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Home » Newsletters » BioWorld

BioWorld

Aug. 31, 2020

View Archived Issues
Palforzia capsules

As FDA crunch bars DBV, Nestle gobbles Aimmune for $2.6B

Less than a month after would-be competitor DBV Technologies SA suffered a regulatory setback with its peanut allergy patch candidate, Aimmune Therapeutics Inc. – which at the start of the year gained FDA clearance for Palforzia in the same space – is undergoing an all-cash takeover valued at $2.6 billion by Nestle SA unit Nestle Health Science SA. Read More

Ionis to acquire the remainder of its spinout Akcea

Times have changed at Ionis Pharmaceuticals Inc. since it spun out Akcea Therapeutics Inc. in 2015. The company’s evolution is such that Ionis is now ready to bring Akcea back into the fold by acquiring the remaining 24% of its affiliate. Read More
Arrow-down.png

Biopharmaceutical sector suffers from the summer blues

It has proved to be a lackluster summer for the biopharmaceutical sector, with the BioWorld Biopharmaceutical index dropping about 2% in value during the past two months, in contrast to the general markets that have enjoyed a much stronger period. Read More
FDA-icons

Seeking transparency: COVID-19 vaccine adcom first of more?

In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market. Read More
Kidneys

Astrazeneca's Farxiga reduces risks for CKD patients in phase III study

Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo. Read More

Polyphor lands $15M up front in back-loaded China deal for balixafortide

DUBLIN – Shares in Polyphor AG gained as much as 12% during early trading Aug. 31 on news of a deal in China for its lead drug, balixafortide, which is currently undergoing a phase III trial in HER2-negative locally recurrent or metastatic breast cancer. Read More

Innocoll gains FDA nod for drug-device pain therapy Xaracoll

The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair. Read More
Enspryng product packaging

Chugai launches NMOSD treatment Enspryng in Japan

HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd. has launched a subcutaneous injection  of Enspryng (satralizumab) in Japan to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica (NMO). Read More
Skin, tissue layer illustration

After AU$45M IPO, Aroa rakes in two new approvals as it ramps up commercial presence

PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity. Read More
Galanin in the brainstem

How running away from your problems works

BioWorld looks at translational medicine: Researchers at Emory University have gained new insights into how exercise confers stress resilience. Read More

ICYMI: Week in review, Aug. 24-28, 2020

A quick look back at top stories. Read More

Appointments and advancements for Aug. 31, 2020

New hires and promotions in the biopharma industry, including: Acadia, Eton, Mannkind, Mersana, Onconova, Recce, Turning Point, Xortx. Read More

Conference data for Aug. 31, 2020: European Society of Cardiology

New and updated preclinical and clinical data presented by biopharma firms at the European Society of Cardiology Congress 2020, including: Akcea, Amarin, Amgen, Arrowhead, Astrazeneca, Boehringer, Innovent, Lilly, Myokardia, Novartis. Read More

Financings for Aug. 31, 2020

Biopharmas raising money in public or private financings, including: Biodol, Cohbar, Compass, Pyramid, Tracon. Read More

In the clinic for Aug. 31, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acasti, Akari, Axsome, Bluebird, Eiger, Embera, GSK, Imbrium, Kiadis, Maat, Mirum, NGM, Novan, Novartis, Orpheris, Provention, Regenerx, Shattuck, VBI, Vir. Read More

Other news to note for Aug. 31, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agex, Arrakis, Bharat, Biocryst, Cheplapharm, Elektrofi, Glycomimetics, Immutep, Kalos, Leo, Ligand, Lineage, Maat, Metagenomi, Mindset, Novavax, PDL, Qualigen, Resverlogix, Regulus, Sanofi, Seneca, Sotio, Unum, Vallaurix, Vor. Read More

Regulatory actions for Aug. 31, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Can-Fite, Cormedix, Cstone, FDS, Gilead, Lipocine, Mustang, Omeros, Oncopeptides, Revive, Sound, Spero, Velosbio, Xortx. Read More

Regulatory front for Aug. 31, 2020

The latest global regulatory news, changes and updates affecting biopharma. Read More

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