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.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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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. JHVE Photo via Getty Images Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 headquarters in Bridgewater, New Jersey.

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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Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling.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.]

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The Pharma Data

JUNE 28, 2021

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer.

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FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality.

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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] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86” WHO Drug Information. 48,000) consisting of 34 amino acid residues.

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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.

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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 focus of this post is to simply show that the accused parties did not disregard patient safety in the manner that the pharmaceutical industry sought to portray. .

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. Protecting the imperatives of and the progress made under the DSCSA are used as a primary argument of the Pharmaceutical Researchers and Manufacturers of America ( PhRMA ) and the U.S. Fake DSCSA Pedigrees.

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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. Clementia Pharmaceuticals. Clementia Pharmaceuticals. 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6]

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. 2018) PLoS One. About Tonix Pharmaceuticals Holding Corp. Jessica Morris (corporate) Tonix Pharmaceuticals investor.relations@tonixpharma.com (212) 688-9421.

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New Drug Approvals

SEPTEMBER 6, 2024

Retrieved 21 August 2024. ^ World Health Organization (2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79” WHO Drug Information. . ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. 20 August 2024. hdl : 10665/330941.

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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.

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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. On two separate occasions, VP-level medicinal chemists from large pharmaceutical companies told me, “We have a solubility model that is so good, we stopped running the assay.” There are many ways to broaden your skills.

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New Drug Approvals

SEPTEMBER 10, 2024

Servier Pharmaceuticals. 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).

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The Pharma Data

NOVEMBER 10, 2020

AlzeCure ® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is extremely limited. STOCKHOLM , Nov.

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The Pharma Data

NOVEMBER 2, 2020

2, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. Europe, Latin America, the Middle East, and most of Asia Pacific, there are currently no licensed medicines for achondroplasia. This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. 20, 2021. In the U.S.,

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

DECEMBER 15, 2020

In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. About Pancreatic Cancer Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2%

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 Delilah Alvarado Staff Reporter post share post print email license The Food and Drug Administration on July 21, 2025, convened a panel of outside experts to discuss antidepressant drug use in pregnant women. Kennedy Jr. One panelist, Kay Roussos-Ross, advocated for continued use of SSRIs in pregnant women.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Molecule Blog

JUNE 11, 2021

We began exploring the combination of IP and NFTs with DeFi in 2018. When interest from potential investors reaches a certain maturity, the IP moves into a new licensing platform built on Web3.0. The legal contract is an IP license with language referencing blockchain transactions, addresses, and signatures.

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New Drug Approvals

SEPTEMBER 29, 2024

2018 ; Ding et al., According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days. Epub 2018 Oct 3 PubMed. Epub 2018 Jan 30 PubMed.

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The Pharma Data

JANUARY 25, 2021

patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. 2018 Sep;28(9):766-777. Epub 2018 Jul 2. 2018 Oct 23;115(43):11066-11071. Epub 2018 Oct 4. This patent family includes one additional U.S. ” The U.S. About DYN101.

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. About Asieris. For more information, please visit us at www.asieris.com.

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LifeSciVC

JANUARY 25, 2024

Getting funding and publishing papers in these two controversial fields was difficult, but the research teams I led there persevered for 15 years and succeeded in discovering new drugs that were licensed to pharma and biotech companies. Importantly, we were also able to publish the underlying work in high-quality journals.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

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Molecule Blog

AUGUST 19, 2021

In a best case scenario, that technology is out-licensed to a pharmaceutical company and the remainder of the development carries on there. Molecule has been exploring a use case for combining IP and NFTs with DeFi in 2018, and this week, that use case was fully realised. And this is the best-case scenario. for patents)?

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals’ SPN-812 for ADHD. Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Adamis Pharmaceuticals’ Zimhi for Opioid Overdose. Food and Drug Administration (FDA) in terms of PDUFA dates.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. PharmaDrug Inc.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. 75% of all bladder cancer cases occur in men. American Cancer Society.

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The Pharma Data

JANUARY 18, 2021

ZTlido ® was approved by the FDA on February 28, 2018. SEMDEXA is a trademark of Semnur Pharmaceuticals, Inc. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.

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Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

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