Generics Bulletin: ジェネリック＆バイオシミラーニュース

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.

Topic fda diabetes biopharmaceutical

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

A Positive Outlook For Deals, With Election Year Caveats

Industry advisers at the BIO CEO & Investor meeting remained optimistic about the pharmaceutical deal environment in 2020 – even with the uncertainty around a looming US election year.

Topic biopharmaceutical

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Pfizer And BioNTech Claim COVID19 Vaccine Success

The companies look to have secured a better than expected 90% efficacy level, but will await safety data before filing later this month.

Topic Coronavirus biopharmaceutical

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Votes To Leave The EU – Where Next For The Life Sciences?

UK vote to leave the EU opens the prospect of years of negotiations over the union's future relationship with one of its most valued member states.

Topic Regulation brexit biopharmaceutical

Chemist + Druggist Data

UK Sees PIP Codes Expand To Cover Hospital Drugs

Chemist + Druggist has expanded its “PIP code” system for UK pharmacy procurement to also encompass hospital drugs.

Topic biopharmaceutical Regulation biosimilars

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Stephen Lightfoot Appointed New Chair Of UK MHRA

The former industry executive and incoming MHRA chair says he wants to see the agency become an “enabler” in the UK health system. Meanwhile, the MHRA is still looking for a permanent chief executive after Ian Hudson stepped down from the post nearly a year ago.

Topic Regulation BioPharmaceutical

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Wary Of Coronavirus Hype And Haste, Themis Looks To Future As Part Of Merck & Co.

Themis’ CEO on how Merck’s commitment to infectious diseases impressed him, and why regulators may not approve suboptimal COVID-19 vaccines.

Topic Coronavirus biopharmaceutical

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

Regular Acceptance Of Simulation Studies More Likely In 2020s

Lyon, France-based Novadiscovery is developing a user-facing technology to run in silico studies, a method it expects to cut development costs and improve trial success rates. But acceptance of “new” data types is often a concern for drug developers, despite world-leading regulatory bodies stating their desire for 21st century approaches.

Topic biopharmaceutical