Lotus Clinical Research Expands Partnership with Veeva to Accelerate Clinical Trials

Fast-growing CRO utilizes Veeva Vault Clinical Suite to substantially decrease startup time

NEW PROVIDENCE, NJ and BARCELONA, Spain — 30 May 2023 —Veeva Systems (NYSE: VEEV) today announced that Lotus Clinical Research expanded its partnership with Veeva and broadened its adoption of Veeva Vault Clinical Suite, a strategic move to strengthen its service delivery and efficiency. This builds on Lotus' existing use of Vault Clinical Suite to implement swifter and more connected studies. The successful incorporation of Veeva Vault CDMS, Veeva Vault eTMF, and Veeva Vault CTMS has effectively scaled Lotus' trial operations while sustaining the highest quality standards. With a unified clinical ecosystem, Lotus has significantly reduced study startup time. More>>

Medigene Announces Pipeline Expansion into Neoantigens with Programs Targeting Multiple KRAS Mutations and HLAs

Medigene is building a broad KRAS library consisting of multiple T cell receptors (TCRs) targeting multiple KRAS mutations and multiple HLAs, covering large patient populations suffering from solid tumors with high unmet need. KRAS TCR-T programs to bene

Planegg/Martinsried, June 1, 2023. Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today announces its pipeline expansion into neoantigens (also known as oncogenic driver mutations) with KRAS (Kirsten rat sarcoma viral oncogene homologue) as the first target in its MDG10xx program, a T cell receptor engineered T cell (TCR-T) therapy being developed in combination with the company’s PD1-41BB switch receptor technology. The first KRAS antigens and HLAs (human leukocyte antigens) of the library announced today are targeting: More>>

Rentschler Biopharma joins forces with Ikarovec to accelerate novel gene therapies for treatment of ophthalmic disease

Rentschler Biopharma to conduct adeno-associated virus (AAV) process development work for manufacturing scale-up at their ATMP site in Stevenage, UK. Ikarovec is developing novel gene therapies to treat serious, but common eye diseases. With accelerated

Norwich, Stevenage, UK and Laupheim, Germany, June 1, 2023 – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), and Ikarovec, which is developing novel multicistronic gene therapies to treat major ophthalmic indications, today announced that the two companies have entered into a collaboration. Under the agreement, Rentschler Biopharma’s ATMP site in Stevenage, UK, will support the bioprocess development of AAV material for planned pre-clinical testing of Ikarovec’s novel gene therapy for the treatment of geographic atrophy. This condition is an advanced form of age-related macular degeneration that can result in the progressive and irreversible destruction of retinal tissue, which can lead to loss of vision over time. More>>

LYNPARZA (olaparib) Plus Abiraterone Approved in the US for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

LYNPARZA combination reduced the risk of disease progression or death by 76% vs. abiraterone alone. First PARP inhibitor approved in combination with a novel hormonal agent underscores clinically meaningful benefit of new treatment approach.

AstraZeneca and Merck & Co., Inc’s, known as MSD outside the US and Canada, LYNPARZA (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). More>>

Phase 2 Study of Upadacitinib (RINVOQ) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus

North Chicago, Illinois, US – 31 May 2023 – PRNewswire – AbbVie (NYSE: ABBV) today announced the results of the Phase 2 SLEek study evaluating upadacitinib (RINVOQ 30 mg) alone and in combination [ABBV-599 high dose (elsubrutinib 60 mg and upadacitinib 30 mg)] in adults with moderately to severely active systemic lupus erythematosus (SLE) who continued to receive standard lupus therapies. The study results are being presented as an oral presentation during the European Congress of Rheumatology, EULAR 2023. More>>

Mural Health and China-based Clinflash Partner to Expand Global Patient Payment Solutions

The strategic partnership marks an important milestone for the industry as Mural Health and Clinflash platforms enable international sponsors to deliver patient payments globally, including China

Berwyn, PA – USA – 23 May, 2023: Mural Health, a clinical trials technology company that improves the patient and caregiver experience in order to improve enrollment rates, participant retention, and increase protocol compliance, has today announced a strategic partnership with Clinflash, a leading provider of information technology in field of clinical development. Building on Clinflash’s IT specialism in clinical trials, the partnership will expand the capacity and global market of patient payments for clinical trials. Having reached an exclusive global agreement the partnership consolidates technical, market and commercial forces, enabling sponsors to access patient payment solutions in the Chinese market and beyond. The two organizations are currently preparing for further collaboration projects. More>>

West Announces the Inauguration of Its Newly Advanced Facility in Singapore, Improving the Manufacturing Efficiency for the Future of Containment of Injectable Medicines

May 24, 2023: Singapore; West Pharmaceutical Services, Inc. (West), a global leader in innovative solutions for injectable drug administration, today inaugurates its newly advanced manufacturing facility in Jurong, Singapore. This is part of West’s commitment to invest more than US$350 million globally in 2023, with the majority used to expand capacity and deliver on demand of drug customers for the West’s products and services, and to meet the growing needs of customers to support sensitive and complex molecules and the changing regulatory environment. More>>

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the Earlier Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Application to the European Medicines Agency is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel in the treatment of patients who received one to three prior lines of therapy. CARTITUDE-4

BEERSE, BELGIUM – 25 May 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma. More>>

Finalists Showcase Innovations in Sustainable Pharmaceutical Packaging, with Winners to be Announced at Connect in Pharma

London, UK – 25 May 2023 – Sciad Newswire – YewMaker and Connect In Pharma announce today the shortlisted finalists for this year’s Sustainable Medicines Packaging Awards. Winners will be announced at an in-person champagne ceremony at Connect In Pharma, an annual event connecting innovators in pharma and biotech to the world’s leading suppliers and manufacturers. More>>

Automata launches LINQ Cloud software to scale and manage lab automation from anywhere

London, UK – 24th May 2023, 9am BST – Automata, a leading company powering life science labs to fully automate their workflows, today launches LINQ Cloud: cutting-edge laboratory automation software. LINQ Cloud connects a lab’s physical and digital environment together, enabling life science organisations to scale while reducing the manual workload for scientists. More>>