Broad Institute

MAY 9, 2024

Initially announced in March 2015, this renewed agreement extends the collaboration until September 2029 and will continue to support ongoing programs focused on the biology and genetics of aging as well as early-stage drug discovery. Terms of the agreement were not disclosed. “We

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. billion by 2029. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc.,

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Agency IQ

JULY 22, 2024

Ultimately, this module will interact with CTIS , the drug clinical trial information system. The preceding version of the EUDAMED roadmap, released late in 2023, showed milestones through 2029 for each of the six modules – actor, devices, certificates, market surveillance, vigilance and CI/PS.

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The Pharma Data

OCTOBER 9, 2021

Safety profile of deucravacitinib consistent with other trials and no new safety signals reported. Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis,” said Samit Hirawat, M.D.

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The Pharma Data

JANUARY 25, 2021

Nasdaq: BBIO) (the “Company,” “we” or “BridgeBio”) announced today the pricing of $650 million aggregate principal amount of 2.25% convertible senior notes due 2029 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).

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Agency IQ

JANUARY 26, 2024

MDR Article 78(14) sets out the original transition deadline in going from voluntary use of the coordinated assessment process to mandatory use as May 25, 2027; for IVDs, use of the coordinated procedure becomes mandatory in May 26, 2029 for all Member States, as set out in IVDR Article 74(14).

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Agency IQ

FEBRUARY 2, 2024

Companion diagnostics (CDx) and cancer trials: In 2023, the MDCG published guidance documents on classifying CDx. This remains a major area of concern for both industry and regulators, with a March 2023 survey from EFPIA finding that the challenges with the IVDR has led to issues with IVDs used in drug trials , and particularly cancer trials.

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