Mon.Dec 09, 2024

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Johnson & Johnson seeks first drug approval for treatment of smoldering myeloma

STAT

This roundup of news from the ASH 2024 conference first appeared in STAT’s “ASH in 30” newsletter. To get future editions,  sign up here. Welcome back, ASH followers. Here’s your rundown of Monday’s news.

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Reprieve for Chinese biotechs as BIOSECURE Act left out of key bill

Pharmaceutical Technology

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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STAT+: Young biotech venture firm raises $500 million for its second fund

STAT

What happens when two computer scientists and a former stem cell researcher become friends while working their way up the venture capital corporate ladder and decide to start their own firm? Well, in Dimension’s case, they end up investing in some buzzy AI startups, counseling pharmaceutical companies, ribbing one another about expense reports, and — as of Monday — are able to raise $500 million for their second fund.

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Pharmacognosy and Drug Patents: Unveiling Nature’s Medicinal Treasures

Drug Patent Watch

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents?

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Imfinzi receives NICE recommendation for lung cancer treatment

Pharma Times

Trial results lead to new treatment option for lung cancer

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Government commits to new workforce plan with 'laser-focus' on community

The Pharmacist

The government has committed to a 'refreshed' workforce plan with a 'laser-focus on shifting care from hospitals and into the community', to be published in the summer. This comes as the Department of Health and Social Care (DHSC) has told The Pharmacistthat community pharmacies 'will play a vital role helping to shift the focus of […] The post Government commits to new workforce plan with 'laser-focus' on community appeared first on The Pharmacist.

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New helpline to support pharmacists 'feeling worried or overwhelmed'

The Pharmacist

A new, confidential, 24/7 text support service has been launched to support healthcare workers 'who may have had a tough day, are feeling worried or overwhelmed, or have a lot on their mind and need to talk it through'. The NHS England (NHSE) support offer will extend to all staff, including community pharmacists and their […] The post New helpline to support pharmacists 'feeling worried or overwhelmed' appeared first on The Pharmacist.

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Citryll gains Series B funds to develop NET-targeting antibody

Pharmaceutical Technology

Citryll has secured an oversubscribed Series B funding round, raising 85m ($89.8m) to advance the clinical development of CIT-013.

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Cobenfy could break dopamine dominance in schizophrenia treatment: GlobalData

Express Pharma

The FDA has recently approved Karuna/Bristol Myers Squibbs KarXT (Cobenfy), an oral medication for the treatment of schizophrenia in adults. Diverging from the traditional dopamine-based therapies, Cobenfy is said to address the critical gaps in the current treatments by targeting muscarinic acetylcholine receptors. Its success can pave the way for broader adoption of non-dopaminergic approaches in the psychiatric market, reshaping the treatment landscape, says GlobalData.

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Priority FDA review given to AstraZeneca’s Imfinzi sBLA for MIBC

Pharmaceutical Technology

The US FDA has granted priority review to AstraZeneca's sBLA for Imfinzi (durvalumab) for muscle-invasive bladder cancer (MIBC) treatment.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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SAEM Clinical Images Series: An On-Target Diagnosis

ALiEM - Pharm Pearls

A 25-year-old female with no pertinent past medical history presented to an emergency department in Massachusetts with four days of generalized malaise, myalgias, congestion, low-grade fever, and a rash behind her left knee. The patient denied cough, shortness of breath, chest pain, abdominal pain, nausea, vomiting, and diarrhea. She lives with three roommates, none of whom were sick, and she denied any other known sick contacts.

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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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European Biotechs Unlocking Parkinson’s Disease

PharmaTech

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to innovative cell and gene therapies.

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Govt provides updates on measures to encourage domestic manufacturing

Express Pharma

The Government of India has taken several measures to encourage domestic manufacturing in the pharmaceutical sector including bulk drugs and medical devices to reduce import dependence, boost domestic manufacturing and attract large investments. The schematic interventions are as follows: Production Linked Incentive (PLI) Scheme for the promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India (al

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

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.

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Multidrug-resistant TB a ‘public health crisis’, says World Health Organization

The Pharmacist

The World Health Organization (WHO) has raised the alarm about soaring cases of tuberculosis (TB) around the world. Last year, more than eight million people were newly diagnosed with the condition, the highest number since they began monitoring in 1995, WHO said. While TB-related deaths did fall last year from 1.32 million to 1.25 million […] The post Multidrug-resistant TB a public health crisis, says World Health Organization appeared first on The Pharmacist.

