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Published on Jan 18, 2025

FDA Accepts NDA for Lecanemab Subcutaneous Autoinjector, RAP-219 Shows Promise in Early Trials, Blarcamesine Treatment ...

WATCH TIME: 4 minutes Welcome to this special edition of Neurology News Network. I'm Marco Meglio. According to a new announcement, the FDA has accepted Eisai’s biologics license application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector …

Source: NeurologyLive - Label Pending
Published on Jan 17, 2025

Rx Rundown: Johnson & Johnson, Eli Lilly, the FDA and more

Deals: Johnson & Johnson announced it will buy Intra-Cellular Therapies for $14.6 billion. Biogen said it will buy all outstanding shares of Sage Therapeutics that it does not already own for $7.22 apiece. Eli Lilly is set to acquire Scorpion …

Source: Medical Marketing and Media - Label Pending
Published on Jan 17, 2025

FDA beats EMA to most approved new drugs in 2024

The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies released respective lists of medicines approved last year. The …

Source: Pharmaceutical Technology - Neutral
Published on Jan 16, 2025

FDA Accepts LEQEMBI BLA for Subcutaneous Dosing in Early Alzheimer’s Treatment

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector (SC-AI) for weekly maintenance …

Source: Pharma Journalist - Neutral
Published on Jan 15, 2025

FDA grants biologics license application for monthly IV Leqembi

January 15, 2025 1 min read Add topic to email alerts Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio The FDA has accepted Eisai and …

Source: Healio News - Neutral
Published on Jan 15, 2025

Biogen/Eisai announce FDA BLA acceptance for injectable Alzheimer’s drug

Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for an injectable formulation of their Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb). The anti-amyloid drug was …

Source: PMLiVE - Neutral
Published on Jan 15, 2025

BioArctic announces US FDA accepts Eisai's BLA for subcutaneous maintenance dosing of Leqembi

BioArctic AB (publ) announced that the US Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing Leqembi is indicated for …

Source: Pharmabiz.com - Neutral
Published on Jan 14, 2025

The FDA Accepts Eisai BLA for Lecanemab Subcutaneous Maintenance Dosing in Adults with Alzheimer Disease

The FDA has accepted the Biologics License Application (BLA) from Eisai for lecanemab-irmb (Lequembi) in a subcutaneous autoinjector (SC-AI) form for weekly maintenance dosing. If approved, LEQEMBI will become the only FDA-approved anti-amyloid therapy for …

Source: Patient Care - Label Pending
Published on Jan 14, 2025

FDA Accepts BLA for Subcutaneous Autoinjector Formulation of Lecanemab

According to a new announcement, the FDA has accepted Eisai’s biologics license application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing in patients with early-stage Alzheimer disease (AD). The agency …

Source: NeurologyLive - Label Pending
Published on Jan 14, 2025

FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi

On Monday, the FDA accepted Eisai Co., Ltd. ESALY and Biogen Inc’s BIIB Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. Leqembi is indicated for Alzheimer’s disease in …

Source: Benzinga - Neutral
Published on Jan 14, 2025

Eisai and Biogen’s subcutaneous Leqembi set for FDA review

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) accepted a biologics licence application (BLA) for a …

Source: Pharmaceutical Technology - Neutral
Published on Jan 15, 2025

FDA Accepts LEQEMBI (Lecanemab-Irmb) Biologics License Application For Subcutaneous Maintenance Dosing For The Treatment ...

(MENAFN- JCN NewsWire) FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the treatment of Early Alzheimer's disease LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could …

Source: MENAFN - Uncategorized
Published on Jul 31, 2024

Notable 2024 FDA decisions

When it comes to innovative new treatments, 2023 was a tough act to follow. Novel drug approvals reached an all-time high last year, with the U.S. FDA greenlighting 55 new drugs, more than half of which targeted rare disease. 2023 was also a breakthrough …

Source: Pharma Manufacturing - Label Pending
Published on Jan 18, 2025

Sage sues Biogen after unsolicited takeover bid

Sage Therapeutics has left its view of Biogen's recent takeover bid in little doubt – it has just filed a lawsuit seeking to block the deal. Specific details of the lawsuit are not yet available as the complaint remains under seal at Delaware Court of …

Source: pharmaphorum - Neutral
Published on Jan 15, 2025

Nivolumab Plus Gemcitabine/Cisplatin Shows Favorable OS/PFS Trend in Asian Unresectable/Metastatic Urothelial Cancer ...

