J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Shots:

  • J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development
  • Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally
  • J&J affirmed its commitment to develop and test its vaccine candidate in accordance with high ethical standards and sound scientific principles, as outlined in a pledge made by 9 vaccine manufacturers in early 2020

Click here­ to­ read full press release/ article | Ref: PR Newswire | Image: Courier Journal

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Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Shots:

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Click here ­to­ read full press release/ article | Ref: Alvotech | Image: Formycon

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CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Shots:

  • CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 M, including $69.5M previously announced have funded preclinical studies and P-l study, preparations for the global pivotal P-ll/lll efficacy study, and initial manufacturing scale-up activities
  • The expanded collaboration will provide $258.5M for a global pivotal P-ll/lll efficacy clinical trial which is expected to begin before the end of 2020 and generates the safety and efficacy data to support licensure of the vaccine candidate in China and across the globe
  • The collaboration anticipates that the vaccine will be made available for procurement and allocation through the COVAX Facility, which aims to fairly distribute 2B doses of COVID-19 vaccine by the end of 2021

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Los Angeles Times

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Thermo Fisher Expands its Direct-to-Patient Service Offerings

Shots:

  • The company has expanded its Direct-to-Patient service offerings for supporting decentralized clinical trials to lessen clinical trial lengths and costs while increasing patient enrollment and participation rates
  • The company’s expanded Direct-to-Patient services build on its global Clinical Site-to-Patient program that launched in early 2020 to ensure that clinical trial patients have uninterrupted access to life-saving drug shipments without visiting a clinic
  • The Direct-to-Patient services include Pharmacy-to-Patient, Depot-to-Patient, and Clinical Site-to-Patient services, enabling clinical trial medication delivered directly to patients’ homes. Clinical Site-to-Patient services are available in 47 countries, supporting 1,500+ shipments to patients globally

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Tele Trader

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Eisai and Cogstate Expand their Agreement to Develop and Commercialize Digital Cognitive Assessment Technologies

Shots:

  • Eisai gets the global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the CBB for use in healthcare and other markets. The agreement allows the two companies to replicate the advancements that have already been launched in Japan, where Eisai has developed and launched a new digital tool using the CBB, named NouKNOW
  • The collaboration is an expansion of an existing agreement signed in 2019, under which Eisai had exclusive development and commercialization rights in Japan for all cognitive function tests including CBB
  • Eisai and Cogstate will work together for the development of digital tools for simpler self-checks of cognitive function and diagnostic tool development for HCPs to promote greater awareness of brain performance globally

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpectrum Asia

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Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

Shots:

  • The two companies will work together to research, discover, and develop therapeutic options related to the deficiency of the protein GBA which is a gene linked to Gaucher disease
  • The collaboration will combine Evotec’s iPSC platform and drug discovery and development capabilities with Centogene’s global rare disease platform, including iPSC lines
  • The collaboration follows the companies 2018 agreement to discover and develop novel small molecules in rare hereditary metabolic diseases

Click here ­to­ read full press release/ article | Ref: Evotec | Image: Wikipedia

Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

Shots:

  • Tango to receive $125M up front, $20M as equity investment, up to $410M/ program as an opt-in, extension, and milestones along with royalties on sales of the products. If Tango opts to co-develop and co-promote the product, the parties will equally split profits/losses and development costs in the US and will receive milestones and royalties on ex-US sales
  • Gilead will have an option for the global rights of up to 15 programs over the next 7yrs. and will pay option extension fees for Tango to lead activities through early clinical development, to which Gilead will retain its option rights. Additionally, Tango get an option to co-develop and co-promote the lead products for up to five programs in the US
  • Tango will continue to leverage its CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The agreement excludes Tango’s lead programs, including one which is expected to be in IND application-enabling studies in 2021

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Touch Oncology

Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Shots:

  • The acquisition will expand Olympus’ offerings in GI therapeutic devices and the development of advanced colonoscopy tools with the aim of improving early detection and treatment of CRC
  • Olympus will obtain full rights to Arc Medical Design’s medical products and will convert its current exclusive distribution rights of Endocuff Vision to a full acquisition of the Endocuff family of products
  • Endocuff Vision is a device attached to the distal end of a colonoscope, designed to maintain and maximize visibility during colonoscopy. The Endocuff technology will increase the 11% ADR that will improve clinical outcomes, reduce overall costs and enhance QoL for patients

Click here ­to­ read full press release/ article | Ref: Olympus | Image: Olympus

Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Shots:

  • The companies expanded the collaboration to support the needs of patients with kidney disease via digital health solutions. The agreement integrates Ayogo’s LifePlan digital platform with Baxter’s expertise in renal care to develop mobile apps and digital solutions that bring personalized and timely support to patients with kidney failure
  • Baxter made an equity investment in Ayogo in exchange for a minority interest in the company. The new initiative will provide patients the ability to proactively manage their home dialysis therapy records in collaboration with their healthcare team
  • Earlier, the two companies collaborated to develop a patient engagement app, CKD&Me that provides customized disease and therapy education for the learning needs of patients with CKD. The companies have launched the app in the US and are preparing to expand it globally

Click here ­to­ read full press release/ article | Ref: Baxter | Image: StraitTimes




AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Shots:

  • Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation
  • The two companies may enter additional commercial manufacturing agreement as the candidate progresses over three years through Emergent’s flexible capacity deployment model. The agreement follows CDMO partnership b/w Emergent and the BARDA signed in June to pave the way for OWS high-priority innovators
  • The University of Oxford and its spin-out company, Vaccitech co-invented AZD1222 and was licensed to AstraZeneca. The vaccine is under clinical trial for COVID-19

Click here ­to­ read full press release/ article | Ref: Emergent | Image: PharmaShots