Tue.Mar 21, 2023

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Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma

Fierce Pharma

Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma fkansteiner Tue, 03/21/2023 - 11:14

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Kite releases pivotal CAR T therapy Phase III study results

European Pharmaceutical Review

Primary overall survival (OS) analysis results from Kite’s Phase III ZUMA-7 study showed a statistically significant improvement for CAR T-cell therapy Yescarta ® in OS versus historical treatment. Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC).

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Biopharma industry lobbies for tax breaks related to US-based manufacturing

Fierce Pharma

Biopharma industry lobbies for tax breaks related to US-based manufacturing kdunleavy Tue, 03/21/2023 - 11:14

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Nvidia, Medtronic Partner to Create AI Platform for Medical Devices

MedCity News

Nvidia and Medtronic recently announced a collaboration focused on embedding AI into medical devices. The two companies plan to create marketplace for AI applications that will allow developers and clinicians to develop their own algorithms to use on Medtronic’s medical devices.

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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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As approvals roll in, Takeda details pricing strategy for dengue vaccine launch

Fierce Pharma

As approvals roll in, Takeda details pricing strategy for dengue vaccine launch zbecker Tue, 03/21/2023 - 10:40

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Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO

Fierce Pharma

Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO fkansteiner Tue, 03/21/2023 - 09:41

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‘The Stakes Couldn’t Be Higher’: How DEA’s Proposal Will Affect Telehealth Controlled Substance Prescribing

MedCity News

The DEA recently released proposed rules that would require an in-person visit before a patient can receive a telehealth prescription for a controlled substance. The DEA touts the change as a way to ensure patient safety, but several telehealth advocates argue it will greatly disrupt access for those who need the drugs — especially at a time when the mental health and substance use crisis is growing.

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Merck, Viatris close in on settlement in long-running Januvia patent case

Fierce Pharma

Merck, Viatris close in on settlement in long-running Januvia patent case esagonowsky Tue, 03/21/2023 - 08:30

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Pharmacists Are Essential to Rural Access to Healthcare

MedCity News

Tapping into community pharmacy can bring water to these rural healthcare deserts. Studies show that nine in ten Americans live within five miles of a pharmacy and high-risk patients visited their community pharmacy an average of 35 times per year, compared to four visits to their primary care provider and nine visits to specialists.

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Biomimetic Construct Models Burn Injuries

Medgadget

Researchers at Harvard University have developed a model of burn injuries that will allow them to investigate the mechanisms underlying healing in such injuries and test out new approaches to enhance this process. Burns can take a long time to heal and can be prone to infection and complicated by the presence of large quantities of dead tissue at the injury site.

Patients 101
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“Culling of the Herd”: How One CEO Believes SVB’s Failure May Accelerate M&A in Healthtech

MedCity News

Included Health CEO Owen Tripp believes that the sudden demise of Silicon Valley Bank may actually lead to a “culling of the herd” as healthtech companies yet to prove their value will stop functioning as standalone companies or get bought by larger companies with stable revenue and a proven business model.

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Employee Spotlight: Rob Moore

InCrowd

Rob Moore the Director of Information Technology for Apollo Intelligence. Get to know more about him below! Tell us about your role: I’m the Director of Information Technology for Apollo Intelligence. Apollo Intelligence supports market insights brands in the life science space. I’m responsible for managing IT infrastructure (on-prem) and in the cloud (Azure Advice Directory) along with establishing and administering security measures within the organization and overall strategies and proc

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Allermi Raises $3.5M in Seed Funding To Grow DTC Allergy Relief Platform

MedCity News

Allermi’s $3.5 million seed funding was led by Nelstone Ventures and included participation from FourSight Capital Partners. The company will use the money to expand nationally.

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Cannabidiol milling: Selecting the right equipment for CBD testing

Pharmaceutical Technology

Cannabidiol is the second most prevalent active ingredient in cannabis (marijuana) and for medical purposes it is derived directly from the hemp plant (which is closely related to marijuana) or made in a laboratory. So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i].

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FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19

MedCity News

The FDA has issued a warning letter to a website that has been selling the antiparasitic drug ivermectin as a treatment for Covid-19. The correspondence directs the company to stop selling its products and correct any misleading language in its marketing material.

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MHRA approves prostate cancer combination therapy

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combination therapy with abiraterone and prednisone or prednisolone. AstraZeneca and MSD’s treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

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Making the leap from the lab to the boardroom

PharmaVoice

Four academics-turned-executives share what they’ve learned about the pivot point between life sciences academia and entrepreneurship.

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Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission

MedCity News

Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.

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CCC to Host Virtual Town Hall on ChatGPT and Information Integrity

Copyright Clearance Center

March 21, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will present a Town Hall discussion via LinkedIn live on 30 March at 11:00 a.m. EDT/16:00 BST/17:00 CEST that will address the questions, “What is the evolving nature of originality and authenticity?” And “What place do human expertise and empathy have when machines provide information?

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8 Vital Skills to be Successful in Medical Sales

MedReps

Obtaining a medical sales job requires more than just the medical skills and knowledge needed to successfully sell the products. You need to demonstrate that you have a number of other vital skills as well. 8 Vital Skills to be Successful in Medical Sales Many of these skills are enhanced or obtained while attending college, as the process of getting a degree teaches you soft skills like communication and time management, but they can be obtained in other ways as well.

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Astellas and Pfizer reveal positive results for Xtandi

PharmaTimes

Research data follows phase 3 EMBARK trial and involves men with non-metastatic prostate cancer

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

The biotech industry is currently undergoing a wider financial upheaval after the collapse of Silicon Valley Bank (SVB) , which was favoured by many biotech companies. In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs).

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The Power of Easy: The Secret to Disrupting Competitors and Winning Market Share

Healthcare Success

Humans have an evolutionary instinct to be lazy. We will always choose the path of least resistance. Take the remote control, for example. Years ago, people had to get up from the sofa and walk to the TV to change the channel. Thanks to the remote control, people can stay nestled comfortably in their favorite spot and channel surf to their heart’s content.

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Vitestro raises vital funding for autonomous blood drawing device

PharmaTimes

Company raises €12m in financing with a view to entering to the European market

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Large medical center uses on-demand patient journey insights to identify $50M opportunity to grow their oncology service line

Clarify Health

A strategy team at a large urban medical center wanted to increase its hospital outpatient department (HOPD) and ambulatory surgery center (ASC) market share for oncology in their service area, but they had limited insight into their outpatient market. They needed to understand the best regions to increase the footprint of their oncology service line, which required assessing physician referral patterns for outpatient facilities.

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The Benefits of Buying a Calgary Directory of Doctors

Scott’s Directories

If you’re looking to break into the medical industry and start selling to doctors in Calgary, then you need the right resources and information. That’s why buying a Calgary doctors directory is a great way to get your business off the ground. Here, we’ll discuss why a directory can be so beneficial, as well as other tips on how to successfully market your products and services to doctors in the area.

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From Restaurant Server To Medical Device Sales Professional In 90 Days With Elizabeth Wild

Evolve Your Success

Elizabeth Wild was once a restaurant server, but her desire to do so much more made her pursue another career. Watching ACL surgeries on YouTube and chatting with surgeons opened her eyes to the many opportunities of medical device sales. In this conversation with Samuel Adeyinka, Elizabeth shares how she got into the Medical Sales Career Builder Program and became a medical device sales professional in just 90 days.

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FDA Considers Biomarker Data Supportive of Tofersen Approval

Pharma Leaders

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

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Sanofi’s Dupixent receives EC approval for atopic dermatitis

Pharmaceutical Technology

Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) for the treatment of severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU). This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of these young children.

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FDA grants fast track status to Prestige’s PBP1510 for pancreatic cancer

Pharma Leaders

The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC). PBP1510 will mainly act on a tumour-specific protein called pancreatic adenocarcinoma upregulated factor (PAUF) , which is overexpressed in most pancreatic cancer patients.

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Drug Solutions Podcast: Point of Care and Patient Manufacturing

PharmaTech

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.

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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Legacy MEDSearch

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). LUMISIGHT is intended for use with the Lumicell Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of

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Gilead Sciences to exclusively license Nurix Therapeutics’ protein degrader

Pharmaceutical Technology

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. The potent, selective, oral IRAK4 degrader named GS-6791 targets the scaffold and kinase functions of the IRAK4 protein kinase for blocking the pro-inflammatory IL1 cytokine family of receptors (IL1Rs) and inflammatory responses downstream of toll-like receptors (TLR).