ISELIN, N.J., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the validation of its Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The formal review process of the MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now set to begin with an estimated decision date expected in early 2024.

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Outlook Therapeutics® Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for...

- Ceapro is pioneering approach with a natural product as a potential anti-inflammatory

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Ceapro Inc. Receives Approval from Health Canada to Commence Phase 1/2a Human Clinical Trial Assessing Avenanthramide Tablets

KRAKOW, Poland, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Ryvu Therapeutics [WSE:RVU], a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced the completion of its public offering of 4,764,674 Series J common shares (“Public Offering”).

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Ryvu Therapeutics Announces Closing of Equity Offering with Gross Proceeds Over PLN 250 Million

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AB Science announces the drawdown of the first tranche of 6 million euros under its financing agreement with the European Investment Bank

TORONTO, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced that it has submitted the Type C meeting request package to the U.S. Food & Drug Administration (“FDA”) to obtain agreement on the revised protocol endpoints for the Company’s Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

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Revive Therapeutics Announces Submission of Type C Meeting Request to FDA for Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced unaudited financial results for the second quarter and first half ended June 30, 2022 and updated its fiscal year 2022 financial outlook. The quarterly and half year results are compared to the same periods in the prior year, unless otherwise specified, and reflect revisions as described below.

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CENTOGENE Reports Second Quarter and First Half 2022 Financial Results

Mechelen, Belgium; 22 December 2022, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced changes in the Executive Committee effective 1 January 2023.

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Galapagos announces changes to Executive Committee

MIAMI and BARRANQUILLA, Colo., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical conglomerate, announces an update on its previously reported definitive agreement, dated as of May 16, 2022 (the “SPA”), to acquire Grupo Somar (including Grupo Farmacéutico Somar, S.A.P.I de C.V., Química y Farmacia S.A. de C.V., Gelcaps Exportadora de Mexico S.A. de C.V. and related entities) from the sellers under the SPA (the “Sellers”).

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Update on Proposed Acquisition of Grupo Somar

CAMBRIDGE, Mass., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that on December 19, 2022, the Compensation Committee of Spero’s Board of Directors approved a grant of 155,000 restricted stock unit awards (RSUs) to one new employee under the Spero Therapeutics, Inc. 2019 Inducement Equity Incentive Plan, as amended, or the 2019 Inducement Plan. The RSUs are being granted as inducements material to the new employee becoming an employee of Spero in accordance with Nasdaq Listing Rule5635(c)(4).

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Spero Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

SHANGHAI, China, Dec. 26, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announces a new exclusive licensing and commercialization agreement with Hikma Pharmaceuticals PLC (Hikma), a multinational pharmaceutical company, for toripalimab in the Middle East and North Africa (MENA). Under the terms of the agreement, Hikma is granted an exclusive license to develop and commercialize toripalimab injection in all its MENA markets. In addition, Junshi Biosciences will grant the right of first negotiation to Hikma for the future commercialization of three under development drugs in MENA.

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Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region