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Home » Newsletters » BioWorld

BioWorld

Feb. 27, 2023

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Self-administered shot

CSL's garadacimab meets endpoints in phase III HAE trial

Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023. Read More

Fed Circuit orders Jazz to delist REMS patent

While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system. Read More
Rare disease illustration

Ethical considerations open FDA’s Rare Disease Day

The U.S. FDA marked the 40th anniversary of the Orphan Drug Act with Rare Disease Day 2023 as Robert Califf, the agency’s commissioner of food and drugs, opened the day by expressing his wonder and accompanying concern regarding gene editing and gene therapy. Read More

Reata hit with investor uncertainty as FDA’s Dunn steps down

Shares of Reata Pharmaceuticals Inc. tanked unexpectedly Feb. 27, a day before the U.S. FDA is set to make a decision on the NDA seeking approval of once-daily Nrf2 activator omaveloxolone for Friedreich’s ataxia, on reports that Billy Dunn, the director of the FDA’s Office of Neuroscience, was stepping down from his position. Read More
Yen-Yuan symbols

Transthera raises $38M, propelling TT-0420 toward market

Transthera Sciences Inc., a Nanjing, China-based company developing small-molecule therapies in cancer, inflammation and cardiovascular disease, raised ¥260 million (US$38 million) in a series D+ funding round to advance its first drug product. Read More
Maximilien Levesque, co-founder and CEO, Aqemia

Aqemia making waves in computational drug discovery

For Aqemia SA, the year got off to a good start, as one of its pharma partners, Les Laboratoires Servier SAS, extended an existing collaboration to drug a supposedly undruggable immuno-oncology target, using its Launchpad artificial intelligence platform. Read More

First RSV vaccines on tap for US adcom

Safety likely will be top of mind when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee meets Feb. 28 and March 1 to advise the agency on two respiratory syncytial virus (RSV) vaccines proposed for use in adults who are at least 60 years old. Read More
Janet Siliciano speaking at podium

HIV cure, a less uncertain journey

HIV research is a winding road where one obstacle leads to another, slowing down success. The first barrier to getting the cure starts before one can even talk about it. “Cure may be too powerful and promising a term. Remission is probably better,” said John Mellors, whose work led to the universal use of plasma HIV-1 RNA and CD4+ T-cell counts in HIV-1 infection.

“Cure means maintaining an undetectable viral load off antiretroviral treatment. That means you cannot transmit it to people. Within that definition, there are people that have complete eradication of every single virus. And then, you have people that have a low level of virus that are able to keep under control without drugs,” Sharon Lewin told BioWorld. “Remission is maintaining a viral load less than 50 copies per milliliter in the absence of any retroviral. But there is still virus detectable,” she explained. Lewin is the director of The Peter Doherty Institute for Infection and Immunity in Melbourne, and the president of the International AIDS Society (IAS). Read More

ICYMI: Week in review, Feb. 20-24, 2023

A quick look back at top stories.

Read More

Biggest gainers and losers for the week of Feb. 20-24, 2023

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

Appointments and advancements for Feb. 27, 2023

New hires and promotions in the biopharma industry, including: Sensorion. Read More

Financings for Feb. 27, 2023

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

In the clinic for Feb. 27, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Astria, Atea, Biocryst, Codexis, Fulcrum, Innocare, Keymed, Merck, Nektar, Nestlé, Orchard, Oscotec, Prilenia, Regenxbio, Tvardi, Werewolf. Read More

Other news to note for Feb. 27, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Biocytogen, Chipscreen, Cincor, Enliven, Essex, Eyepoint, Galapagos, Genescence, Henlius, HRA, Imara, Novartis, Obseva, Perrigo, Pliant, Rallybio, Sinopia. Read More

Regulatory actions for Feb. 27, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber. Read More

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