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MHRA champions patient voices through new policyÂ
Through its PPIE initiative, the MHRA plans to consider a diverse range of patient and public opinions when making regulatory decisions.
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Pharma Tech
Armada to combine with Brains Bioceutical in $750m deal
Armada Acquisition has entered a definitive business combination agreement with Brains Bioceutical that values the latter at an implied pre-money equity value of $750m.
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Pharma Tech
Alfasigma receives EC’s expanded approval for filgotinib to treat axSpA
Alfasigma has received the EC's expanded approval for Jyseleca to treat adult patients living with active axial spondyloarthritis (axSpA).
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Pharma Tech
Cordavis to stay in CVS Health after bifurcation of $117bn empire
Cordavis was established by CVS Health three years ago to capture more of the US biosimilar supply chain.
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Big pharma-backed T-Therapeutics snags $133m to bring TCEs to clinicÂ
T-Therapeutics will now generate proof-of-concept data for its oncology and immunology TCE drugs with “blockbuster” potential.
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PharmaShots
Nov 6, 2026, 11:08 AM
ANI Pharmaceuticals Announces ~$560M Recommended Cash Offer to Acquire Egetis Therapeutics
Shots: ANI Pharmaceuticals has announced a recommended public cash offer to acquire Egetis Therapeutics for SEK 11.25/share (27% premium to the 60-day VWAP), valuing the offer at ~SEK 5.6B (~$560M); EV ~$434M after adjusting for Egetis’ $190M Rare Pediatric Disease PRV sale Deal adds Emcitate (tiratricol), the first & only approved therapy in the US… The post ANI Pharmaceuticals Announces ~$560M Recommended Cash Offer to Acquire Egetis Therapeutics appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:07 AM
The US FDA Sets PDUFA Date of Apr 9, 2027 for Elevar’s Resubmitted Rivoceranib + Camrelizumab NDA in 1L uHCC
Shots: The US FDA has assigned a PDUFA target action date of Apr 9, 2027, for Elevar Therapeutics’ resubmitted NDA of rivoceranib + Hengrui Pharma’s resubmitted BLA of camrelizumab as 1L systemic therapy for unresectable or metastatic HCC Applications will be reviewed under an integrated process; the Oct 9, 2026, resubmissions respond to the FDA’s… The post The US FDA Sets PDUFA Date of Apr 9, 2027 for Elevar’s Resubmitted Rivoceranib + Camrelizumab NDA in 1L uHCC appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:05 AM
Theraclion’s Sonovein Receives the US FDA’s De Novo Authorization for Non-Invasive Treatment of GSV Reflux
Shots: The US FDA has granted De Novo marketing authorization (Nov 4, 2026) to Theraclion’s Sonovein for coagulation of blood vessels in pts with superficial venous reflux in Great Saphenous Vein (GSV) segments, establishing a new device classification Authorization was supported by the Pivotal (VEINRESET) study (n=70; 4 US & EU centers; NCT05926830), which met… The post Theraclion’s Sonovein Receives the US FDA’s De Novo Authorization for Non-Invasive Treatment of GSV Reflux appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:03 AM
PulseAI Receives the US FDA’s 510(k) Clearance for AI-Powered Arrhythmia Analysis Model for Wearables
Shots: PulseAI has received the US FDA’s 510(k) clearance for its AI-powered arrhythmia analysis model for wearables, enabling cloud-based automated ECG interpretation for compatible devices & software platforms In a prospective study of 296 participants published in Heart Rhythm, PulseAI’s algorithm improved AFib detection sensitivity while reporting a 92% reduction in inconclusive interpretations vs the… The post PulseAI Receives the US FDA’s 510(k) Clearance for AI-Powered Arrhythmia Analysis Model for Wearables appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:02 AM
MetaVia Reports P-I Part 3B Interim Data of DA-1726 Showing 68% Placebo-Adjusted Liver Fat Reduction
Shots: MetaVia has reported interim P-I Part 3B data of once-weekly DA-1726 (GLP1R/GCGR dual agonist) in adults with obesity, showing a 68% PBO-adjusted liver-fat reduction (MRI-PDFF; GMR 0.32; p<0.001) & 13.5% PBO-adjusted weight loss at Day 109 (~16wks.) In the MRI substudy (n=12 vs 4 PBO), 83% achieved ≥30% relative liver-fat reduction vs 0% on… The post MetaVia Reports P-I Part 3B Interim Data of DA-1726 Showing 68% Placebo-Adjusted Liver Fat Reduction appeared first on PharmaShots.
Pharma Tech
Nov 6, 2026, 11:01 AM
MHRA champions patient voices through new policyÂ
Through its PPIE initiative, the MHRA plans to consider a diverse range of patient and public opinions when making regulatory decisions.
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Google News
Nov 6, 2026, 3:41 PM
Don’t Ban U.S. Biotech Companies From China - Unleash Prosperity
Don’t Ban U.S. Biotech Companies From China  Unleash Prosperity
Google News
Nov 6, 2026, 3:18 PM
DFE Pharma appoints Peter Rose as new Chief Operating Officer - Manufacturing Chemist
DFE Pharma appoints Peter Rose as new Chief Operating Officer  Manufacturing Chemist
Google News
Nov 6, 2026, 3:03 PM
Amphastar Pharmaceuticals stock hits 52-week high at $30.34 - Investing.com
Amphastar Pharmaceuticals stock hits 52-week high at $30.34Â Â Investing.com
Google News
Nov 6, 2026, 3:01 PM
Takeda Pharmaceutical Co President Trades $1.16M In Company Stock - Benzinga
Takeda Pharmaceutical Co President Trades $1.16M In Company Stock  Benzinga
Google News
Nov 6, 2026, 2:59 PM
Alnylam Pharmaceuticals stock hits 52-week low at $155.22 - Investing.com
Alnylam Pharmaceuticals stock hits 52-week low at $155.22Â Â Investing.com
Google News
Nov 6, 2026, 2:44 PM
Pharmacy negotiator pauses contractor levy payments - The Pharmaceutical Journal
Pharmacy negotiator pauses contractor levy payments  The Pharmaceutical Journal
Google News
Nov 6, 2026, 2:42 PM
Pharmalittle: We're reading about a Novartis gene therapy, faster U.K. drug reviews, and more - STAT
Pharmalittle: We're reading about a Novartis gene therapy, faster U.K. drug reviews, and more  STAT
Google News
Nov 6, 2026, 2:42 PM
Lilly, Hims Join Forces to Reach More Weight-Loss Drug Patients - Bloomberg.com
Lilly, Hims Join Forces to Reach More Weight-Loss Drug Patients  Bloomberg.com
Google News
Nov 6, 2026, 2:26 PM
Novartis reports cases of tumours in children following treatment with Zolgensma - SWI swissinfo.ch
Novartis reports cases of tumours in children following treatment with Zolgensma  SWI swissinfo.ch
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