Sat.Apr 13, 2024 - Fri.Apr 19, 2024

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Amgen CEO nabs pay raise thanks to Horizon deal. Does that incentivize aggressive M&A?

Fierce Pharma

Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company’s acquisition of Horizon Therapeutics. | Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company's acquisition of Horizon Therapeutics.

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What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

MedCity News

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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Estetrol by Mithra Pharmaceuticals for Genitourinary Syndrome of Menopause (GSM): Likelihood of Approval

Pharmaceutical Technology

Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).

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Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

Fierce Pharma

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

MedCity News

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.

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Heart disease risk ‘calculator’ could save lives

pharmaphorum

UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

Pharma 96
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Pfizer, BioNTech win pause in patent infringement case from rival Moderna

Fierce Pharma

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today!

MedCity News

In addition to panel discussions around some of the hottest topics in healthcare transformation, there is also a startup pitch contest, a presentation on government funding for startups and networking opportunities. The post Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today! appeared first on MedCity News.

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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Fujifilm plans $1.2 billion investment in major US manufacturing facility

European Pharmaceutical Review

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

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With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Fierce Pharma

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

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Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

MedCity News

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. The post Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too appeared first on MedCity News.

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Brexit is ‘driving NHS medicines shortages,’ says report

pharmaphorum

Drug shortages fuelled by Brexit are now the 'new normal' in the UK and worsened in 2023, says Nuffield Trust report.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Trial Findings for Minimally Invasive Parafascicular Technology Show Promise for Intracerebral Hemorrhage Treatment

Pharmaceutical Commerce

Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Guidance and Education For Employees Facing a Cancer Journey

MedCity News

In vulnerable moments when employees need it most, virtual specialty care delivers a human connection that offers empathy, support, and guidance. The post Guidance and Education For Employees Facing a Cancer Journey appeared first on MedCity News.

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Activist hedge fund seeks big shake-up at Novavax

pharmaphorum

Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Clearmind licenses psychedelic compounds for mental disorders

Pharmaceutical Technology

Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.

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Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Fierce Pharma

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

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Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status

MedCity News

Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. The post Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status appeared first on MedCity News.

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Healthware re-launches as Eversana Intouch full service affiliate

pharmaphorum

Life sciences service provider (and pharmaphorum parent company) Eversana has completed the integration of Healthware Group, the Italy-based global agency and consultancy it acquired in October. The group will now be known as Eversana Intouch Healthware and will operate as Eversana’s sixth full-service affiliate.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Teva enters into oncology biosimilar licensing agreement

European Pharmaceutical Review

A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space.

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Medincell, AbbVie link up in long-acting injectable development pact worth up to $1.9B

Fierce Pharma

After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. | Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday. Under the deal, Medincell is line to receive an upfront payment of $35 million plus much more in potential development and commercial milestones.

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Star Ratings and Member Experience: Two Sides of the Same Coin

MedCity News

The challenge? Maintaining high Star Ratings or improving upon existing ratings gets increasingly difficult over time. The post Star Ratings and Member Experience: Two Sides of the Same Coin appeared first on MedCity News.

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Telehealth firm Cerebral faces $7m FTC fine over privacy

pharmaphorum

The FTC is seeking a $7 million fine on telehealth company Cerebral for violating patients' data privacy and making cancellation difficult.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.