STAT

AUGUST 29, 2024

On Thursday, the California Department of Food and Agriculture announced it is investigating the possible introduction of H5N1 bird flu in cattle at three dairy farms in the Central Valley. If confirmed, they would be the first known cases in that state. In a statement, officials said testing of samples from the three farms is currently underway in the state’s veterinary diagnostic lab.

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PharmaVoice

AUGUST 29, 2024

Cognition Therapeutics touted what the C-suite saw as a promising mid-stage study in Alzheimer’s, but investors read a different story.

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STAT

AUGUST 29, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. We await one of the year’s biggest biotech readouts, and have lots of GLP-1 news today: Eli Lilly’s offer to slash pricing for Zepbound isn’t as magnanimous as it appears, and more.

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Drug Pricing Drug Development 297

BioPharma Dive

AUGUST 29, 2024

Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.

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STAT

AUGUST 29, 2024

I dreamed of having children from a young age — so much so that I assumed I had to be a cisgender woman. Society had taught me that only a cisgender woman would want so badly to carry and birth a child, so I suppressed any feelings that suggested I might not be a cisgender woman. I did not realize I was transgender until well after I had my children.

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BioPharma Dive

AUGUST 29, 2024

The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.

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Express Pharma

AUGUST 29, 2024

Indian Immunologicals Limited (IIL) has announced a partnership with the Central Institute of Brackishwater Aquaculture (CIBA), Chennai, an Indian Council of Agricultural Research (ICAR) institute. This collaboration aims to develop a recombinant monovalent viral nervous necrosis (VNN) vaccine for finfish, a technology developed by CIBA. IIL entered the aquaculture sector in October 2022, introducing products for pond management and fish or shrimp gut management.

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Vaccines 105

STAT

AUGUST 29, 2024

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. Labor Day is almost here, which means the sprint to the end of 2024 is upon us.  If you’re reading this late-August newsletter from the beach, the pool, or the mountains, I thank you for it.

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Express Pharma

AUGUST 29, 2024

Torrent Pharmaceuticals has announced that the U.S. FDA has issued an Establishment Inspection Report (EIR) for its manufacturing facility at Indrad, Gujarat. The inspection, conducted from June 3 to June 12, 2024, has been classified as Voluntary Action Indicated (VAI). The inspection process is now officially closed. The post U.S. FDA issues EIR with VAI classification for Torrent Pharmaceuticals’ Indrad facility appeared first on Express Pharma.

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STAT

AUGUST 29, 2024

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. Good morning and happy Thursday! Yesterday it was announced that my colleague Usha Lee McFarling won the 2024 Victor Cohn Prize for Excellence in Medical Science Reporting. I’m genuinely so honored to work in the same newsroom as Usha. Her stories — read them all — have elucidated so many under-covered, unresolved racial health inequities within in our health care syst

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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.

Express Pharma

AUGUST 29, 2024

Neurocrine Biosciences, said on Wednesday its drug helped reduce the severity of schizophrenia symptoms in a mid-stage trial, but its shares fell nearly 17 per cent on worries whether the benefit could be replicated in larger trials. A 20 milligram dose of the drug, the lowest, achieved a 7.5 points reduction in a scale used to measure the severity of symptoms in the study that enrolled 210 patients, the company said, performing better than higher doses.

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The Pharmacist

AUGUST 29, 2024

Medicines shortages and unavailability of community pharmacy staff are affecting adult social care providers in the UK, a survey by the Care Quality Commission (CQC) and Ipsos has suggested. Some 49% of adult social care providers responding to the survey said the medication support they receive from community pharmacies fully meets their needs and 39% […] The post Pharmacy pressures impacting care homes, suggests CQC survey appeared first on The Pharmacist.

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Community Pharmacies 102

BioPharma Dive

AUGUST 29, 2024

Testimony from the heads of Express Scripts, Optum Rx and Caremark in July defending pharmacy benefit managers’ business practices could be coming back to bite them.

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Express Pharma

AUGUST 29, 2024

At the recently held International Association for the Study of Pain (IASP) World Congress, a presentation during a topical workshop revealed significant discrepancies in clinical practice guidelines (CPGs) across countries for opioid use in chronic pain management. The inconsistencies raise concerns about the role of CPGs in the overprescription of opioids, potentially exacerbating the risk of opioid use disorder (OUD) among chronic pain patients, according to GlobalData.

