BioPoint Inc

BioPoint Inc. is a US-based Life Sciences consulting firm focused in the areas of Drug Safety.

is a US based life sciences consulting organization focused in the areas of Drug Safety, Health Economic

02/23/2026

The FDA is developing a bespoke approval pathway focused on gene-editing and RNA-based therapies for rare diseases. The framework aims to speed access to highly personalized treatments by using targeted biology and alternative clinical evidence approaches. https://www.biospace.com/fda/fdas-bespoke-pathway-to-focus-on-gene-editing-and-rna-based-treatments-for-rare-diseases

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.

02/20/2026

Next-generation obesity therapies aim to move beyond GLP-1 drugs by improving muscle preservation, tolerability, and adherence through oral options and combination approaches. https://www.biospace.com/business/redefining-obesity-treatment-beyond-glp-1-limits

In this episode of Denatured, you'll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We'll discuss next-generation obesity solutions tackling GLP-1's muscle loss and adherence challenges, through innovative muscle....

02/19/2026

The FDA will now default to requiring just one pivotal clinical trial for new drug applications instead of two. The change aims to speed approvals while still allowing additional studies when safety or complexity warrants them. https://www.biospace.com/fda/its-official-fda-will-now-default-to-one-clinical-trial-for-drug-applications

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.

02/18/2026

The FDA reversed its earlier refusal and will now review Moderna’s mRNA flu vaccine after the company amended its filing and proposed an age-based approval pathway. A decision is expected by August, potentially allowing the shot to be available for the 2026–27 flu season. https://www.biospace.com/fda/fda-reverses-course-on-modernas-mrna-flu-shot-application-promising-august-decision

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.

02/17/2026

Compass Pathways’ psilocybin therapy COMP360 showed durable antidepressant effects and strong Phase 3 results, strengthening its path toward FDA review. The data suggest a potential breakthrough treatment for therapy-resistant depression. https://www.biospace.com/drug-development/compass-psychedelic-shows-durability-in-spades-as-path-to-fda-clears

Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.

02/16/2026

Eli Lilly has built a large pre-launch inventory of its oral GLP-1 obesity pill orforglipron ahead of a potential FDA approval. The stockpile aims to prevent shortages and support a rapid launch in the competitive weight-loss market. https://www.fiercepharma.com/pharma/lillys-pre-launch-inventory-oral-glp-1-candidate-swells-ahead-expected-fda-obesity-nod

Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron. | Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly....

02/13/2026

Vertex’s kidney disease franchise is drawing attention as its painkiller Journavx surpasses 500,000 prescriptions filled. The milestone underscores strong demand and momentum for the company’s broader portfolio. https://www.biospace.com/business/all-eyes-on-vertexs-kidney-franchise-as-painkiller-journavx-tops-half-a-million-scripts

Analysts are keeping a close eye on Vertex’s kidney disease portfolio, anchored by the IgAN drug povetacicept, as its nonopioid painkiller Journavx is poised for “incremental” growth in the first half 2026, according to BMO Capital Markets.

02/11/2026

The FDA refused to review Moderna’s mRNA flu vaccine application, citing shortcomings in the company’s clinical trial data. The decision delays regulatory progress and highlights ongoing challenges in proving efficacy for the vaccine candidate. https://www.biospace.com/fda/fda-refuses-to-review-modernas-mrna-flu-vaccine-claims-trial-inadequacies

After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.

02/06/2026

The article lists the top 10 most anticipated drug launches expected in 2026. These upcoming launches span major therapeutic areas and could drive significant market impact. https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2026

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Like last year, 2026 appears poised to herald the arrival of multiple mega-blockbusters—albeit on an even grander scale than 2025’s plenty-respectable slate of major rollouts.According to Evaluate’s annual analysis of the biggest potential drug launches of the coming year, the top 10 most anti...

02/05/2026

Eli Lilly is discontinuing three experimental therapies as it refocuses its pipeline toward GLP-1 and other high-priority products. The move streamlines R&D to align resources with its most promising growth areas. https://www.biospace.com/lilly-axes-three-therapies-amid-pipeline-in-a-product-push-for-glp-1

One of the assets shelved by Eli Lilly is a gene therapy for dementia, which it obtained in its $1.04-billion acquisition of Prevail Therapeutics in late 2020.

02/04/2026

Amgen says it will not withdraw its rare-disease drug Tavneos despite the FDA’s request, standing by its belief that the therapy is effective and has a favorable benefit-risk profile. The FDA had asked for the withdrawal over concerns about how key trial data were handled, but Amgen has informed the agency it intends to keep Tavneos on the market. https://www.biospace.com/fda/amgen-will-not-heed-fda-request-to-withdraw-rare-disease-drug-tavneos

After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.

02/03/2026

Roche’s Genentech struck a deal to license RNAi technology from SangeneBio, paying $200 million upfront and up to $1.5 billion in milestones to develop new siRNA therapies. The pact expands Roche’s RNAi pipeline across multiple disease areas. https://www.biospace.com/deals/roche-keeps-the-deals-coming-with-up-to-1-5b-sangenebio-rnai-pact

The alliance will add to Roche’s RNAi efforts, which include the hypertension candidate zilbesiran, partnered with Alnylam under a July 2023 agreement.

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