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Home » Newsletters » BioWorld

BioWorld

Sep. 1, 2021

View Archived Issues
Craig Gibbs, CEO, Asher Biotherapeutics

Asher Bio closes $108M series B round to move IL-2 program to the clinic in 2022

Less than six months after closing a $55 million series A round, Asher Biotherapeutics Inc. has added another $108 million in a series B round to accelerate development of its early stage pipeline of targeted cytokine-based immunotherapies for cancer, autoimmune disease and infection. Read More

Hebecell raises a $53M series A to develop an NK therapy

Hebecell Corp. closed on a $53 million series A funding to continue advancing its off-the-shelf pluripotent stem cell CAR-natural killer cell (PSC-CAR-NK) therapy program into the clinic. Allen Feng, Hebecell’s chief scientific officer, has worked in stem cell development for more than 16 years. He’s seen a lot of technological change, especially in the past two years. Everyone is using the same technology, he said, but added that Hebecell’s technology is different from anyone else’s. It’s much simpler technology and has “very good potential” to move into large-scale industrial production. Read More
Respiratory syncytial virus, 3D illustration

Dressed for success, Bavarian’s RSV vaccine on faster track after phase II results

“Now it’s all about time to market,” Bavarian Nordic A/S CEO Paul Chaplin said as the company disclosed positive results from the phase IIa study with its respiratory syncytial virus (RSV) vaccine, MVA-BN RSV. “We’re looking at designs [for phase III] that give us the fastest approval possible” in the competitive space, he said, adding that the previously envisioned two-season setup “has gone out the window” with the latest findings. Read More

Pfizer and Merck push on with late-stage COVID-19 antiviral trials

The race to develop better antivirals for COVID-19 is heating up after Pfizer Inc. and Merck & Co. Inc. pushed ahead with clinical development of late-stage candidates, while Rigel Pharmaceuticals Inc. announced encouraging midstage data. Read More
Youth COVID test

One in seven teens report Long COVID symptoms after positive COVID-19 test, study shows

LONDON – One in seven children and young people who have COVID-19 go on to develop symptoms of Long COVID, according to the first cut of data from a large national study involving 6,804 participants ages 11 to 17 who had PCR tests between January and March this year. Read More
Coronavirus-pandemic2

Pandemic numbers rise; hospitalizations high among unvaccinated

A look at the COVID-19 cases and deaths globally and on a weekly basis suggest that the world is not doing any better than it was this time last year, even though numerous vaccines are now authorized and approved. Read More

Astellas stops dosing gene therapy for rare neuromuscular disease after trial's fourth SAE

Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function. Read More
Medici Drug Delivery System

No happy ending for once-charmed biotech unicorn

Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending. Read More
P53 tumor suppressor

All is loss for P53 mutations, study argues

More than half of cancers have mutations in the transcription factor p53, making p53 one of the most frequently mutated genes in solid tumors. Read More

BMS’ Opdivo greenlighted as first immunotherapy for first-line advanced gastric cancer in China

Bristol Myers Squibb Co.’s Opdivo (nivolumab) is now the first and only immunotherapy for the first-line treatment of advanced gastric cancer in China. Read More

More bad news for JAK inhibitors

In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib). Read More

Appointments and advancements for Sept. 1, 2021

New hires and promotions in the biopharma industry, including: Briacell, Brickell, Bryn, Caladrius, Cantargia, Cidara, Dermata, Hummingbird, Immunos, Lineage Cell, Novocure, Promis, Ribon, Science 37, Seelos, Silence. Read More

Financings for Sept. 1, 2021

Biopharmas raising money in public or private financings, including: Ascendis, Etern, Medigene. Read More

In the clinic for Sept. 1, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adial, Amarin, Axerovision, Bayer, Curevac, Genentech, Gennova, Gensight, GSK, HDT, J&J, Nocion, Pharmaxis, Poseida, Roche, Senhwa, SK Bioscience, Tauriga. Read More

Other news to note for Sept. 1, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Comet, Galapagos, Immunogenesis, Jacobio, Kalgene, Mindset, Omnix, Pharmacyte, Preveceutical, Sonnet, Vectivbio, Vifor. Read More

Regulatory actions for Sept. 1, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, ANI, Genhouse, Gloria, Huya, Innocare, Jazz, Ligand, Medipharm, Medivir, Merz. Read More

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