Sat.Nov 09, 2024 - Fri.Nov 15, 2024

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BioNTech signs agreement to acquire Biotheus

Pharmaceutical Technology

BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Where Medicare Advantage Goes From Here

MedCity News

Now is the time for health plans to step up and embrace the tools and strategies that will not only meet regulatory demands, but also drive innovation in care delivery. The post Where Medicare Advantage Goes From Here appeared first on MedCity News.

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial. In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.

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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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EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).

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AstraZeneca CEO defends corporate oversight, $80B revenue target amid China probes

Fierce Pharma

Despite China’s investigations into insurance fraud, allegedly illegal importation of unapproved drugs and improper collection of patient data that have implicated senior executives, AstraZeneca CE | Despite China’s investigations that have implicated senior executives, AstraZeneca CEO Pascal Soriot argued that the company did not lose oversight and remains on track to achieve his ambitious $80 billion-by-2030 revenue goal.

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Sanofi wins appeal in spat with NICE over Sarclisa

pharmaphorum

Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside Bristol-Myers Squibb/Celgene's Imnovid (pomalidomide) and dexamethasone (Isa-Pd) for relapsed RRMM.

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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

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In boost to GSK's £3B plan for Blenrep, myeloma ADC shows survival edge over J&J's Darzalex

Fierce Pharma

GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.

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Centering Caregiver and Provider Feedback in Home-Based Care Innovation

MedCity News

The best healthcare technology emerges from collaborative efforts. Here’s why working alongside physicians, nurses, and home health caregivers builds a stronger foundation. The post Centering Caregiver and Provider Feedback in Home-Based Care Innovation appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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Citing 'capacity constraints,' Novo Nordisk plots global wind-down of human insulin pen production

Fierce Pharma

As sales of Novo Nordisk’s GLP-1 drugs for diabetes and obesity continue to soar, the Danish drugmaker is once again adjusting its insulin production priorities. | Citing 'capacity constraints,' Novo Nordisk plans to transition its human insulin—which is currently sold in pens and vials—to vials only. The decision is playing a part in a broader discussion around equitable access to diabetes treatments in less-wealthy countries.

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Bundling Boomer Housing with On-site Primary Care and Wellness-Focused Living: It Just Makes Sense

MedCity News

Providing proactive and preventive health-focused living among younger, less affluent senior populations — and extending this into value-based care — just makes sense. The post Bundling Boomer Housing with On-site Primary Care and Wellness-Focused Living: It Just Makes Sense appeared first on MedCity News.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Aignostics leads latest crop of digital health financings

pharmaphorum

Recent funding rounds in the digital health arena feature digital pathology startup Aignostics, remote care specialists TCC, Yazen Health, and Nema Health, wearables developer Alimetry, and clinical trial automation startup Research Grid.Digital pathology specialist Aignostics, which develops artificial intelligence algorithms to glean information from medical images and combine it with epidemiological, clinical, and genomic data, has completed a $34 million Series B financing.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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Remote Patient Monitoring Works … What are Payers and Providers Waiting for?

MedCity News

To overcome challenges and ensure that RPM reaches its full potential, both providers and payers need to implement several key strategies — and technology is a key component to making everything easier on all organizations. The post Remote Patient Monitoring Works … What are Payers and Providers Waiting for? appeared first on MedCity News.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Metsera gets $215m for obesity trials, and other financings

pharmaphorum

If any further evidence were needed for the insatiable investor appetite for companies with obesity assets, look no further than New York startup Metsera.After emerging from stealth with a $290 million first round in April, the biotech has added another $215 million to its coffers via a Series B led by Wellington Management and Venrock Healthcare Capital Partners, taking the total raised by the company over $500 million in just seven months.

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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease

Pharmaceutical Technology

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

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Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years

Fierce Pharma

Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years fkansteiner Wed, 11/13/2024 - 14:37

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Merck Is Paying $588M for Potential Successor to Cancer Drug Juggernaut Keytruda

MedCity News

Merck is acquiring global rights to a bispecific antibody from LaNova Medicines that blocks two cancer targets, PD-1 and VEGF. The deal comes one day after BioNTech announced an $800 million acquisition that gives it full rights to a molecule in this hot class of cancer drug candidates. The post Merck Is Paying $588M for Potential Successor to Cancer Drug Juggernaut Keytruda appeared first on MedCity News.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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PTC gets FDA okay for first brain-delivered gene therapy

pharmaphorum

More than two years after its approval in Europe, PTC Therapeutics' gene therapy for rare genetic disorder AADC deficiency will soon be made available to patients in the US.The FDA has approved PTC's eladocagene exuparvovec – known as Upstaza in Europe – under the Kebilidi trade name in the US. It is cleared for both children and adults with AADC (aromatic L-amino acid decarboxylase) deficiency, a fatal disease that causes severe disability and suffering from the first months of life.

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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims

Fierce Pharma

In a flurry of activity, Europe’s human medicines committee has done an about-face on Eisai and Biogen’s Alzheimer’s disease med Leqembi, endorsed a clutch of biosimilars, recommended a slew of lab | In a flurry of activity, the European Medicines Agency's CHMP has done an about-face on Eisai and Biogen’s Alzheimer’s disease med Leqembi, endorsed a clutch of biosimilars, recommended a slew of label expansions and put forward new cancer and COVID drugs for approval.

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Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence

MedCity News

By fostering collaboration and seamless data integration into healthcare systems, the industry is laying the groundwork for a future in which “personalized medicine” is so commonplace within clinical practice that we will just start calling it “medicine.” The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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GSK hails survival data with revived myeloma drug Blenrep

pharmaphorum

GSK's multiple myeloma therapy Blenrep's increase in overall survival in the DREAMM-7 trial has achieved statistical significance

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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine 

Pharmaceutical Technology

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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AstraZeneca and Merck's Koselugo delivers phase 3 trial win in adults with NF1, teeing up filings

Fierce Pharma

Four years after winning an FDA approval for Koselugo to treat children with the rare disorder neurofibromatosis type 1 (NF1), AstraZeneca is touting a trial result that could allow the company and | Four years after scoring an FDA approval to treat children with NF1, AstraZeneca says its Merck-partnered Koselugo has shown promise in adults.

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Video: What Would Happen If Prior Authorization Went Away?

MedCity News

Prior authorization is a sore subject for payers and providers. So what if it went away? In a recent fireside chat hosted by MedCity News, Don Antonucci, CEO of Providence Health Plan, shared his thoughts. The post Video: What Would Happen If Prior Authorization Went Away? appeared first on MedCity News.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A