LifeSciVC

APRIL 27, 2023

Our ACC inhibitor, now named firsocostat, remains first-in-class, and is in a Phase 2b study in severe NASH patients run by Gilead, who acquired the program in 2016. We kept 5% of the Gilead deal proceeds in 2016 in the hopes we could span our way to a next BD deal in our pipeline – and we did!

Small Molecule 52

Small Molecule Computational Chemistry Engineering Clinical Development 52

The Pharma Data

NOVEMBER 2, 2020

Taking into account also the shares which may be issued pursuant to the Company’s previously implemented employee option programs Employee Option Program 2016/2023, Co-worker LTIP 2017, Co-worker LTIP 2018 and Co-worker LTIP 2019, as well as the Company’s previously implemented incentive programs Board LTIP 2018, Board LTIP 2018.2,

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

Drug Discovery World

AUGUST 16, 2022

In recent times, however, governing bodies and pharmaceutical sponsors of clinical studies are starting to identify this as a serious issue and are beginning to enforce representation in trial design.” . It was, therefore, considered cost-prohibitive for pharmaceutical sponsors to set up clinical trials in these locations.

Research 130

Research Clinical Trials Trials Drug Development 130

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. GSK has built an industry-leading and high-performing Vaccines business, which has increased revenues from £4.6billion in 2016 to £7.0billion in 2020, and is expected to deliver high single digit % sales CAGR in 2021-26.

Government 52

Government Vaccine Production Science 52

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 85

Engineering Vaccine Production RNA 85

Codon

FEBRUARY 13, 2024

3 Another considerable obstacle to pharmaceutical companies’ interest (and investment) is the fact that for a product to be patentable — and therefore profitable — it has to be considered new and inventive. 4 But the same barriers still exist today. I cover this more extensively in The Good Virus.

Therapies 118

Therapies Virus DNA Clinical Trials 118

Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. And it really is the entire package that has been formed. … Last week, the FDA and AACR co-hosted a two-day workshop on the topic of optimizing dose-finding in oncology drug development. A lot of times the lower dose wins, right?

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. 24, 2016), the EPA must complete the final action for the Taconite Iron Ore Processing NESHAP by December 18, 2023. Pursuant to the D.C.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

This action also proposed the second supplemental standard addressing the remand of the 2016 standard-setting rulemaking. EPA’s risk evaluation for PCE, describing the conditions of use is in docket EPA-HQ-OPPT-2019-0502, with the 2022 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0732.

Regulations 40

Regulations Compliance Production Science 40

Codon

JUNE 26, 2023

In 2016, Belmonte “reported that sick mice lived 30% longer than expected after receiving a cocktail of special reprogramming proteins,” according to the article in MIT Technology Review. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Throughout the 1940s, several U.S.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

In 2016, Belmonte “reported that sick mice lived 30% longer than expected after receiving a cocktail of special reprogramming proteins,” according to the article in MIT Technology Review. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Throughout the 1940s, several U.S.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Agency IQ

JANUARY 4, 2024

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. 24, 2016), the EPA must complete the final action for the Taconite Iron Ore Processing NESHAP by December 18, 2023. Pursuant to the D.C.

Regulations 40

Regulations Compliance Government Science 40

Drug & Device Law

JULY 31, 2023

2016) (citations omitted). Medicis Pharmaceutical Corp. , 2016) (citation and quotation marks omitted). ADT, LLC , 2016 WL 3208483, at *3 (N.D. June 10, 2016); GCube Insurance Services., 2016 WL 6836950, at *4 (C.D. 28, 2016) ( Winter citation omitted). [C]ourts 2016 WL 4480693 (D.

Production 52

Production International Trials Government 52

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). The G/N MDL was created in 2013 and mostly settled in 2016. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th 4th 851 (6th Cir. denied , 144 S. 4th 696 (3d. 13) McGee v.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. See In re Accutane Litigation , 2016 WL 5958375, at *19, *27, 33, *47-48 (N.J. Janssen Pharmaceuticals, Inc.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , Novartis Pharmaceuticals Corp. , Salinero also followed the recent Hubbard v. 3d 1223, 1233 (11th Cir. as opposed to temporary hair loss ?

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59