Drug Target Review

JULY 29, 2025

Kyle previously consulted for biotech finance teams at JDK Consulting & Advisory (2018–2021), following senior finance roles at Gerrity Group and PIRCH. Jennifer has been a licensed CPA (California) since July 2014. Meet Jennifer Kyle Jennifer Kyle is Co-founder and CEO of Condor Software, Inc. Available from: [link]

Clinical Trials

New Drug Approvals

AUGUST 7, 2025

15 (2018) 731–747. [90] 8 (2018) 1227–1236. [91] Rogers, Gialir Macrocyclic Polymorph, 2018. October 2018). Davare, Resistance profile and structural modeling of next-generation ROS1 tyrosine kinase inhibitors, Mol. Cancer Therapeut. 21 (2022) 336–346. [89] Scaltriti, A. Drilon, S.I. Camidge, J. Whitten, J.K. CD-18-0484.

FDA

BioPharma Drive: Drug Pricing

JULY 16, 2025

Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. Editor’s note: This story has been updated with additional details and commentary from Sarepta executives. Track how they’re performing. Track how they’re performing.

Therapies

New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). Retrieved 11 September 2018.

FDA

New Drug Approvals

JULY 7, 2025

History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 2023) [link] ^ “Abbisko Therapeutics Announced the Entry into a Licensing Agreement for Pimicotinib (ABSK021) with Merck” [link] (Press release). 2018-11-29. [2].

Small Molecule

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

Government

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. However, it flamed out in testing in 2018 and Incyte was forced to pivot research toward other candidates. Since then, Incyte has had some success building out its portfolio.

Therapies

BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 • Updated 2 hours ago Delilah Alvarado Staff Reporter post share post print email license A sign bearing Sanofi's logo sits outside the company's U.S. Vicebio was formed by European life sciences investment firm Medicxi in 2018. headquarters in Bridgewater, New Jersey. Track how they’re performing.

Vaccine

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. See AgencyIQ’s full analysis of the 2018 framework, and industry response, here.]

FDA

New Drug Approvals

OCTOBER 12, 2024

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. 2018; 32(9): 849–861. [2]. 2018 Mar;57(3):315-333. Tramiprosate was reported to inhibit Aβ42 aggregation into toxic oligomers ( Gervais et al., 2007 ; Kocis et al., 2016 ; Abushakra et al., Hey JA, et al. Clin Pharmacokinet.

Pharmacokinetics

Drug Target Review

FEBRUARY 28, 2024

Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). Normality sensing licenses local T cells for innate-like tissue surveillance. J Front Immunol 9:1409 (2018). Davey M, Willcox C, Baker A, et al. Recasting human Vδ1 lymphocytes in an adaptive role. Davey M, Willcox C, Hunter S, et al. Fisher J, Anderson.

Therapies

The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). 1) GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. Source link: [link].

Small Molecule

The Pharma Data

MARCH 11, 2021

MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

Clinical Trials

The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

FDA

The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda.

Licensing

FDA Law Blog: Biosimilars

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. As one might expect, the lion’s share of the registered facilities—over 2,000 of the total—are located here in the U.S.

FDA

The Pharma Data

JUNE 26, 2021

About the Sanofi Pasteur and Translate Bio collaboratio n In June 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur, the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

Clinical Trials

Agency IQ

APRIL 26, 2024

In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. However, the 2018 guidance it did not offer advice for interchangeable product labeling. regarding its administration, preparation, storage, or safety). However, the guidance didn’t offer recommendations on promotional materials.

Biosimilars

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

Pharmaceuticals

New Drug Approvals

SEPTEMBER 8, 2024

2] Palopegteriparatide was granted an orphan drug designation by the US Food and Drug Administration (FDA) in 2018, [7] and by the EMA in 2020. [8] Palopegteriparatide is a pegylated synthetic peptide (molecular weight: ca. 48,000) consisting of 34 amino acid residues. 1] [2] It is a transiently pegylated parathyroid hormone. [4]

FDA

The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

Vaccine

Policy Prescription

MARCH 11, 2022

The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson , gets his pharmacist license back after it was revoked in 2019. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs. clinics in 2011.

Online Pharmacies

The Pharma Data

MARCH 1, 2022

The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. Syndesi’s Series A financing was co-led by Novo Holdings together with Fountain Healthcare Partners, with participation from Johnson & Johnson Innovation – JJDC, Inc., Source link: [link].

Small Molecule

The Pharma Data

DECEMBER 1, 2020

Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.

Cell Biology

New Drug Approvals

SEPTEMBER 6, 2024

Retrieved 21 August 2024. ^ World Health Organization (2018). . ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer” Johnson & Johnson (Press release). 20 August 2024. hdl : 10665/330941.

FDA Approval

Agency IQ

AUGUST 25, 2023

Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.] Regulatory Context: Labeling for Biosimilar Products In 2018, the FDA released a guidance document entitled Labeling for Biosimilar Products. However, it also notes that it may be necessary to mention uses for non-approved conditions in order to ensure safe use.

Biosimilars

The Pharma Data

NOVEMBER 17, 2020

of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. (b) The Prospectus stipulates that approximately 10.0%

Licensing

Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. As alleged by Gilead’s complaint , filed in the Eastern District of New York, licensed U.S. We purchased our products only from state-licensed suppliers who went through an extensive vendor vetting process.”.

Pharmacy

NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. 2018 Feb 12. Such studies suggested that 10 percent or less of newly approved drugs were based on academic patents.

Research

The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

Licensing

New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 17 September 2018. 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6] 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C., Grogan, D. .

FDA

Practical Cheminformatics

DECEMBER 7, 2023

Mark Murcko’s 2018 paper in J Med. It should be noted that not all biotechs skimp on software licenses. In my experience, the most successful drug discovery project leaders are curious people with broad scientific knowledge. There are many ways to broaden your skills. Read papers from areas outside your discipline.

Computational Chemistry

New Drug Approvals

SEPTEMBER 10, 2024

April 2018). LC-MS: m/z 415 (M+H) +.Compound Compound 6-(6-Chloropyridin-2-yl)-N 2 ,N 4 -bis(1,1,1-trifluoropropan-2-yl)-1,3,5-triazine-2,4-diamine 1 H NMR (400 MHz, CDCl 3 ) δ 8.29-8.16 8.16 (m, 1H), 7.72 (d, J=7.6 Hz, 1H), 7.41 (d, J=7.9 Hz, 1H), 5.70-5.13 5.13 (m, 2H), 5.09-4.71 4.71 (m, 2H), 1.34 (m, 6H). LC-MS: m/z 415 (M+H) +.

FDA Approval

The Pharma Data

FEBRUARY 5, 2021

American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. N= 3,525 total study population.

Treatment

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests.

FDA

The Pharma Data

JULY 22, 2021

The two companies had previously announced in 2018 a separate research collaboration and license agreement for the discovery and development of drug candidates using Arvinas’ PROTAC technology. Terms of the Collaboration. The agreement is a worldwide co-development and co-commercialization collaboration.

Targeted Protein Degradation

The Pharma Data

OCTOBER 22, 2020

Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies (André et al, Cell 2018). AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015.

Clinical Trials