On August 1, 2022 Fresenius Kabi reported that it closed the majority stake acquisition of mAbxience Holding S.L. ("mAbxience"), a leading international biopharmaceutical company (Press release, Fresenius, AUG 1, 2022, View Source [SID1234617184]). The transaction was announced in March 2022 .

The acquisition significantly strengthens Fresenius Kabi’s footprint in the biopharmaceuticals space by broadening the product portfolio and expanding its production network with three state-of-the-art facilities for the production of biologic drug substance. This will enable Fresenius Kabi to cover the entire biopharmaceuticals value chain in the future and create flexible, competitive capacities for the production of the expanded biosimilars portfolio. The additional production capacities are expected to generate significant cost synergies with regard to the company’s own biosimilars portfolio. Furthermore, the acquisition enables further expansion in the high-growth CDMO (Contract Development and Manufacturing Organization) market for biologics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The purchase price will be a combination of c. €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets. The contractual provisions also include a put / call option scheme regarding the sellers’ and future co-owners’ remaining shares in mAbxience (45%).

On August 1, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2022, before the market open on Thursday, August 11, 2022, and will host a corporate update conference call at 8:30am Eastern Time (Press release, CorMedix, AUG 1, 2022, View Source [SID1234617183]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 1, 2022 Immedica Pharma AB reported that the MOPH Pharmacy & Drug Control Department has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, AUG 1, 2022, View Source [SID1234617182]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to bring a new treatment choice to patients in Qatar with relapsed SCLC," said Anders Edvell, CEO at Immedica Pharma. "The Qatar MOPH approval of lurbinectedin underscores its potential to fill an unmet need in the SCLC community."

Immedica has a strategic alliance with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.

The approval of Zepzelca by Qatar MOPH Pharmacy & Drug Control Department is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.

On August 1, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported that on Friday, July 29, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold (Press release, Beam Therapeutics, AUG 1, 2022, View Source [SID1234617181]). BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June. The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 1, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that after a successful call for proposals, University of Dundee has been awarded its first funding within the beLAB1407 BRIDGE initiative (Press release, Evotec, AUG 1, 2022, View Source [SID1234617180]). beLAB1407 is a translational BRIDGE collaboration between Evotec and Bristol Myers Squibb, aiming to accelerate translational research from the UK’s academic life science ecosystem.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Building on unique insights into cytokine biology originating from the lab of Dr Ignacio Moraga at the University of Dundee, the selected project will focus on the development of novel biologics for the treatment of inflammatory disorders including inflammatory bowel disease ("IBD"). By promoting the regenerative properties of cytokines while negating the often detrimental inflammatory properties, this method offers a unique approach to treat a variety of conditions. The lab of Dr Mairi McLean at Dundee will provide complimentary expertise in gastrointestinal human tissue organoid cultures.

Using Evotec’s integrated discovery and development platform, beLAB1407 will validate the concept of the approach. beLAB1407 was launched in May 2021 as a translational collaboration between Evotec and Bristol Myers Squibb.

Dr Thomas Hanke, EVP & Head of Academic Partnerships at Evotec, commented: "We are delighted to award and fund a Dundee project within the beLAB1407 BRIDGE. After being initiated in 2021, beLAB1407 makes good progress in supporting a portfolio of competitive drug discovery projects and we are pleased to work on the project aiming to resolve chronic autoimmune processes proposed by Dr Ignacio Moraga and his team."

Anne Muir, Head of IP and Commercialisation at University of Dundee commented: "I am delighted that this first award for Dundee involves the Schools of Life Sciences and Medicine working together. We look forward to more awards from this exciting initiative and to successfully supporting the spinout opportunities that it will enable."