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Home » Newsletters » BioWorld

BioWorld

June 24, 2022

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Hemophilia-test-tube-dna

Biomarin outlines pricing strategy for costly hemophilia A gene therapy after backing from European regulators

The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5. Read More
Limb exam

Exon skipper still mobile in DMD, Sarepta gassed up for speedy answers to clinical hold

Sarepta Therapeutics Inc. aims to resolve “very quickly” the clinical hold placed by the U.S. FDA on SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy (DMD), said Louise Rodino-Klapac, chief scientific officer. Read More
Illustration of cancer cells and immunotherapy treatment

Tessa raises $126M in series A financing for autologous and allogeneic cell therapies

Tessa Therapeutics Ltd. has a closed a $126 million series A financing round to advance its ongoing clinical development, which includes the initiation of a pivotal trial of autologous CD30-CAR-T therapy (TT-11) and advancement of allogeneic CD30.CAR EBVST therapy (TT-11X) programs. Read More

Sanofi-GSK’s beta-antigen COVID-19 vaccine posts strong numbers against omicron

Sanofi SA and GSK plc said new phase III data show their adjuvanted bivalent D614 and beta (B.1.351) COVID-19 vaccine candidate responded well against omicron despite it being designed to fight the original SARS-CoV-2 virus and the beta variant. Read More
finance-dollar-growth.png

Alladapt’s goal is to help food allergy sufferers adapt

The only way to avoid food allergies right now is to stay away from whatever triggers them and, at best, grab some rescue epinephrine in case there’s trouble. Peanut allergies have an FDA-approved treatment, but the remainder of the troublemakers don’t have any therapies. Hoping to change that, Alladapt Immunotherapeutics Inc. closed a $119 million financing to develop its food allergy treatments. The Menlo Park, Calif.-based company’s lead candidate is ADP-101, an oral immunotherapy that is in a phase I/II trial and an open-label extension study of children and adults. Read More

Carbon Biosciences takes aim at cystic fibrosis, launching with $38M toward next-gen gene therapy

Although there has been huge progress in treatment of cystic fibrosis over the last decade, with Vertex Pharmaceuticals Inc. becoming the first to address the underlying cause of the disease with its Kalydeco (ivacaftor), approved in 2012, there are still many patients who aren’t eligible for treatment. Read More
Nonprofit stamp

Infection tops nonprofit deal efforts; U.S. covers 57% of grants

Nonprofit deals with biopharma companies in 2022 indicate that 92% of the disclosed funds are going toward infectious disease therapies, with COVID-19 accounting for 79% of the total. Read More

Appointments and advancements for June 24, 2022

New hires and promotions in the biopharma industry, including: Blueprint, Celyad, Oragenics, Tevogen, Valneva. Read More

Financings for June 24, 2022

Biopharmas raising money in public or private financings, including: Pfizer, Valneva. Read More

In the clinic for June 24, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Albireo, Astrazeneca, Cognition, Dermbiont, Diffusion, Disc, Gilead, Novaremed, Scynexis, Timber, Uniqure, Vistagen, Vivoryon, Xenon. Read More

Other news to note for June 24, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, Can-Fite, Dr. Reddy’s, Eton, Galapagos, Greenfire, Mirum, Molecure, Redhill, Repertoire, Saniona, Siga, Soligenix, Turning Point, Versanis, Voltron, Xentria. Read More

Regulatory actions for June 24, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alterity, Amryt, Astrazeneca, Biontech, CNS, Fusion, Menarini, Merck & Co., Novartis, Novavax, Radius, Realta, Rockwell, Valneva. Read More

Money raised by biopharma: 2022 vs. 2021 vs. 2020 vs. 2019

Total raised in public, private and other financings of biopharma companies, comparing 2022 vs. 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-June 23, 2022

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

Biggest gainers and losers for the week of June 20-24, 2022

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

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