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Developers request revocation of remdesivir’s ODD for COVID-19
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
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Drug Markets
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India to set up $1.3bn pharma manufacturing fund, says report
Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.
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COVID-19 update: Eli Lilly assures security of insulin supply
Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.
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MHRA issues FMD over HMS Wholesale Limited products
A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.
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FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
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Anti-malarial drugs donated to aid fight against COVID-19
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
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CMA launches COVID-19 taskforce to combat drug price hikes
In the UK, the CMA has announced it will establish a taskforce to handle businesses that exploit the COVID-19 outbreak and inflate drug prices.
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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.
