Mon.Jun 17, 2024

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New Merck pneumococcal vaccine wins FDA approval

STAT

The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18 and older. The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases.

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How can you prepare pharmaceutical data for AI consumption?

PharmaVoice

While AI has exploded in popularity across various industries, including pharma and life sciences, many companies have launched models that haven't delivered on their full potential.

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Bird flu snapshot: A critic of the U.S. response speaks out, and USDA tries to ‘corner the virus’

STAT

Bird flu snapshot: This is the first in a series of regular updates on H5N1 avian flu that STAT is publishing on Monday mornings. To read future updates you can also subscribe to STAT’s Morning Rounds newsletter. Seth Berkley, the former head of Gavi, the Vaccine Alliance, gave voice last week to a point of view STAT has been hearing for a while about the U.S. response to the H5N1 bird flu outbreak in dairy cows.

Vaccines 363
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The hunt for the brain’s biomarkers

PharmaVoice

How Roche is finding better ways to diagnose brain conditions like Alzheimer’s and Parkinson’s disease.

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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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Vaping is just as good as Chantix at helping people quit cigarettes, new study finds

STAT

WASHINGTON — E-cigarettes were about as effective at helping people quit smoking as the gold-standard pharmaceutical drug, varenicline, according to a clinical trial published Monday in JAMA Internal Medicine. The trial randomized 458 people who smoked daily and wanted to quit to receive either a nicotine-containing e-cigarette and placebo tablets, varenicline and an e-cigarette without nicotine, or a placebo tablet and a nicotine-free e-cigarette for 12 weeks.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

BioPharma Dive

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

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More Trending

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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What’s the evidence for the Surgeon General’s proposed social media warning?

STAT

United States Surgeon General Vivek Murthy wants to add a warning label on social media. “It is time to require a surgeon general’s warning label on social media platforms, stating that social media is associated with significant mental health harms for adolescents,” he wrote in an op-ed published on Monday in the New York Times, calling on Congress to take action to add the warning, which would be along the lines of the ones issued against tobacco and alcohol consumption.

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PulmCrit: Bilevel Sequence Intubation (BSI) – The new standard

EMCrit Project

introduction Bilevel Sequence Intubation (BSI) refers to initiation of noninvasive bilevel positive pressure ventilation with a backup rate prior to intubation (either using a BiPAP machine or a full-featured mechanical ventilator). BSI is distinct from traditional rapid sequence intubation (RSI), since BSI involves the delivery of machine-initiated, pressure-controlled breaths following administration of sedation and paralytics. […] EMCrit Project by Josh Farkas.

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STAT+: Former medical device CEO who sold fake plastic parts sentenced to 6 years in prison

STAT

The former CEO of Stimwave, a company that sold pain-relief devices with dummy pieces of plastic, was sentenced Monday by a New York judge to six years in prison.  Stimwave sold nerve stimulation devices to combat pain. Under CEO Laura Perryman’s leadership, the company warped the design of their devices to earn more reimbursement money from insurers, resulting in unnecessary plastic parts that allowed doctors to claim around $18,000 more than they previously could.

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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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Could Amazon or Google hold the key to the future of public health diagnostics?

pharmaphorum

Discover how leading tech giants such as Amazon, Google, Apple, and Microsoft are shaping the future of public health diagnostics through MedTech innovations. Explore the potential impact on healthcare and stay informed on the latest developments.

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Opinion: I’m a hypochondriac. Here’s how the health care system needs to deal with people like me

STAT

A late-night Flomax commercial is sometimes all it takes for me to start spinning in a cycle of anxiety. If I don’t need Flomax to help me pee better, then I imagine I probably need a screening for prostate cancer. I’m a hypochondriac. I’m also a health care executive with insight into how the U.S. health care system works — and doesn’t work — which may contribute to my hyper focus on health.

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Address the impact of trending health information with conversation data

pharmaphorum

Explore the impact and influence of trending health information, like Ozempic and the Eddy Effect on platforms like TikTok, through conversation data analysis. Learn more about these trends and their implications.

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STAT+: Under pressure to thwart pharma patent abuse, the PTO proposes a new rule. But will it fly?

STAT

In a bid to prevent the patent system from being abused, the U.S. Patent and Trademark Office has proposed a new rule designed to stem the use of so-called patent thickets , which are wielded by pharmaceutical companies to delay the arrival of lower-cost generic medicines in the marketplace. Essentially, thickets are collections of numerous patents that add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients.

