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Home » Newsletters » BioWorld

BioWorld

Dec. 17, 2021

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EMA’s CHMP rejects Biogen’s application for European approval of Aduhelm in Alzheimer’s

DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.” Read More

Scant backlash from NASH crash as Genfit scores $539M-plus Ipsen deal in PBC

Genfit SA’s global development and commercialization deal with Ipsen Pharma SA for phase III-stage elafibranor in primary biliary cholangitis (PBC) – plus a separate arrangement for rights to an asset earlier in development from Genoscience Pharma SA – represent “the logical next steps in the implementation of a strategy that we outlined to you about 18 months ago,” Genfit CEO Pascal Prigent said during a conference call with investors. Read More
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Awaiting NASH data, Northsea pads coffers with $80M series C

LONDON – Metabolic diseases specialist Northsea Therapeutics BV closed a $80 million series C to fund phase II development in two further indications, as it awaits the final results from the phase IIb trial of its lead product, icosabutate, in the treatment of nonalcoholic steatohepatitis (NASH), which are due at the start of 2023. Read More

Bellerophon posts strong phase II data in pulmonary hypertension

Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis. Read More
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Qilu in-licenses HBV-focused RNAi therapy from Arbutus in $300M deal

Qilu Pharmaceutical Co. Ltd. licensed rights to AB-729, an RNA interference (RNAi) therapeutic from Arbutus Biopharma Corp., in a deal worth up to $300 million. Qilu obtained rights to develop and commercialize the phase II asset for the treatment of hepatitis B (HBV) in mainland China, Hong Kong, Macau, and Taiwan. Under terms of the agreement, Qilu will pay Arbutus $40 million up front, as well as up to $245 million in development, regulatory and sales milestones. In addition, Qilu will make a $15 million equity investment in Arbutus at a price of $4.19 per share. Read More

Best year on record for IPOs, VC rounds; biopharma raises $116B in 2021

With a few weeks left in the year, the biopharma industry has raised a total of $116.18 billion through 1,506 transactions, both of which are second only to 2020. Read More

Appointments and advancements for Dec. 17, 2021

New hires and promotions in the biopharma industry, including: Chemomab, Cohbar, Coherus, Exelixis, Gritstone, Norgine, Onconano, Oncosec, Synerkine, Transcenta. Read More

Conference data for Dec. 17, 2021: ASH

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Century, Forma. Read More

Financings for Dec. 17, 2021

Biopharmas raising money in public or private financings, including: 20n Bio, Abeona, Addex, Amylyx, Bellus, Eqrx, Omega Funds, Specific Biologics. Read More

In the clinic for Dec. 17, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Albireo, Alligator, Apnimed, Applied, Aptinyx, Arcturus, Attralus, Axcella, Celyad, Cullinan, Debiopharm, Denovo, Diffusion, Douglas, Emergent, Ensysce, Fortress, In8bio, Innate, Kodiak, Kura, Kymera, Mallinckrodt, Matinas, Navidea, Nicox, Novaliq, Proqr, Seres, Uniqure, Valneva, Zealand. Read More

Other news to note for Dec. 17, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaxis, Amplyx, Biomarin, Cadila, Cassiopea, Cava, Cosmo, Hyloris, Iktos, Kineta, Lipidor, Mynd, Pfizer, Providence, Purdue, Skyline, Vaneltix, Vera. Read More

Regulatory actions for Dec. 17, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab. Read More

Money raised by biopharma: 2021 vs. 2020 vs. 2019

Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-Dec. 16, 2021

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

Biggest gainers and losers for the week of Dec. 13-17, 2021

The top 10 biopharma stock gainers and losers for the week. Read More

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