Category Archives: Global News Feed

POMPANO BEACH, FLORIDA., Dec. 16, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTCQB: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics, is pleased to announce that its common shares have been successfully up-listed from the OTC Pink Sheet Open Market to the OTCQB Venture Market (the “OTCQB”) by the OTC Markets Group Inc. (“OTC Markets”). The Company’s common shares will begin trading on the OTCQB under the symbol “BSEM” as of the opening of market on December 16, 2022.

Go here to see the original:
BioStem Technologies Announces Up-Listing to the OTCQB Venture Market

Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

Original post:
Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

Basel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ?1% and ? 5%) with a severe bleeding phenotype. It is estimated that people with moderate haemophilia A make up 14% of the haemophilia A population.3

Original post:
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A

Full-year 2022 product sales guidance maintained at 20-25% growth year-over-year Full-year 2022 product sales guidance maintained at 20-25% growth year-over-year

See the article here:
Athenex Exits 503B Sterile Compounding Business

MADRID, Spain and BOSTON, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the approval by the EU-intergovernmental organization EUREKA secretariat of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) under the Eurostars-3 program. This project will be developed in collaboration with two European partners: the Danish company ImProTher and the University of Copenhagen, and will evaluate the role of iadademstat in several immunotherapy strategies, including checkpoint inhibitors and/or oncological vaccines, in solid tumors.

The rest is here:
ORYZON Awarded EU Grant to Further Explore the Role of Iadademstat in Oncological Immunotherapy Approaches

Topline data readout from study expected in first half of 2023

View original post here:
Palisade Bio Provides Update on U.S. Phase 2 Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions

CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data

Originally posted here:
Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase alfa) for Late-Onset Pompe Disease

NEW HAVEN, Conn., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Brad Margus, M.B.A., has stepped down from the company’s Board and Everett Cunningham has been appointed to join.

See the original post:
Arvinas Announces Changes to its Board of Directors

WOBURN, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced the final voting results from its 2022 Annual Meeting of Stockholders held on December 12, 2022.

Here is the original post:
Biofrontera Inc. Announces Voting Results from 2022 Annual Meeting of Stockholders

Closing of Three Separate Transformative Capital Financings, Including Two Significant Non-Dilutive Transactions, Generates Combined Gross Proceeds of More than $100 Million Which Reduce Outstanding Debt from $100 Million to $36.9 Million

See the original post:
Societal CDMO Completes Strategic Recast of Capital Structure Highlighted by Reduction and Refinancing of Outstanding Debt