PharmaShots Weekly Snapshots (July 31 – August 04, 2023)

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PharmaShots Weekly Snapshots (July 31 – August 04, 2023)

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

Read more: Taiho Oncology and Taiho Pharmaceutical

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

Read more: Evox Therapeutics & Icahn Mount Sinai

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

Read more: Agios & Alnylam

  • Terumo's Reveos automated whole blood processing system snags the US FDA clearance to boost US platelet supply

Read more: Terumo

  • Teleflex wins the US FDA’s clearance for an expanded indication of QuikClot Control+ hemostatic device in cardiac surgical procedures

Read more: Teleflex

Related Post: PharmaShots Weekly Snapshots (July 24 – 28, 2023)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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