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
19 October, 03:36
𝗔 𝗖𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗚𝘂𝗶𝗱𝗲 𝗣𝗗𝗙 𝗼𝗻 #Pharmacy_Benefit_Management
📚 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝘁𝗵𝗶𝘀 𝗣𝗗𝗙 𝗮𝘁: https://lnkd.in/d5SHDcFh
The pharmacy benefit management system is operated by third party administrators (#TPAs) who act as a liaison between pharmacists, insurance providers (payers), and drug manufacturers. There are established companies offering these services who aid in reducing drug prices by negotiating with retail pharmacies and drug manufacturers. #patients who have enrolled in various health plans and those uninsured can get the benefits of pharmacy benefit management system. #health plans collaborate with the pharmacy benefit managers to offer medications at a lower price than those available at retail pharmacies.
#pharmacybenefitmanagement #pbm #Healthcare #employees #ceo #employers #ascend #ascendpbm #insurance #savingsanalysis #benefitplan #cfo #plansponsor #unions #broker #chr #pharmacy #tpa #employeeengagement #pharmacybenefits
📚 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝘁𝗵𝗶𝘀 𝗣𝗗𝗙 𝗮𝘁: https://lnkd.in/d5SHDcFh
The pharmacy benefit management system is operated by third party administrators (#TPAs) who act as a liaison between pharmacists, insurance providers (payers), and drug manufacturers. There are established companies offering these services who aid in reducing drug prices by negotiating with retail pharmacies and drug manufacturers. #patients who have enrolled in various health plans and those uninsured can get the benefits of pharmacy benefit management system. #health plans collaborate with the pharmacy benefit managers to offer medications at a lower price than those available at retail pharmacies.
#pharmacybenefitmanagement #pbm #Healthcare #employees #ceo #employers #ascend #ascendpbm #insurance #savingsanalysis #benefitplan #cfo #plansponsor #unions #broker #chr #pharmacy #tpa #employeeengagement #pharmacybenefits
06 October, 03:19
Pain relief without opioids' ill effects? Researchers find new molecules
By Helen Floersh
-
The over-prescription of addictive opioid pain medications has led to untold suffering on account of widespread abuse. Still, the drugs are effective in patients with cancer or who are recovering from surgery, creating a need for a viable alternative or adjunct treatment to reduce reliance on opioids for pain relief.
Now, University of California, San Francisco (UCSF) scientists funded by a DARPA grant have identified a new set of non-opioid molecules that ease pain without sedation, according to a study published Sept. 30 in Science. Their hope is that the drugs can be used alongside opioids, lowering the dose needed for relief.
“If we can create a drug that works in combination with a much lower dose of opiate, that would be the dream,” Allan Basbaum, Ph.D., co-author and UCSF anatomy chair, said in a press release.
Read more at https://www.fiercebiotech....
From Ken Checicki on LinkedIn
By Helen Floersh
-
The over-prescription of addictive opioid pain medications has led to untold suffering on account of widespread abuse. Still, the drugs are effective in patients with cancer or who are recovering from surgery, creating a need for a viable alternative or adjunct treatment to reduce reliance on opioids for pain relief.
Now, University of California, San Francisco (UCSF) scientists funded by a DARPA grant have identified a new set of non-opioid molecules that ease pain without sedation, according to a study published Sept. 30 in Science. Their hope is that the drugs can be used alongside opioids, lowering the dose needed for relief.
“If we can create a drug that works in combination with a much lower dose of opiate, that would be the dream,” Allan Basbaum, Ph.D., co-author and UCSF anatomy chair, said in a press release.
Read more at https://www.fiercebiotech....
From Ken Checicki on LinkedIn
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
26 September, 04:58
Despite being a $4 trillion annual expense, #Healthcare delivery drives only 10-20 percent of health outcomes. #Behavioral and #social determinants of health — like having a job, eating right, not over-consuming alcohol, avoiding drugs, and hazardous behavior — play a much bigger role in overall #health and #longevity . #SDOH
26 September, 03:52
I am actively looking for new partners/distributors for the LatAm market of rapid tests (and other products)
Infectious diseases and Drugs of Abuse are my main target.
Visit our website www.lumiquick.com and contact me if you are interested.
tfrancolumiquick.com
Infectious diseases and Drugs of Abuse are my main target.
Visit our website www.lumiquick.com and contact me if you are interested.
tfrancolumiquick.com
23 September, 03:32
Based on application, the 3D bioprinting market is segmented into research applications and clinical applications. The research applications segment accounted for the larger share of the 3D bioprinting market in 2021. The market for research applications is further segmented into #drug research, regenerative medicine, and 3D cell culture. Among these, the drug research segment accounted for the largest share of the market in 2021, due to the growing adoption of 3D bioprinting technology by biopharmaceutical companies.
Get PDF Brochure: https://lnkd.in/dAPVWgSc
#3D #bioprinting #technolog
Get PDF Brochure: https://lnkd.in/dAPVWgSc
#3D #bioprinting #technolog
23 September, 02:54
Bonjour,
- FDA approves world’s costliest therapy, priced at US$ 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
