20 October, 03:19
#Phispers Week 41 - Weekly Pharma News Recap
Bonjour,
- FDA publishes GDUFA III user fees, increases ANDA, DMF fees.
- Merck’s cardiovascular disease drug succeeds in late-stage trial, validates US$ 11.5 bn Acceleron buyout.
- FDA grants fast-track status to Lilly’s diabetes drug Mounjaro to treat obesity.
- Bayer’s Vividion signs potential US$ 930 million oncology deal with Tavros.
- GSK’s Boostrix vaccine gets add-on approval to prevent whooping cough in infants.
- Sanofi, Regeneron flaunt Dupixent’s benefit in eosinophilic esophagitis trial in kids.
- Two-year data on Roche’s Evrysdi shows benefit in spinal muscular atrophy.
- US ADHD drug crisis deepens as Novartis’ Sandoz also reports shortage of Adderall.
- EDQM finds one major deficiency at Biocon’s API facility in Bengaluru.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry
https://lnkd.in/dE5X4qag
Bonjour,
- FDA publishes GDUFA III user fees, increases ANDA, DMF fees.
- Merck’s cardiovascular disease drug succeeds in late-stage trial, validates US$ 11.5 bn Acceleron buyout.
- FDA grants fast-track status to Lilly’s diabetes drug Mounjaro to treat obesity.
- Bayer’s Vividion signs potential US$ 930 million oncology deal with Tavros.
- GSK’s Boostrix vaccine gets add-on approval to prevent whooping cough in infants.
- Sanofi, Regeneron flaunt Dupixent’s benefit in eosinophilic esophagitis trial in kids.
- Two-year data on Roche’s Evrysdi shows benefit in spinal muscular atrophy.
- US ADHD drug crisis deepens as Novartis’ Sandoz also reports shortage of Adderall.
- EDQM finds one major deficiency at Biocon’s API facility in Bengaluru.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuticals #pharmanews #pharmaceuticalindustry
https://lnkd.in/dE5X4qag
FDA steps up user fee under GDUFA III; Merck’s heart drug succeeds in late-stage study | Radio Compass Phisper
On September 30, the US President Joe Biden had signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027. In this week’s Phispers, we bring you the new GDUFA III fe...
https://lnkd.in/dE5X4qag
26 September, 05:01
#Phispers Week 38 - Weekly Pharma News Recap
Bonjour,
- FDA approves world’s costliest therapy, priced at US$ 3 million, from Bluebird bio.
- Mallinckrodt receives FDA approval to treat life-threatening liver condition.
- Novartis to move Supreme Court to secure validity of Gilenya patent.
- FDA issues Form 483 with 12 observations to Catalent’s Indiana site.
- BMS, AbbVie to lay off up to 360 employees in California.
- BMS’ Opdivo shows promise as adjuvant treatment for melanoma.
- EMA recommends AstraZeneca-Sanofi’s RSV drug for infants.
#Phispers in a minute - PharmaCompass.c
Bonjour,
- FDA approves world’s costliest therapy, priced at US$ 3 million, from Bluebird bio.
- Mallinckrodt receives FDA approval to treat life-threatening liver condition.
- Novartis to move Supreme Court to secure validity of Gilenya patent.
- FDA issues Form 483 with 12 observations to Catalent’s Indiana site.
- BMS, AbbVie to lay off up to 360 employees in California.
- BMS’ Opdivo shows promise as adjuvant treatment for melanoma.
- EMA recommends AstraZeneca-Sanofi’s RSV drug for infants.
#Phispers in a minute - PharmaCompass.c
23 September, 02:54
Bonjour,
- FDA approves world’s costliest therapy, priced at US$ 3 million, from Bluebird bio.
- Mallinckrodt receives FDA approval to treat life-threatening liver condition.
- Novartis to move Supreme Court to secure validity of Gilenya patent.
- FDA issues Form 483 with 12 observations to Catalent’s Indiana site.
- BMS, AbbVie to lay off up to 360 employees in California.
- BMS’ Opdivo shows promise as adjuvant treatment for melanoma.
- EMA recommends AstraZeneca-Sanofi’s RSV drug for infants.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuti
- FDA approves world’s costliest therapy, priced at US$ 3 million, from Bluebird bio.
- Mallinckrodt receives FDA approval to treat life-threatening liver condition.
- Novartis to move Supreme Court to secure validity of Gilenya patent.
- FDA issues Form 483 with 12 observations to Catalent’s Indiana site.
- BMS, AbbVie to lay off up to 360 employees in California.
- BMS’ Opdivo shows promise as adjuvant treatment for melanoma.
- EMA recommends AstraZeneca-Sanofi’s RSV drug for infants.
#Phispers This Week - PharmaCompass.com's Weekly News Recap
#Healthcare #pharmaceuti
Bluebird ousts its own gene therapy approved last month as world’s costliest; Catalent hit by FDA’s Form 483 | Radio Compass Phisper
Exactly a month after Bluebird bio’s gene therapy Zynteglo became the most expensive treatment at US$ 2.8 million, a second therapy from the drugmaker has clinched that title. The drug – Skysona or eli-cel – approved by the US Food and Drug Administration (FDA) to treat a rare n...
https://lnkd.in/dkGiTYgm
