Wed.Jun 26, 2024

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes

MedCity News

The American Hospital Association sent letters to the Senate and House urging them to support legislation that would prevent the CMS from enforcing its final rule on minimum staffing requirements for long-term care facilities. The organization argued that the mandate could lead nursing homes to reduce capacity or close altogether. The post AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes appeared first on MedCity News.

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With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market

Fierce Pharma

Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.

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Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms

MedCity News

The 2024 Benefit Consultant Sentiment Index published by MedCity News and sponsored by Quantum Health, now in its second year, is based on a survey of more than 100 seasoned healthcare benefits consultants who represent a cross-section of employer size. A few shared their impressions of some of the report findings. The post Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms appeared first on MedCity News.

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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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After stock crash and staff cuts, Amarin wins bid to revive Vascepa patent lawsuit

Fierce Pharma

The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. | Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval

Fierce Pharma

The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. | Even after the FDA has converted J&J’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod, the door to an accelerated approval in the same indication remains open, according to AstraZeneca spinout Dizal Pharma.

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New US fill finish facility receives $4.1 billion investment

European Pharmaceutical Review

Novo Nordisk has announced one of its largest manufacturing investments; $4.1 billion will support the construction of a second fill and finish facility for aseptic manufacturing in Clayton, North Carolina, US. The increased capacity will add 1.4 million ft 2 of production space, double the combined square footage of all three of the company’s existing facilities in North Carolina.

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Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's

Fierce Pharma

With U.K. consumer health giant Haleon slimming down and India’s Dr. Reddy’s Laboratories beefing up its over-the-counter offerings, the two have arrived at a deal that makes sense for both. | Haleon has continued its push to divest, selling its nicotine replacement therapy (NRT) business outside of the United States to Dr. Reddy’s for 500 million pounds ($633 million).

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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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Bridging Authenticity: The Transformative Power of Allyship

ALULA

Since our Pride Month series is all about prompting more open conversations about LGBTQIA+ allyship, I took the opportunity to interview my colleague Brian Cole about his allyship journey. Not only is Brian my colleague , but he is also my dad, so it was powerful to address how features of allyship show up across our shared work, home, and social spaces.

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Sanofi asks for private equity bids for its consumer health unit: Bloomberg

Fierce Pharma

It finally appears to be go-time in Sanofi’s continuing effort to separate from its consumer health unit. | Sanofi has told prospective buyers of its consumer health unit to provide bids for its consumer division by the middle of July, Bloomberg reports. Private equity firms Advent International and PAI Partners are believed to be the most serious potential suitors.

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Magazine: UK’s new Netflix-style funding model for antibiotics goes live

Pharmaceutical Technology

In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.

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Sumitomo Pharma's new CEO weighs layoffs in Japan after sharp sales drop, US job cuts: report

Fierce Pharma

A recent layoff round affecting 400 U.S. staffers was just the latest in Sumitomo Pharma’s waves of workforce reductions. | Sumitomo Pharma's new CEO is looking to restructure and cut jobs in the company's home country after a sharp revenue dip, according to an interview he gave with Nikkei Asia.

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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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The Financial Potential of Convertible Notes in the Pharmaceutical Sector

MedCity News

These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. The post The Financial Potential of Convertible Notes in the Pharmaceutical Sector appeared first on MedCity News.

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EuroAPI telegraphs 2 site sales, hundreds of layoffs as it rolls ahead with restructuring scheme

Fierce Pharma

The toll of Sanofi spinoff EuroAPI’s newly unveiled restructuring scheme is coming into focus as the manufacturer moves forward with its sweeping four-year efficiency plan. | The toll of Sanofi spinoff EuroAPI’s newly unveiled restructuring scheme is coming into focus as the manufacturer moves forward with its sweeping 4-year efficiency plan.

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Mavida Health Expands Offerings for LGBTQIA+ Families

MedCity News

Mavida Health’s new offerings for LGBTQIA+ patients include virtual spaces for queer parents to connect, gender-affirming care for queer and trans birthing people, specialized perinatal mental health providers in the LGBTQIA+ community and educational content inclusive of all identities. The post Mavida Health Expands Offerings for LGBTQIA+ Families appeared first on MedCity News.

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EvolutionaryScale emerges with $142m for AI drug discovery

pharmaphorum

AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.

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

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Streamlining the Patient Consent Process

MedCity News

Velatura, a leading multi-jurisdictional health information exchange and health data utility, along with Docusign, the leading intelligent agreement management solution that accelerates the process of doing business, have joined forces to streamline the process of obtaining and managing informed patient consent. The post Streamlining the Patient Consent Process appeared first on MedCity News.

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Wales and NI follow England in backing Vertex CF therapies

pharmaphorum

Three of the four UK nations have agreed a long-term deal with Vertex Pharma for reimbursement of its cystic fibrosis therapies, ensuring permanent access to the drugs for eligible patients.The new agreement with England, Wales, and Northern Ireland marks the end of a long-standing and sometimes bitter dispute over the high cost of Vertex's CFTR modulator drugs.

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A Tipping Point: Organ Shortages and the Future of Transplantation

MedCity News

Increasingly, more patients qualify for transplants, making organ shortages today’s most pressing issue. The post A Tipping Point: Organ Shortages and the Future of Transplantation appeared first on MedCity News.

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Akili lifted by FDA nod for adult ADHD digital therapeutic

pharmaphorum

Digital health company Akili will go into its merger with Virtual Therapeutics with FDA approval for its adult ADHD app

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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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After 33 years, Geron’s first approval marks a turn in Nobel-winning science

PharmaVoice

The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.

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Quality Considerations in Changing Excipient Providers

PharmaTech

In the premiere episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

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Smith+Nephew takes sports injury message to Wimbledon

pharmaphorum

Smith+Nephew takes sports injury message to Wimbledon Phil.

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CDER Gives Update on New Drugs Regulatory Program

PharmaTech

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER process.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

MedCity News

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. The post Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease appeared first on MedCity News.

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Imfinzi fails lung cancer trial, but scores in bladder cancer

pharmaphorum

AstraZeneca’s hopes of positioning its PD-L1 inhibitor Imfinzi as a post-surgery therapy for people with earlier-stage lung cancer have taken a knock, although it performed well in a bladder cancer study.Top-line results from the phase 3 ADJUVANT BR.31 study showed that giving Imfinzi (durvalumab) as adjuvant therapy for stage IB-IIIA non-small cell lung cancer (NSCLC) was no better than placebo at extending disease-free survival (DFS).

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Lilly joins fellow pharma giants in OpenAI partnership

Pharmaceutical Technology

The collaboration is intended to leverage OpenAI's generative AI-based platform to invent novel antimicrobials to treat drug-resistant pathogens.

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Pharma Pulse 6/26/24: How to Thrive in a Cookie-Less Era, Why Consumers are Switching Providers and Payers & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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