STAT

APRIL 10, 2024

SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner. “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Can

Vaccines 354

Vaccines Immunity Immunization Drug Development 354

PharmaVoice

APRIL 10, 2024

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

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STAT

APRIL 10, 2024

The number of ongoing and active drug shortages in the U.S. stood at 323 during the fourth quarter of last year — the highest figure reached since such data began being tracked in 2001 — underscoring growing concerns about patient harm across the country. Unresolved shortages have, in fact, been hovering above 300 for more than a year as numerous basic and life-saving medicines are in short supply.

Chemotherapy 331

Chemotherapy Immunity Immunization 331

PharmaVoice

APRIL 10, 2024

TAE Life Sciences is bringing radiation-based cancer therapy to clinical trials globally in the coming years.

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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.

STAT

APRIL 10, 2024

Vertex Pharmaceuticals will buy Alpine Immune Sciences, a maker of protein-based medicines that harness the immune system, for $4.9 billion, the companies announced Wednesday. It is the largest acquisition in Vertex’s history. The acquisition gives Vertex a drug called povetacicept, which has shown promise in treating IgA nephropathy (IgAN), an autoimmune disorder of the kidney that can lead to end-stage renal disease and affects 130,000 people in the U.S.

Immunity 327

Immunity Immunization 327

The Pharmacist

APRIL 10, 2024

Government and regulators must ‘clearly communicate’ the extent of community pharmacists’ responsibilities when asked to dispense privately prescribed puberty suppressing hormones to children and young people, an independent review has said. The final report of the Cass review, published today, called for measures to reduce inappropriate overseas prescribing of puberty suppressing hormones.

Communication 111

Communication 111

BioPharma Dive

APRIL 10, 2024

The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.

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STAT

APRIL 10, 2024

In an era when huge price hikes for prescription drugs are almost guaranteed to draw criticism, is there any circumstance when a 486% increase for a medicine might appear to be justified? A small company called Harrow argues that it can make the case for an injectable eye treatment that has been used to combat several serious conditions. Company executives maintain the medication, which has been largely out of stock for the past few years, requires substantial investment in order to restore a st

Drug Pricing 308

Drug Pricing 308

The Pharmacist

APRIL 10, 2024

Nine independent expert members (IEMs) have been appointed to the UK Pharmacy Professional Leadership Advisory Board. The UK-wide advisory board was set up last year with the aim of supporting and enabling collaborative working between organisations representing pharmacists and pharmacy technicians in different settings. The four UK chief pharmaceutical officers (CPhOs) then embarked on a […] The post Independent experts recruited to UK pharmacy leadership board appeared first on The Pharm

Pharmacy Technician 104

Pharmacy Technician 104

STAT

APRIL 10, 2024

The widespread attention to the recent revelations of cancer diagnoses by Princess Catherine , actress Olivia Munn , and King Charles , among others, demonstrate yet again that cancer is a feared disease. For good reason: It is a cruel killer, the second leading cause of death in the U.S. and a top killer around the world. So public faith in cancer screening (checking seeming healthy people for signs of hidden disease) is deep, driven by the widespread understanding that finding cancer early &#x

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pharmaphorum

APRIL 10, 2024

Discover how Sunshine transparency reporting can be simplified, streamlined, and secured for emerging pharmaceutical companies with a focus on Healthcare Professionals (HCP) and Healthcare Organisations (HCO).

Pharmaceutical Companies 112

Pharmaceutical Companies Pharmaceutical Companies 112

STAT

APRIL 10, 2024

WASHINGTON — The biotech industry’s largest trade group has parted ways with its top lobbyist, the group confirmed to STAT, adding to a recent bout of organizational tumult. The departure of Nick Shipley may be part of a greater shake-up spearheaded by the Biotechnology Innovation Organization’s new CEO, John Crowley, who took over in December.

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BioPharma Dive

APRIL 10, 2024

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

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STAT

APRIL 10, 2024

The U.S. Department of Justice filed a lawsuit accusing Regeneron Pharmaceuticals of manipulating Medicare pricing by inflating the average sales price for its expensive and widely prescribed Eylea treatment for serious eye disease. In its lawsuit, the Justice Department claimed the company failed for more than a decade to report how it paid “hundreds of millions of dollars” to subsidize Eylea purchases by reimbursing drug distributors for credit-card processing fees.

Drug Pricing 288

Drug Pricing 288

BioPharma Dive

APRIL 10, 2024

The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.

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STAT

APRIL 10, 2024

Suicide is the second leading cause of death among children aged 10 to 14 in the U.S. That’s evidence of a systemic failure in identifying and addressing mental health concerns in young people. Compounding the problem is the average delay of 11 years between the onset of a mental health condition and its diagnosis. Think about it: a child exhibiting signs of mental health challenges at age 6 may not receive proper diagnosis or treatment until age 17.

