June 12th 2025
The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.
June 2nd 2025
A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.
May 28th 2025
The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.
April 30th 2025
Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.
April 28th 2025
The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.
FDA Approves New Treatment for Depression
Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.
Latest ARB Recall Triggered by New Impurity
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
FDA to Miss Gottlieb’s Leadership
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
FDA Commissioner Scott Gottlieb, MD, Resigns
The FDA commissioner plans to leave the agency in April.
FDA Issues Draft Guidance on OSD Continuous Manufacturing
FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.
Apotex Recalls Drospirenone and Ethinyl Estradiol Tablets, USP
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
Caught in a Conundrum
Do patients get what they pay for when they demand cheaper drugs?
Handle with Care
Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.
Europe Pushes for Global Easing of Generics Approvals
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
Is Simplification Aiding Data Integrity Compliance?
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
Cell and Gene Therapies Gain Streamlined FDA Oversight
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
Reinterpreting Benchmarks for Innovative Therapies
While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
Aclaris Therapeutics Gains Approval for ESKATA from Swedish Medical Products Agency
Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.
Recipharm Gains New ISO Certification Recognizing Sustainability Efforts
Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.
FDA Provides Guidance on Bioavailability Studies
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
More Products Recalled Due to NDEA
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.
EMA Recommends Suspension of Fenspiride Medicines
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.
FDA Reacts to Generic Drug Critics
In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.
Swissmedic to Enter GMP Information into EudraGMDP
The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.
FDA Publishes Guidance on the Development of Nicotine Replacement Therapies
As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.
FDA Encourages Development of Regenerative Medicines
The agency clarified the process for development programs for regenerative medicine therapies.
SK Biopharmaceuticals, Arvelle Partner on Anti-Epileptic Drug for Europe
In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.
Poland and Slovenia Added to EU–US Mutual Recognition Agreement
The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
EMA Releases Report on Big Data
A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
FDA Publishes Competitive Generic Therapy Guidance
The guidance explains the process of applying for competitive generic therapy designation.
Sanofi Gets FDA Approval for Nanobody-Based Therapeutic
The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.
FDA Approves Novartis Drug for Tropical Disease
The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.
FDA Big Winner in Final Congressional Budget Agreement
FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.
EC Approves BMS Leukemia Drug in Pediatric Combination Therapy
The approval expands the indications for Sprycel (dasatinib) in Europe.
Aigenpulse Achieves ISO Certification for AI Data Technology
Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.