Sat.Sep 28, 2024 - Fri.Oct 04, 2024

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Opinion: Louisiana’s new mifepristone and misoprostol law puts my patients at unnecessary risk

STAT

In the delivery room, time is everything. When I care for a patient experiencing an obstetric emergency, a few minutes can mean the difference between life and death. A pregnant uterus receives 700 milliliters of blood per minute leading up to delivery, and the same amount can be lost each minute if a postpartum hemorrhage is not adequately treated immediately after being recognized.

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After scoring a first for an off-the-shelf CAR-T, can Atara maintain momentum?

PharmaVoice

The company’s allogeneic therapy was OK’d in the EU and could become the first of its kind approved by the FDA in January — while eyeing the next frontier.

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SAEM Clinical Images Series: Didn’t See That Coming

ALiEM - Pharm Pearls

A 23-year-old healthy male presented to the emergency department with left eye pain, soreness, and blurry vision after being hit in the left eye with a Nerf gun bullet two days prior. He had no prior ophthalmologic history and does not wear corrective lenses. Physical Exam Left eye : Visual acuity 20/30. Intraocular Pressure 17. Pupil 3mm, irregular, minimally reactive.

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Kailera Therapeutics emerges from stealth with $400M for obesity drugs

BioPharma Dive

The company’s official launch comes five months after major investors such as Atlas Venture and Bain Capital filed a Shanghai stock exchange filing for a biotech named “Hercules CM NewCo.

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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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Was Missouri’s bird flu case a one-off or something more? Quest for answers faces testing delay

STAT

U.S. health officials have run into obstacles in their efforts to determine whether a Missouri person infected with H5N1 bird flu passed the virus on to others, causing a delay that will likely fuel concerns about the possibility that there has been human-to-human transmission. The Centers for Disease Control and Prevention has blood samples from several health workers and a household contact of the Missouri case that it plans to test for antibodies that would indicate whether they too had been

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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?

PharmaVoice

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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More Trending

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Gilead strikes deal to expand HIV drug access in 120 countries

pharmaphorum

Gilead has partnered with six generic manufacturers to expand access to HIV Drug lenacapavir in high-incidence, resource-limited countries following promising clinical trial results.

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Rwanda to receive experimental vaccines, therapeutics to combat Marburg outbreak

STAT

Experimental vaccines and therapeutics to combat the deadly Marburg virus will begin arriving this weekend in Rwanda, where they will be used in clinical trials expected to begin soon, a U.S. government official confirmed on Friday. There are currently no licensed vaccines or drugs to prevent or treat Marburg, a cousin of the Ebola family of viruses that transmits and causes illness in the same way as Ebola.

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Top pharma and biotech conferences 2025

PharmaVoice

Mark your calendars for the most important industry conferences in 2025.

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My 2024 Jimmy Fund Walk

The Honest Apothecary

Founded in 1947 with a mission to provide compassionate care while pursuing cutting-edge research to combat cancer, Dana-Farber Cancer Institute, is a world leader in cancer treatment and research. One of its most notable fundraising events is the Jimmy Fund Walk, which began in 1989.

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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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October Pharmacy First thresholds lowered to 20

The Pharmacist

The Pharmacy First October threshold will remain at 20 clinical pathway consultations, rather than rising to 30 as originally planned. This means that pharmacies will need to conduct a minimum of 20 Pharmacy First clinical pathway consultations in October to be eligible for the monthly payment. Community Pharmacy England (CPE) said it had 'been discussing […] The post October Pharmacy First thresholds lowered to 20 appeared first on The Pharmacist.

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Marburg virus outbreak in Rwanda draws concern over possibility of international spread

STAT

A large outbreak of Marburg virus in Rwanda is drawing international concern about the possibility of spread beyond the country’s borders. The number of cases detected so far, 27 , already makes the outbreak one of the biggest involving Marburg on record. Nine of those individuals have died. There are currently no licensed vaccines to combat the disease.

Vaccines 363
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Roche turns to a startup in search for new breast cancer drugs

BioPharma Dive

The Swiss pharma is paying Regor Therapeutics $850 million to buy a pair of prospects it sees as potential successors to blockbuster medicines from Pfizer and Eli Lilly.

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Amgen to face investor lawsuit over $10.7bn tax liability disclosure

pharmaphorum

A federal judge in New York has ruled that Amgen must answer to claims of misleading investors about billions owed to US tax authorities, allowing a securities-fraud class action to proceed against the pharmaceutical giant.

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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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SK pharmteco to strengthen small molecule and peptide capacity with $260 million investment

Outsourcing Pharma

SK GroupĂ¢s contract development and manufacturing organization (CDMO) arm SK pharmteco is spending $260 million to expand its small molecule and peptide manufacturing muscle in South Korea.

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New analysis reveals postpartum sterilization rates are higher among U.S. women with sickle cell

STAT

Often, women with sickle cell disease are told not to have kids. They might come to an appointment, happily pregnant, only for the doctor to tell them they shouldn’t be. They might be preparing for a scheduled C-section when their OB-GYN says that this pregnancy has gone smoothly but the next one could kill them. The illness is associated with an increased risk of serious pregnancy complications, which warrants a discussion — but sometimes that discussion can blur the line between

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FDA makes end of Zepbound, Mounjaro shortage official

BioPharma Dive

Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded versions.