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Biocon receives EIR with VAI status

Express Pharma

Biocon has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (US FDA). The company received the EIR for their API facility (Site 2), located at SEZ Plot no. 2,3,4 and 5 Bommasandra-Jigani Link Road, Bengaluru, Karnataka. This is based on a surveillance inspection conducted by the agency between September 23-27, 2024.

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ASHP Midyear: Nearly Half of Adults With Epilepsy Use CBD Products

Pharmacy Times

Adults with epilepsy are underrepresented in most CBD trials, including common etiologies.

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UCB presents epilepsy research at American Epilepsy Society Annual Meeting

Pharmafile

Belgian-based biopharmaceutical company UCB has announced it will present 32 abstracts at the American Epilepsy Society (AES) Annual Meeting taking place 6-10 December 2024 in California, US covering clinical and real-world data and medical research, from its pipeline programmes. The highlights of the abstracts include data in seizures associated with Dravet syndrome and […] The post UCB presents epilepsy research at American Epilepsy Society Annual Meeting appeared first on Pharmafile.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

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Daiichi Sankyo secures breakthrough designation for NSCLC treatment

Pharmaceutical Technology

The breakthrough designation for Daiichi Sankyo comes after early pooled results from two ongoing trials finding the drug was well tolerated.

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Protecting High-Risk Adults from Severe RSV: New Vaccination Recommendations and Strategies

Pharmacy Times

Pharmacists play a key role in vaccination efforts to prevent respiratory illnesses.

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Novo Holdings’ acquisition of Catalent gains EC approval

Pharmaceutical Technology

Novo Holdings, the investment arm of the Novo Nordisk Foundation, has gained approval from the EC for its acquisition of Catalent.

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ASH 2024: Circulating Tumor Cells Can Serve as Biomarker for Poor Outcomes in Multiple Myeloma

Pharmacy Times

Luca Bertamini, MD highlights the potential clinical implications of using circulating tumor cells as a biomarker in patients with newly-diagnosed multiple myeloma.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

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.

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Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001

Express Pharma

Ichnos Glenmark Innovation (IGI), a clinical-stage biotech company developing multispecifics in oncology, presented first-time clinical data from the early dose-escalation portion of its Phase 1 study of ISB2001 for the treatment of relapsed or refractory multiple myeloma (RRMM). ISB2001 is an investigational trispecific TREAT antibody for the treatment of RRMM that targets BCMA and CD38 on myeloma cells and CD3 on T cells.

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Phase 3 CEPHEUS Trial: DARA Plus VRd Is a Standard of Care for Frontline Treatment in Transplant-Ineligible Multiple Myeloma

Pharmacy Times

The phase 3 CEPHEUS trial demonstrated that adding daratumumab (DARA) to the VRd regimen significantly improves minimal residual disease negativity, progression-free survival, and overall response in transplant-ineligible or transplant deferred patients with newly diagnosed multiple myeloma, establishing a new standard of care.

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Did Industry Fumble the DSCSA Deadline?

Pharmaceutical Commerce

Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliancebut time to catch up on boosting the supply chains interoperable efforts.

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Phase 3 GMMG-HD7 Trial: Impact of Isatuximab on MRD Negativity and PFS in Multiple Myeloma

Pharmacy Times

The GMMG-HD7 trial evaluated the addition of isatuximab to standard induction therapy in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation, demonstrating significantly higher rates of minimal residual disease negativity and improved progression-free survival (PFS).

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Position Your Pharmacy for Expansion

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.

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Yescarta Demonstrates Promise in Treating Relapsed/Refractory Large B-Cell Lymphoma

PharmExec

Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high overall survival rate in patients with relapsed/refractory large b-cell lymphoma.

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ASHP Midyear: Expert Discusses Strategies for Recruitment, Retention, and Interprofessional Collaboration for Rural Pharmacies

Pharmacy Times

The primary challenge facing rural pharmacies include recruitment and retention of staff, the need for pharmacists to handle multiple roles and expertise, and the impact of burnout and stress.

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CPHI Middle East Sees Domestic Manufacturing Expansion in Saudi Arabia

PharmaTech

The first CPHI Middle East event will be held Dec. 1012, 2024 at the Riyadh Front Exhibition & Convention Center Riyadh in Saudi Arabia and is expected to be host to 30,000 pharma professionals.

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CMS Issues Sweeping End-Of Year Rule on Medicare Advantage and Medicare Part D

Putting Patients First Blog

CMS Issues Sweeping End-Of Year Rule on Medicare Advantage and Medicare Part D December 9, 2024 By: Allen Pinn, Coordinator, Policy The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would have sweeping impacts on programs such as Medicare Advantage, the Medicare Cost Plan Program, Programs of All-Inclusive Care for the Elderly (PACE), and Medicare Part D.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.