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Home » Newsletters » BioWorld

BioWorld

June 23, 2021

View Archived Issues
Laptop displaying FDA logo

Same as it ever was: FDA docs reaffirm how Aduhelm got here

More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance. Read More

How Abata new strategy in non-relapsing MS? Third Rock leads $95M series A

CEO Samantha Singer said Abata Therapeutics Inc. “spent a considerable amount of time finding the right indication” for its approach, which deploys autologous regulatory T cells (Tregs) made to express T-cell receptors (TCRs). That disease is progressive, non-relapsing multiple sclerosis (MS). “We’re going to be able to succeed with these patients where other options have failed,” she told BioWorld. Read More
3D dollar sign

Tvardi raises $74M to advance STAT3 inhibitors for cancer, fibrosis

Tvardi Therapeutics Inc., a company targeting a protein essential to cancer cells' survival and immune evasion, closed a $74 million series B financing. The round will help it advance candidates through multiple midstage trial readouts in cancer and fibrosis, the Houston-based company said. Read More
Emma Walmsley, CEO, Glaxosmithkline

Under-pressure CEO Walmsley outlines GSK’s breakup plans

Glaxosmithkline plc CEO Emma Walmsley has set out further details of the company’s forthcoming split, saying that the firm’s late-stage pipeline could help deliver sales of more than £33 billion by 2031. Read More
Green approved stamp

China grants first CAR T approval to Fosun Kite

China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod. Read More
Bacteria-in-petri-dishes.png

Infectious disease companies surge on upcoming FDA decision and COVID-19 wins

It has been a bumpy rollercoaster ride for many biopharma companies throughout the pandemic, but overall, the 17 firms that make up BioWorld’s Infectious Disease Index are coming out ahead this year with stocks up by 44.8%. Read More

Hutchmed earns NMPA approval for savolitinib amid IPO plan

Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. Read More

mRNA vaccines to get myocarditis warning

Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines. Read More
Capitol.png

Cures 2.0 includes provisions for real-world evidence for drug postmarket study

The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H). Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm. Read More

Appointments and advancements for June 23, 2021

New hires and promotions in the biopharma industry, including: Amunix, Arcutis, Draupnir, Gritstone, Omega, Som, Theratechnologies, Veralox. Read More

Conference data for June 23, 2021: EASL

New and updated preclinical and clinical data presented by biopharma firms at The International Liver Congress – The Annual Meeting of the European Association for the Study of the Liver, including: Antios, Arrowhead, Assembly, Brii, Durect, Enanta, Mirum. Read More

Financings for June 23, 2021

Biopharmas raising money in public or private financings, including: Bioasis, Biocytogen, Bioxcel, Century, Cyteir, Glycomine, Hutchmed, Immuneid, Orum, Strand, Vita. Read More

In the clinic for June 23, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, ADC, Alzheon, Amerimmune, Biocardia, Corcept, Cymabay, Dicerna, Entera, Galecto, Gemini, Hansa, Hightide, Histogen, Imbria, Immutep, Innate, Innovent, Keros, Merck, Nordic Nanovector, Pfizer, Pharming, Sanofi, Santhera, Scancell, Seven and Eight, Shenzhen Kangtai, Soligenix, Sorrento, Sosei, Telix, Xbiotech. Read More

Other news to note for June 23, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aarkus, Aleta, Alzheon, Celsion, Cerecor, Chemomab, Cocrystal, Dermtech, Etherna, Kedrion, Liminal, Mercaptor, Microbiotica, Mynd, Public Health Vaccines, Qu, Recursion, Scancell, Sorrento, SQZ, Tessa, Titan, Tiziana, Xenter. Read More

Regulatory actions for June 23, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algenex, Antares, Astrazeneca, Boehringer Ingelheim, Caladrius, Fennec, Grace, Xentria. Read More

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