Nivolumab (Opdivo) plus gemcitabine and cisplatin demonstrated a trend toward improved overall survival (OS) and progression-free survival (PFS) compared with gemcitabine and cisplatin alone as first-line treatment in patients with previously untreated …

Source: OncLive - Label Pending
Published on Jan 14, 2025

JPM25, Day 2: Biogen ready to stand its ground in Alzheimer's showdown, CEO says

The first day of the J.P. Morgan Healthcare Conference is in the books, featuring high-profile deal announcements from Johnson & Johnson, Eli Lilly, GSK and several other biopharma players. Besides deal announcements, many companies took an …

Source: Fierce Pharma - Neutral
Published on Jan 14, 2025

Could New Leqembi Formulations Boost Lagging Sales in Alzheimer's?

As Biogen and Eisai await an FDA decision later this month on a monthly maintenance regimen of Leqembi, the regulator has accepted a biologics license application for a subcutaneous maintenance formulation of the Alzheimer’s therapy. The convenience factor …

Source: BioSpace - Label Pending
Published on Jan 14, 2025

What's Going On With Firefly Neuroscience Stock Tuesday?

Firefly Neuroscience, Inc. AIFF shares are trading higher on Tuesday after the company announced the advancement of research to assess a patient’s brain age. The Details: Firefly announced that it can utilize its FDA-cleared Brain Network Analytics (BNA) …

Source: Benzinga - Neutral

02 days 00:45:41

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Published on January 18, 2025 - 18:00 GMT

$HAREHOLDER ALERT: The M&A Class Action Firm Continues To Investigate The Merger - BERY, OMIC, EMKR, AMCR

NEW YORK, Jan. 18, 2025 (GLOBE NEWSWIRE) -- Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report. We are …

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Published on January 18, 2025 - 13:40 GMT

ROSEN, THE FIRST FILING FIRM, Encourages Joint Stock Company Kaspi.kz Investors to Secure Counsel Before Important ...

NEW YORK, Jan. 18, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Joint Stock Company Kaspi.kz (NASDAQ: KSPI) between January 19, 2024 and September 19, 2024, both dates inclusive (the “ …

Distribution channels: Consumer Goods, Law ...

Published on January 18, 2025 - 11:24 GMT

Exploring the Future: Photomochi Studio’s Stunning CES 2025 Coverage of Incredible Companies

San Francisco, California, Jan. 18, 2025 (GLOBE NEWSWIRE) -- Photomochi Studio, widely recognized for its unparalleled expertise in photography and videography, delivered outstanding coverage of CES 2025, capturing the essence of groundbreaking innovations …

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Published on January 17, 2025 - 21:01 GMT

AvidXchange Announces Timing of Its Fourth Quarter 2024 Financial Results Conference Call and Webcast

CHARLOTTE, N.C., Jan. 17, 2025 (GLOBE NEWSWIRE) -- AvidXchange Holdings, Inc. (Nasdaq: AVDX), a leading provider of accounts payable (AP) automation software and payment solutions for middle market businesses and their suppliers, today announced that its …

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Published on January 18, 2025 - 14:00 GMT

OpenEyes Technologies Gives Early Support to New Aspire2STEAM Program Students4Students

Software Development Company Gives Early Support to Program Training Future Nonprofit Leaders DAVENPORT, IA, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Aspire2STEAM.org, which provides educational scholarships, recognition, and …

Distribution channels: Business & Economy, Companies ...
Published on January 18, 2025 - 19:57 GMT

Re-Inventing Private Wildlife Removal Services - Wildlife, Inc

Wildlife, Inc., a Denver, Colorado-based wildlife removal service company, has been re-inventing how wildlife is removed from clientele's homes. DENVER, CO, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Wildlife, Inc., a leader in …

Distribution channels: Environment ...
Published on January 17, 2025 - 18:52 GMT

Mentorship That Moves You Forward: Monterey Bay Economic Partnership CEO Tahra Goraya Highlighted at Mentoring Monday

MBEP President & CEO will be one of 50 regional leaders invited to share secrets of success during the 12th annual event MARINA, CA, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Monterey Bay Economic Partnership (MBEP) President …

Distribution channels: Business & Economy, Conferences & Trade Fairs ...
Published on January 17, 2025 - 18:33 GMT

TU SONRISA VALE X3: UNA INICIATIVA CON CAUSA DE THE DOLPHIN COMPANY

The Dolphin Company, operador de parques de presencia mundial, a través de su Fundación Dolphin Discovery I.A.P presenta “Tu Sonrisa Vale X3” CANCúN, QUINTANA ROO, MEXICO, January 17, 2025 /⁨EINPresswire.com⁩/ -- The Dolphin Company, operador de …

Distribution channels: Travel & Tourism Industry ...

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Published on January 18, 2025 - 15:47 GMT

Prosperity Of Life Celebrates the Successful Delivery of Shane Krider’s MOJO MASTERY Program

Prosperity Of Life's free 3-day MOJO MASTERY by Shane Krider empowered clients with insights on mindset, goals, and growth, fostering success and transformation FOUNTAIN HILLS, AZ, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on January 18, 2025 - 15:42 GMT

Assembly Smart Introduces Mobile App for Streamlined Furniture Assembly and Home Services

The New App Aims to Simplify Furniture Assembly, TV Mounting, and Home Services in Jacksonville & Nationwide JACKSONVILLE, FL, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Assembly Smart, a new Jacksonville-based startup in home …

Distribution channels: Business & Economy, Companies ...
Published on January 18, 2025 - 15:21 GMT

Wood Panel Wall USA Launches Modern Wood Panel Designs for 2025 Interior Design Trends

Introducing a new collection of premium wood panels designed to elevate interior spaces with style, functionality, and sustainable craftsmanship. SUN VALLEY, CA, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Wood Panel Wall USA, a …

Distribution channels: Building & Construction Industry, Business & Economy ...
Published on January 18, 2025 - 14:00 GMT

Kiosco Marietta Square Wins 2024 Best of Georgia Award

MARIETTA, GA, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Kiosco Marietta Square, the Mediterranean-European bistro that has become Marietta’s downtown favorite, is proud to announce its 2024 Best of Georgia Award recognition. This …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on January 18, 2025 - 14:00 GMT

OpenEyes Technologies Gives Early Support to New Aspire2STEAM Program Students4Students

Software Development Company Gives Early Support to Program Training Future Nonprofit Leaders DAVENPORT, IA, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Aspire2STEAM.org, which provides educational scholarships, recognition, and …

Distribution channels: Business & Economy, Companies ...
Published on January 18, 2025 - 13:00 GMT

Sotheby’s Concierge Auctions: Bidding Now Open for Inaugural Live Auction with RM Sotheby’s During Arizona Car Week

For the first time ever, real estate will be offered live alongside rare and collectible automobiles as part of RM Sotheby’s 27th annual car auction. NEW YORK, NY, UNITED STATES, January 18, 2025 /⁨EINPresswire.com⁩/ -- Sotheby’s Concierge …

Distribution channels: Automotive Industry, Banking, Finance & Investment Industry ...
Published on January 18, 2025 - 23:21 GMT

FST Corp.、啟坤科技股份有限公司宣佈與Chenghe Acquisition I Co.合併並於美國公開上市

香港和臺北, Jan. 19, 2025 (GLOBE NEWSWIRE) -- 創新高爾夫球桿製造商啟坤科技股份有限公司（“FST”）和Chenghe Acquisition I Co.（“SPAC”）日前宣佈，於2025年1月15日完成了業務合併交易（“合併”）。新成立的控股公司FST Corp.的普通股在2025年1月16日在納斯達克全球市場開始公開交易。 FST以其自有品牌KBS …

Distribution channels: Companies, Consumer Goods ...
Published on January 18, 2025 - 00:48 GMT

Join the Climate Revolution: Contribute to the Next Chapter of Building Fjords in the Great Deserts

Collaborate with global experts and advocates to refine groundbreaking solutions for climate resilience, water sustainability, and environmental restoration GLENDALE, CA, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- As the climate …

Distribution channels: Building & Construction Industry, Companies ...
Published on January 18, 2025 - 00:29 GMT

Girls on the Run International Reflects on 2024 and Prepares for 2025

The girl empowerment nonprofit shares achievements including serving more than 173,000 girls across North America in 2024 CHARLOTTE, NC, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Today, Girls on the Run International (GOTRI), an …

