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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Drug Markets
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UK government calls for increased supply of COVID-19 testing kits
The UK government has reached out to the life sciences sector to ask potential suppliers of COVID-19 testing kits to get in contact.
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Mylan and Upjohn transaction closure delayed by COVID-19
Mylan and Upjohn (a Pfizer company) revealed they have delayed the transaction due to meeting restrictions and concerns over staff health and safety during the COVID-19 pandemic.
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Indian government ceases exports of Ipca (hydroxychloroquine)
India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
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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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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.
