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Drug major Pfizer Inc. (PFE) Wednesday announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients with alopecia areata. It is an autoimmune disease driven by an immune attack on the hair follicles that causes hair loss on the scalp and...

Moderna, Inc. (MRNA) said it has been granted Fast Track designation for mRNA-1345, the company's investigational single-dose mRNA vaccine against respiratory syncytial virus in adults older than 60 years of age. Respiratory syncytial virus is a common respiratory virus that generally causes cold-like...

Eli Lilly and Co. (LLY) and Incyte (INCY) Tuesday said that new data from Phase 3 COV-BARRIER sub-study indicated that baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation. As per the data, one death prevented for every six baricitinib-treated patients...

Genentech, a member of the Roche Group (RHHBY.PK), said FDA has granted priority review for Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. The company's application is based on disease-free survival results from an interim analysis of the phase III IMpower010...

Biotechnology company Vaxart, Inc. (VXRT) announced Monday that the U.S. Food and Drug Administration has cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. The vaccine candidate expressing S-only protein produced higher serum antibodies than...

Global Biopharmaceutical company Alkermes plc (ALKS), on Monday, said it has received Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma. The company noted that this is an important milestone for the nemvaleukin development program and underscores nemvaleukin's...

AbbVie (ABBV) announced Wednesday that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation or BTD to venetoclax (VENCLEXTA) in combination with azacitidine in Higher Risk Myelodysplastic Syndrome or MDS. The BTD is granted for the potential treatment of adult patients...

Immunome Inc. (IMNM) said that its three-antibody cocktail (IMM-BCP-01) has neutralized the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. In Tuesday pre-market trading, IMNM was trading at $21.03 up $4.39 or 26.38%. In addition, the antibody cocktail showed in-vitro activity via...

pfizer july20 Drug major Pfizer is recalling twelve lots of Chantix (Varenicline) Tablets, a treatment to help patients quit smoking, citing the presence of a nitrosamine impurity, N-nitroso-varenicline, above the established Acceptable Daily Intake or ADI level. The U.D. Food and Drug Administration noted that the recall involves two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets,...

lymphomatreatment july16 VetDC Inc.'s Tanovea (rabacfosadine injection) has received U.S. Food and Drug Administration's full approval to treat lymphoma, a type of cancer, in dogs. The regulator noted that Tanovea is the first conditionally approved new animal drug for dogs to achieve its full approval. Lymphoma, also called lymphosarcoma, is a type of cancer of the lymph nodes and lymphatic system.

IMV Inc. (IMV), a clinical-stage biopharmaceutical company, on Thursday said it priced its public offering of 14,285,714 units at $1.75, aggregating to $25 million.

The Israeli Government on Tuesday said that it would allow its adult citizens with pre-existing medical conditions to receive a third dose of the Pfizer vaccine against the coronavirus, thus making it the first country to administer the third dose. The decision comes in the backdrop of higher coronavirus...

jnj fda 071321 The U.S. Food and Drug Administration is reportedly planning to announce a new warning on Johnson & Johnson's (JNJ) coronavirus vaccine linking it to a rare neurological condition. According to the Washington Post, federal health officials are investigating the possibility that Johnson & Johnson's...

Aditxt Inc. (ADTX) said that it has launched high-sensitivity neutralizing antibody test to detect individual immune response to COVID-19. In Monday pre-market trading, ADTX was trading at $2.68 up $0.18 or 7.20%. The company noted that AditxtScore for COVID-19, which was first introduced in August...

The U.S. Food and Drug Administration has called for an investigation on the recent approval of Biogen Inc.'s (BIIB) Alzheimer's drug, Aduhelm. Acting FDA Commissioner Dr. Janet Woodcock has asked the Office of the Inspector General to investigate interactions between the U.S. agency and Biogen representatives...

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