Mon.Apr 29, 2024

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Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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AI in Precision Medicine: Transforming Obesity Treatment

Pharma IQ

Discover how artificial intelligence is revolutionizing the field of precision medicine. In this insightful article, Tim O’Connor, Chief Data Scientist at Phenomix Sciences, discusses the pivotal role.

Medicine 130
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FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin

Fierce Pharma

For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,

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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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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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AstraZeneca, Daiichi tout Enhertu trial win in earlier, broader HER2-low breast cancer

Fierce Pharma

AstraZeneca and Daiichi Sankyo’s trailblazing Enhertu appears to have outdone itself. | AstraZeneca and Daiichi Sankyo’s trailblazing Enhertu appears to have outdone itself. After spearheading the new HER2-low category in breast cancer treatment, Enhertu has shown it could be useful against tumors with even lower expression of the HER2 protein.

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Merck, Huma alliance bears fruit with UK bladder cancer app

pharmaphorum

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

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X4 Pharma gets first FDA okay for WHIM syndrome drug

pharmaphorum

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.

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Alexis Borisy sheds 2 board jobs to stay with Blueprint as Ayvakit maker tightens director policy

Fierce Pharma

After losing majority shareholder support for his directorship at Blueprint Medicines last year, serial biotech entrepreneur Alexis Borisy has cut two outside titles to retain his seat at the compa | After losing majority shareholder support for his directorship at Blueprint Medicines last year, serial biotech entrepreneur Alexis Borisy has cut two outside titles to retain his seat at the company, which is further tightening its board policy.

Medicine 191
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Ono Pharma’s Plan to Become a Global Player Picks Up a New Piece With $2.4B Deciphera Acquisition

MedCity News

Ono Pharmaceutical’s acquisition of Deciphera Pharmaceuticals adds to a cancer drug pipeline that already spans multiple modalities. Deciphera develops drugs that target the on-off switch of enzymes that drive cancer cell growth. The post Ono Pharma’s Plan to Become a Global Player Picks Up a New Piece With $2.4B Deciphera Acquisition appeared first on MedCity News.

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X4 enters commercial fold with FDA approval of rare disease drug Xolremdi

Fierce Pharma

With the approval of X4 Pharmaceuticals’ first product mavorixafor, there’s a new commercial rare disease player in town. | Following a 10-year development journey, the FDA on Monday approved X4 Pharmaceuticals’ Xolremdi. The nod marks X4’s commercial debut and provides WHIM patients with the first therapy to tackle the underlying cause of their disease.

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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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European Pharmaceutical Review Issue 2 2024

European Pharmaceutical Review

Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies Drew Hope, Ryan Guest and Clare Blue eXmoor Pharma SUPPLY CHAIN Fresh or frozen? Navigating the cryopreservation dilemma for CGT Priya Baraniak OrganaBio GUIDE TO TESTING LoD requirements of qualitative microbiological methods for short shelf-life products Edwin van den Heuvel Eindhoven U

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Pivot Podcast: A Conversation with Capital Rx CEO A.J. Loiacono

MedCity News

Season 2 of the MedCity Pivot Podcast has launched with a special focus on the evolution of pharmacy and pharmacy benefit management. The first guest this season is A.J. Loiacono, who leads Capital Rx. The post Pivot Podcast: A Conversation with Capital Rx CEO A.J. Loiacono appeared first on MedCity News.

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CGT Catapult appoints new Non-Executive Directors

European Pharmaceutical Review

The Cell and Gene Therapy Catapult (CGT Catapult) has appointed three new Non-Executive Directors to its board. This supports the organisation ’s mission to advance the industry in the UK and facilitate wider adoption of advanced therapies. Dr Jim Faulkner is an “experienced, innovative biopharmaceutical development leader with specialist skills in cell and gene therapy”, according to CGT Catapult.

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Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

MedCity News

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

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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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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. The treatment is indicated for adults with moderate to severe haemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening haemorrhage, Pfizer stated.

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Ono swoops on Deciphera in $2.4 billion takeover

pharmaphorum

Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.

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Rapid method for whole-genome fungal ID

European Pharmaceutical Review

Researchers have reported a novel universal fungal identification method called Analysis of whole GEnome (AGE) for “the first-time demonstration of the identification potential of sequences from unannotated genomic regions”. Developing new approaches for microbiological identification across the entire fungal kingdom remains “a major challenge”, Qi et al. explained.

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Navigating Healthcare’s New Era of Algorithmic Transparency

MedCity News

What EHR/EMR vendors need to know to comply with ONC’s HTI-1 final rule The post Navigating Healthcare’s New Era of Algorithmic Transparency appeared first on MedCity News.

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

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J&J gets CHMP nod for Rybrevant in first-line lung cancer

pharmaphorum

CHMP backs EU approval of J&J's Rybrevant as a first-line therapy for NSCLC with EGFR exon 30 insertion mutations, filling a void left after Takeda's Exkivity was pulled from sale

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Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee

MedCity News

Abbott earned FDA approval for its dissolving stent designed to unclog arteries below the knee. This marks the first time the FDA has approved a stent or drug-coated balloon to help arteries stay open below the knee. The post Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee appeared first on MedCity News.

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Pfizer receives FDA approval for haemophilia B gene therapy

Pharmaceutical Technology

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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Ex-Ironwood CEO Mark Mallon pops up at George Medicines

pharmaphorum

George Medicines has appointed former Ironwood CEO Mark Mallon to lead the company as it tries to get its triple therapy for hypertension over the finish line.

Medicine 105
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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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Cell and gene therapy companies trip at scalability hurdle

Pharmaceutical Technology

Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.

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ETH Zurich researchers use AI to develop drug molecules based on protein structures

PharmaTimes

The new process makes generating active pharmaceutical ingredients quicker and easier

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As BMS announces major cuts, its Karuna deal looks poised to drive growth

PharmaVoice

The company's schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.

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KCL study reveals particles in cows’ milk effective for oral delivery of RNA drugs

PharmaTimes

The method has the potential to be used to deliver RNA to the bloodstream for a range of diseases

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Inequity in Interoperability: The Haves and Have-Nots & How QHINs Can Help

MedCity News

Interoperability is moving ahead, but major health systems and hospitals in large population centers must ensure they don’t leave their smaller and more rural counterparts behind. The post Inequity in Interoperability: The Haves and Have-Nots & How QHINs Can Help appeared first on MedCity News.

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AstraZeneca’s Fasenra: Approval for asthma may initiate COPD approval

Pharmaceutical Technology

AstraZeneca has recently announced that Fasenra has been approved for severe asthma, specifically for the eosinophilic phenotype, in children aged 6-11 years in more than 80 countries, including the US, EU, and Japan.

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Provider Feedback Loop: The Missing Link in AI Development, Use and Adoption

MedCity News

With the right solutions, providers can spend more time with the patient, building the relationship, earning their trust, and focusing on the forward-looking health journey. The post Provider Feedback Loop: The Missing Link in AI Development, Use and Adoption appeared first on MedCity News.

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Bioprocessing/Bioproduction In-Depth Focus 2024

European Pharmaceutical Review

Unlocking the potential of biologics production: a comprehensive exploration Different types of biologics require different sized bioreactors and different manufacturing approaches, as Sridevi Khambhampaty, Vice President at Syngene International Limited, elucidates. Bioconjugation of antibody-drug conjugates: the past, present and future Development of antibody-drug conjugates (ADCs) has experienced significant growth over the past two decades.

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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