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Home » Newsletters » BioWorld

BioWorld

Aug. 11, 2020

View Archived Issues
COVID-19 vaccine vials

From Russia with flub? Safety jitters ripple after quick COVID-19 vaccine approval

Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied. Read More

Bayer adding to women’s health pipeline with Kandy buy for $425M up front

LONDON – Women’s health specialist Kandy Therapeutics Ltd. is to be acquired by Bayer AG for $425 million up front, with a further $450 million to come in milestone payments up to the launch of NT-814, a treatment for menopause symptoms that recently completed phase IIb. Read More

Biopharmas on track for a record year of innovation

Recovering from a complete response letter (CRL) in 2018, Trevena Inc. resubmitted its NDA for oliceridine, branded Olinvyk. On Aug. 7, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. opioid and for patients whose alternative treatments are inadequate. The FDA has now approved a total of 34 new molecular entities (NMEs) so far this year. That total is well ahead of the 18 NMEs that were approved at this time in 2019 even though the FDA suggested back in May that it might have trouble meeting PDUFA dates due to the resources it needed to devote to the COVID-19 pandemic. Read More
Stock-crashes.png

Mesoblast sees stock tumble 31% ahead of FDA adcom meeting

PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Read More
boy in wheelchair

Fulcrum looks for balance in its phase II FSHD study

An interim analysis from Fulcrum Therapeutics Inc.’s phase II study of losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD) produced data that pleased the CEO and displeased investors. Read More

Fennec's Pedmark lands CRL over manufacturing issues

Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors. Read More

No resiliency in having eggs in one manufacturing basket

While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support. Read More

Lytix finds partner for skin cancer agent LTX-315 in $113.5M Verrica deal

LONDON – After 17 years of patient toil, Lytix Biopharma AS has landed the first commercial endorsement of its oncolytic peptide platform, agreeing to a potential $113.5 million deal in which Verrica Pharmaceuticals Inc. will develop the lead product, LTX-315, as a transdermal treatment for skin cancer. Read More

Regulatory front for Aug. 11, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Kodak, Moderna. Read More

Financings for Aug. 11, 2020

Biopharmas raising money in public or private financings, including: Akers, Atriva, Aveo, Betterlife, Citius, Diamedica, Genome, Harmony, Iterum, Northwest, Omeros, PDS, Santhera, Scioto, Tearclear, TFF. Read More

Earnings for Aug. 11, 2020

Quarterly snapshots from biopharma companies with marketed products, including: Catalyst, Rockwell. Read More

Other news to note for Aug. 11, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Helix, Actinium, Altitude, Amydis, Ana, Appili, Arctic Vision, Aum, Axim, Beyond Air, Beyondspring, Biostem, Blue Tech, Bridgebio, Caris, Chrysalis, Elevation, Evotec, Eyenovia, Hemogenyx, Innate, Janone, Known Med, Lianbio, Ligand, Molecular Partners, Nascent, Nexeos, Quotient, Resolute, Revive, Saillant, Sapphire, Sarepta, Tevogen. Read More

In the clinic for Aug. 11, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Arcturus, Arrowhead, BMS, Byondis, Catalyst, Destiny, Eisai, Equillium, Fulcrum, Indalo, Kezar, Kymab, Revance, Romark, SAB, Tyme. Read More

Regulatory actions for Aug. 11, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Arvelle, Atyr, Clearside, Equillium, Fennec, Kyorin, Mersana, Mesoblast, Neurogene, Protalix. Read More

Appointments and advancements for Aug. 11, 2020

New hires and promotions in the biopharma industry, including: Avacta, Aztherapies, Gamida Cell, Stridebio. Read More

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