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Home » Newsletters » BioWorld

BioWorld

Dec. 6, 2021

View Archived Issues
Clinical data illustration

Aeglea posts positive phase III data but stock staggers

Despite hitting the primary endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. had a tough go of it Dec. 6 as the price of its stock (NASDAQ:AGLE) plunged 36.5% to close at $3.81 per share. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The study results were positive enough to prompt Aeglea to say it planned to submit a BLA to the FDA in the first half of 2022. Read More

Recordati poised to acquire Eusa Pharma for about $817.5M

Milan-based Recordati SpA has proposed acquiring the global specialty pharma Eusa Pharma Ltd., a specialist in rare and niche oncology, for about €724 million (US$817.5 million) net of around €26 million in debt Eusa held at last report, midyear. The transaction offers Recordati a "great growth opportunity" while giving it the chance to "build scale in a new-for-us and very attractive and underserved therapeutic area," thus providing further diversification for Recordati's existing rare diseases business, said Chairman Andrea Recordati. Read More
cancer-cell-light.png

Isofol stock drops 27% as PFS reporting issue emerges in phase III cancer trial

Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan. Read More

Prices for state covered drugs in China to be slashed by an average of 61.7%

Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions. Read More

Top trends of 2021: R&D drives investment, SPACs dominate, but crowding, rising burn rates, new rules, threaten smooth ride

Financings ramped up dramatically in 2015 with $68 billion collected, but the amount does not touch biopharma investment in the last two years. The industry has raised $113 billion in 2021, down from the $134.5 billion full year 2020 total, but more than every five-year combination total from the years 2000 to 2014. It is an increase of 65% over 2015, 200% over 2016, 118% over 2017, 68% over 2018 and 95% over 2019. Both IPOs ($23.7 billion) and venture capital rounds ($37.8 billion) have hit all-time records this year. But will the onslaught of money continue for the industry? Read More

Adcom could be a hard sell for Reata

The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas. Read More

Immune imprinting may be key to future SARS-CoV-2 vaccine development

LONDON – New research shows the extent to which an individual’s immune response to the SARS-CoV-2 virus is affected by which variants they are initially exposed to, a finding that has consequences for attempts to update vaccines against emerging variants of concern. Read More

Beigene’s siltuximab gets China nod for multicentric Castleman disease as firm preps $3.5B STAR Market listing

Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe. Read More
Brain with puzzle piece removed

Viagra, cataract surgery associated with lower risk of Alzheimer’s disease

Far from the Groundhog Day spectacle of amyloid-targeting antibodies that do little to nothing for patients in trial after trial, researchers have reported success in reducing the risk of Alzheimer’s disease (AD) in unexpected ways. Researchers at the Cleveland Clinic Foundation have discovered that a Viagra prescription was associated with a roughly 70% reduced risk of being diagnosed with AD. And investigators from the University of Washington reported that in the prospective Adult Changes in Thought study, a long-term study into risk and protective factors for dementia, persons who underwent cataract surgery reduced their risk of AD by 30%, an effect that lasted for 10 years after surgery. Read More
Capitol.png

Senators pressured to pass drug pricing reforms in spending bill

With the $2 trillion Build Back Better spending bill held up in the U.S. Senate, President Joe Biden took to his public microphone Dec. 6 to call on senators to pass the bill that will permit Medicare negotiation of certain prescription drug prices, impose an excise tax on drug companies that raise the price of their products beyond inflation and set a monthly cap on cost-sharing for insulin. Read More
ICYMI illustration

ICYMI: Week in review, Nov. 29- Dec. 3, 2021

A quick look back at top stories. Read More

Appointments and advancements for Dec. 6, 2021

New hires and promotions in the biopharma industry, including: Adverum, Ambys, Amphista, Anheart, AGTC, Arrakis, Axcella, Biohaven, Calyxt, Curis, Decibel, Enveric, Escape, Iecure, Immunos, Kancera, Matinas, Poxel, Roche, Satellos, Yarrow. Read More

Financings for Dec. 6, 2021

Biopharmas raising money in public or private financings, including: Bellicum, Benevolentai, Bioplus, Cyrus, Longeveron, Odyssey, Trince. Read More

In the clinic for Dec. 6, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagene, Adicet, Astrazeneca, Bayer, Bellicum, Biofrontera, Bolt, Eupraxia, Fulcrum, Hummingbird, I-Mab, Immunicum, Immunocore, Janssen, Merus, Neurona, Revive, Scynexis, Springworks, Stoke, Surface Oncology, Viacyte. Read More

Other news to note for Dec. 6, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abionyx, Alpha Cognition, Aqilion, Bayer, Bsense, CAMP4, Carisma, GB Biosciences, Greenlight, Gritstone, IO, Inflammasome, J&J, Julphar, Kaleido, Merck & Co., NGM, Pfizer, Phylex, Poolbeg, Pulmocide, Quantum, Rarestone, Recursion, RDIF, Rhythm, Secura, Sinovac. Read More

Regulatory actions for Dec. 6, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Abcellera, Amicus, Amydis, Ascletis, Atamyo, Beigene, Biotheus, BMS, Cyclo, Eli Lilly, Eusa, Henlius, Jacobio, Junshi, Kolon, Legend, Longeveron, Merck & Co., Noramco, RDIF, Redhill, Roche, Sapience, Spectrum, Ultimovacs, Valneva. Read More

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