On September 2, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at Citi’s 15th Annual BioPharma Virtual Conference, which will be webcast on Tuesday, September 8, 2020 (Press release, Bristol-Myers Squibb, SEP 2, 2020, View Source [SID1234564265]). Samit Hirawat, MD, EVP, Chief Medical Officer and Rupert Vessey, MA, BM BCh, FRCP, DPhil, EVP of Research and Early Development will answer questions about the company at 12:15 p.m. EDT.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On September 2, 2020 Targovax ASA, reported that members of its senior management team is invited to present at upcoming conferences (Press release, Targovax, SEP 2, 2020, View Source [SID1234564242]).

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Pareto Securities’ 11th Annual Health Care Conference 2020, virtual
Date: 2 September 2020
Presenter: Torbjørn Furuseth (CFO)

Presentation:
– Time: 11:30 CET

2nd Annual RAS-Targeted Drug development summit, virtual
Date: 15 September 2020
Presenter: Erik Digman Wiklund (CBO)

Presentation:
Title: Adopting a Polyvalent Approach to Aid Development of Vaccines Against Mutant RAS
Time: 15:40 EDT / 21:40 CET

Panel discussion:
Live Q&A Panel
Time: 16:10 EDT / 22:10 CET

Presentations will be available to download at www.targovax.com after the event.

On September 1, 2020 Pierre Fabre reported 2020 Annual Report (Presentation, Pierre Fabre, SEP 1, 2020, View Source [SID1234639492]).

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On September 1, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer and has granted the application Priority Review. The FDA grants Priority Review to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications1. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021. Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

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"We are working diligently with the FDA on this Priority Review to bring Oral Paclitaxel to patients with metastatic breast cancer as quickly as possible," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "Intravenous (IV) Paclitaxel is a foundational chemotherapy in multiple tumor types and we plan to invest in broadening the label and uses for Oral Paclitaxel."

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, also stated, "We are delighted to have achieved this major milestone for Athenex. We continue to finalize our commercial preparations to ensure a successful launch of Oral Paclitaxel, if approved. We see Oral Paclitaxel as a potentially important alternative to IV infusions, especially during the current pandemic, as it may allow cancer patients to take the oral chemotherapy at home. We believe the Oral Paclitaxel program validates our broader Orascovery platform, and we are committed to applying the technology to convert other IV chemotherapies into oral agents."

The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer. The study is a randomized, controlled clinical trial designed to compare the safety and efficacy of Oral Paclitaxel monotherapy versus IV paclitaxel monotherapy. As previously reported, the study achieved its primary endpoint showing statistically significant improvement in overall response rate, along with a lower neuropathy, for Oral Paclitaxel compared to IV Paclitaxel.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On September 1, 2020 Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), reported the expansion of its collaboration with LifeArc, a UK based independent medical research charity, with a new agreement aimed at the development of highly innovative prototype assays in the field of infectious and immune-related diseases on Biocartis’ fully automated molecular diagnostics platform Idylla (Press release, LifeArc, SEP 1, 2020, View Source [SID1234565508]).

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The new licence and development agreement is an extension of the existing partnership[1] between LifeArc and Biocartis, which is today focused on the development and the commercialization of the Idylla ABC (Advanced Breast Cancer) assay[2]. This assay is positioned to target a multi-gene panel of predictive and resistance-inducing mutations based on an FFPE[3] sample type. Under the new agreement, LifeArc obtains a non-exclusive licence to use the Idylla platform for the development of Idylla assays in the area of infectious and immune-related diseases, aimed at supporting patient stratification and treatment monitoring of patients with, amongst others, bacterial, fungal and/or viral infections.

Today even more than ever, there is a clear need for improved diagnostics and monitoring of infectious and immune related disease. Central labs struggle to meet the growing demand, which is driven by rising incidence and prevalence of communicable diseases as well as a growing elderly population, who generally have a weaker immune response.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: "Although our focus remains in oncology, we know the Idylla platform to have a much broader capability such as in infectious disease testing. We have always said we were keen exploring opportunities there together with partners. LifeArc is one of the largest UK charitable medical research institutions and an organization that works with some of the most advanced and comprehensive technologies available today. Adding to the ongoing development of our proprietary Idylla SARS-CoV-2 Test and to our collaboration with Immunexpress on sepsis testing, this collaboration will further help build an innovative Idylla test pipeline in the area of infectious and immune related diseases with high clinical need. We’re pleased to see our partnering activities continue to add to the test menu and attractiveness of the Idylla platform."

Michael Dalrymple, Executive Director, Diagnostics & Science Foresight at LifeArc, said: "Based on our experience with Idylla as a great sample-to-result platform for rapid molecular diagnostics, we believe the technology can deliver patient benefit beyond oncology. Through this additional licence and development agreement, we can explore the development of highly innovative assays, and ultimately develop new tests that benefit patients."

Financial details of the agreement are not disclosed.