Generics Bulletin: ジェネリック＆バイオシミラーニュース
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.
Topic Coronavirus EU Policy & Regulation
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Glenmark has received the go-ahead in India for and launched its low-priced favipiravir product for mild to moderate COVID-19 under an accelerated approval process.
Topic Coronavirus drug-review
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Coronavirus-induced stockpiling and advanced prescribing of medicines has resulted in generics companies across the world registering unprecedented growth during the first quarter of 2020. However, many companies predict sales will level off again in the next quarter and beyond. And as demand fluctuates following the COVID-19 outbreak, companies have started taking precautionary measures to avoid supply-chain disruptions.
Topic Coronavirus
Generics Bulletin: ジェネリック＆バイオシミラーニュース
A second wave of COVID-19 infection later this year would put even greater pressure on drugs used in patients hospitalized with serious respiratory problems, a new report warns.
Topic Coronavirus Distribution
Generics Bulletin: ジェネリック＆バイオシミラーニュース
In the first part of an exclusive two-part interview, James Burt – Accord’s executive vice-president for Europe, the Middle East and North Africa – talks to Generics Bulletin about the key actions taken by the generics industry to mitigate the coronavirus pandemic, and the changed landscape that the off-patent arena can expect to see in future.
Topic Coronavirus Manufacturing
Biomedtracker: 開発中医薬品をFDA承認確率で評価, Trialtrove: 医療用医薬品の臨床試験情報デ...
Access the infographic below which explores the number of treatment drugs for COVID-19 currently in clinical trials or in development, events including progress updates, partnerships, regulatory and trial announcements etc, and the number of articles published on COVID-19 as of March 3, 2020. This data has been tracked and reported via Informa Pharma Intelligence’s clinical, regulatory and commercial data and analytics, and news and insight tools including Biomedtracker, Trialtrove, Pharmaprojects, Scrip, Pink Sheet, Medtech Insight, and Generics Bulletin etc.
Topic Coronavirus
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Having seen its development partner Bioeq file with the FDA in December last year, Coherus is confident that it will be a leader in the US biosimilar ranibizumab market targeting Lucentis.
Topic biosimilars deal-trends
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.
Topic Biosimilars Launches Regulation
Generics Bulletin: ジェネリック＆バイオシミラーニュース
California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.
Generics Bulletin: ジェネリック＆バイオシミラーニュース
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
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Private equity group True North continues to back the Biocon group and is picking up a minority stake in Biocon Biologics in a deal that values the subsidiary at $3bn. Separately, another subsidiary, Biocon Biosphere, has also been set up as part of efforts to unlock the full potential of the business.
Topic deal-trends strategy
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Alberta has become the second Canadian province to announce a biosimilar switching program, following the example set by British Columbia earlier this year. The move has been welcomed by Biosimilars Canada but criticized by originator-backed body Crohn’s and Colitis Canada.
Topic biosimilars Regulation
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Pfizer has reported 80% growth in its global biosimilars business for the third quarter of 2020, on the back of recent oncology launches. Though the company’s sterile injectables saw a slight drop in business, Pfizer’s biopharma business saw 4% growth.
HBW Insight : コンシューマーヘルスケア産業のニュース, Generics Bulletin: ジェネリック...
Keep up with topics you care about in Pharma and Medtech with the new Alexa Skill from Informa Pharma Intelligence. Access daily news briefings to stay up to date with the latest news, right from your Alexa smartphone app!
Generics Bulletin: ジェネリック＆バイオシミラーニュース
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
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