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Dr Reddy’s Laboratories completes acquisition of Nicotinell and related brands

Express Pharma

Dr Reddy’s Laboratories has announced the completion of its acquisition of Haleon plc’s global portfolio of nicotine replacement therapy (NRT) brands outside the United States. This follows the earlier announcement on 26 June 2024, regarding the purchase made through Dr Reddy’s wholly-owned subsidiary, Dr Reddy’s Laboratories SA, Switzerland. The transaction includes the acquisition of Northstar Switzerland SARL, a Haleon group company, along with its subsidiaries, North Star OpCo Limited (UK) a

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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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Blue Shield of California bypasses PBMs to slash Humira prices by 90%

pharmaphorum

In a bold move to tackle soaring drug costs, Blue Shield of California is pioneering a strategy that bypasses traditional pharmacy benefit managers to slash the cost of Humira by 90%

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STAT+: Health care CEOs dialed back their pay in 2023. They still made $3.5 billion

STAT

Health care stocks stumbled compared with the rest of the market in 2023. Companies missed their profit targets. Some CEOs even lost their bonuses. But the biggest names in health care still made $3.5 billion combined last year, compared with $4 billion in 2022. The average chief executive brought home $11 million, while the median was $4.1 million.

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Calculating the Regulatory Review Period for Patent Term Extension: A Comprehensive Guide

Drug Patent Watch

In the complex world of intellectual property and pharmaceutical development, understanding the intricacies of patent term extension (PTE) is crucial for innovators and businesses alike. One of the most critical aspects of PTE is calculating the regulatory review period, which can significantly impact the lifespan and profitability of a patented product.

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Biocon Biologics refinances $ 1.1 bn long-term debt through USD bonds and new syndicated facility

Express Pharma

Biocon Biologics, a subsidiary of Biocon, announced the successful pricing of Biocon Biologics’ debut $ 800 million (Rs 66,763 million) senior secured Notes due 2029 at a coupon of 6.67 per cent. The Bonds will be issued by Biocon Biologics Global which is a wholly owned subsidiary of Biocon Biologics and will be backed by a strong security package.

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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.

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Ensuring compliance - The Functional Point of Contact (FPOC) story

pharmaphorum

Learn how Advanced Clinical ensures compliance through the Functional Point of Contact (FPOC) story. Explore their innovative approach to maintaining regulatory standards.

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Q&A: NIAID’s Jeanne Marrazzo speaks on bird flu, mpox, and succeeding Anthony Fauci

STAT

A year ago last week, Jeanne Marrazzo stepped into a very big pair of shoes.  Marrazzo became the first new director of the National Institute of Allergy and Infectious Diseases in decades, taking over a job held for 38 years by Anthony Fauci, whose long-term status as a science god in Washington gave way to Covid-19 fall guy in some quarters during and after the pandemic.

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Hub and spoke changes 'delayed beyond 1 January'

The Pharmacist

Changes to hub and spoke regulation will not come into effect on 1 January 2025, as was previously intended, according to Community Pharmacy England (CPE). This is because the government needs time to brief new ministers before the proposed changes can be implemented, CPE has suggested. The negotiator said it did not have further clarity […] The post Hub and spoke changes 'delayed beyond 1 January' appeared first on The Pharmacist.

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Indoco Remedies receives U.S. FDA approval for generic Cetirizine tablets

Express Pharma

Indoco Remedies has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). The product is a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg, produced by Johnson & Johnson Consumer Inc.

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Mounjaro and Zepbound shortages over, declares FDA

pharmaphorum

FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.

Diabetes 101
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Why a map of a fruit fly’s brain has neuroscientists ‘blown away’

STAT

Mapping the brain is a daunting task because it contains a huge number of cells and cell connections. It took almost 50 labs around the world to create a new neural map, or connectome, of an adult fruit fly — the largest map of its kind, and an effort that will allow researchers to better understand the brain’s inner workings. Access to the full connectome, as published Wednesday in a series of papers in Nature , could represent a new era for neuroscience, according to some re

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When Do Drug Patents Expire: Understanding the Lifecycle of Pharmaceutical Innovations

Drug Patent Watch

Have you ever wondered why some medications seem to cost an arm and a leg, while others are surprisingly affordable? The answer often lies in the complex world of drug patents. Let’s dive into the fascinating realm of pharmaceutical intellectual property and explore when drug patents expire. Drug patents are a crucial aspect of the pharmaceutical industry.

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LoQus23 Therapeutics raises £35m to advance therapy for Huntington’s disease

Outsourcing Pharma

The proceeds of the financing will support the development of LoQus23Ă¢s lead candidate, a small molecule inhibitor that is expected to enter the clinic in 2026.

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FDA approval give BMS an edge in NSCLC treatment

pharmaphorum

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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STAT+: After Cassava Alzheimer’s drug fiasco, the FDA must intervene to protect patients

STAT

For nearly a year, my stance on Cassava Sciences and its Alzheimer’s disease drug candidate simufilam has been clear: Emerging evidence shows the drug is inert, and patients with Alzheimer’s were misled into participating in ongoing Phase 3 clinical trials, so therefore, the Food and Drug Administration must take immediate steps to protect these vulnerable people from further harm.

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