Language – Talk Bio

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

2 weeks ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial

Appia Bio Shuts Down Before Reaching Clinical Trials Amid Biotech Funding Crunch

2 weeks ago talkbio0Tagged Appia Bio, biotech closures, Cell Therapy, Clinical Trials, Indonesian language, Kite Pharma partnership, Neoplasms

Appia Bio; cell therapy; biotech shutdown; funding challenges; clinical trials; Kite Pharma partnership; oncology; biotech closures; IND application

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

4 weeks ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints

1 month ago talkbio0Tagged ALS, Amyotrophic Lateral Sclerosis, Application procedure, Clinical Trials, Coya Therapeutics, Indonesian language, resource shortage, United States Food and Drug Administration

FDA; Coya Therapeutics; IND application; ALS; clinical trial delay; COYA 302; resource shortage

LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema

2 months ago talkbio0Tagged Anzupgo, Approved, Chechen language, chronic hand eczema, delgocitinib, pan-JAK inhibitor, Pharma, topical treatment, United States Food and Drug Administration

LEO Pharma; Anzupgo; delgocitinib; FDA approval; chronic hand eczema; pan-JAK inhibitor; moderate-to-severe CHE; topical treatment

German cancer antibody biotech eyes SPAC as route to Nasdaq

5 months ago talkbio0Tagged Antibodies, German language, Nasdaq, SPAC, Veraxa

Veraxa, Antibodies, SPAC, German language, Nasdaq

Ascletis Advances in Obesity Treatment with Promising Oral GLP-1 Data

7 months ago talkbio0Tagged ASC30, Ascletis, Chinese Language, Glucagon-Like Peptide 1, Obesity, Oral cavity, Pharma, pharmaceutical innovation

Ascletis Pharma, oral GLP-1, obesity treatment, weight loss, ASC30, Chinese biotech, pharmaceutical innovation

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

7 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

Bain Capital Acquires Mitsubishi Tanabe Pharma for $3.3 Billion in Strategic Japanese Pharma Investment

7 months ago talkbio0Tagged Acquisition, Bain Capital, carve-out, Drug Industry, Investments, Japanese language, Mitsubishi, Private Equity, Transaction

Bain Capital, Mitsubishi Tanabe Pharma, acquisition, Japanese pharmaceutical industry, carve-out transaction, private equity, life sciences investment

CDC Orders Retraction of Research Papers and Removes Website Content Amid New Language Restrictions

7 months ago talkbio0Tagged Centers for Disease Control and Prevention (U.S.), Feeling content, Gender, Languages, LGBTQ+, removal technique, research retraction, restrictions, Scientific Publication, Sense of identity (observable entity), Web Site

CDC, research retraction, website content removal, language restrictions, LGBTQ, gender identity, scientific publications