Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills.

Pharmaceuticals

The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

Drug Development

Drug Target Review

NOVEMBER 25, 2024

Her journey in drug R&D and business development has been marked by significant achievements, including leading groundbreaking efforts to treat neglected cancers and breaking barriers for women in the biotech industry. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.

Treatment

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Unlike most approved drugs, which work by turning cell signaling up or down like a dimmer switch, this approach aims to rid cells of problem proteins entirely.

Targeted Protein Degradation

BioPharma Drive: Drug Pricing

AUGUST 13, 2025

13, 2025 Ned Pagliarulo Lead Editor post share post print email license B cells, like those pictured above, malfunction in autoimmune diseases. 13, 2025 Ned Pagliarulo Lead Editor post share post print email license B cells, like those pictured above, malfunction in autoimmune diseases. Published Aug. Published Aug.

Licensing

Drug Target Review

DECEMBER 9, 2024

Baker’s model could revolutionise drug development, synthetic biology, and nanotechnology, opening possibilities for new medical treatments, vaccines, nanomaterials, and sensors. The Rosetta algorithm has been incorporated into AI-powered tools like RoseTTAfold, which uses a three-track neural network to predict protein structures.

Engineering

The Pharma Data

JUNE 6, 2025

Otsuka Unveils Promising Phase 3 Results for Sibeprenlimab in IgA Nephropathy, Marking Significant Proteinuria Reduction and Advancing a Novel APRIL-Targeted Therapy Otsuka Pharmaceutical Development & Commercialization, Inc., in collaboration with Otsuka Pharmaceutical Co.,

Trials

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. The drug, formerly known as TAK-861 but now called oveporexton, was evaluated in two Phase 3 studies in a main type of narcolepsy.

Drugs

The Pharma Data

JUNE 24, 2025

Bayer and Tsinghua University Deepen Strategic Alliance to Advance Pharmaceutical Innovation in China Bayer and Tsinghua University (THU), two powerhouses in global pharmaceutical innovation and academic research, have announced a renewed commitment to their long-standing partnership.

Pharma R&D

Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. “The classic paradigm with todays psychiatry drugs involves patients chronically taking a daily medication,” says Donello.

Treatment

Drug Target Review

MARCH 4, 2025

In this interview, Bagnall explains how this approach is improving patient outcomes and driving the development of better obesity drugs. Knowing a patients subtype or phenotype can be used to guide obesity treatments of all kinds, including drug therapy, devices, bariatric surgery and even diet and lifestyle interventions, Bagnall explains.

Therapies

New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. Drugs 2024, 84, 111− 117. (71) 70) Keam, S. 71) Hoffman, E.

FDA

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] Food and Drug Administration.

FDA

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Food and Drug Administration (FDA).

FDA

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

The Pharma Data

JULY 2, 2025

Continued authorization of Ziihera for this indication will depend on positive outcomes from the ongoing Phase 3 HERIZON-BTC-302 trial , which is evaluating the drug in combination with standard-of-care therapy in the first-line setting. Ziihera is being jointly developed by Jazz Pharmaceuticals and BeOne Medicines Ltd. In the U.S.,

Therapies

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1] under nitrogen.

FDA

New Drug Approvals

AUGUST 14, 2025

2] It is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma by the US Food and Drug Administration. [2] Food and Drug Administration (FDA). “Jazz Pharmaceuticals Announces U.S. Jazz Pharmaceuticals. 3] Dordaviprone was approved for medical use in the United States in August 2025. [2]

Clinical Trials

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinical trials become more complex, and the importance of robust financial oversight has never been clearer.

Clinical Trials

Drug Patent Watch

DECEMBER 18, 2024

Drug patent prosecution is a complex and critical process that can make or break the success of a new medication. As a business professional in the pharmaceutical industry, understanding and implementing effective strategies for drug patent prosecution can be the difference between market domination and missed opportunities.

Pharmaceuticals

New Drug Approvals

APRIL 11, 2025

1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Food and Drug Administration. Fitusiran 1711.0g/mol, 1] It is given by subcutaneous injection. [1]

Clinical Trials

New Drug Approvals

JULY 2, 2025

Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] 1] It was discovered by Chugai Pharmaceutical Co. then was licensed to Lilly in 2018. [1] 1] It was discovered by Chugai Pharmaceutical Co. Hz), 7.59 (1H, d, J ＝8.6

Small Molecule

New Drug Approvals

JULY 10, 2025

1] The US Food and Drug Administration granted the application for sebetralstat orphan drug designation. [4] 1] The US Food and Drug Administration granted the application for sebetralstat orphan drug designation. [4] PMID 36251573. ^ “Sebetralstat Orphan Drug Designations and Approvals” U.S.

FDA

New Drug Approvals

JUNE 29, 2025

3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3]

International

New Drug Approvals

JUNE 15, 2025

Retrieved 15 September 2024. ^ “Notice: Multiple additions to the Prescription Drug List (PDL) [2024-08-13]” Health Canada. Retrieved 15 August 2024. ^ “Regulatory Decision Summary for Zilbrysq” Drug and Health Products Portal. Food and Drug Administration (FDA). Food and Drug Administration (FDA).

FDA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Dive Insight: Nuvation is a successor, of sorts, to Medivation, which developed the prostate cancer drug Xtandi and sold to Pfizer nearly a decade ago.

FDA

SugarCone Biotech

JULY 6, 2025

Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets. This is an active drug development landscape with a lot of recent news. This is where the rest of the drug development field comes in.

Drug Development

New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] . : 321839-75-2 Molecular Weight 519.50 1] It is taken by mouth. [1]

FDA

New Drug Approvals

MAY 15, 2025

5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information.

FDA Approval

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. In a statement Monday , Sarepta said it plans to cut approximately 36% of its staff and pause research on several drug programs.

Therapies

BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime. Kennedy Jr.,

Vaccine

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. Since the drug’s U.S. The disease, which affects an estimated 10,000 to 20,000 people in the U.S., By Jonathan Gardner • Sept.

Drugs

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Retrieved 12 October 2024. ^ “Details for: Sibboran” Health Canada.

FDA

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. By Jonathan Gardner • Sept.

RNA

BioPharma Drive: Drug Pricing

JULY 30, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially. drug production.

Production

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials