Deals, Development and Manufacturing

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.

Innovate UK has awarded Epsilogen with further grant funding for the development of the next generation antibody treatments for ovarian cancer.

Dewpoint’s condensate platform works to target individual molecules and interacting groups of molecules within condensate communities to create new treatments for incurable and untreatable diseases.

Through the deal, Roche will gain co-commercialization rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of RET-altered non-small cell lung cancer, medullary thyroid cancer, and other types of thyroid cancer

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

The agreement will fund the late-stage clinical development, a Phase III clinical trial, large-scale manufacturing, and the delivery of 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373.

Emergent is entering into a five-year agreement with Janssen Pharmaceuticals for the large-scale drug substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine, Ad26.COV2-S.

Lonza is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.

COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.

Vertex Pharmaceuticals has announced that it has extended its agreement with the National Health Service (NHS) England for its cystic fibrosis medicines.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.

Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit-a deep tech company-and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research.

The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.

The partnership combines Malvern’s physicochemical characterization expertise and Concept Life Sciences’ chemistry and analytical services to provide services that focus on analytics, know-how, instrumentation, and expert support to customers.

Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.

Symbiosis Pharmaceutical Services has signed a supply agreement with AstraZeneca for the sterile manufacture of AZD1222, a COVID-19 recombinant adenovirus vaccine, to be used in clinical trials.

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.

The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases.