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Ultragenyx Pharmaceutical Inc. (RARE) reported new long-term durability data from the phase 1/2 studies of DTX401 for Glycogen Storage Disease Type Ia and DTX301 for Ornithine Transcarbamylase deficiency. The additional longer-term phase 1/2 data with DTX401 for Glycogen Storage Disease Type Ia showed...

Athenex, Inc. (ATNX) said its Marketing Authorization Application for oral Paclitaxel for the treatment of advanced breast cancer has been validated by the United Kingdom's Medicines and Healthcare products Regulatory Agency for review. A single pivotal phase III study of oral Paclitaxel was the basis...

vaccine nov17 29nov21 Major covid vaccine makers said they are investigating Omicron, the new, heavily mutated coronavirus variant that was first detected in South Africa, and working to adapt their vaccines, if needed. The World Health Organization, which named the new variant omicron, said the new strain is a "variant of concern" that could pose a higher risk of reinfection compared to the previous mutations.

Viracta Therapeutics, Inc. (VIRX) announced the FDA has granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified. Ivor Royston, CEO...

Avacta Group plc (AVCT.L) said FDA has approved its Investigational New Drug application for AVA6000, which will allow the Group to expand its phase I trial, ALS-6000-101, into clinical trial sites in the U.S. Enrollment in US clinical trial sites is anticipated to begin in early 2022, the company said. AVA6000...

Thermo Fisher Scientific Inc. (TMO) confirmed Monday that its polymerase chain reaction or PCR TaqPath COVID-19 Combo Kit, and TaqPath COVID-19 CE-IVD RT-PCR Kit, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results. The...

takedafda nov25 The U.S. Food and Drug Administration has approved Takeda Pharmaceuticals Co. Ltd.'s Livtencity (maribavir) as the first drug to treat post-transplant cytomegalovirus or CMV in adults and pediatric patients. The approval is to treat patients 12 years of age and older and weighing at least 35 kilograms with post-transplant CMV infection/disease that does not respond...

Janssen, the pharmaceutical companies of Johnson & Johnson (JNJ), announced that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. "We are delighted by Health Canada's decision to approve the Johnson & Johnson COVID-19 vaccine...

Seqirus, a business of CSL Limited, announced the FDA has granted supplemental approval of a multi-dose vial presentation of AUDENZ, the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1). Seqirus noted that the...

Gilead Sciences, Inc. (GILD) said the European Commission has granted marketing authorization for Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate, as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer. The company...

Clinical-stage biopharmaceutical company Gracell Biotechnologies Inc. (GRCL) announced the FDA has granted Orphan Drug Designation for GC012F, the company's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma. GC012F is currently being evaluated in investigator-initiated...

AbbVie (ABBV) has reached an agreement with the pan-Canadian Pharmaceutical Alliance for VENCLEXTA in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia. Following the agreement, Quebec is the first province to reimburse the combination...

Oramed Pharmaceuticals Inc. (ORMP) and Genomma Lab Internacional announced the formation of a 50/50 joint venture between Genomma Lab and Oramed's majority-owned subsidiary Oravax Medical to develop and commercialize Oravax's COVID-19 vaccine candidate in Mexico. Oramed and Genomma Lab also announced...

Pfizer Inc. (PFE) has agreed to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, PAXLOVID, to the U.S. government. The agreement is subject to regulatory authorization from the FDA. Currently, the company is seeking Emergency Use Authorization of PAXLOVID...

CureVac N.V. (CVAC) published the extended preclinical study of the second-generation vaccine candidate, CV2CoV, jointly developed with GSK. The data features a direct comparison of CV2CoV with the licensed mRNA vaccine, Comirnaty. Neutralizing antibody levels measured following full vaccination of animals...

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