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

10/28/2026

The FDA issued new draft guidance to streamline approvals of personalized gene therapies, potentially accelerating treatment access for patients with rare genetic diseases. https://www.biospace.com/fda/new-fda-draft-guidance-doubles-down-on-expediting-approvals-of-personalized-gene-therapies

The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.

10/26/2026

Johnson & Johnson’s prostate cancer drug JNJ-6143 achieved a 75% tumor response rate in early Phase 1 trials, demonstrating promising potential for advanced cancer treatment. https://www.biospace.com/drug-development/esmo-2026-j-j-delivers-immaculate-early-data-for-prostate-cancer-drug-from-halda

JNJ-6143, which came from Johnson & Johnson’s $3 billion takeover of Halda Therapeutics in 2025, showed a 75% overall response rate in the Phase 1 readout.

10/22/2026

Roivant’s brepocitinib significantly reduced steroid dependence in patients with inflammatory eye disease across two Phase 3 trials, supporting plans for expanded FDA approval. https://www.biospace.com/drug-development/roivants-tyk2-jak-inhibitor-reduces-need-for-steroids-in-inflammatory-eye-disease

Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”

10/21/2026

The FDA approved GSK and Ionis’ Hibsago for chronic hepatitis B, offering eligible patients a potential functional cure after six months of treatment. https://www.biospace.com/fda/gsk-ionis-win-fda-nod-for-hepatitis-b-functional-cure-that-controls-virus-after-treatment

10/20/2026

Gilead’s oral drug emvistegrast showed promising Phase 2 results in ulcerative colitis, strengthening its expansion into immunology and inflammation ahead of Phase 3 trials. https://www.biospace.com/drug-development/gileads-highly-competitive-mid-stage-ulcerative-colitis-data-validate-i-i-push

10/19/2026

Veradermics’ oral minoxidil treatment improved hair coverage in men in a Phase 3 trial, supporting plans for FDA approval. https://www.biospace.com/drug-development/veradermics-minoxidil-pill-improves-hair-coverage-in-men-in-phase-3

10/14/2026

Verdiva Bio discontinued a Phase 2 trial of its oral GLP-1 obesity treatment due to market changes, while continuing development for other weight-loss uses. https://www.biospace.com/drug-development/verdiva-ends-mid-stage-study-of-oral-glp-1-amid-market-evolution

The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglutide in the Asian country.

10/13/2026

BioNTech’s mRNA cancer therapy failed to improve progression-free survival in a Phase 3 head and neck cancer trial, marking its third recent mRNA setback. https://www.biospace.com/drug-development/biontech-faces-3rd-mrna-setback-as-head-and-neck-cancer-therapy-fails-to-improve-survival

While BNT113 failed to improve progression-free survival in patients with a type of head and neck cancer during a Phase 3 trial, BioNTech is holding out hope for an overall survival win—but analysts say that outcome is now "less likely."

10/12/2026

Fierce Pharma’s regulatory tracker highlights key FDA approvals, label expansions and regulatory developments shaping the pharmaceutical industry in the second half of 2026. https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026-h2

Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, bu...

10/08/2026

Zealand Pharma’s obesity drug petrelintide achieved up to 9.2% weight loss in Phase 2 trials, but its blood sugar results disappointed analysts. https://www.biospace.com/drug-development/despite-zealand-assets-intriguing-weight-loss-analysts-underwhelmed-by-blood-sugar-numbers

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