New Drug Development & Regulatory News
Eisai clears all-case study condition for antiepileptic agent Inovelon
Eisai Co. has received notification from MHLW that the "all-case study" for approval of antiepileptic agent Inovelon Tablets (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of LGS has been cleared. Read more
25 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Novel drug combination progresses to Phase 3 for uncomplicated malaria
Novartis and MMV announce the decision to progress ganaplacide/lumefantrine- solid dispersion formulation (SDF) into Phase 3 development for the treatment of patients with acute uncomplicated malaria due to Plasmodium falciparum. Read more
24 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Positive NICE recommendation for Takeda’s treatment for rare lung cancer
NICE has published a positive recommendation for EXKIVITY (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). Read more
17 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
First rescue medication for asthma recommended for US approval
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older. Read more
9 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
![ALiS, the latest innovation from Particle Works, enables automation and high-throughput screening of LNP formulation[2] copy.png](https://pharmaceuticalmanufacturer.media/downloads/9258/download/ALiS%2C%20the%20latest%20innovation%20from%20Particle%20Works%2C%20enables%20automation%20and%20high-throughput%20screening%20of%20LNP%20formulation%5B2%5D%20copy.png?cb=7018a55a7a5906aa78e2afebd925b11d&w=640 "ALiS, the latest innovation from Particle Works, enables automation and high-throughput screening of LNP formulation[2] copy.png")
Particle Works launches automated platform for LNP formulation screening
Particle Works launches its second platform, the Automated Library Synthesis (ALiS) System, enabling automation and high-throughput screening of lipid nanoparticle (LNP) formulations and mRNA candidates in early-stage drug development. Read more
7 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
ALTURiX acquires UK Rights to oral solution for nocturnal enuresis
ALTURiX - a rapidly-growing British pharmaceutical company - has acquired the exclusive rights to desmopressin oral solution for the United Kingdom following the finalisation of an agreement with GP Pharm and REIG JOFRE, both based in Spain. Read more
10 Oct 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
![ALiS, the latest innovation from Particle Works, enables automation and high-throughput screening of LNP formulation[2] copy.png](https://pharmaceuticalmanufacturer.media/downloads/9258/download/ALiS%2C%20the%20latest%20innovation%20from%20Particle%20Works%2C%20enables%20automation%20and%20high-throughput%20screening%20of%20LNP%20formulation%5B2%5D%20copy.png?cb=7018a55a7a5906aa78e2afebd925b11d&w={width}&h={height} "ALiS, the latest innovation from Particle Works, enables automation and high-throughput screening of LNP formulation[2] copy.png")
Aenova and Microcaps enter partnership to extend range of capsule formulations
Aenova and Microcaps are entering into a strategic partnership that will start on October 31, 2022, with the aim to accelerate and improve the development and production of pharmaceuticals and numerous other products. Read more
21 Oct 2022
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
Sepha showcases leak detection technology for blister packaging
At Pack Expo International 2022, Sepha will showcase its latest packaging and leak test innovations, including the VisionScan 3D, the Multi-Q HD and the EZ Blister+. Read more
14 Oct 2022
MHRA approves treatment for ADHD children with sleep onset insomnia
Weybridge-based pharmaceutical company Colonis, a subsidiary company of the Clinigen Group, have announced that the MHRA has approved Colonis’ Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 with ADHD. Read more
3 Oct 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Eisai clears all-case study condition for antiepileptic agent Inovelon
Eisai Co. has received notification from MHLW that the "all-case study" for approval of antiepileptic agent Inovelon Tablets (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of LGS has been cleared. Read more
25 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Bormioli & Pierre Fabre develop 100% recycled PET packaging for mouthwash
Bormioli Pharma and Pierre Fabre have developed an innovative 100% recycled PET packaging for the mouthwashes of the ELUDRIL brand, a European specialist in oral care within the pharmacy channel. Read more
25 Nov 2022
Pivotal partnership seeks to transform Cystic Fibrosis research
LifeArc, a national medical research charity, joined the Cystic Fibrosis (CF) Antimicrobial Resistance (AMR) Syndicate in a strategic partnership alongside Cystic Fibrosis Trust and Medicines Discovery Catapult (MDC). Read more
24 Nov 2022
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
Novel drug combination progresses to Phase 3 for uncomplicated malaria
Novartis and MMV announce the decision to progress ganaplacide/lumefantrine- solid dispersion formulation (SDF) into Phase 3 development for the treatment of patients with acute uncomplicated malaria due to Plasmodium falciparum. Read more
24 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Airnov celebrates five years of manufacturing in India
Airnov Healthcare Packaging, a specialist in controlled atmosphere packaging, has surpassed five years of manufacturing at its production facility in India, and announces it participation to CPhI India 2022. Read more
18 Nov 2022
Positive NICE recommendation for Takeda’s treatment for rare lung cancer
NICE has published a positive recommendation for EXKIVITY (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). Read more
17 Nov 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Sponsored Content
Lonza - New Webinar: Solid Form Screening and Rapid Formulation Selection to Meet Demands of Accelerated Timelines
Compare formulation strategy advantages and disadvantages through case studies Read more
1 Jun 2022
Sponsored Content
Lonza - New Webinar: Solid Form Screening and Rapid Formulation Selection to Meet Demands of Accelerated Timelines
Compare formulation strategy advantages and disadvantages through case studies Read more
1 Jun 2022
Melaphone Visual Audio
Manufacturers of sterile acoustic communication systems Read more