Compounding 279

Compounding 279

pharmaphorum

APRIL 10, 2024

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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STAT

APRIL 10, 2024

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

Drug Pricing 207

Drug Pricing 207

Pharmaceutical Commerce

APRIL 10, 2024

If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.

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STAT

APRIL 10, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we get some optimism from the new director of the National Cancer Institute, despite a brain drain playing out in the industry and stagnant funding numbers. Also, advocates press the federal government to encourage manufacturing for the prostate cancer drug Xtandi.

Drug Pricing 177

Drug Pricing Drug Development 177

Express Pharma

APRIL 10, 2024

Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe.

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Pharma Times

APRIL 10, 2024

Solid tumour cancers account for 90% of adult human cancers and 50% of childhood malignancies

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pharmaphorum

APRIL 10, 2024

In another departure from its focus on genetic medicines, Vertex Pharma has agreed a $4.9 billion purchase of Alpine Immune Sciences, adding a mid-stage drug candidate for kidney disease IgA nephropathy (IgAN). The $65-per-share deal is due to close within the next three months, said Vertex, which plans to fund the acquisition with cash in hand. It is the largest acquisition in the biopharma sector so far in 2024.

Immunity 92

Immunity Immunization 92

Express Pharma

APRIL 10, 2024

The pharma industry has experienced a notable uptick in licensing agreements for innovator drugs incorporating c lustered regularly interspaced short palindromic repeats (CRISPR)-based technology over the past five years. These agreements, primarily concentrated in oncology, immunology, and central nervous system therapeutics, have collectively accumulated an impressive $21 billion in deal value.

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pharmaphorum

APRIL 10, 2024

Essential Pharma has bought Renaissance Pharma, adding its first developmental drug candidate, a therapy for rare cancer neuroblastoma.

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Outsourcing Pharma

APRIL 10, 2024

Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome, how to avoid suffering in silence and her 'just do it' mantra.

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The Pharmacist

APRIL 10, 2024

The Pharmacists’ Defence Association (PDA) has warned of a ‘growing disconnect’ between ‘demanding’ targets for pharmacy services and the reality of workforce pressures on the sector. Yesterday, NHS England (NHSE) announced intentions to ‘grow patient volumes’ across pharmacy services over the next year. By March 2025, NHSE wants the community pharmacy sector to deliver 320,000 […] The post PDA warns pharmacy targets 'must not sacrifice quality for quantity' appeared first on The

Community Pharmacies 88

Community Pharmacies 88

pharmaphorum

APRIL 10, 2024

e-therapeutics is the latest UK biotech to say it plans to delist from the AIM, citing a lack of interest from institutional investors.

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World Pharma News

APRIL 10, 2024

Infection with the influenza virus leads to lung injury through inflammation over-activation that causes collateral damage to cells required for breathing. Such damage can be life-threatening, but scientists have a new preventative treatment. A team from St. Jude Children's Research Hospital, University of Houston, Tufts University School of Medicine and Fox Chase Cancer Center created a drug that can prevent flu-induced lung injury.

Immunity 86

Immunity Immunization Hospitals 86

Pharma Times

APRIL 10, 2024

The most common form of cancer in men is responsible for 12,000 deaths every year in the UK

Hospitals 106

Hospitals 106

European Pharmaceutical Review

APRIL 10, 2024

A novel routine nuclease testing regimen developed to ensure resilience against nuclease contamination can be utilised as part a laboratory’s quality management system (QMS), a paper reports. The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Cleavable, fluorescent DNA and RNA substrates were used to detect, monitor and control for nuclease contamination in the laboratory, according to the authors.

Documentation 74

Documentation 74

pharmaphorum

APRIL 10, 2024

Roche gets EU approval for its HER2-low companion diagnostic, used to identify breast cancer patients eligible for treatment with Enhertu.

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Pharmafile

APRIL 10, 2024

Oryzon Genomics has announced that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to initiate a phase 1/2 trial with iadademstat plus immune checkpoint inhibitors in the first line treatment of small cell lung cancer (SCLC) patients with extensive disease. This trial will be the first to test […] The post FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment appeared first on Pharmafile.

Immunity 63

Immunity Immunization 63

pharmaphorum

APRIL 10, 2024

Discover the latest trends in leadership appointments and C-suite hires in the digital and supplier space from March 2024 in our in-depth analysis.

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Pharmafile

APRIL 10, 2024

TILT Biotherapeutics has announced promising preliminary safety and efficacy data from its ongoing phase 1 clinical trial (NCT05271318) in platinum resistant or refractory ovarian cancer. The results were announced at the American Association for Cancer Research (AACR) Annual Meeting 2024. The trial has demonstrated that TILT-123 in combination with Merck’s (known as MSD outside of […] The post TILT Biotherapeutics shares data on TILT-123 with Keytruda for ovarian cancer treatment appeared

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