Wed.Jan 24, 2024

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Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.

Safety 261
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Pharma Horizons: Artificial Intelligence

European Pharmaceutical Review

The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. AI/ML is predicted to be the top technology investment for 60 percent of life sciences companies over the next two years, according to a recent survey 1 from the Pistoia Alliance.

Pharma 130
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Leo scores again in hand eczema with its JAK inhibitor cream

Fierce Pharma

It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgoci | It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgocitinib to treat atopic dermatitis. Slowly but surely, Denmark’s Leo Pharma—which gained the rights to develop and commercialize delgocitinib in the rest of the world a decade ago—is working toward its first green light for the topical cream.

Pharma 228
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CG Oncology is first biotech IPO of 2024, raising $380m

pharmaphorum

CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.

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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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Cabometyx, Tecentriq stave off prostate cancer progression as Exelixis joins Novartis on FDA's wait list

Fierce Pharma

Another prostate cancer trial has hit its main goal, and yet the drug developer can’t immediately file for an FDA approval. | In a similar pattern as Novartis' radiotherapy Pluvicto, Exelixis now has positive prostate cancer data for a combination of Cabometyx and Roche's Tecentriq, and yet the drug developer can't immediately file for an FDA approval.

FDA 184
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This Mom Was Frustrated with the Scarcity of Child Development Specialists — So She Launched a Startup

MedCity News

After experiencing firsthand the shortcomings of existing public and private programs to treat children’s developmental delays, Jen Wirt founded a startup called Coral Care. The company, which announced its official launch on Tuesday, brings pediatric developmental specialty care into families’ homes.

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Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

MedCity News

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy.

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Apotex, Heritage and Breckenridge settle with purchasers in generics price-fixing case

Fierce Pharma

Over the years, myriad generic drugmakers have had to ante up fines and settlement fees for allegedly colluding on the prices of copycat drugs. | Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017.

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Securing the Healthcare Cloud in 2024 with Cloud Managed Services

MedCity News

By partnering with a cloud managed service provider, one can overcome cloud staffing and security issues and better align internal resources with the things that make your business special, like developing new apps and features that enhance healthcare services and improve health outcomes for end users.

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Fake versions of Novo Nordisk's Ozempic linked to 3 dangerous hypoglycemia cases in US: Reuters

Fierce Pharma

Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Contr | Dangerously low levels of blood sugar—attributed to potentially counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters.

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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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KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions

PharmaTech

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

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5 Ways To Make a Business Case for Virtual Reality in Healthcare

MedCity News

Virtual reality reduces the cost of training while also improving learning efficiency and knowledge retention. It’s not just universities and medical students that are embracing VR technology for learning. I travel all over the world to work with healthcare teams implementing VR and have observed, that a growing number of hospitals are using it for continuing education.

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J&J’s 2024 strategy will focus on newer meds to offset Stelara’s patent cliff

PharmaVoice

Executives on the healthcare giant’s full-year earnings call highlighted a strong cash position and incremental dealmaking as a way to get past incoming competition.

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How One Company Hopes To Monitor Health and Safety Through Its New Home-Based Product

MedCity News

Cherish Health recently launched Cherish Serenity, a device that sits in the home and can detect falls across multiple rooms. If there is an emergency, it will notify a caregiver or response center for help.

Safety 105
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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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LEO says chronic hand eczema drug bests its only rival

pharmaphorum

LEO Pharma's chronic hand eczema drug delgocitinib has outperformed the only approved drug for the condition in a phase 3 trial.

Pharma 109
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Technology as a Cure: Alleviating Clinician Burnout, Empowering Pharmacists to Fill Care Gaps This Cold and Flu Season

MedCity News

In 61% of counties with a PCP shortage, there is a high volume of retail pharmacies. It reveals an opportunity for pharmacists, who have the education and training, and are already providing vaccinations, tests and frontline treatments to amplify the impact they can have on providing accessible care in the communities they serve.

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Accent Therapeutics secures funding to advance cancer therapies

Pharmaceutical Technology

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

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BenevolentAI names pharma vet Jörg Möller as its new CEO

pharmaphorum

BenevolentAI’s search for a new chief executive has concluded with the appointment of industry bigwig Dr Jörg Möller to the role, four months after Joanna Shields stepped down and as the company emerges from a restructuring drive. The UK artificial intelligence specialist said in a statement that Möller is “an accomplished R&D leader and champion of the application of AI to drug discovery.

Pharma 94
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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4DMT secures rare paediatric designation for cystic fibrosis gene therapy

Pharmaceutical Technology

The company could be in line for a priority review voucher if 4D-710, currently in Phase I/II clinical trials, is approved.

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BARDA backs Locus phage therapy for resistant E coli

pharmaphorum

BARDA has given $24 million to Locus Bio to support a mid-stage trial of bacteriophage therapy LBP-EC01 for resistant E coli infections.

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Complying With the DSCSA

Pharmaceutical Commerce

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA).

Pharma 64
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DiMe project will develop recipe for digital health success

pharmaphorum

A consortium led by the Digital Medicine Society (DiMe) has been formed to tackle a thorny problem for digital health product (DHP) developers – how to bring them to market in a way that ensures they are commercially sustainable.

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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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NHS to test new blood group genotyping test on inherited blood disorder patients

PharmaTimes

Patients living with sickle cell disease and thalassaemia will be eligible for the test

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Breast cancer tops list of most studied diseases

PharmaVoice

The most studied diseases last year included three types of cancer as research into COVID-19 fell sharply in the post-pandemic era.

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Calluna Pharma announces €75m series A financing for immunological diseases

PharmaTimes

The new company will develop novel therapies to benefit the body’s immune system

Pharma 86
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Forecasting Physician Demands in Manitoba with Data Insights

Scott’s Directories

Manitoba’s healthcare system is experiencing a growing population coupled with an aging demographic. Effective management and planning hinge on informed decision-making powered by robust data insights. Here, the Manitoba physician directory from MD Select emerges as an indispensable tool, offering unprecedented access to comprehensive data crucial for accurately forecasting physician demands.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA to Require Boxed Warning Labels on CAR T-Cell Therapies for Secondary Cancer Risks

Pharmaceutical Commerce

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.

FDA 52
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Sanofi bets $1.7b on potential best-in-class rare disease therapy

European Pharmaceutical Review

Sanofi has agreed to acquire Inhibrx, Inc. for approximately $1.7 billion, therefore taking on a potential best-in-class treatment for rare lung and liver disease alpha-1 antitrypsin deficiency (AATD). A promising best-in-class rare disease treatment AATD is an inherited rare disease of the lungs and liver, which according to Sanofi, is characterised by low levels of AAT protein, a neutrophil elastase inhibitor.

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Bristol Myers Squibb Completes Acquisition of Mirati to Bolster Oncology Pipeline

PharmExec

Under the agreement, Bristol Myers Squibb obtains Mirati’s entire portfolio, including Krazati (adagrasib) for the treatment of KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer.

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Bristol Myers Squibb Grows Oncology Pipeline With Completion of Mirati Acquisition

Pharmaceutical Commerce

The definitive merger agreement was reached in October 2023, with Bristol Myers Squibb acquiring Mirati for $58 per share in cash, for a total equity value of $4.8 billion.

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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