pharmaphorum

OCTOBER 22, 2024

Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen

Fierce Pharma

OCTOBER 22, 2024

Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.

Drug Topics

OCTOBER 22, 2024

A discussion with Madison Irwin, PharmD, BCPS, clinical pharmacist specialist in palliative care at University of Michigan Health and clinical assistant professor at the University of Michigan College of Pharmacy.

Fierce Pharma

OCTOBER 22, 2024

With multiple high-profile production pacts already in the books for 2024, CDMO Samsung Biologics has hooked another big one. | Following a string of high-profile deals, Samsung Biologics has locked down a $1.2 billion contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037. Samsung did not elaborate on the identity of its new partner or the types of drugs it will help produce under the accord.

Pharmaceutical Companies

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

Patient Care

Drug Topics

OCTOBER 22, 2024

Analyzing copayments and coverage plans for popular weight-loss drugs in the US, researchers addressed the cost-effectiveness of GLP-1 medications for treating obesity.

PharmaVoice

OCTOBER 22, 2024

Leaders advancing health advocacy, DEI initiatives and better medicine access for patients.

PharmaVoice

OCTOBER 22, 2024

Pfizer’s proxy battle with Starboard has gotten messy. It’s the latest in a series of activist investor campaigns that have been on the rise in recent years.

Drug Topics

OCTOBER 22, 2024

Three posters showcased at IDWeek 2024 focused on enhancing access to HIV prevention and treatment, as well as increasing uptake of pre-exposure prophylaxis (PrEP) among women.

STAT

OCTOBER 22, 2024

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years.

Compounding

Drug Topics

OCTOBER 22, 2024

Results of the SOUL clinical trial will be presented at a scientific meeting in 2025.

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.

Pharmacy Times

OCTOBER 22, 2024

In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

FDA

STAT

OCTOBER 22, 2024

Senators led by Sen. Dick Durbin (D-Ill.) on Monday demanded answers from Pfizer and Eli Lilly about their relationship with the telehealth prescribers they point patients to from their websites, seeking to determine whether the pharma giants are violating the federal anti-kickback statute. This year, both Pfizer and Eli Lilly launched websites that allow users to learn about their medications, follow links to “talk to a doctor now,” and fill their prescriptions through an online p

Pharmacy Times

OCTOBER 22, 2024

The therapy offers new hope in solid tumor treatment with fewer adverse effects.

STAT

OCTOBER 22, 2024

There’s a fundamental barrier to scientific certainty in food science. People eat foods, not nutrients. The experts charged with advising federal health officials on the 2025-2030 Dietary Guidelines for Americans had to scale a mountain of research challenges like this basic impediment, starting with the impossibility of randomly assigning people to eat only x or y for 30 to 40 years.

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Pharmacy Times

OCTOBER 22, 2024

Comprising most cases of this rare form of lymphoma, it is essential that pharmacists and treatment providers are aware of the health-related burdens patients with these subtypes consistently face.

STAT

OCTOBER 22, 2024

Ten years ago, neither Allyson Berent, Terry Pirovolakis nor Michelle Werner expected to be founders of biotech companies. But they’ve all done so with the goal of helping to treat their children’s rare diseases.  The three parents took the stage at the 2024 STAT Summit to talk about the challenges of trying to find treatments for rare diseases — from securing funding to translating research in animals to humans to commercial barriers.

Pharmacy Times

OCTOBER 22, 2024

Pharmacists are positioned to combat the opioid crisis through educating the public and advocating for policy changes to enable harm reduction strategies.

STAT

OCTOBER 22, 2024

Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an email reviewed by STAT and sent out to FDA device staff on Tuesday afternoon. Tarver has temporarily served in the role since veteran devices head Jeffrey Shuren announced his departure in July. The agency conducted a nationwide search for Shuren’s replacement, but Tarver quickly seemed to be the top pick, shadowing Shuren at conferences and town halls.

FDA

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Pharmacy Management Software

Fierce Pharma

OCTOBER 22, 2024

Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job. | Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.

STAT

OCTOBER 22, 2024

Editas Medicine said Tuesday it will license out or partner its lead sickle cell treatment, the latest shift for a tarantella company that has repeatedly switched direction and leadership since first emerging as one of the first CRISPR biotechs a decade ago.    Editas will now focus on a different, newly announced sickle cell program.

Chemotherapy

Pharmacy Times

OCTOBER 22, 2024

New recommendations from the American Stroke Association (ASA) emphasize the importance of healthy lifestyle habits and addressing health equity to reduce stroke risk.

STAT

OCTOBER 22, 2024

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Will ‘responsible AI’ spawn a new market for tech? This year’s gathering features HLTH ‘s signature opulence and spectacle: as usual, a hair salon for attendees, an indoor puppy park, and a vast exhibit floor crammed with flashy booths, giveaways a

Pharmacy Times

OCTOBER 22, 2024

The FDA previously accepted the biologic license application for CT-P13 as a subcutaneous formulation.

FDA

STAT

OCTOBER 22, 2024

Genetics can be cruel. Lawrence Ingrassia, a longtime journalist, has learned that the hard way. A genetic mutation that runs in his family predisposes those who carry it to developing malignant tumors of all types. It’s why, at age 69 and 30 days, he became the longest living member of his family.

Pharmacy Times

OCTOBER 22, 2024

Endometriosis is a systemic disease that can affect multiple parts of the body, not just the pelvis.

STAT

OCTOBER 22, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. Check out the latest promo we’re running, where you can get your first three months of a STAT+ subscription for $20.

Fierce Healthcare

OCTOBER 22, 2024

Amazon One Medical, working with the online retail company's technology teams, developed artificial intelligence tools for its clinicians to help them save time. | Amazon One Medical, working with the online retail company's technology teams, developed artificial intelligence tools for its clinicians to help them save time.

Fierce Pharma

OCTOBER 22, 2024

With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had

STAT

OCTOBER 22, 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. Hello and happy Thursday! In a tense election season, my go-to feel-good show has been The Great British Baking Show. Feelings about Caramel Week and news tips are always welcome to rachel.cohrs@statnews.com.

Fierce Healthcare

OCTOBER 22, 2024

Price transparency regulations are leveling the cost landscape for consumers, but that doesn’t always lead to lower prices, according to a new report from Turquoise Health. | Recent price transparency regulations have caused prices to converge for outpatient services but led to more discrepancy for inpatient services, according to findings from Turquoise Health.

Fierce Pharma

OCTOBER 22, 2024

MacroGenics’ first commercial product, breast cancer drug Margenza, is heading off to TerSera Therapeutics through a $40 million hand-off. | The 2020-approved breast cancer med booked $17.9 million in 2023 sales as it struggled to make a mark in the crowded market.

pharmaphorum

OCTOBER 22, 2024

AstraZeneca and Ionis are on track for EU approval of ATTR polyneuropathy therapy Wainzua after the CHMP backs the drug

Fierce Healthcare

OCTOBER 22, 2024

LAS VEGAS—Suki AI has inked a deal with the nation’s largest telehealth platform, Zoom Healthcare, to integrate an AI assistant into Zoom’s telehealth experience. | Suki will deploy its current AI assistant features like ambient scribe and clinical note generation and build out new technology to reimagine telehealthcare.