This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Biotech, Pharma, MedTech and M&A. Check out our full report below:

The US FDA has approved Verrica Pharmaceuticals’ Ycanth (cantharidin) for pediatric and adult patients with molluscum contagiosum which was safe and effective for patients aged ≥2yrs.

Read more: Verrica Pharmaceuticals

Merck’s Gefapixant, orally administered, selective P2X3 receptor antagonist receives EMA’s CHMP positive opinion for chronic cough, based on the P-III (COUGH-1 & 2) trial results

Read more: Merck

The CHMP recommends Menarini Group and Stemline Therapeutics’ Orserdu to treat patients with ER+, HER2- locally advanced or metastatic breast, based on the P-III (EMERALD) trial

Read more: Menarini Group and Stemline Therapeutics

The US FDA has cleared an IND application of Nectero Medical’ Nectero EAST system to initiate P-II/III (stAAAble) study for small to mid-sized abdominal aortic aneurysms 

Read more: Nectero Medical

The NMPA has accepted the BLA and granted priority review of Overland ADCT BioPharma, a collaboration b/w Overland Pharmaceuticals and ADC Therapeutics’ Zynlonta for diffuse large B-cell lymphoma

Read more: Overland ADCT BioPharma

The EC has approved Boehringer Ingelheim and Eli Lilly’ Jardiance (empagliflozin) for adults with CKD, based on the P-III trial (EMPA-KIDNEY)

Read more: Boehringer Ingelheim and Eli Lilly

The US FDA has approved Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solution) for the treatment of demodex blepharitis, based on two studies (Saturn-1 & 2) showing an improvement in eyelids

Read more: Tarsus Pharmaceuticals

The EC has approved AstraZeneca’ Soliris for refractory generalised myasthenia gravis in children and adolescents, based on the P-III trial showed a clinical benefit in paediatric patients

Read more: AstraZeneca

The EC has approved Gilead’s Trodelvy (sacituzumab govitecan) for pre-treated HR+/HER2- metastatic breast cancer, based on the P-III study (TROPiCS-02) showing a significant & clinical OS benefit

Read more: Gilead

The US FDA has accepted Boehringer Ingelheim’s sNDA for Ofev (nintedanib) in children and adolescents aged 6-17yrs. with fibrosing interstitial lung disease (ILD)

Read more: Boehringer Ingelheim

HC has authorized Mirum’s Livmarli (maralixibat oral solution) for cholestatic pruritus in patients with ALGS based on data from the P-IIb study (ICONIC) in 31 patients aged 1–18yrs.

Read more: Mirum

Alnylam & Roche collaborated to co-develop and co-commercialize Zilebesiran, RNAi therapeutic targeting angiotensinogen which is currently in the P-II development for hypertension in patients with high cardiovascular risk

Read more: Alnylam & Roche

ImmunoGen entered into an agreement with ImmunoBiochem to research novel, first-in-class ADCs while agreement also enables ImmunoBiochem to expand its discovery platform and innovative pipeline

Read more: ImmunoGen and ImmunoBiochem

Astellas and PeptiDream entered protein degrader discovery deal for two targets that are chosen by Astellas

Read more: Astellas and PeptiDream

Spinal Stabilization Technologies to go Public via BlueRiver Acquisition Corp. SPAC Merger for ~$302M

Read more: Spinal Stabilization Technologies

Quince Therapeutics to acquire EryDel SpA to advance EryDel’s AIDE technology & development of EryDex for ataxia-telangiectasia patients

Read more: Quince Therapeutics

Ayala Pharmaceuticals merge with Biosight & add a clinical stage oncology asset to Ayala’s portfolio

Read more: Ayala Pharmaceuticals

Teleflex to acquire Palette Life Sciences AB for ~$650M which includes an upfront cash fee of $600M & an additional ~$50M upon achievement of commercial milestones

Read more: Teleflex and Palette Life Sciences

Syndax and Incyte highlighted positive P-II trial (AGAVE-201) results of axatilimab for chronic graft-versus-host disease showing robust responses in a heavily pre-treated patient population

Read more: Syndax and Incyte

Elevar Therapeutics highlighted P-III Study (CARES 310) results of rivoceranib + camrelizumab as a 1l therapy for unresectable hepatocellular carcinoma, published in The Lancet

Read more: Elevar Therapeutics

RemeGen reported P-II clinical study results of Telitacicept published in Rheumatology Journal, demonstrated promising clinical benefits in patients with primary sjogren's syndrome 

Read more: RemeGen

AbbVie’ risankizumab met co-primary and secondary endpoints in P-IV (IMMpulse) study for patients with moderate plaque psoriasis

Read more: AbbVie

Mersana reported (UPLIFT) clinical trial results of ADC targeting the sodium-dependent phosphate transport protein NaPi2b, upifitamab rilsodotin for Pt-resistant ovarian cancer

Read more: Mersana

Eli Lilly highlighted P-III (SURMOUNT-3 & 4) studies results of Tirzepatide for obesity and overweight demonstrated significant and superior-weight-loss

Read more: Eli Lilly

UroGen Pharma reported P-III trials results of UGN-102 as first non-surgical therapy for non-muscle invasive bladder cancer demonstrated a robust and consistent therapeutic profile across multiple clinical trials

Read more: UroGen Pharma

Merck and Moderna Initiated the P-III (V940-001) trial evaluating V940 + Keytruda (pembrolizumab) for Adjuvant Treatment of Resected High-Risk (Stage IIB-IV) Melanoma

Read more: Merck and Moderna

Checkpoint Therapeutics reports new, longer-term results from pivotal studies of Cosibelimab for advanced cutaneous squamous cell carcinoma

Read more: Checkpoint Therapeutics
 

Everest Medicines launch world's first fluorocycline antibiotic Xerava (eravacycline) in China

Read more: Everest Medicines

Under the new EU Medical Devices Regulation, Palliare has received a CE mark for EVA15 insufflator and smoke evacuation system as Class 2b device

Read more: Palliare

Related Post: PharmaShots Weekly Snapshots (July 17 – 21, 2023)