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Home » Newsletters » BioWorld

BioWorld

March 25, 2024

View Archived Issues
Heart, DNA and ECG

Novo nabs Cardior in €1B deal, gaining phase II-stage miRNA drug

In what co-founder and CEO Claudia Ulbrich called the “right decision with right partner at the right point in time,” Cardior Pharmaceuticals GmbH agreed to an acquisition by Novo Nordisk A/S in a deal worth up to €1.025 billion (US$1.1 billion) that puts a potentially disease-modifying heart failure candidate in the hands of a big pharma player in the midst of establishing its presence in cardiovascular disease. Read More

Axsome Symphony phase III plays well in narcolepsy

An asset that some investors may have overlooked came through for Axsome Therapeutics Inc., which rolled out phase III data from the trial called Symphony with AXS-12 (reboxetine), which hit the primary endpoint by significantly reducing cataplexy attacks in narcolepsy patients vs. placebo. Read More
Magnifying glass, FDA concept image

Regeneron starts the week with two CRLs

The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab. Read More

Invivyd’s COVID MAb Pemgarda gains US EUA with boxed warning

The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis. Read More
Radiotherapy of cancer

China Grand Pharma advances radionuclide ITM-11 to phase III

China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors Read More

Aribio scores $770M deal in China for Alzheimer’s drug candidate

South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties. Read More

NMD Pharma’s oral myasthenia drug NMD-670 entering phase IIb

Neuromuscular disease specialist NMD Pharma A/S has been given U.S. FDA approval for a phase IIb trial of NMD-670, after demonstrating proof of mechanism for the orally-available chloride ion channel-1 inhibitor in generalized myasthenia gravis. Read More
AI-generated image of illustration of MRI of lungs with fibrosis

AI-driven research identifies pulmonary fibrosis target and inhibitor

Deep learning algorithms have enabled the discovery of molecular structures of interest in biomedicine to design treatments against aggressive diseases such as idiopathic pulmonary fibrosis (IPF). Scientists at Insilico Medicine Inc. selected a target for IPF using artificial intelligence (AI), then designed an inhibitor to block it, and tested it in vitro, in vivo, and in clinical trials. Read More

Benevolentai’s BEN-8744 shows promise in ulcerative colitis

Benevolentai Ltd. is betting on its oral phosphodiesterase 10 inhibitor BEN-8744 as having first-in-class potential for moderate to severe ulcerative colitis, after healthy volunteers in a phase Ia trial remained free of central nervous system-associated side effects. Read More

ICYMI: Week in review, March 18-22, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for March 18-22, 2024

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

Appointments and advancements for March 25, 2024

New hires and promotions in the biopharma industry, including: Ardelyx, Dyne, Sagimet, Siga. Read More

Financings for March 25, 2024

Biopharmas raising money in public or private financings, including: Aquestive, Bioxcel, Defence, Maia, Nkarta, TFF. Read More

In the clinic for March 25, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Blue Lake, Hutchmed, Innate, Molecure, Okyo, Pharmnovo, Summit, Umecrine. Read More

Other news to note for March 25, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Abl, Anheart, Biocytogen, Dr. Reddy’s, Eton, Ferrer, Landos, Nuvation, Pharmazz, Relief, Verge Genomics. Read More

Regulatory actions for March 25, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Belite, Brepco, Celltrion, Eisai, Irlab, Italfarmaco, NMD, Norgine, Novartis, Novo Nordisk, Outlook, Pfizer, Sandoz. Read More

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