Pharmaceutical Technology

SEPTEMBER 9, 2022

US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). It is expected to expedite the development of a wide range of new therapeutics using the small non-coding area of the genome that is not explored.

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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval.

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Bio Pharma Dive

AUGUST 16, 2021

The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment.

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48

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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The CMAs of the company can lower fat throughout the body through mitochondrial uncoupling, a natural process that causes energy regulation. The post Rivus raises $132m to advance clinical development of obesity treatment appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

DECEMBER 7, 2023

GlobalData’s report assesses the drugs in the Apoptosis Regulator BAX pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 4, 2023

The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon undertake development of pharmacopoeia standards for the Ayurveda, Siddha, Unani and Homoeopathy drugs under the ‘One Herb One Standard’ (OHOS) among other initiatives during the financial year 2023-24.

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Pharma Times

OCTOBER 27, 2023

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

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Bio Pharma Dive

MARCH 11, 2022

On the heels of its Syndesi acquisition, the company has announced an agreement with Gedeon Richter focused on researching and developing new dopamine-regulating drugs for neuropsychiatric diseases.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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Drug Patent Watch

JANUARY 14, 2025

But how do companies develop these cost-effective alternatives? Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. ”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation.

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Bio Pharma Dive

JULY 16, 2024

The Merck KGaA spinout has a tau-regulating medicine it claims could be an “ideal therapy” for Alzheimer’s. The pitch has intrigued both healthcare investors and pharma venture arms.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. But what can be done to mitigate these risks and ensure the success of generic drug development?

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

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Bio Pharma Dive

OCTOBER 8, 2023

Mirati shareholders could also receive another $1 billion should an experimental cancer drug the biotech is developing make it to U.S. regulators’ desks.

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Drug Patent Watch

JANUARY 21, 2025

Navigating the Complex World of Generic Drug Development: Risk Management Strategies to Know As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. One of the biggest risks generic drug developers face is patent infringement. But patent risk is just the tip of the iceberg.

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pharmaphorum

FEBRUARY 23, 2024

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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Pharmaceutical Technology

APRIL 18, 2023

Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients.

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Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drug development? Share your experiences and insights in the comments below!

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Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. While not fatal to the application, this development is certainly a setback for the sponsor, primarily in terms of a delay in approval.

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Pharmaceutical Technology

FEBRUARY 28, 2024

IRA regulations have changed how pharma is approaching innovation in cancer drug discovery and development.

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Development Drugs Regulation 130

Pharmaceutical Technology

NOVEMBER 1, 2023

Kite has signed agreement with Epic Bio for the development of new cancer cell therapies leveraging the latter’s gene regulation platform.

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Development Gene Regulation 130

Camargo

OCTOBER 14, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.

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Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. 2024: 48 staffers. 2025: 29 staffers.

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Pharmaceutical Technology

JANUARY 5, 2025

NMDA Regulator is under clinical development by Boehringer Ingelheim International and currently in Phase I for Unspecified Central Nervous System Disorders.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Camargo

OCTOBER 15, 2020

Similarly, in rare disease drug development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Natural history data becomes critical for product development when there is no concurrent control. For more insights on RWE, see the Camargo Blog and the FDA’s framework for RWE program.

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Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated.

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Worldwide Clinical Trials

DECEMBER 19, 2024

As regulatory frameworks like the General Data Protection Regulation (GDPR) have heightened the emphasis on data privacy and individual rights, Europe is leading the way in terms of privacy and data. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

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Pharmaceutical Technology

FEBRUARY 4, 2025

Developers celebrate gains for advances with radiopharmaceuticals while regulators and isotope suppliers work to keep up.

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XTalks

MAY 3, 2024

Challenges and Need for Vigilance: Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. How Common Is Salmonella in Chicken? The recall soon extended to other fresh basil brands sold in Illinois and Missouri.

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Bio Pharma Dive

SEPTEMBER 13, 2022

The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.

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