Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. 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.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. This bill would extend the designation deadline until September 30, 2029, a five-year extension (and would require yet another GAO report).

Disease 64

Disease FDA FDA Approval Government 64

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”).

Marketing 52

Marketing Disease Clinical Trials Clinical Development 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

SEPTEMBER 27, 2021

3.375% Notes due 2029 532457 BV9 12 1.250% due August 15, 2031 1.321% 15 bps $1,130.16 and Citigroup Global Markets Inc. Treasury Security Reference Yield Fixed Spread Total Consideration (1)(2) 4.150% Notes due 2059 532457 BU1 1 (3) 2.375% due May 15, 2051 1.865% 80 bps $1,347.88 Lilly has retained BofA Securities, Inc.

Disease 52

Disease Marketing 52

The Pharma Data

SEPTEMBER 7, 2021

3.375% Notes due 2029. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 360,745,000. 1.750% due August 15, 2041. 3.700% Notes due 2045. 532457 BJ6. 412,467,000. 2.375% due May 15, 2051. 532457 BV9. 1,150,000,000. 1.250% due August 15, 2031.

Licensing 52

Licensing Licensing Marketing 52

The Pharma Data

SEPTEMBER 27, 2021

and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. As a result, tendered notes may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law. Lilly has retained BofA Securities, Inc.

Marketing 40

Marketing Disease 40

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).

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

NOVEMBER 27, 2023

BY RAYAN BHARGAVA, MSC | NOV 17, 2023 4:53 PM CST Regulatory background The European Partnership for the Assessment of Risks from Chemicals (PARC) is the seven year program, lasting from 2022 to 2029, which aims to facilitate, share, and improve research on chemical risk assessment.

Animal Testing 40

Animal Testing Research Regulations Compliance 40

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40