The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch. Read More
Bold up-fronts and even bigger milestones defined ambitious neurology deals Abbvie Inc. struck with Voyager Therapeutics Inc. in 2018 and 2019. With vectorized antibodies, they planned to target multiple indications tied to excess aggregations of tau and tragic synucleinopathies. Considerable progress was made, said Omar Khwaja, Voyager's chief medical officer. But despite millions of dollars invested in the programs, Abbvie has now decided to quit the venture, leaving Voyager to either go it alone or find a new partner in its work on the challenging indications. Read More
The biopharmaceutical sector welcomed a further 11 new IPO graduates in July, bringing the number to 39 that have started to trade on the U.S. markets this year. The companies going public last month collectively raised more than $2.5 billion and most of them made a favorable impression following their first day of trading, with the group increasing their share values by an average of 16%. Read More
LONDON – Redx Pharma plc is in the process of handing its RXC-006 program over to Astrazeneca plc, after signing a potential $377 million development and commercialization deal for the porcupine inhibitor in the treatment of fibrotic disease. Read More
Nanjing, China-based Simcere Pharmaceutical Co. Ltd. became the second Chinese player to seek assets from G1 Therapeutics Inc., of Research Park Triangle, N.C., this year. On Tuesday, it licensed trilaciclib, an intravenous CDK4/6 inhibitor, from G1 Therapeutics in a $170 million deal for Greater China rights. Read More
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest. Read More
HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials. Read More
Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said. Read More
New hires and promotions in the biopharma industry, including: Arcutis, Athenex, Autolus, Black Diamond, Excision, Coherus, Curevac, Lyra, Mission, Neophore, Selecta. Read More
Biopharmas raising money in public or private financings, including: Achieve, Allovir, Astrazeneca, Bryn, Emergent, Immunic, Nervgen, Nuview, Point, Salarius, Sonnet, Transgene. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angion, Arch, Avelas, Cellectar, Clene, Karuna, Keros, GT, Novartis, Oncopeptides, Regenxbio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ana, Biophytis, Biosight, Cerecor, DBV, Deciphera, Eloxx, I-Mab, Leo, Myr, Reviral, Vivoryon. Read More
