Last week, the US Food and Drug Administration (FDA) had said it will not review Moderna’s application for its experimental influenza vaccine — mRNA-1010. This week, the agency did a volte-face, agreeing to review an amended application filed by the American biotech.On its part, Moderna has said it is looking for growth overseas, by leveraging its
partnership with governments in the UK, Canada, and Australia.Eli Lilly is swiftly building
stock of its experimental weight loss drug orforglipron, which is likely to
receive an FDA approval in April. Its approved weight loss medicine Zepbound (tirzepatide) has shown greater benefit in treating psoriasis when used along with its approved treatment for psoriasis Taltz (ixekizumab), as compared to Taltz alone, in a late-stage study. And its cancer drug Retevmo (selpercatinib) has shown statistically significant and clinically meaningful improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive non-small cell lung cancer (NSCLC).FDA has rejected Disc Medicine’s new drug application (NDA) for bitopertin as a treatment for a rare blood disorder. The drug was being reviewed under the FDA Commissioner’s National Priority Voucher (CNPV) program. Disc Medicine will now pursue a traditional FDA approval pathway for this drug.In trials, Compass Pathway’s psilocybin-based therapy — COMP360 — eased symptoms in patients with treatment-resistant depression (TRD). Ocular Therapeutix’s experimental eye drug — Axpaxli — has shown superior
benefits in treating wet age-related macular degeneration (wet-AMD) as compared to Regeneron’s Eylea (aflibercept) in a key late-stage trial. And Roche’s Gazyva met its primary endpoint in a phase 3 trial in patients with primary membranous nephropathy (pMN), a rare autoimmune kidney disorder.Meanwhile, PTC Therapeutics has withdrawn the NDA resubmission for its Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) following FDA’s negative feedback on the data submitted.In a volte-face, FDA to review Moderna’s amended flu vaccine applicationA
week after rejecting the original submission, FDA has agreed to review an amended application filed by Moderna for its mRNA-based flu vaccine candidate — mRNA-1010. The agency is expected to make a decision on the vaccine by August 5.Last week, the agency declined to review the vaccine, arguing that Moderna lacked an “adequate and well-controlled” study. In August last year, the Trump administration halted funding for certain mRNA projects amid growing skepticism toward immunizations.Following FDA’s initial refusal, Moderna said it is looking for growth overseas. The vaccine maker plans to
leverage its partnership with governments in the UK, Canada, and Australia to
drive growth this year, a Reuters report said.In
its fourth-quarter results, Moderna has forecast up to 10 percent revenue growth in 2026
compared to the previous year, driven primarily by
international sales. The company now expects roughly half of its revenue to
come from the US, down from about 62 percent in 2025.Lilly builds stock of obesity drug orforglipron ahead of FDA
approvalAnticipating
approval in the coming months, Eli Lilly has stockpiled US$
1.5 billion worth of its experimental weight loss
drug orforglipron. This will ensure a strong
launch to the product. FDA is likely to approve orforglipron in April.Lilly
has been gearing up for the orforglipron launch for a long time and has been
ramping up manufacturing capacity since 2024. In February 2025, it had said it
has already stockpiled US$ 548 million worth of
orforglipron.Zepbound+Taltz shows benefit in psoriasis: Lilly’s weight loss medicine Zepbound (tirzepatide) used along with its psoriasis treatment
Taltz (ixekizumab) has shown better results in psoriasis patients in a late-stage study, as compared to Taltz alone.Retevmo shows benefit in NSCLC: Lilly’s Retevmo (selpercatinib), an FDA-approved drug to
treat lung and thyroid cancers that have a mutation or fusion to the RET gene, has demonstrated “highly statistically significant and clinically meaningful” improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive NSCLC. The twice-daily oral medication was tested against placebo in patients who had
undergone surgery or radiation therapy. No accelerated approval for Disc’s rare disease med under priority voucher programDisc Medicine has said the FDA has rejected its
application for bitopertin as a treatment for patients with erythropoietic
protoporphyria (EPP), a rare blood disorder characterized by extreme sensitivity to light. The drug was being reviewed under the FDA Commissioner’s National Priority Voucher (CNPV) program, which fast-tracks the process to one to two months from the typical 10 to 12 month timeline. Incidentally, the rejection took four months to materialize,
raising questions about the CNPV program. According to a Reuters report,
Disc Medicine will now pursue a traditional FDA
approval pathway for its rare disease drug.Compass’ psychedelic-based depression treatment scores second late-stage study winIn a
late-stage trial, Compass Pathways’ psilocybin-based therapy — COMP360 — eased symptoms in treatment-resistant
depression (TRD). This is the second such late-stage trial win for the therapy, which consists of a synthetic
formulation of psilocybin, the active ingredient in “magic mushrooms”, and is designed as a short-term, episodic alternative to daily antidepressants for TRD patients.Ocular’s wet AMD drug beats Regeneron’s Eylea: Ocular Therapeutix’s experimental eye drug — Axpaxli — has shown superior benefits as compared to Regeneron’s Eylea (aflibercept) in a key late-stage trial. Ocular said Axpaxli is the first experimental treatment for wet age-related macular degeneration to show better results than an approved treatment, while also meeting FDA’s strict trial standards.Roche’s Gazyva scores phase 3 win in rare autoimmune kidney disorderRoche’s Gazyva (obinutuzumab) could emerge as the first
approved therapy for primary membranous nephropathy (pMN), a rare autoimmune
kidney disorder. In a phase 3 trial, Gazyva met its primary endpoint, and according to top-line results, significantly more people achieved complete remission at two years with Gazyva, as
compared to immunosuppressant tacrolimus.PTC withdraws DMD drug application: PTC Therapeutics has withdrawn the NDA resubmission for its Duchenne
muscular dystrophy (DMD) drug Translarna (ataluren) following FDA’s negative feedback on the data
submitted.Gilead in licensing deal with Chinese biotech for cancer therapyGilead Sciences has entered into a licensing agreement with Chinese biotech Genhouse Bio to secure
exclusive worldwide rights to GH31, an experimental therapy targeting multiple types of tumor. Under the agreement, Gilead will pay US$ 80
million upfront to Genhouse Bio, with potential milestone payments worth up to US$ 1.45 billion.Sanofi names Belén Garijo as new CEO: Sanofi’s board has ousted Paul Hudson and appointed Belén Garijo as the new chief executive officer. She will take up her duties on April 29.
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