Tue.Feb 27, 2024

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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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Viking Therapeutics Obesity Drug’s Data Raise Best-in-Class Expectations

MedCity News

The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

Biopharma 139
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Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

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Seven Trends to Watch in Healthtech AI

MedCity News

As the role of AI in healthcare settings continues to evolve and generate debate, here are seven things to keep an eye on.

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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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One Up, One Down: Allecra scores FDA nod for antibiotic combo after Venatorx hit with rejection

Fierce Pharma

Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. | Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. The U.S. regulator has signed off on Allecra Therapeutics’ Exblifep as a treatment for cUTIs, including the severe kidney condition pyelonephritis.

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Growth or Profitability: Which One Do Investors Care More About?

MedCity News

In the venture capital community, there’s a bit of a debate about what matters more to digital health investors in today’s fundraising environment — growth or profitability. Cathy Gao, a partner at Sapphire Ventures, thinks VCs are still putting a premium on growth, but she noted that the conversation is very nuanced.

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More Trending

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Janux Rides Its TRACTr to Validation in Prostate Cancer and More Solid Tumors

MedCity News

A Janux Therapeutics T cell engager has early clinical data showing improvement in cases of advanced prostate cancer, validating the technology platform that produced the therapy. Janux is now leveraging its soaring stock price to raise $175 million in a stock offering.

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Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Fierce Pharma

Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side ef | Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side effects—especially in kids.

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UK biotech Curve swings £40.5m in Pfizer-backed round

pharmaphorum

UK biotech Curve Therapeutics raises $51 million in a Pfizer-led Series A that will support its platform for screening drugs within cells.

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BioMarin testing programs for 2 top-selling drugs under scrutiny from DOJ

Fierce Pharma

BioMarin has provided documents to the U.S. | BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.

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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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It’s Time to Evolve Beyond FMTs and Advance LBPs

MedCity News

The FMT era has been productive, but now it’s time to rally together as an industry to accelerate next-generation LBP drug discovery, development and FDA approval.

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Minerva slumps as FDA finds fault with schizophrenia filing

pharmaphorum

FDA has turned down Minerva Neurosciences' marketing application for roluperidone as a treatment for the negative symptoms of schizophrenia

FDA 114
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MHRA Chief Executive to step down

European Pharmaceutical Review

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. Dame June will remain in the position until then to support the new Chief Executive’s transition into the role. Leading the MHRA – a five year journey Professor Graham Cooke, interim chair of the MHRA board, remarked that Dame June’s “leadership of the MHRA over the last five years, particularly during the COVID-19 pand

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FDA says yes to Allecra, no to Venatorx UTI drugs

pharmaphorum

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

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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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Blackbird Health Secures $17M To Expand Youth Mental Health Model

MedCity News

Blackbird Health’s $17 million Series A funding round was led by Define Ventures and included participation from Frist Cressey Ventures and GreyMatter. In total, the startup has raised nearly $23 million.

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Study rings warning bell over cancer therapy access in UK

pharmaphorum

UK cancer survival is lagging 10-15 years behind other countries due to lower rates of chemotherapy and radiotherapy, says UCL study backed by CRUK.

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Beyond Faith: Can Hospitals Collect When Patients Rely on Sharing Ministries?

MedCity News

There is a ubiquitous lack of understanding and regulation surrounding the HCSM coverage which leaves hospitals stuck with the bill and negatively impacts the bottom line.

Patients 107
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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

Amgen has opened a new biomanufacturing plant in Central Ohio, US. It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. “As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us

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

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Novo Nordisk joins molecular glue club with Neomorph deal

pharmaphorum

Novo Nordisk has signed a wide-ranging deal with US molecular glue biotech Neomorph that could be worth up to $1.46 billion.

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Bristol Myers Squibb acquires RayzeBio for $4.1bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a radiopharmaceutical company, for $4.1bn.

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Trademarks on the rise: applications recover in 2023 after a dip in 2022

Clarivate

When global trademark filing activity fell in 2022 , questions rose around what this signified. Would 2023 data show a second year of decline, indicating uncertain economic outlooks? Or would filing activity recover? To answer this question, we dove into curated trademark data from CompuMark to analyze application and filing history. With access to over 147 million trademark records, including application and filing history gathered directly from Patent and Trademark Offices (PTOs) such as the E

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Operational risks with gene therapies should improve with time, exec says

Pharmaceutical Technology

Making therapies feasible from biological, regulatory, and commercial standpoints drives scalable genetic medicine.

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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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CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen

PharmaTech

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

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Novo Nordisk signs $1.46bn deal to develop molecular glue therapies

Pharmaceutical Technology

Novo Nordisk has partnered with US startup Neomorph to develop multiple molecular glue degraders for cardiometabolic and rare diseases.

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UK and Netherlands researchers call for funding to investigate cancer treatments

PharmaTimes

The white paper outlines three strategic recommendations to support further research

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Innovation takes precedence with AI use for techbios in pharma

Pharmaceutical Technology

The industry must utilise AI with the mindset to innovate over the desire to slash drug costs and reduce time to commercialisation.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sponge-on-a-string test to benefit NHS patients with oesophageal cancer

PharmaTimes

Eight out of ten patients who took the test were discharged without needing further testing

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EMA Recommends New ALS Treatment

PharmaTech

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

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Gilead’s Biktarvy gains FDA expanded indication approval for HIV

Pharmaceutical Technology

Gilead Sciences has received FDA approval for an expanded indication for Biktarvy to treat HIV patients with M184V/I resistance mutations.

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Six ways AI can help providers drive transformation in healthcare

Clarify Health

In the United States, an aging population and the rising prevalence of chronic disease highlight the limitations of most healthcare systems, putting increased pressure on providers. Artificial intelligence (AI) can be a potent tool providers and healthcare leaders can use to help identify inefficiencies and reduce costs without compromising quality.

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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