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 352

Immunity Immunization 352

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.

130

130

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Communication

STAT

FEBRUARY 1, 2024

The federal government is unveiling new regulations meant to modernize methadone treatment , the first major update to patient care standards at methadone clinics in more than 20 years. The new rules are aimed at increasing access to methadone, which has been used to treat opioid addiction in the U.S. since the early 1970s. The medication is highly effective: Studies show that people taking it are roughly 60% less likely to die of an opioid overdose.

355

355

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 Hospitals Pharmacy Management 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.

130

130

STAT

FEBRUARY 1, 2024

South Korea is the only country to officially recognize digital therapeutics as a category. Nevertheless, the concept of software-based tools designed to manage or treat medical conditions has received enormous attention in the U.S. as proponents tout their potential to both widen access to care and improve patient outcomes. This optimism has driven significant financial investment in the sector, which ballooned to $3.4 billion in 2021.

325

325

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.

130

130

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.

Drug Pricing 308

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 308

Advertisement

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.

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

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?

322

322

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

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 315

Hospitals 315

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.

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.

Vaccines 118

Vaccines Community Pharmacies Packaging 118

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 304

Drug Pricing Vaccines Communication Drug Development 304

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.

118

118

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.

277

277

Advertisement

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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.

116

116

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.

267

267

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.

108

108

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 252

Drug Pricing 252

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

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.

111

111

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.

124

124

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.

119

119

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.

102

102

Advertisement

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.

Pharmacy Management

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.

118

118

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.

111

111

pharmaphorum

FEBRUARY 1, 2024

A single dose of a gene-editing drug being developed by Intellia Therapeutics almost eliminated attacks in patients with hereditary angioedema (HAE) in a clinical trial, pointing to the potential of CRISPR-based drugs delivered in vivo to treat diseases.

111

111

European Pharmaceutical Review

FEBRUARY 1, 2024

The National Institute for Health and Care Excellence (NICE) has recommended AbbVie’s Tepkinly ® (epcoritamab) as the first injectable bispecific antibody for certain adults with the blood cancer diffuse large B-cell lymphoma (DLBCL). Epcoritamab is indicated as an additional administration option for DLBCL, in adults whose cancer has relapsed or been refractory after two or more lines of systemic therapy.

Immunity 98

Immunity Immunization Hospitals 98

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 104

Vaccines Immunity Immunization 104