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Home » Newsletters » BioWorld

BioWorld

June 21, 2022

View Archived Issues
COVID-19 vaccine vials on conveyor belt

WTO’s COVID-19 IP waiver playing to rotten tomatoes

While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track. Read More

Afrigen, Univercells, Etherna collaborate on African-owned mRNA COVID-19 vaccine

Afrigen Biologics (Pty) Ltd. is teaming up with two Belgian firms to co-develop and produce an mRNA-based COVID-19 vaccine intended for distribution throughout Africa. It’s an open question whether the vaccine will actually contribute to the present pandemic response, given the timelines involved in both validating the production facility that will produce the end product and in running the necessary trials in order to gain approval. Read More
Person holding stomach in pain

9 Meters stock shrinks as study needs more participants

In this case, more is just too much. The number of participants needed to determine a significant clinical outcome in 9 Meters Biopharma Inc.’s phase III of larazotide in treating celiac disease has grown too large to support the study. The company said an independent statistician’s interim analysis convinced it to take a step back and re-evaluate its options for developing the zonulin inhibitor in the indication. Read More

Give ITT a try: PTC heads to FDA (again) with Translarna data in DMD

After an up-and-down day – mostly up, toward the end – during which the phrase “totality of the data” got air time aplenty, shares of PTC Therapeutics Inc. (NASDAQ:PTCT) closed at $34.07, a rise of $5.66, or almost 20%, on word of top-line data from Study 041 with Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy (DMD). Read More
Eyepoint injector

China’s NMPA gives green light to Ocumension’s Yutiq intravitreal implant for uveitis

China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye. Read More

Ionis, Astrazeneca target filing for amyloid-driven disease after phase III readout

Ionis Pharmaceuticals Inc. and Astrazeneca plc, partners on the antisense oligonucleotide inhibitor eplontersen, said interim phase III data showed the candidate had a positive impact on disease progression in patients with hereditary transthyretin-mediated amyloid polyneuropathy, giving them confidence to plan for a U.S. FDA NDA filing in the indication before the end of 2022. Read More

Appointments and advancements for June 21, 2022

New hires and promotions in the biopharma industry, including: Acer, American Gene Technologies, Cetya, Chemomab, Frontier Medicines, Hookipa, Lixte, Onkure, Opus Genetics, Piramal, Point, Quralis. Read More

Financings for June 21, 2022

Biopharmas raising money in public or private financings, including: Burning Rock, Carbon, Day One, Galapagos, Marvel, Therorna. Read More

In the clinic for June 21, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AOP, Edgewise, Engrail, Kinarus, Pharmaessentia, Ultimovacs, Xbiotech. Read More

Other news to note for June 21, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Affinivax, Amniotics, Anixa, Ashvattha, Emercell, Kinarus, Onward. Read More

Regulatory actions for June 21, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acepodia, BMS, Eli Lilly, Hepion, Moderna. Read More

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