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GEBRO and Spektus sign collaboration for ActraFlex
GEBRO Holding and Spektus Pharma have agreed a global commercialisation partnership for ActraFlex, an extended-release pain management therapy taken twice daily.
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FDA to review uniQure’s BLA for Huntington’s gene therapy
The FDA has accepted a BLA under its accelerated approval pathway from uniQure for ifezuntirgene inilparvovec to treat Huntington’s disease.
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Express Pharma
Lupin launches Raltegravir Tablets USP, 600 mg in the US
The product has received US FDA approval and is eligible for 180-day generic drug exclusivity The post Lupin launches Raltegravir Tablets USP, 600 mg in the US appeared first on Express Pharma.
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Lupin appoints Akhil Gupta as Independent Director to its Board
The appointment brings over four decades of experience in business development, corporate strategy, finance, governance and mergers and acquisitions to the Board The post Lupin appoints Akhil Gupta as Independent Director to its Board appeared first on Express Pharma.
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Nov 4, 2026, 11:26 AM
Idorsia Receives the US FDA’s Breakthrough Therapy Designation for Daridorexant to Treat Pediatric Insomnia Disorder
Shots: The US FDA has granted Breakthrough Therapy Designation to Idorsia‘s daridorexant, a dual orexin receptor antagonist (DORA), for the treatment of insomnia disorder in pts aged 10 to <18yrs. The designation was supported by a P-II dose-finding study (n=165), which showed a significant dose-dependent improvement in total sleep time (p=0.0185); a single 50mg dose… The post Idorsia Receives the US FDA’s Breakthrough Therapy Designation for Daridorexant to Treat Pediatric Insomnia Disorder appeared first on PharmaShots.
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Nov 4, 2026, 11:21 AM
Graviton BioScience Receives the US FDA’s Fast Track Designation for GV101 to Treat Friedreich’s Ataxia
Shots: The US FDA has granted Fast Track Designation to Graviton BioScience‘s GV101, an oral, selective ROCK2 inhibitor, for the treatment of Friedreich’s ataxia (FA), following the recent clearance of its IND Graviton is initiating a 12wk., randomized, PBO-controlled, dose-finding P-II trial of GV101 in pts with FA, with first enrollment at US sites expected… The post Graviton BioScience Receives the US FDA’s Fast Track Designation for GV101 to Treat Friedreich’s Ataxia appeared first on PharmaShots.
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Nov 4, 2026, 11:19 AM
Nxera Pharma Enters into a Global License Agreement with AbbVie for NXE0033744 to Treat Inflammatory Bowel Disease
Shots: Nxera Pharma‘s subsidiary has entered into an exclusive global license agreement with AbbVie for its EP4 agonist program, incl. NXE0033744, granting AbbVie worldwide rights to develop & commercialize it for IBD Nxera will receive $100M upfront and is eligible for up to $1.37B in development & commercial milestones, plus tiered royalties on net sales;… The post Nxera Pharma Enters into a Global License Agreement with AbbVie for NXE0033744 to Treat Inflammatory Bowel Disease appeared first on PharmaShots.
PharmaShots
Nov 4, 2026, 11:18 AM
Boehringer Ingelheim and Sino Biopharmaceutical Enter into an Option and License Agreement Worth Over $7B to Advance Next-Gen Cancer Therapies
Shots: Boehringer Ingelheim & Sino Biopharmaceutical (SBP Group) have entered into a strategic multi-program option & license agreement to advance next-gen cancer therapies based on ADC & T-cell engager (TcE) technologies SBP Group will receive $358M in upfront & near-term payments and is eligible for ~$7B in option-exercise, development, regulatory & commercial milestones, plus up… The post Boehringer Ingelheim and Sino Biopharmaceutical Enter into an Option and License Agreement Worth Over $7B to Advance Next-Gen Cancer Therapies appeared first on PharmaShots.
PharmaShots
Nov 4, 2026, 11:13 AM
Beckman Coulter Receives the US FDA’s Clearance for Access MeMed BV Assay to Differentiate Bacterial vs Viral Infections
Shots: The US FDA has cleared Beckman Coulter‘s Access MeMed BV assay, developed in collaboration with MeMed, a rapid host-response blood test to help differentiate bacterial from viral infections in adult & pediatric pts (aged ≥90 days) The assay runs on the DxI 9000 & Access 2 immunoassay analyzers already installed in hospital labs, with… The post Beckman Coulter Receives the US FDA’s Clearance for Access MeMed BV Assay to Differentiate Bacterial vs Viral Infections appeared first on PharmaShots.
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Nov 4, 2026, 11:12 AM
Rockwell Medical to Acquire Vantive’s Global Hemodialysis Business for Up to $170M
Shots: Rockwell Medical has entered into an equity & asset purchase agreement to acquire Vantive‘s hemodialysis (HD) concentrates, HD machines (incl. AK-98), water treatment systems and related consumables & technical services business As per the deal, Vantive will receive a base purchase price of $125M, financed via two $50M term loans from Vantive & a… The post Rockwell Medical to Acquire Vantive’s Global Hemodialysis Business for Up to $170M appeared first on PharmaShots.
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Nov 4, 2026, 12:09 PM
AstraZeneca appoints Naveen Krishna Yamarthi as managing director of India operations - Pharmabiz.com
AstraZeneca appoints Naveen Krishna Yamarthi as managing director of India operations Pharmabiz.com
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Nov 4, 2026, 11:54 AM
CPHI India and PMEC India 2026 to Connect Pharmaceutical Industry Across Two Delhi-NCR Venues - Machine Maker
CPHI India and PMEC India 2026 to Connect Pharmaceutical Industry Across Two Delhi-NCR Venues Machine Maker
Google News
Nov 4, 2026, 11:37 AM
Centre proposes stricter microbial contamination norms under Schedule M - Business Standard
Centre proposes stricter microbial contamination norms under Schedule M Business Standard
Google News
Nov 4, 2026, 11:27 AM
The iPhone effect in healthcare: How Mounjaro is rewriting the economics of India’s pharma market - Livemint
The iPhone effect in healthcare: How Mounjaro is rewriting the economics of India’s pharma market Livemint
Google News
Nov 4, 2026, 11:16 AM
Swiss pharma industry behind in technology and clinical trials, index shows - TradingView
Swiss pharma industry behind in technology and clinical trials, index shows TradingView
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Nov 4, 2026, 11:05 AM
Bayer seeks bigger role in fast-growing Latin American biologicals market - Reuters
Bayer seeks bigger role in fast-growing Latin American biologicals market Reuters
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Nov 4, 2026, 11:03 AM
Does Your Pharmaceutical WMS Grow with You? - Pharmaceutical Commerce
Does Your Pharmaceutical WMS Grow with You? Pharmaceutical Commerce
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Nov 4, 2026, 11:00 AM
Swiss Pharmaceutical Industry Loses Ground in Global Innovation Race - Bloomberg.com
Swiss Pharmaceutical Industry Loses Ground in Global Innovation Race Bloomberg.com
Google News
Nov 4, 2026, 10:28 AM
Novo Nordisk hikes 2026 outlook again as Wegovy pill beats forecasts - Reuters
Novo Nordisk hikes 2026 outlook again as Wegovy pill beats forecasts Reuters
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