The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.

Licensing 52

Licensing Licensing Disease Small Molecule 52

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? Drugs/Biologics/Devices / Tobacco (CDER, CBER, CDRH, CTP) These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA).

Government 76

Government Compliance FDA Licensing 76

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

Treatment 52

Treatment Licensing Licensing Science 52

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? Directionality and Druggability: Does the proposed “direction” of insult and therapeutic intervention make sense, and can we drug our novel target with a compelling modality? in the case of CFTR for Trikafta).

Production 133

Production Small Molecule Regulations Trials 133

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 52

Treatment Small Molecule Clinical Trials Trials 52

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Laboratories 81

Laboratories FDA Regulations Licensing 81

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. we highlight potential implications of the IRA for the drug channel. If you have any questions before purchasing a license to the report, please email me. In Subsection 12.5.1.,

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

Drug Patent Watch

JANUARY 14, 2025

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. These agreements tie a drug’s price to its real-world performance, aligning the interests of manufacturers, payers, and patients.

Pharmaceuticals 54

Pharmaceuticals Compliance Licensing Licensing 54

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 52

Therapies Treatment Clinical Trials Science 52

BMG Labtech

DECEMBER 20, 2024

These applications are incredibly useful for basic research, studying the environment , probing different aspects of biotechnology , or contributing to undertakings like drug discovery. Improved understanding Understanding metabolism is also crucial for drug discovery and investigating disease mechanisms. coli enzyme (Fig.

Regulations 52

Regulations Laboratories Research Production 52

Policy Prescription

MAY 28, 2021

For the past decade, I’ve written extensively about my view that pharma-funded organizations and initiatives are responsible for misleading Americans about the safety of buying more affordable prescription drugs over the Internet for import from Canada and other countries. Here’s one example and you can be the judge.

Pharmacy 52

Pharmacy Licensing Licensing Online Pharmacies 52

Drug Target Review

APRIL 14, 2025

A deep interest in political science and the political economy of drugs led him to focus on how drugs are priced and distributed across different jurisdictions. Preventative drugs, unlike antibiotics used to treat infections, are taken proactively, which opens a broader market.

Therapies 52

Therapies Marketing Drug Development Treatment 52

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

FDA Law Blog: Biosimilars

AUGUST 8, 2024

With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, the agency had received over 43,500 comments. Some states have authorities that regulate marijuana exclusively. Department of Justice (“DOJ”) and DEA respond?

Regulations 59

Regulations Pharmacy Licensing Licensing 59

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International 40

International Regulations Licensing Licensing 40

The Pharma Data

MARCH 30, 2021

These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Targeted radioligand therapy is a type of precision medicine combining two key elements: a targeting compound, or ligand, and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication.

Therapies 52

Therapies Licensing Licensing Protein Expression 52

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

Regulations 40

Regulations Government Compliance Marketing 40

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such.

Therapies 119

Therapies FDA FDA Approval Treatment 119

The Pharma Data

JANUARY 18, 2021

18, 2021 — As more states legalize marijuana and more shops begin to sell it, more young adults are using pot and developing drug-use disorders, a new study finds. People with a higher number of licensed marijuana outlets within four miles of home were more likely to have used pot in the past month, the survey showed.

Licensing 52

Licensing Licensing Regulations Research 52

DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. 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.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

The Pharma Data

DECEMBER 13, 2020

SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. . CAMBRIDGE, Mass., 14, 2020 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. About RLY-1971.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients.

Pharmacy 40

Pharmacy Drugs Licensing Licensing 40

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

Trials 80

Trials Clinical Trials Regulations FDA 80

Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

Science 59

Science Drugs Compliance Drug Development 59

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

FDA 59

FDA Biosimilars Production Regulations 59

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

Clinical Research 81

Clinical Research Disease Research Clinical Trials 81

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. ii When appropriately applied, concurrent validation provides a powerful tool to address impractical limitations of bringing new drugs and biologics to market.

Small Molecule 52

Small Molecule Drugs FDA Production 52

The Pharma Data

MAY 4, 2021

House Democrats ramp up pressure on drug prices ( Politico ). Democrats Disagree About How to Spend Potential Prescription Drug Windfall ( KHN ). A Psychedelic Drug Passes a Big Test for PTSD Treatment ( NYTimes ) ( Endpoints ). In Focus: International. Interim Order No.

Vaccine 52

Vaccine FDA Approval FDA Licensing 52

The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,

Production 52

Production Efficacy & Potency Packaging Drugs 52

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

Biosimilars 52

Biosimilars International Licensing Licensing 52

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients.

Production 59

Production FDA Licensing Licensing 59

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

Packaging 40

Packaging Licensing Licensing Regulations 40

Crown Bioscience

MAY 4, 2021

Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

A new roadmap for cannabis and cannabis policy research mfleming Fri, 01/03/2025 - 11:38 Nora's Blog January 14, 2025 Image Getty Images/ Fiordaliso The greatly increased availability of cannabis over the last two decades has outpaced our understanding of the public-health impacts of the drug.

Research 78

Research Production Licensing Licensing 78

FDA Law Blog: Biosimilars

APRIL 25, 2024

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) l)(1) (e.g., Comments to the revised draft guidance are due to the docket by June 25, 2024.

Biosimilars 59

Biosimilars Production FDA Licensing 59

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 57

FDA FDA Approval Therapies Trials 57

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

Clinical Trials 52

Clinical Trials Regulations Doctors Government 52