STAT

FEBRUARY 1, 2024

New data released Thursday by the Centers for Disease Control and Prevention suggest that the most recent Covid-19 booster offers about 54% percent protection against infection with the virus. A study published in the CDC’s online journal Morbidity and Mortality Weekly Report showed that the updated vaccine was essentially equally effective at protecting against the strain targeted by the vaccine — called XBB.1.5 — and the JN.1 subvariant, which emerged after the vaccin

Vaccines 364

Vaccines 364

Safe Biologics

FEBRUARY 1, 2024

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development On January 25, the European Medicines Agency’s (EMA’s ) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development” The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

STAT

FEBRUARY 1, 2024

Researchers have long known that women are more likely to develop autoimmune disorders than men, though they’ve struggled to fully understand why. Now a new study in mice suggests a key part of the answer may be that an RNA molecule that’s indispensable for female survival steers the body toward immune friendly fire. A team led by Stanford scientists found that Xist, a molecule that teams up with proteins to keep female cells from activating a double (and deadly) dose of X chromoso

Immunity 354

Immunity Immunization 354

LifeProNow

FEBRUARY 1, 2024

January 23,2024: “BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced that it has exercised its option to exclusively license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for the treatment of primary photoreceptor diseases, from FUJIFILM Cellular Dynamics and Opsis Therapeutics.

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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

FEBRUARY 1, 2024

Last spring, I joined a rebellion. The entire editorial board of the prestigious scientific journal NeuroImage, of which I was a member, resigned after its publisher refused to take steps to ease the high costs scientists are required to pay for publication in the journal. While this decision threw the brain imaging research community into a frenzy, the rest of the world barely noticed.

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Pharmacy Is Right For Me

FEBRUARY 1, 2024

Adversities and life’s trials often serve as catalysts that guide individuals toward their destined paths, unveiling unforeseen opportunities. Such is the transformative journey of Dr. Jorie Kreitman, a dedicated pharmacy manager at Walgreens. Early Inspiration Dr. Kreitman’s passion for pharmacy ignited at the tender age of 7 when she was diagnosed with Supraventricular Tachycardia (SVT), a condition characterized by irregularly fast or erratic heartbeats.

Community Pharmacies 130

Community Pharmacies Pharmacy Technician Pharmacy Management Hospitals 130

PharmaVoice

FEBRUARY 1, 2024

In the first earnings call since the $43 billion Seagen deal closed, CEO Albert Bourla stressed that Pfizer is all in on the promise of ADCs to make up for COVID losses.

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STAT

FEBRUARY 1, 2024

WASHINGTON  — The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said. The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 290

PharmaVoice

FEBRUARY 1, 2024

The company is open to deals the size of its prior Acceleron and Prometheus buyouts. “We continue to believe we need more,” CEO Rob Davis said.

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STAT

FEBRUARY 1, 2024

Happy Groundhog Day eve. Some takes and thoughts on Bluebird Bio’s quest for gene therapy profits, a reality check on Vertex’s highly touted pain drug, and more ADC investor FOMO. Bluebird and the case for gene therapy profits Genetic treatments that are potential cures for inherited diseases are a huge medical advance, but can these transformational (and expensive) products become a profitable business?

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Pharmacy Management

Safe Biologics

FEBRUARY 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “ Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines” The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023. It examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, in

Drug Pricing 100

Drug Pricing Biosimilars 100

STAT

FEBRUARY 1, 2024

General Catalysts’s grand vision for a venture capital-owned hospital system seamlessly blending AI and tech into everyday appointments and rewarding staff for keeping patients healthy might sound alluring. But the firm’s bold experiment is facing hurdles even before it has started as the community served by the health system it hopes to buy is pushing back.

Hospitals 271

Hospitals 271

Safe Biologics

FEBRUARY 1, 2024

On January 25, the European Medicines Agency’s (EMA’s ) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development” The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also announces a three-month public consultation period running from Fe

Biosimilars 100

Biosimilars Documentation 100

STAT

FEBRUARY 1, 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, everyone. Damian here with the latest twist in biotech’s recovery, a close look at Bluebird Bio, and the uncertain future of a Covid-19 player. The need-to-know this morning Merck   reported  earnings for the fourth-quarter and 2023.

Drug Pricing 265

Drug Pricing Vaccines Communication Drug Development 265

The Pharmacist

FEBRUARY 1, 2024

Independent community pharmacies across the UK will begin offering private Covid vaccinations this spring, services provider Pharmadoctor has announced. For pharmacies that sign up for Pharmadoctor’s a patient group direction (PGD) package from today, the Nuvaxovid XBB.1.5 dispersion for injection vaccines will be available by 1 April 'at the latest', the company said today.

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Vaccines Community Pharmacies Packaging 121

STAT

FEBRUARY 1, 2024

MORRISVILLE, N.C. — Ten minutes from the Raleigh airport, the future of biotech is under construction. On either side of a new stretch of four-lane highway sit two $1 billion biomanufacturing campuses, which will bring a combined 2.5 million square feet of research and development and advanced manufacturing space to a region that has become the No. 1 place where North America makes prescription drugs.

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The Pharmacist

FEBRUARY 1, 2024

Dr Alison Cave, chief safety officer at the Medicines and Healthcare products Regulatory Agency (MHRA), asks healthcare professionals to work together to better protect patients from the unnecessary harms of valproate, and to prescribe safer alternatives. New guidance was launched on 31 January The teratogenic effects of valproate, prescribed in the UK to treat epilepsy […] The post Work together to implement new safety measures for valproate appeared first on The Pharmacist.

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STAT

FEBRUARY 1, 2024

What makes a blockbuster? Can biotech learn from Aduhelm? And how do you replace a singular regulator? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We explain the debate over Vertex Pharmaceuticals’ novel pain drug, whose success in clinical trials comes with a sizable caveat. We also talk about the latest news in the life sciences, including an epitaph for Aduhelm and the retirement of an FDA icon.

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The Pharmacist

FEBRUARY 1, 2024

The Royal Pharmaceutical Society (RPS) has changed its stance on the separation of prescribing and dispensing, now accepting that both can be done by the same healthcare professional. The RPS said its new position had been formulated in response to changing practices in healthcare. The society’s previous guidance had emphasised the need for separation of […] The post RPS changes position on prescribing and dispensing separation appeared first on The Pharmacist.

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STAT

FEBRUARY 1, 2024

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. An inside look at Medicare drug negotiation’s day in court The post-pandemic world we live in has gotten more friendly to remote hearings and meetings — but not the U.S.

Drug Pricing 175

Drug Pricing 175

pharmaphorum

FEBRUARY 1, 2024

Explore the current state of pharmaceutical meetings and events in 2024, including the shift from in-person to virtual and hybrid formats. Discover how the industry is embracing diversity, equity, and inclusion in these gatherings.

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Express Pharma

FEBRUARY 1, 2024

Overall, the Union Budget 2024 reflects a forward-looking approach OPPI commends the Government’s approach towards the healthcare and pharmaceutical sector in the Union Budget 2024. The emphasis on leveraging existing hospital infrastructure for establishing new medical colleges is a strategic move that aligns with the need for a robust healthcare workforce.

Vaccines 108

Vaccines Hospitals 108

pharmaphorum

FEBRUARY 1, 2024

A phase 2 trial of Lundbeck’s alpha-synuclein-targeting drug Lu AF82422 has failed to reach statistical significance in patients with multiple system atrophy (MSA), although the company says there are encouraging “signals of efficacy” in the data.

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The Pharmacist

FEBRUARY 1, 2024

Pharmacy owners and superintendent pharmacists (SPs) will need to ‘continually assess’ whether enough trained and competent staff are available to provide Pharmacy First safely and effectively, the General Pharmaceutical Council (GPhC) has said. ‘We recognise that offering a wider range of services brings challenges as well as opportunities,’ the GPhC said in an email sent […] The post GPhC: ‘Continually assess staffing’ to provide Pharmacy First safely appeared first on The Pharmacist.

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pharmaphorum

FEBRUARY 1, 2024

On today's podcast, brought to you by Kadans Science Partners, host Jonah Comstock is joined by Bradley Hardiman, Astellas Pharma’s Senior Director of Business Development; Mike Murray, head of Murray International Partners Ltd; and Mairi Dillon, Kadans' Ecosystem Manager for UK & Ireland.

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BioPharma Dive

FEBRUARY 1, 2024

Roche said it was shelving those drugs in favor of experimental programs to treat obesity that it gained from its takeover of Carmot Therapeutics.

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pharmaphorum

FEBRUARY 1, 2024

As cyberattacks continue to target the healthcare sector, it is crucial to look back at cybersecurity incidents from the past year and prepare for the challenges that lie ahead. This retrospective discusses the impact on patients, health systems, insurers, and vendors, and highlights the importance of cybersecurity measures in protecting sensitive healthcare information.

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BioPharma Dive

FEBRUARY 1, 2024

François-Xavier Roger will replace current CFO Jean-Baptiste Chasseloup de Chatillon as Sanofi continues a research pivot and cost-cutting drive.

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Pharma Times

FEBRUARY 1, 2024

Tumours with high mtDNA mutations more likely to respond to Opdivo

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Express Pharma

FEBRUARY 1, 2024

Phase 3 trial data results of The R21/Matrix-M vaccine developed by Oxford University and Serum Institute of India, leveraging Novavax’s Matrix-M adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. The R21/Matrix-M vaccine was designed in 2011 as a potential improvement on the RTS, S/AS01 malaria vaccine designed in the 1980s.

Vaccines 97

Vaccines Immunity Immunization 97

pharmaphorum

FEBRUARY 1, 2024

Almirall has formed a three-year alliance with Microsoft designed to accelerate the discovery and development of personalised dermatology therapies.

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Express Pharma

FEBRUARY 1, 2024

Recent regulatory changes have underlined the fissure between the large and mid- MSME segments of the pharma sector. The most recent evidence of this fissure is the representations of the pharma MSME sector to the Prime Minister’s Office (PMO) and to state governments to defer the implementation of the Revised Schedule M of the Drugs Act 1940 that was amended by the Ministry of Health & Family Welfare vide Notification GSR 922 (E) dated December 28 last year.

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Pharmaceutical Manufacturing 94

Pharmaceutical Technology

FEBRUARY 1, 2024

Merck & Co (MSD) has reported a 1% revenue increase from 2022, and may face setbacks in the next few years from top-selling drugs.

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pharmaphorum

FEBRUARY 1, 2024

Hybrid and multi-cloud: The next step for biotech to secure flexible, scalable scientific workflows Mike.

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BioPharma Dive

FEBRUARY 1, 2024

The agreement gives Protagonist an experienced hand in Takeda, which can help the former commercialize its product.

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