eli Lilly’s blockbuster obesity medicine lower the risk of diabetes? And will Recursion Pharma, the AI drug developer, live up to all the hype? We discuss all that and more on this week’s episode of “The Readout LOUD.

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Diabetes Drug Development 278

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Express Pharma

AUGUST 22, 2024

Alkem MedTech, a wholly-owned subsidiary of Alkem Laboratories has entered into an agreement with Exactech, a global medical device company headquartered in Gainesville, Florida, USA, to manufacture and market Exactech’s large joint replacement implants in India. Exactech develops, manufactures and markets joint replacement implants, surgical instruments and smart technologies that enhance surgeons’ ability to improve patients’ mobility worldwide.

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The Guardian - Pharmaceutical Industry

AUGUST 22, 2024

Decision by Nice to rule out drug being available on NHS comes despite medicines licensing body giving green light The UK’s health regulator has rejected a drug that can slow the progression of Alzheimer’s disease, saying its benefits are too small to justify the costs of the therapy and close monitoring of patients for signs of “serious side-effects”.

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Outsourcing Pharma

AUGUST 22, 2024

In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.

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Express Pharma

AUGUST 22, 2024

Eugia Pharma, a wholly-owned subsidiary of Hyderabad-based Aurobindo Pharma received a warning letter from the USFDA. Eugia’s facility at Pashamylaram near Hyderabad was inspected between January 22 to February 2, 2024, after which serevral observations were issued. Subsequently, the company received Official Action Indicated (OAI) status in May 2024.

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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.

The Pharmacist

AUGUST 22, 2024

The UK medicines regulator has approved lecanemab – the first drug shown to slow cognitive decline in patients in the early stages of Alzheimer’s – but NICE said it was too costly for the NHS. NICE’s draft guidance, published today, has been put out for a four-week consultation after the committee concluded the benefits of […] The post NICE rules Alzheimer’s-slowing drug lecanemab too expensive for NHS appeared first on The Pharmacist.

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pharmaphorum

AUGUST 22, 2024

BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change

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Express Pharma

AUGUST 22, 2024

Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

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Chemotherapy Immunization Immunity 96

Pharmaceutical Technology

AUGUST 22, 2024

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

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Packaging 98

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Pharmacy Management

Pharmaceutical Commerce

AUGUST 22, 2024

The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.

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The Pharmacist

AUGUST 22, 2024

A consultation into the standardisation of pack sizes of oral nutritional supplements (ONS) has highlighted the potential for prescribing errors, patient safety risks, increased waste and cost, and increased workload for community pharmacists under the current system. The Advisory Committee on Borderline Substances (ACBS) has decided to explore these concerns before recommending any action on […] The post Oral nutritional supplement errors impact pharmacy workload appeared first on The Pha

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Pharma Times

AUGUST 22, 2024

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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pharmaphorum

AUGUST 22, 2024

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

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Pharma Times

AUGUST 22, 2024

The grant will support clinical trials of rare disease therapy for leukodystrophy

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BioPharma Dive

AUGUST 22, 2024

The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.

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pharmaphorum

AUGUST 22, 2024

Changing Faces explores the digital and supplier hires of July, including Biomedica, Signant Health, Arima Genomics, and more. Stay updated on this exciting industry.

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PharmaTech

AUGUST 22, 2024

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

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BioPharma Dive

AUGUST 22, 2024

Borealis Biosciences launches with money from Novartis, which last year bought the biotech’s predecessor for a pair of drugs that treat a rare kidney disorder.

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World Pharma News

AUGUST 22, 2024

Artificial intelligence (AI) can help identify molecules that could serve as new drugs for mental health disorders. AI can be used to predict the three-dimensional structures of important receptors and thereby speed up the development of potential drugs. This is the result of a new study from Uppsala University published in Science Advances. In drug development, experimental methods are often used to determine the three-dimensional structures of target proteins and to understand how molecules bi

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Drug Development 70