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EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
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Drug Markets
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First annual Pharmaceutical Invention Index released
The first Pharmaceutical Invention Index, which looks at the breadth and depth of novel agents currently being developed within the most innovative pharma pipelines, has been released.
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FDA approves Helicobacter pylori infection treatment
The US FDA has granted approval for the marketing authorisation of Talicia, intended to treat adults with H. pylori infection.
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Marketing authorisation recommended to be withdrawn for preterm birth drug
A vote by an FDA committee has resulted in the suggestion that marketing authorisation is revoked for preterm birth treatment Makena.
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Seasonal influenza vaccine market to be worth $6.5bn by 2028
The transition from egg-based towards cell-based, recombinant and universal influenza vaccines will drive growth in the seasonal influenza vaccine market, a report has said.
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Ten European countries enter initiative to lower drug prices
A scheme called the International Horizon Scanning Initiative will allow ten European countries to work together on a database of medicines and reduce drug prices.
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Relapsing multiple sclerosis drug approved by FDA
VUMERITY has been granted approved by the FDA for the treatment of relapsing forms of multiple sclerosis based on data from a New Drug Application submission.
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FDA proposes three solutions to mitigate drug shortages
The FDA has compiled a report which identifies the root causes of medicine shortages and suggests potential ways to alleviate scarcities.
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CAR-T cell therapy granted RMAT for relapsed/refractory multiple myeloma
An investigational CT053 CAR-T cell therapy for RRMM has been given Regenerative Medicine Advanced Therapy designation.
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Allergan to reportedly settle Alzheimer’s therapy lawsuit for $750m
Allergen is to reportedly settle a class-action lawsuit which alleges that it worked to delay generic competition for Alzheimer’s disease therapy Namenda.
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The potential of the Indian pharmaceutical industry
According to research from the Indian Pharmaceutical Alliance, the country’s pharma sector has capacity to grow. This article investigates some of the goals, challenges and proposals the report sets out for the industry.
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FDA releases statement on reducing drug shortages
The FDA has announced its support of a drug manufacturer rating system that would allow purchasers to identify which have the most reliable supply, in an effort to reduce shortages.
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NHS England and Vertex announce agreement for cystic fibrosis medicines
A new agreement will allow eligible cystic fibrosis patients in England to have access to CFTR modulators to treat the underlying cause of their disease.
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Pelosi drug pricing bill approved by House committee
Speaker Pelosi’s bill to lower medicine prices in the US has passed through a House committee, ready for a full vote.
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FDA approves drug to prevent heart failure in type 2 diabetes patients
Farxiga, a treatment to reduce the risk of heart failure in patients with type 2 diabetes has been approved by the FDA.
