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Home » Newsletters » BioWorld

BioWorld

Nov. 9, 2021

View Archived Issues
Migraine-brain-light-aura

In a $1.24B deal, Biohaven and Pfizer to commercialize rimegepant outside the U.S.

In the Biohaven Pharmaceutical Holding Co. Ltd. and Pfizer Inc. collaboration to commercialize Nurtec ODT (rimegepant) outside the U.S., Biohaven will receive tiered double-digit royalties on ex-U.S. net sales as well as milestone payments of up to $1.24 billion. The target: more than 1 billion migraine sufferers worldwide with lots of clinical competition. Read More

Biogen investigating death, ARIA incidents in Aduhelm safety reports

As part of its pharmacovigilance program for Alzheimer’s drug Aduhelm (aducanumab), Biogen Inc. is evaluating a handful of reports published in the FDA Adverse Event Reporting System Public Dashboard, including the Aug. 18 death of a 75-year-old woman with Alzheimer’s and other co-morbidities. Read More
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Zai Lab strikes deals to advance Blueprint cancer and Karuna psychiatric candidates in greater China

Zai Lab Ltd. and Blueprint Medicines Corp. have inked an exclusive collaboration and license agreement for the development and commercialization of two candidates for the potential treatment of patients with EGFR-driven non-small-cell lung cancer (NSCLC) in greater China, where Clarivate forecasts total NSCLC market sales are poised to grow from $3.2 billion in 2020 to $9.5 billion in 2030. Read More

Psilocybin drug trips on side effects in TRD as Compass nails phase IIb endpoint

Compass Pathways plc rolled out favorable top-line findings from the largest randomized, controlled, double-blind psilocybin therapy study ever completed, showing that COMP-360 at 25 mg yielded a highly statistically significant and clinically relevant reduction in symptom severity after three weeks in patients with treatment-resistant depression (TRD) . Read More
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Brain infections rare but brain symptoms common with SARS-CoV-2

The sprint of fighting COVID-19 has been in respiratory medicine. For patients who become acutely ill, the short-term danger is in respiratory failure. But increasingly, it seems like the pandemic’s marathon fight may come to be against the neurological symptoms of COVID-19. Read More

Ascletis gets the global rights of envafolimab from Alphamab to treat hepatitis B

Ascletis Pharma Inc. has obtained the global development and commercialization right for ASC-22 (envafolimab) outside greater China from Suzhou-based Alphamab Oncology Co. Ltd. to treat viral diseases including hepatitis B. Read More

Surprise! Janssen seeks abrupt end to Alkermes U.S. paliperidone royalty agreements

Shares of Alkermes plc slipped 15% Nov. 9 on news that longtime partner Janssen Pharmaceutica NV plans to partially terminate two license agreements related to know-how royalties on U.S. sales of paliperidone products using Alkermes’ nanoparticulate technology. While the move is expected to result in only a modest near-term impact on the Dublin-based firm’s bottom line, it took both company management and investors by surprise. Read More

J&J wins appeal of $465 million ‘public nuisance’ judgment

Lawfully selling prescription opioid drugs is not a public nuisance, the Oklahoma Supreme Court said in overturning a $465 million judgment against Johnson & Johnson (J&J). Read More

Appointments and advancements for Nov. 9, 2021

New hires and promotions in the biopharma industry, including: Alentis, Anocca, Aspen, Braxia, Certara, Defence, Enosi, Histogen, Inotrem, Kintara, Lava, Noema, Nordic Nanovector, Oncoresponse, Onkure, Progenity, Relief, Shape, Verismo Xalud. Read More

Financings for Nov. 9, 2021

Biopharmas raising money in public or private financings, including: Alltrna, Amyris, Ani, Asgard, Chinook, Evotec, Home, IO, Ocuterra, Oramed, Xortx. Read More

In the clinic for Nov. 9, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Affimed, Alnylam, Asklepios, Astrazeneca, Bayer, BMS, Bugworks, Crinetics, Curis, Diamedica, Diamond, Galmed, GSK, Ionctura, Kalvista, Neoimmune, Nkgen, Novartis, Oncoinvent, Pieris, Regeneron, Selecta, Servier, Teva, TFF, Urovant. Read More

Other news to note for Nov. 9, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abl, Angany, Contrafect, Arcus, Ascendis, Athenex, Atriva, Atyr, Biovaxys, Beximco, Cstone, Dotbio, Edigene, Eisai, Gamida, Gilead, Huyabio, I-Mab, Imvax, Massachusetts General Hospital, Merck & Co., Ridgeback, Shanghai, University of Wisconsin-Madison, Washington University School of Medicine. Read More

Regulatory actions for Nov. 9, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Diamedica, Eton, Liquidia, Ocugen, Prelude, Seelos, Soligenix. Read More

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