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Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
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UK bans parallel exporting of crucial medicines to help COVID-19 patients
The UK government has announced that the parallel export of certain essential medicines is banned, to preserve drugs for the treatment of coronavirus patients.
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Digitalising marketing to physicians: what pharma needs to know
European Pharmaceutical Review explores how the pharmaceutical industry could develop its digital marketing and sales strategies to better align with physician expectations and needs.
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Olumiant (baricitinib) granted Breakthrough Therapy designation by FDA
Baricitinib has been granted Breakthrough Therapy as a treatment for alopecia areata, an autoimmune condition with no FDA-approved therapies.
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Court rules against Mallinckrodt ARD LLC in Medicaid rebates lawsuit
The US District Court of Columbia has upheld the decision to alter rebate calculations and left Mallinckrodt with a retroactive liability of $650 million.
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NICE fails to recommend pembrolizumab in final draft guidance
The UK NICE has not found pembrolizumab cost-effective for use on the NHS, after a review of evidence collected while the drug was available via the Cancer Drugs Fund.
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What pharma needs to know about commercial strategy
European Pharmaceutical Review explores commercial strategy with Dr Simone Seiter, Partner and expert at Simon-Kucher & Partner’s Life Sciences division.
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India should reduce dependence on China for APIs, says industry insider
According to a report, supply disruption scares and price hikes due to COVID-19 are a 'wake-up call' for India to reduce its dependence on China for APIs.
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NICE recommends fremanezumab for chronic migraine prevention
The UK’s National Institute for Health and Care Excellence, NICE, recommends the use of fremanezumab on the NHS for preventing chronic migraine.
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New HIV PrEP drug could derail efforts to expand virus prevention coverage
US researchers have stated a newly approved HIV pre-exposure prophylaxis (PrEP) therapy does not have benefits that warrant its price tag and could deter generic competition.
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Ten drugs in pre-registration likely to be blockbusters by 2025, finds report
New research has found that of the drugs in the pre-registration phase, 10 are expected to become blockbusters over the next six years.
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FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
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CMA levels over £3.4m in fines for competition law breaches
The UK’s Competition and Markets Authority (CMA) has fined four companies in because of anti-competitive practices in the supply of nortriptyline.
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Innovations in CAR-T therapies in APAC will make market more competitive, report highlights
Research has shown that the CAR-T therapies in development in Asia-Pacific will make the worldwide market more competitive and drive down prices.
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EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
