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Home » Newsletters » BioWorld

BioWorld

March 22, 2024

View Archived Issues
Doctor examining child in wheelchair

Italfarmaco’s Duchenne nonsteroidal therapy gets FDA approval

The U.S. FDA has approved Duvyzat (givinostat), from Italfarmaco SpA, for treating Duchenne muscular dystrophy (DMD). It is the first oral, nonsteroidal drug for treating all of DMD’s genetic variants. The oral treatment is approved for those ages 6 and older. Read More
kidney-nephrology.png

Eledon takes new ‘tac’ with tegoprubart in kidney transplant

Eledon Pharmaceuticals Inc.’s tegoprubart, an investigational anti-CD40 ligand antibody, was used as part of the immunosuppressive regimen after the first-ever transplant of a kidney from a genetically modified pig to a human. The tegoprubart procedure was done March 16 at Massachusetts General Hospital on a 62-year-old man with end-stage renal disease. Read More
Europe-pills-syringe-flag

EMA’s CHMP backs new antibiotic, oral PNH drug in March meeting

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe. Read More

Kazia licenses rare epilepsy drug paxalisib to Korea’s Sovargen

Kazia Therapeutics Ltd. has out-licensed paxalisib as a potential treatment for intractable epilepsy in focal cortical dysplasia type 2 and tuberous sclerosis complex disease in a carve-out deal with Sovargen Co. Ltd. for $20.5 million plus sales royalties. Read More
Zepbound

US CBO: Numbers don’t add up yet for Part D obesity drug coverage

When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure. Read More

CMS: Coverage of obesity drug Wegovy for cardiovascular events OK

Following the U.S. FDA’s March 11 approval of Novo Nordisk A/S’ glucagon-like peptide 1 receptor agonist, Wegovy (semaglutide), to reduce the risk of major adverse cardiovascular events such as heart attack and stroke, the Centers for Medicare & Medicaid Services (CMS) has issued guidance ensuring coverage. Read More
FDA-approve-green.png

11 US approvals in February include biosimilar, treatments for frostbite, HIV

In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals. Read More
alzheimers-tau-neuro.png

What’s going on beyond amyloid-β in Alzheimer’s disease management

After many years of testing different monoclonal antibodies against amyloid-β protein, the results obtained are far from being outstanding, and the control of the progression and symptoms of Alzheimer’s disease (AD) remains elusive. At the recent AD/PD 2024 conference held in Lisbon, new non-anti-amyloidogenic strategies in the starting line against AD were discussed. Professor Einar Sigurdsson from New York University gave a presentation entitled, “Single domain antibodies for therapy and diagnosis of synucleinopathies and tauopathies.” Read More

Money raised by biopharma

Total raised in public, private and other financings of biopharma companies, comparing 2019-2024. Read More

Biopharma money raised: Jan. 1-March 21, 2024

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

Appointments and advancements for March 22, 2024

New hires and promotions in the biopharma industry, including: Maat, Orion, Theratechnologies. Read More

Financings for March 22, 2024

Biopharmas raising money in public or private financings, including: Adocia, Eisbach, Sangamo. Read More

In the clinic for March 22, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bergenbio, Camp4, India Globalization Capital, Merck, Mission, Nykode, Otsuka, Public Health Vaccines, Sosei, Theratechnologies. Read More

Other news to note for March 22, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Cymabay, Gilead, Graphite Bio, GSK, Lenz, Morphosys, Nika, Nkarta, Novartis, Parvus, Sosei. Read More

Regulatory actions for March 22, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 2seventy, Bristol Myers Squibb, Johnson & Johnson, Lisata, Oscotec, Phanes, Scilex, Vertex. Read More

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