This week PharmaShots’ news was all about the updates on clinical trials, regulatory, biotech, pharma, M&A, DigiHealth, MedTech and Animal Health. Check out our full report below:

• Alnylam highlighted P-II study (KARDIA-1) results of Zilebesiran for hypertension in patients at high cardiovascular risk showed a dose-dependent, clinical reduction in 24hr. mean systolic blood pressure

Read more: Alnylam

• Arcutis highlighted interim results from the P-III (INTEGUMENT-OLE) trial of Roflumilast for mild to moderate atopic dermatitis, were found to be well-tolerated with durable & improved efficacy over time

Read more: Arcutis

• Roche highlighted P-III (ALINA) study results of Alecensa (alectinib) for ALK-positive early-stage lung cancer & showed a significant and clinical improvement in DFS

Read more: Roche

• Rallybio highlighted P-I single ascending dose results of RLYB116 for complement-mediated diseases, presented at ICW 2023 showed a reduction in free C5 ≤99% at 24hrs.

Read more: Rallybio

• Valneva and Pfizer highlighted P-II study (VLA15-221) results of VLA15 for Lyme Disease showed a strong anamnestic Ab response for all serotypes in pediatric, adolescent & adults

Read more: Valneva and Pfizer

• Janssen highlighted P-III study (MARIPOSA-2) results of Rybrevant (amivantamab-vmjw) for EGFR-mutated NSCLC showed a significant and clinical PFS improvement

Read more: Janssen

• Brii Biosciences highlighted interim results from the P-II study of BRII-179 (VBI-2601) + PEG-IFNα for Chronic Hepatitis B 

Read more: Brii Biosciences

• invIOs starts the patient enrolment of APN401 in the P-Ib trial (PALINDROM) for solid tumors, conducted in Austria with 2 GMP-compliant manufacturing sites in Vienna and Linz

Read more: invIOs

• Genmab and Seagen highlighted P-III trial (innovaTV 301) results of Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer which met its 1EPs of OS

Read more: Genmab and Seagen

• Oncorena treated first renal cancer patient with ONC175 (orellanine) in the P-I/II trial

Read more: Oncorena

• The NMPA has approved AstraZeneca’s Calquence (acalabrutinib) for chronic lymphocytic leukaemia in China, based on the P-III (ASCEND) and P-I/II trials

Read more: AstraZeneca

• The NMPA has approved Gloria Biosciences’ Zimberelimab for recurrent or metastatic cervical cancer in China, based on the P-II clinical trial results

Read more: Gloria Biosciences

• NICE has recommended BMS’ Camzyos (mavacamten) as an add-on treatment option for adults with symptomatic obstructive hypertrophic cardiomyopathy

Read more: BMS

• The MHLW has approved Guardant Health’ Guardant360 CDx as companion diagnostic for Enhertu to treat non-small cell lung cancer 

Read more: Guardant Health

• The US FDA has accepted the BLA of Genentech’s Crovalimab for Paroxysmal Nocturnal Hemoglobinuria, based on the P-III trial (COMMODORE 2)

Read more: Genentech

• The NICE has recommended Chiesi’s Elfabrio (pegunigalsidase alfa) for adults with Fabry Disease, based on results from P-III clinical trials

Read more: Chiesi

• The MHRA has granted marketing authorisation of AbbVie’ Aquipta (atogepant) for the Prevention of migraines in adults, based on (ADVANCE) trial for episodic and (PROGRESS) for chronic migraine

Read more: AbbVie

• Italfarmaco Group received EMA’s validation of MAA for Givinostat to treat duchenne muscular dystrophy, based on the P-III trial (EPIDYS) results

Read more: Italfarmaco Group

• The US FDA has granted the BTD to INOVIO’ INO-3107 for recurrent respiratory papillomatosis, based on the P-I/II trial results showed 81.3% of patients had a decrease in surgical interventions

Read more: INOVIO

• Janssen submit MAA to the EMA for Erdafitinib in LA or metastatic urothelial cancer with susceptible FGFR alterations, based on the results from Cohort 1 of the P-III study (THOR)

Read more: Janssen

• The US FDA has granted IND approval for P-II trial (VB-C-04) to evaluate Nykode Therapeutics’ VB10.16 in HPV16-positive cervical cancer

Read more: Nykode Therapeutics

• Braeburn’s Brixadi (buprenorphine) extended-release injection is now available in the US for moderate to severe opioid use disorder

Read more: Braeburn

• Arcturus Therapeutics and CSL announced EMA’s validation of MAA for ARCT-154 vaccine to prevent COVID-19

Read more: Arcturus Therapeutics and CSL

• The US FDA has approved Boston Scientific’ WATCHMAN FLX Pro Left Atrial Appendage Closure Device to reduce stroke risk in patients with NVAF who need an alternative to oral anticoagulation therapy

Read more: Boston Scientific

• Nurix & Seagen collaborated on new class of cancer therapies & Seagen will be responsible for conjugating the selected degraders to antibodies, turning them into degrader-antibody conjugates

Read more: Nurix & Seagen

• Otsuka collaborated with ShapeTX to develop novel AAV gene therapies for ocular diseases combining ShapeTX’s AAVid capsid discovery platform and transgene engineering technology with Otsuka’s expertise in genetic payload design and ophthalmology

Read more: Otsuka and ShapeTX

• Zenas BioPharma & BMS collaborated to develop and commercialize Obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia

Read more: Zenas BioPharma & BMS

• Abbott to acquire Bigfoot Biomedical to make diabetes management more precise & personal

Read more: Abbott and Bigfoot Biomedical

• Novozymes & Bactolife collaborated to finish the development and commercialization of biosolution Ablacto+ to reduce post-weaning diarrhea & antibiotic consumption

Read more: Novozymes & Bactolife

• Elanco launch Varenzin-CA1, the first-of-its-kind oral treatment for Anemia in Cats with CKD in the US  

Read more: Elanco

Related Post: PharmaShots Weekly Snapshots (August 28 – September 01, 2023)