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pharmaphorum

AUGUST 29, 2024

Shares in Neurocrine Biosciences took a tumble after it reported mid-stage data for a key pipeline drug for schizophrenia that failed to impress investors

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The Pharmacist

AUGUST 29, 2024

Some pharmacies will soon be able to issue NHS electronic prescriptions as the next stage of the community pharmacy prescribing pathfinder project is rolled out. In a letter sent to regional pharmacy leads today, NHS England said it had procured a national clinical system to allow community pharmacists to generate prescriptions via the NHS Electronic Prescription […] The post BREAKING: Some pharmacies to start issuing NHS electronic prescriptions appeared first on The Pharmacist.

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Community Pharmacies 84

pharmaphorum

AUGUST 29, 2024

Digital health firm Curio raises $10m+ in first-round financing that will be used to fund the rollout of its MamaLift Plus app for postpartum depression

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Drug Patent Watch

AUGUST 29, 2024

Ensuring that a generic drug meets FDA standards is crucial for maintaining the high quality and efficacy of medications. The FDA’s Office of Generic Drugs (OGD) plays a vital role in this process by following a rigorous review process to ensure that generic medications meet the same standards as their brand-name counterparts. The FDA’s review process for generic drugs involves several key steps.

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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.

pharmaphorum

AUGUST 29, 2024

GSK gets EU approval for its RSV vaccine Arexvy in a younger age group, a potential leg-up in a market tussle with Pfizer and Moderna

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Vaccines 103

Pharmaceutical Commerce

AUGUST 29, 2024

Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.

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The Guardian - Pharmaceutical Industry

AUGUST 29, 2024

For years we’ve been told to use pharmacies rather than GPs whenever possible. The would be fine – if so many of them hadn’t closed down Until I’d woken up in the middle of an orchard at 2am with a child so covered in bites it was like trying to share a tent with a bag of feral cats, I hadn’t quite realised the extent of the pharmacy shortage in the UK.

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The Pharmacist

AUGUST 29, 2024

Library staff across England will help people access online health services, as part of a new NHS England (NHSE) scheme to increase the use of the NHS App. The commissioner said that work is already underway in a number of libraries across England to support people to get started with the NHS App, and that […] The post Libraries to help patients use NHS app appeared first on The Pharmacist.

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Pharmacy Management

pharmaphorum

AUGUST 29, 2024

Novartis partners with startup Lindy in a near-$1bn deal to develop subcutaneous formulations of biologic drugs

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Big Molecule Watch

AUGUST 29, 2024

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions from applicants and other interested parties. regarding postapproval manufacturing changes. made to licensed biosimilars and licensed interchangeable biosimilars.

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Biosimilars 70

Express Pharma

AUGUST 29, 2024

The National Institute for Health and Care Excellence (NICE) approved abaloparatide for treating patients at high risk of fractures in the UK, providing a new and effective treatment option for severe osteoporosis. This approval marks a critical milestone in improving patient outcomes and broadening therapeutic choices in the UK’s osteoporosis market, according to GlobalData.

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Outsourcing Pharma

AUGUST 29, 2024

The European Commission has approved ARS Pharmaceuticalsâ adrenaline nasal spray for the emergency treatment of severe allergies, EURneffy.

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pharmaphorum

AUGUST 29, 2024

Bayer takes oral anti-HER2 drug into phase 3 for HER2-altered lung cancer, a key pillar of its drive to become a major player in oncology

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

By Kurt R. Karst & Michael D. Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. 3582 —well before the Biologics Price Competition an

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Biosimilars 59

Pharmafile

AUGUST 29, 2024

The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England or Wales with moderately or severely active ulcerative colitis (UC) who have not responded well to or cannot tolerate conventional or biological therapy including a tumour necrosis factor (TNF) alpha inhibitor will now have the option of skyrizi (risankizumab).

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Pharmaceutical Business Review

AUGUST 29, 2024

lncRNAs are a class of therapeutic targets that play a critical role in disease by recruiting RNA-binding proteins (RBPs). The companies will focus on advancing two oncology programmes under this deal. The first is an lncRNA-targeting small molecule programme currently underway at NextRNA and is presently in the early preclinical development stage. For the second programme, NextRNA will continue to identify lncRNA targets, with Bayer having the option to choose one for joint development.

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European Pharmaceutical Review

AUGUST 29, 2024

A major new £400 million public-private collaboration has launched in the UK, aimed at enhancing the life sciences sector’s economic growth and the competitiveness over the next five years. The Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme is a joint initiative between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI).

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Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

AUGUST 29, 2024

Follow along on a journey from deep depression to mental health advocacy, discovering ways to cope and support others along the way.

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