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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.
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FDA approved 1,171 generic drugs in 2019
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
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Breakthrough therapy for cystic fibrosis approved by FDA
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
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Teva to supply treatment in settlement agreement on Track 1 opioid case
Teva has agreed to supply opioid medication and make a cash payment in a settlement agreement that removes it from the Track 1 opioid litigation.
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HER2-positive metastatic breast cancer treatment granted Priority Review
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
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First non-injectable treatment for severe hypoglycaemia recommended
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
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Osteoarthritis therapeutics market to be worth $10.1bn by 2024, says report
A new report has said the osteoarthritis therapeutics market is estimated to grow due to rapid increase in the geriatric and obese population.
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First-in-class migraine treatment approved by FDA
Reyvow (lasmiditan), for the treatment of acute migraine, has received approval from the FDA following success in clinical trials.
