Mon.Feb 12, 2024

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In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’

Fierce Pharma

Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection. But the first FDA-approved oral eosinophilic esophagitis therapy comes with a limitation.

FDA 263
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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

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PTC's Emflaza to face generics this month after Aurobindo's final FDA nod

Fierce Pharma

After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S. | After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.

FDA 258
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Unlocking the Potential of AI-Driven Biomarkers: A New Era in Personalized Cancer Care

MedCity News

By leveraging AI and machine learning, researchers can analyze complex data sets, identify novel biomarkers, and provide more effective and tailored treatment options for cancer patients.

Patients 113
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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records

Fierce Pharma

When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by f | When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list.

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Dermatology pharma Alys launches with $100m from Medicxi

pharmaphorum

Medicxi has combined six biotechs with dermatology medicines in development in a single drugmaker, called Alys Pharma, which starts life with $100 million in financing.

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3 Reasons to Attend the Payer Insights Sessions at ViVE 2024 [Sponsored]

MedCity News

The Payer Insights Program at ViVE 2024, in partnership with MedCity News, kicks off day one at the event. This new immersive program will focus on the impact of rising healthcare costs, recent regulatory changes, and innovative payer solutions for optimizing data insights, minimizing costs, and expanding access to care.

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After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel

Fierce Pharma

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. | Following a rejection in 2023, the FDA has accepted the resubmission of Xspray’s application for its leukemia candidate Dasynoc, which is seeking to dethrone Bristol Myers Squibb’s entrenched cancer blockbuster Sprycel (dasatinib).

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FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

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AbbVie wraps up its $10.1B buyout of ImmunoGen well ahead of schedule

Fierce Pharma

AbbVie has closed its $10.1 billion buyout of antibody-drug conjugate specialist ImmunoGen. | AbbVie has closed its $10.1 billion buyout of antibody-drug conjugate specialist ImmunoGen. And the good news from an industry perspective is that deal took less than three months to complete.

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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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Rare Disease Day 2024: Advocating for Awareness and Support

PM360

This February we celebrate the 16th annual Rare Disease Day , established in 2008, to raise awareness of the more than 7,000 identified rare diseases worldwide. Rare Disease Day is observed annually on the “rarest” day of the year, February 28th or 29th depending on leap years. Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and

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Views of Digital Health from the Oregon Trail

MedCity News

Today, many hope artificial intelligence will be the key that unlocks the value of digitization. Perhaps it will, but the claim that better technology will necessarily improve healthcare is no longer credible. Having lived in both analog and digital worlds, who better than us Oregon Trail doctors to help ensure digital health technologies best serve our workforce, patients, and communities?

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Biologics – manufacturing trends in a modern facility

European Pharmaceutical Review

Bringing a therapeutic to market is a long and complex process. ‘From bench to bedside’ is a well-known aphorism that merely hints at the arduous journey drug treatments must undergo from their position as a candidate molecule or soon to be explored pathway, to becoming a tablet, injection, or infusion administered to patients worldwide. The scientific rigour of development and the various regulatory hurdles involved mark most of that journey.

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Who Needs To File With OHCA Under California’s New Healthcare Transaction Regulations?

MedCity News

Who do the California Office of Healthcare Affordability’s cost and market impact review regulations apply to? That depends on three questions, according to a recent webinar.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Raman and machine learning show promise for online monitoring of bioreactors

European Pharmaceutical Review

Researchers based in France have demonstrated a robust online Raman monitoring model for bioreactors, which combines Raman spectroscopy and machine learning (ML). In the study, the fermentation of alcohol by Saccharomyces cerevisiae ( S. cerevisiae) was used as a benchmark bioprocess. The method was validated across numerous batches and a fed-batch bioreactor.

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Apple devices enrich patent data in arthritis trial

pharmaphorum

Study finds that monitoring of rheumatoid arthritis patients with an Apple Watch and iPhone and AI algorithm improves on standard practices.

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How Access to Capital Benefits Radiology and Radiologists

MedCity News

Private equity is a way to help achieve scale. Groups that use scale to better serve the stakeholders that matter most, including radiologists, hospitals, referring physicians and—most importantly—patients, will be best positioned to not just survive, but thrive.

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Gilead to buy liver disease specialist CymaBay for $4.3bn

pharmaphorum

Gilead Sciences has beefed up its pipeline with an agreement to buy CymaBay Therapeutics and its seladelpar drug for primary biliary cholangitis (PBC) for $4.

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

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Navigating the Challenges of Pediatric Surgery With Robotic-Assisted Procedures

MedCity News

With the many advantages of robotics, it is time for pediatric patients to garner the same attention and technology development that adult patients have benefitted from for decades.

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FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

pharmaphorum

GSK’s antisense-based drug for chronic hepatitis B, bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval

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Gilead’s $4.3B CymaBay Acquisition Adds Liver Disease Drug Under FDA Review

MedCity News

Acquiring CymaBay Therapeutics gives Gilead Sciences another drug for its liver disease portfolio. CymaBay’s molecule, seladelpar, is under FDA review for treating primary biliary cholangitis, a rare disease affecting the bile ducts of the liver.

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CSL’s post-heart attack therapy flunks big phase 3 test

pharmaphorum

Biotech giant CSL has seen almost 5% wiped off the value of its shares after one of its most anticipated pipeline products failed a phase 3 trial in heart attack patients

Patients 110
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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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Does Chronic Disease Management in Medicare Advantage Need a ‘Retail’ Makeover?

MedCity News

Adopting consumer strategies from leading retailers can give MA plans an edge in an increasingly competitive market filled with new entities while improving quality, reducing cost, and improving member loyalty.

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Disc wins orphan drug tag for rare blood cancer  

Pharmaceutical Technology

The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.

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First UK patients receive experimental mRNA therapy for cancer in global trial

PharmaTimes

The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359

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FDA changes its mind and approves Takeda’s Eohilia

pharmaphorum

At its second attempt, Takeda has won FDA approval for Eohilia, the first and only oral therapy in the US for eosinophilic oesophagitis

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Scientists develop micofluidic chip to make cell therapy safer

PharmaTimes

The chip removes cells, which could become tumours, before they are implanted in a patient

Patients 106
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FDA inches closer to defining its regulatory role in AI

PharmaVoice

Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.

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Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

PharmaTimes

The platform delivers digitalised patient data to improve clinical trials and development

Patients 105
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Unlocking Pharma Sales Success: Is NAPSRx's CNPR Certification Your Golden Key?

Contrarian Sales Techniques

NAPSRx stands for the National Association of Pharmaceutical Sales Representatives®, and it's basically a cool club for folks who want to rock the pharmaceutical sales world. They offer this certification called CNPR, short for Certified National Pharmaceutical Representative, which is like a golden ticket if you're new to the scene or looking to step up your game in pharma sales.

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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