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Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies

Drug Patent Watch

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

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STAT+: Why health care spending keeps climbing

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. Putting your money where your mouth is Large companies rarely switch health insurance vendors. It’s a pain in the butt for everyone involved, even if the current setup is a raw deal.

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CALQUENCE plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial

Express Pharma

The recent results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab demonstrated an improvement in progression-free survival (PFS) and showed a favourable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

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FDA offers new guidelines for Covid-19 vaccine

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we talk about the uptick in physicians using ctDNA to determine if resected cancers are truly gone, we see the FDA offering new guidelines for Covid-19 vaccines, and more.

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Upscaling your brand strategy: New ways of planning

pharmaphorum

Learn how to upscale your brand strategy with new and innovative ways of planning. Discover effective brand planning strategies to take your brand to the next level.

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STAT+: Why a big California employer ditched Elevance for some of its health plans

STAT

The California Public Employees’ Retirement System is making a drastic change to one of its major health insurance plans for the state’s employees and retirees: It’s switching health insurance carriers, and forcing its new partners to earn their fees instead of automatically getting them. The new contract could serve as a model for other large employers that are fully on the hook for their workers’ health care costs and want their insurance companies to do more to kee

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Innovative Approaches to Extend the Life of Drug Patents

Drug Patent Watch

Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs. Here are some key approaches with examples: New Formulations One common strategy is to develop and patent new formulations of the existing drug compound to provide benefits like reduced dosing frequency, easier administration, improved bioavailability, or reduced side effects.

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Abortion pill ruling offers measure of relief for FDA, biotech

BioPharma Dive

One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

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Ascentage Pharma signs option agreement with Takeda

Express Pharma

Ascentage Pharma, a global biopharmaceutical company engaged in developing therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, recently announced the signing of an option agreement with Takeda to enter into an exclusive licence agreement for olverembatinib, an oral, BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukaemia (CML) and other haematological cancers.

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A Practical Guide to FtO Analysis for Drug Repurposing Ventures

Drug Patent Watch

A recent whitepaper by Hermann Mucke summarizes the steps to performing an FTO for drug repurposing: Overview An FtO analysis determines if a new product or process can proceed without infringing third-party intellectual property (IP) rights, especially patents. It is crucial for drug repurposing projects involving known compounds that may still be patent-protected.

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U.S. FDA approves CAPVAXIVE (V116), specifically designed for pneumococcal disease in adults

Express Pharma

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for, active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

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Telehealth firm fraud charges may worsen ADHD drug shortage

pharmaphorum

Two executives at telehealth startup Done Global have been arrested and face allegations of fraud involving the distribution of medicines for ADHD

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Leuko device to remotely monitor cancer patients during chemotherapy

Pharma Times

Cancer was estimated to be responsible for more than 18 million cases worldwide in 2020

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Lupin appoints Abdelaziz Toumi as CEO of its API CDMO subsidiary

Express Pharma

Global pharma major Lupin (Lupin) announced the appointment of Abdelaziz Toumi (Abdel) as the Chief Executive Officer of its newly formed subsidiary, Lupin Manufacturing Solutions (LMS). LMS is engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients and is starting to build its Contract Development and Manufacturing Operations (CDMO) business.

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New data at EHA backs Sanofi, Innate’s NK cell engager

pharmaphorum

Sanofi and Innate Pharma NK cell engager therapy SAR443579 shows promising efficacy in AML patients in a phase 1/2 trial reported at EHA.

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Syncona melds two gene therapy biotechs for better shot at new nervous system treatments

BioPharma Dive

The new company, Spur Therapeutics, is getting another $50 million from Syncona to support its broadened pipeline, which targets Parkinson’s disease as well as heart conditions.

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TC-110 by Adaptimmune Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

TC-110 is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).

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Study finds low secondary cancer risk with CAR-Ts

pharmaphorum

Stanford Medicine study finds risk of secondary cancers with CAR-T therapies is low and likely unrelated to the treatments themselves

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Equecabtagene autoleucel by Nanjing IASO Biotherapeutics for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Refractory Multiple Myeloma.

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Epilepsy fail hands late-stage pipeline blow to Takeda

pharmaphorum

Takeda’s experimental epilepsy drug soticlestat has failed phase 3 trials in Dravet syndrome and Lennox-Gastaut syndrome

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Equecabtagene autoleucel by Nanjing IASO Biotherapeutics for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Relapsed Multiple Myeloma.

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