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Home » Newsletters » BioWorld

BioWorld

Oct. 2, 2023

View Archived Issues
Silhouette of overweight family

With high societal costs, a burgeoning market size, developers seek reimbursement for weight-loss meds

The multibillion-dollar market potential for obesity medications that analysts expect in the next decade signifies change is afoot for a patient population historically plagued with unsafe options and generally dismissed by investors and insurers. While glucagon-like peptide 1 receptor agonists have paved the way – offering hope-filled patients the first significant non-surgical weight loss benefit upwards of 15%  – only a small portion of the obesity population and certain overweight patients are treated with medication, and even a smaller percentage receive insurance reimbursement. Read More

Biogen now has the first FDA-approved biosimilar to Roche’s blockbuster Actemra

With Tofidence (tocilizumab-bavi), a monoclonal antibody from Biogen Inc., the U.S. FDA has approved the first biosimilar to the Roche Group AG’s Actemra (tocilizumab), a blockbuster with declining numbers. Tofidence was greenlighted Sept. 29 for treating rheumatoid arthritis  in adults, and for treating polyarticular and systemic juvenile idiopathic arthritis in those ages 2 and older. It’s also the first biosimilar approved to treat systemic juvenile idiopathic arthritis. Read More
Acute myeloid leukemia

Ahead in menin inhibitor race, Syndax plans FDA filing in high-risk leukemias this year

Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia. Read More

Novo’s Rivfloza approved in US as new option for rare disease PH1

Three years after Alnylam Pharmaceuticals Inc. gained U.S. FDA approval of the first treatment for rare disease primary hyperoxaluria type 1 (PH1), Novo Nordisk A/S solidified its own marketing clearance for RNAi therapy Rivfloza (nedosiran). Read More
Seesaw with pill bottle and coins

With no injunction, US Rx price negotiations begin

Even as the court challenges continue, the first round of U.S. government price negotiations for selected Medicare Part D drugs officially began Oct. 1 with manufacturers of those drugs having to sign agreements to participate in the process. While the Centers for Medicare & Medicaid Services had yet to disclose, as of press time, how many manufacturers signed the negotiation agreements, all the companies with selected drugs reportedly had indicated they would sign by the deadline even as they pursue litigation. Read More
Nobel Prize graphic with illustrations of Katalin Karikó and Drew Weissman

Perseverance on mRNA therapy research wins the 2023 Nobel Prize in Medicine after saving millions of lives

Researchers who follow their instincts and achieve slow results while trying to break barriers have little support. They replace it with persistence. This is the story of Katalin Karikó and Drew Weissman. What was once a dream in their minds was later a success. Their work together for decades was essential to achieving mRNA vaccines, and their perseverance was rewarded today with the 2023 Nobel Prize in Medicine. Read More
Cyclopharm Technegas

FDA approves Cyclopharm’s Technegas combo product for visualizing pulmonary ventilation

After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date.

Read More

ICYMI: Week in review, Sept. 25-29, 2023

A quick look back at top stories. Read More

Biggest gainers and losers for Sept. 25-29, 2023

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

Appointments and advancements for Oct. 2, 2023

New hires and promotions in the biopharma industry, including: Aadi, Apnimed, Bpgbio, Broken String, Eledon, Newron, Profound, Repligen. Read More

Financings for Oct. 2, 2023

Biopharmas raising money in public or private financings, including: Abivax, Amicus, Mogrify, Neurosense, SAB, Vistage. Read More

In the clinic for Oct. 2, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Ascletis, Astrazeneca, Callidtas, Immunogenesis, Ionis, JCR, Nanobiotix, Scisparc, Structure, Verastem, Vericel. Read More

Other news to note for Oct. 2, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch + Lomb, Clade, Gadeta, Infinity, Mei, Moderna, Nkgen, Novartis. Read More

Regulatory actions for Oct. 2, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Biontech, Capricor, Erydel, Geron, Hutchmed, Outlook, Pfizer, Quince, Regeneron, Takeda. Read More

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