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UK agency pilots biobank to study links between genetics and drug side effects

Pharmaceutical Technology

The biobank will work in parallel with the MHRA’s Yellow Card website, which is used for reporting adverse events and side effects caused by medicines and medical devices, per the 25 May announcement. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed.

Safety 111
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Thursday pharma headlines

World of DTC Marketing

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. She recovered very nicely and is now in charge of a team at Amazon.com.

Pharma 180
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Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

pharmaphorum

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. 2018; 8(1). EMA/95098/2010.

Medicine 116
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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. Irinotecan – also known by the brand name Campto/Camptosar ® (Pfizer Ltd.) – has proven to be an effective chemotherapy agent against several types of gastrointestinal cancer. About the author. Oncotarget.

Patients 104
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ATRAG formulations for lung disease

European Pharmaceutical Review

This data, together with a favourable safety profile, make C21 a potential game-changer for IPF patients, particularly those who are currently not treated due to the side effects of the available drugs, according to Dalsgaard.

Pharma 98