Distribution channels: Companies ...
Published on January 17, 2025 - 22:55 GMT

Celebrating and Supporting Nurses at Columbine Health

FORT COLLINS, CO, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- At Columbine Health Systems, our nurses are the heart and soul of the care we provide. Their unwavering dedication, compassion, and skill make a profound difference in the …

Distribution channels: Companies, Conferences & Trade Fairs ...
Published on January 17, 2025 - 22:47 GMT

Tennessee Pediatric Chiropractic Practice Reports 40% Efficiency Gains Through Digital Implementation

In healthcare, where generic websites often misguide patients, one Pediatric chiropractor's success story is changing how providers approach marketing. MARGATE, NJ, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Cherry Picked Websites …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on January 17, 2025 - 22:00 GMT

Tracked N' Solved Investigations Expands to Idaho Falls

Idaho Falls private investigators expands services, ensuring confidentiality and client satisfaction. IDAHO FALLS, ID, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Meet Their Expert Team of Investigators Tracked N' Solved is …

Distribution channels: Companies, Emergency Services ...
Published on January 17, 2025 - 21:44 GMT

All Aces Promotional Staffing - New Payrolling Assistance Service

All Aces Promotional Staffing has unveiled its new Payrolling Assistance Services, aimed at reducing administrative burdens for businesses and professionals. LONG ISLAND CITY, NY, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- All Aces …

Distribution channels: Business & Economy, Companies ...
Published on January 17, 2025 - 21:42 GMT

Feeding Pets of the Homeless Provides Relief to Pet Owners Displaced by Los Angeles Fires

1,420 Pounds of Pet Food Shipped to Support Pets in Need CARSON CITY, NV, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- In response to the devastating fires in the Los Angeles area, Feeding Pets of the Homeless, a national nonprofit …

Distribution channels: Business & Economy, Companies ...
Published on January 17, 2025 - 21:07 GMT

Rapid Surplus Refund: How National Equity Agency is Redefining Fund Recovery

Every year, millions of dollars in surplus funds from foreclosures go unclaimed, often because homeowners and heirs are unaware of their right to reclaim them. WEST PALM BEACH, FL, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- In the …

Distribution channels: Banking, Finance & Investment Industry, Companies ...
Published on January 17, 2025 - 21:00 GMT

Amalfi Jets Launches Exclusive 'Enterprise Founding Member' Promotion with 50% Minimum Deposit Reduction

Amalfi Jets, a leading private jet charter company, launches its Enterprise Founding Member promotion, offering new clients a 50% minimum deposit reduction. LOS ANGELES, CA, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Amalfi Jets, a …

Distribution channels: Aviation & Aerospace Industry, Business & Economy ...
Published on January 17, 2025 - 20:36 GMT

Lukin Center for Psychotherapy Launches a New Virtual Program: DBT Skills Group

The Lukin Center for Psychotherapy in Northern NJ announced the launch of their new virtual DBT (Dialectical Behavior Therapy) Skills Group. HOBOKEN, NJ, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- This program is designed for young …

Distribution channels: Business & Economy, Companies ...
Published on January 17, 2025 - 20:35 GMT

Estate Heir Recovers Surplus Funds Swiftly with National Equity Agency’s Expert Assistance

National Equity Agency has successfully assisted an estate heir in reclaiming unclaimed surplus funds left behind after a foreclosure. WEST PALM BEACH, FL, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- In a remarkable case of foreclosure …

Distribution channels: Banking, Finance & Investment Industry, Companies ...
Published on January 17, 2025 - 20:26 GMT

Cindy Cavoto Launches Transformative Coaching Program to Help Professionals Take Charge of Their Time

Cindy Cavoto's new coaching program helps busy professionals take control of their time and schedules. ST. AUGUSTINE, FL, UNITED STATES, January 17, 2025 /⁨EINPresswire.com⁩/ -- Cindy Cavoto, the visionary behind CindyCavoto.com, is thrilled …

Distribution channels: Book Publishing Industry, Business & Economy ...
Published on January 17, 2025 - 20:24 GMT

Trueness Project Partners with Kenya National Library Service to Promote Leadership, Flags Off Maiden Donation

NAIROBI, KENYA, January 17, 2025 /⁨EINPresswire.com⁩/ -- The Trueness Project, a nonprofit organization committed to fostering leadership and mentorship, has announced a strategic partnership with the Kenya National Library Service (KNLS), a …

Distribution channels: Banking, Finance & Investment Industry, Book Publishing Industry ...