On May 18, 2021 Sandoz, a Novartis division, reported that plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain (Press release, Novartis, MAY 18, 2021, View Source [SID1234580190]). By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market.

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In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. This investment will allow Sandoz to leverage its position in Kundl as the hub and center of the only major end-to-end antibiotics supply chain in Europe, covering all production steps from API to Finished Dosage Forms (FDF) for many leading antibiotics.

In addition to the investment in Kundl, Sandoz announces plans for an expansion of its Palafolls site in Spain, planning to invest around €50 million in new production technology and increased capacity for the production of sterile penicillin APIs and sterile API mixtures.

As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Les Franqueses site in Spain, which it plans to close in 2024. Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. Sandoz is committed to its people and will offer full support to its associates who might be impacted.

Sandoz CEO Richard Saynor said: "Antibiotics are the backbone of modern healthcare and a key strategic pillar of our business. Despite a temporary drop in demand due to the pandemic, we remain as confident as ever in the mid- to long-term prospects for this segment, which meets a significant quantity of the global disease burden. This investment, which comes shortly after we announced plans to acquire GSK’s global cephalosporin antibiotics, confirms our commitment to securing the future of our leading global business".

Giovanni Barbella, Head of Sandoz Technical Operations, said: "Our goal is to produce and supply high-quality antibiotics at a cost-competitive price to patients around the world. The important investments announced today will enable our world-class manufacturing network in Europe to meet future requirements".

Sandoz is the global leader in generic antibiotics and operates the only vertically-integrated antibiotic network left in Europe, despite fierce competition from Asia.

On May 18, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that members of the executive management team will participate in a virtual fireside chat at the UBS Global Healthcare Virtual Conference on Monday, May 24 at 3:00 p.m. ET (Press release, LabCorp, MAY 18, 2021, View Source [SID1234580207]).

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A live webcast of the presentation will be available via the Investor Relations section of the company’s website at www.Labcorp.com and archived for replay.

On May 18, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, MAY 18, 2021, View Source [SID1234580223]).

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Clinical and Corporate Developments include:

In December 2020, CEL-SCI stated that its pivotal Phase 3 head and neck cancer study completed database lock and entered the statistical analysis phase. CEL-SCI remains blinded to the study data and is not involved in the analysis process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define safety and efficacy, those clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck.
In preparation for the anticipated commercial launch of Multikine, CEL-SCI has been expanding and upgrading its dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, is expected to be completed soon and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
"We believed in cancer immunotherapy when few did. We were the first to administer an immunotherapy drug right after diagnosis, ahead of surgery, radiation and chemotherapy, because we believe that the activation of an anti-tumor response by the immune system is best achieved before standard therapies damage it. We believe that it is possible to develop a non-toxic cancer drug. Our Phase 3 study took years longer than expected because it took longer than expected to reach the required number of events (patient deaths) in the comparator arms of the study. It is all about the final data," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $17.3 million for the six months ended March 31, 2021 versus an operating loss of $13.6 million for the six months ended March 31, 2020. CEL-SCI reported an operating loss of $8.5 million for the quarter ended March 31, 2021 versus an operating loss of $6.7 million for the quarter ended March 31, 2020.

During the six and three months ended March 31, 2021, CEL-SCI incurred approximately $6.9 million and $3.3 million, respectively, in capitalized costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.6 million, of which approximately $9.5 million has been incurred through March 31, 2021. The landlord of the property has agreed to finance the final $2.4 million of costs and allow for the repayment through increased lease payments beginning March 1, 2021.

On May 18, 2021 OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its first-in-class targeted oncology therapies, reported that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will present at the Jefferies Virtual Healthcare Conference taking place June 1-4, 2021 (Press release, OncXerna Therapeutics, MAY 18, 2021, View Source [SID1234580191]).

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The live presentation will occur on June 4, 2021 from 10:30 a.m. to 10:55 a.m. ET. A link to the live webcast of the presentation can be found here.

On May 18, 2021 Light Chain Bioscience | Novimmune SA reported that under its global collaboration agreement with TG Therapeutics (NSDAQ: TGTX) a predefined milestone was reached in the clinical development of TG-1801 (NI-1701), a bispecific antibody targeting CD19 and CD47 (Press release, Light Chain Bioscience, MAY 18, 2021, View Source [SID1234580208]).

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"We are excited with the progress of TG-1801 in the current Phase I clinical trial in Australia by our partner TG Therapeutics, as well as the recent approval of an IND and start of Phase I in the US. TG-1801 is the first bispecific antibody allowing for selective CD47 targeting on tumor cells, a unique mechanism of action that we are deploying in other internal and partnered bispecific programs for the treatment of cancer" said Nicolas Fischer CEO of Light Chain Bioscience. "The clinical progress of TG-1801 brings further validation to our bispecific kappa-lambda body format that maintains the native structure of a human IgG."