Johnson & Johnson said it has temporarily paused further dosing of its adenoviral vector-based COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant. Trial enrollment is also on hold while the company awaits a recommendation on how to proceed from the study's data safety monitoring board. Read More
An NIH-sponsored phase III trial testing Eli Lilly and Co.'s SARS-CoV-2 neutralizing antibody candidate, LY-CoV555, alongside the Gilead Sciences Inc. antiviral Veklury (remdesivir) has been paused at the request of its data safety monitoring board, the company told BioWorld. Read More
LONDON – Apogenix GmbH has added its CD95 ligand inhibitor, asunercept, to the band of cancer immunotherapies that are being repurposed to treat the most severe effects of COVID-19 infection. Read More
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%. Read More
Genome editing startup Edigene Inc. has raised RMB450 million ($67 million) in a series B financing round to move two of its programs for blood diseases into clinical trials. The financing round was led by 3H Health Investment, and supported by Sequoia Capital China, Alwin Capital and Kunlun Capital. Previous investors such as IDG Capital, Lilly Asia Venture, Huagai Capital and Green Pine Capital Partners also joined the round. Read More
DUBLIN – The cash spigot is still turned on, as two more European firms disclosed series A rounds on Oct. 13. Chord Therapeutics SA took in €16 million (US$18.8 million) to repurpose cladribine for rare autoimmune disorders. Rappta Therapeutics Oy raised €9 million to take forward a novel concept in cancer, focused on developing small-molecule activators of protein phosphatase 2A (PP2A). Read More
The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB. Read More
Voicing the frustrations of an industry alternately battered and lauded amid a politicized pandemic, leaders of the Biotechnology Innovation Organization (BIO) on Tuesday called for substantive changes they said are necessary to maintaining America's biomedical leadership. Read More
Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19. Read More
New hires and promotions in the biopharma industry, including: Agenus, Aro, Evox, F4, Inozyme, Inversago, Larimar, Maxcyte, Neubase, Nitrome, Oxurion, Recode, VBL. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axovant, CTI, Inventiva, Nanobiotix, Nuvation, Pluristem, PMV, Prestige, Voyager. Read More
