Top Ten most popular articles on Pharmafile.com this week

pharmafile | September 22, 2017 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing top ten 

It’s been a great week for drug research and access, with the first-ever FDA approval of a biosimilar in cancer treatment, and the agency also gave its first OK to a digital app, which coulld pave the way for more digital medical solutions in the future.

However, it wasn’t all good news as Santhera saw its Duchenne muscular dystrophy drug rejected in Europe, and the FDA expands its trial holds on immunotherapy drugs, raising further safety concerns about the treatment area after its recent shows of strength.

Check out the week’s ten most popular articles on Pharmafile.com now!

10. Santhera ‘surprised’ by European rejection of DMD drug

Santhera Pharmaceutical has announced the EMA’s CHMP rejected its treatment for Duchenne muscular dystrophy (DMD) but revealed that it planned to appeal the decision.

9. GDPR and Human Data Samples: Being ‘somewhat prepared’ is not enough

The 25th May 2018 will be a critically important date for the UK – pharmaceutical companies will immediately recognise it as the inauguration of the General Data Protection Regulation (GDPR) and all of the implications therein.

8. Merck and Pfizer’s joint skin cancer drug gets EU approval

Merck KGaA and Pfizer have announced that European authorisation of their jointly developed drug Bavencio as a monotherapy in the treatment of metastatic Merkel cell carcinoma, a rare and aggressive skin cancer.

7. FDA approves first-ever biosimilar for cancer treatment

The FDA has announced the news that it has awarded approval to the first-ever biosimilar for the treatment of cancer in the US – Amgen’s Mvasi (bevacizumab-awwb), a biologic version of Genetech’s Avastin (bevacizumab).

6. FDA approves first medical app, for use in addiction

The FDA has taken a major first step towards the digitisation of healthcare by approving the reSET app for substance use disorder, created by Pear Therapeutics.

5. Standing together: Supercharging the clinical trial in Europe

The European Medicines Agency is on the cusp of rolling out one of the most ground-breaking digital platforms for facilitating collaboration and efficiency in clinical trials. Matt Fellows investigates.

4. GSK receives positive opinion for triple-therapy inhaler

GSK, alongside its partner Innoviva, has announced that it has received a positive opinion from the EMA’s CHMP for its Trelegy Ellipta treatment for chronic obstructive pulmonary disease.

3. Witty, Ex-CEO of GSK, keeps busy with two new roles in two days

It was always unlikely that Andrew Witty, former CEO of GSK, would take his ‘retirement’ from the company literally, but he has stepped up his work after the company into a new gear, with two appointments in as many days.

2. Roche and AbbVie’s leukaemia combo smashes Phase 3 endpoint

Venclexta/Venclyxto (venetoclax) successfully met its primary endpoint in Phase 3 trials, providing prolonged, progression-free survival in chronic lymphocytic leukaemia (CLL) when administered with Rituxan (rituximab).

1. FDA locks down combo immunotherapy trials, Roche added to hold

Roche’s Tecentriq has been added to the list of immunotherapy treatments placed on a partial hold by the FDA over safety concerns.

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