FDA accepts Zejula sNDA application as a maintenance treatment for ovarian cancer
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
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FDA approves first generic of ProAir HFA inhalation aerosol
The generic of ProAir HFA (albuterol sulfate) inhalation aerosol has been approved by the FDA to advance patient access to lower-cost medicines.
FMD alert issued for diamorphine hydrochloride lyophilisate for solution by MHRA
A defect in the 2D matrix for the expiration date of diamorphine hydrochloride lyophilisate for solution has been announced by the MHRA.
COVID-19 update: therapeutic and regulatory developments
European Pharmaceutical Review rounds up the latest news surrounding COVID-19, including a vaccine moving to clinical trials and the FDA's update on Chinese import inspections.
Nanoparticle drug delivery could be the future of targeted cancer therapies
Researchers have created targeted, modifiable nanoparticles which could be combined with pharmaceuticals as a form of drug delivery to treat cancer.
FDA centres collaborate to evaluate conclusions of pharmacogenetic testing
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
US pharma industry leaders support blockchain tech to aid track and trace systems
A report released by pharmaceutical industry leaders in the US demonstrates how blockchain helps to track and trace prescription medicines.
Lilly announces agreement to acquire Dermira for $1.1bn
Eli Lilly has announced it is to acquire Dermira for $18.75 per share, or approximately $1.1 billion, which will expand Lilly's immunology pipeline.
Two lots of Phenytoin Oral Suspension voluntarily recalled
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension USP due to concerns about failure to re-suspend resulting in under or overdosing.
Single catalyst could simplify biomanufacturing, lowering costs
Chemists have synthesised a single catalyst, able to perform multistep cascades of chemical reactions to produce a pharmaceutical product.
Oncology top area for non-industry sponsored clinical trials
Researchers have found that oncology therapies had the most investment in non-industry sponsored clinical trials last year.
Experts highlight importance of reducing pharma packaging waste
At a recent event, pharmaceutical packaging experts discussed strategies to reduce waste and protect the bottom line.
FDA Breakthrough Therapy granted to bladder cancer treatment
FDA Breakthrough Therapy Designation has been granted to PADCEV™ in combination with pembrolizumab in first-line advanced bladder cancer.
Top R&D countries and UK companies listed in new research
Researchers have revealed the countries which spend the most on R&D as compared to revenue, as well as the companies in the UK investing in research.
