PharmaShots Weekly Snapshots (July 31

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

Biogen to acquire Reata Pharmaceuticals for ~$7.3B to bolster neurological drug portfolio with Reata’s recently-approved treatment for Friedreich's ataxia whose commercial launch in the US is underway

Read more: Biogen and Reata Pharmaceuticals

Regeneron highlighted 2yr. results from (PHOTON) trial of Aflibercept demonstrating the substantial impact in reducing the treatment burden for patients with diabetic macular edema

Read more: Regeneron

Apellis presented P-III (GALE) extension study results of Syfovre for geographic atrophy continues to sow robust and increasing effects through 30mos. with both monthly and every-other-month treatment

Read more: Apellis

Merck highlighted P-III (KEYNOTE-756) trial results of Keytruda for high-risk, early-stage ER+/HER2- breast cancer which significantly improved pCR rate over neoadjuvant PBO + CT

Read more: Merck

Sumitomo Pharma and Otsuka failed to meet its 1EPs of Ulotaront in P-III trials (DIAMOND 1 & 2) for Schizophrenia which were not superior to those for patients treated with PBO

Read more: Sumitomo Pharma and Otsuka

Tonix Pharmaceuticals completed the patient enrolment in the NDA-enabling P-III trial (RESILIENT) of TNX-102 SL for fibromyalgia

Read more: Tonix Pharmaceuticals

Cybin initiated dosing of CYB003 in the final cohort of the P-II trial & provide the goal to determine an optimal dose for CYB003 and assessing the potential as a safe and effective therapeutic for patients with MDD

Read more: Cybin

Aravive highlighted P-III (AXLerate-OC) trial results of Batiraxcept for Pt-resistant ovarian cancer which did not meet the primary endpoint of PFS

Read more: Aravive

The patient enrolment has been completed in the P-II (FOCUS) study for Ultimovacs’ UV1 in head and neck cancer with its primary objective to determine the clinical performance of UV1 vaccination as an add-on to standard pembrolizumab treatment

Read more: Ultimovacs

CAGE Bio highlighted P-II study results of CGB-500 for AD, meeting all primary and secondary EPs & achieved a reduction of 98% in lesional Eczema Area Severity Index (EASI) scores

Read more: CAGE Bio

Basilea submits NDA of Ceftobiprole for the treatment of severe bacterial and fungal infections, based on the P-III studies (ERADICATE) for SAB, (TARGET) for ABSSSI, and a P-III study in CABP

Read more: Basilea

Mithra signed an agreement with Searchlight Pharma for the licensing of orally administered Estetrol (E4)-based hormone therapy product Donesta in Canada

Read more: Mithra and Searchlight Pharma

Amarin & Lotus Pharmaceuticals collaborated to distribute and commercialize Vazkepa (icosapent ethyl) in Southeast Asia and South Korea & focuses on novel and transformative treatments for patients

Read more: Amarin & Lotus Pharmaceuticals

Replimune collaborated with Incyte to evaluate RP1 + INCB99280 for patients with high-risk, resectable CSCC

Read more: Replimune and Incyte

TG Therapeutics signed an ex-US commercialization agreement with Neuraxpharm for Briumvi (ublituximab-xiiy) for adult patients with relapsing forms of multiple sclerosis

Read more: TG Therapeutics

MindMed & Catalent signed an exclusive license agreement for patented Zydis fast-dissolve technology incorporated in MM-120 & seek to enhance competitive advantage in the marketplace

Read more: MindMed & Catalent

Ionis and Novartis expand their collaboration to develop a next-generation program targeting Lp(a) for cardiovascular disease who are at high risk of cardiovascular events

Read more: Ionis and Novartis

The EC has approved Marinus’ Ztalmy (ganaxolone) for adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder, based on the P-III trial (Marigold)

Read more: Marinus

The US FDA has approved GSK’s Jemperli as the 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer, based on the interim analysis results from part 1 of the P-III study (RUBY)

Read more: GSK

The EC has approved Taiho’s Lonsurf (trifluridine/tipiracil) + bevacizumab as a 3L treatment of refractory metastatic colorectal cancer, based on the P-III trial (SUNLIGHT)

Read more: Taiho

RedHill Biopharma received approval in the UAE for Talicia, the first approved rifabutin-containing all-in-one combination product to treat H. Pylori

Read more: RedHill Biopharma

Taiho Oncology and Taiho Pharmaceutical win US FDA nod for Lonsurf (trifluridine/tipiracil) in adults with metastatic colorectal cancer resulting in significant clinical improvements in OS

Health Canada has authorized Janssen’s Tecvayli (teclistamab) for r/r MM, based on the P-I/II study (MajesTEC-1)

Read more: Tecvayli

Samsung Bioepis and Organon highlighted interchangeability study results of SB5 (biosimilar, adalimumab) for the treatment of chronic plaque psoriasis patients

Read more: Samsung Bioepis and Organon

ProQR offloads 2 eye disease assets Sepofarsen and Ultevursen to Théa thus supporting ProQR’s focus on the Axiomer RNA editing technology platform and continued advancement of pipeline programs

Read more: ProQR

BlueRock Therapeutics & bit.bio collaborated to discover and manufacture iPSC-derived regulatory T cells (Tregs) & use bit.bio's machine learning-powered discovery platform to identify transcription factor (TF) combinations for reprogramming iPSCs into Tregs

Read more: BlueRock Therapeutics & bit.bio

Evox Therapeutics & Icahn Mount Sinai collaborated to advance exosome-delivered AAV to tackle long-standing challenges in cardiovascular disease for heart disease

Agios & Alnylam collaborated to develop and commercialize Alnylam’s novel preclinical siRNA targeting TMPRSS6 for patients with polycythemia vera

Read more: Agios & Alnylam