Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2022
Industry sponsorship bias in cost effectiveness analysis: registry based analysis
22 June 2022 - The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and ...
Posted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 21 Jun 2022
Paratek Pharmaceuticals’ Nuzyra receives FDA fast track designation for the treatment of pulmonary non-tuberculous mycobacterial disease caused by mycobacterium avium complex and mycobacterium abscessus
21 June 2022 - Phase 2b study in MAB pulmonary infections on-going and enrolling as planned. ...
Posted by Michael Wonder on 21 Jun 2022
EQRx announces acceptance of marketing authorisation application by the UK's Medicines and Healthcare Products Regulatory Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
14 June 2022 - Application is based on data from pivotal Phase 3 AENEAS trial in the first-line treatment of EGFR ...
Posted by Michael Wonder on 21 Jun 2022
Medicare could’ve saved $3.6 billion by buying drugs at same prices as Mark Cuban’s online pharmacy, according to a new study
22 June 2022 - Medicare’s drug program could have saved up to $3.6 billion in 2020 by mirroring the pricing ...
Posted by Michael Wonder on 21 Jun 2022
AbbVie submits supplemental new drug application to U.S. FDA for atogepant (Qulipta) to support label expansion for the preventive treatment of migraine
21 June 2022 - Submission is based on pivotal Phase 3 PROGRESS chronic migraine study evaluating atogepant (Qulipta) in adult patients ...
Posted by Michael Wonder on 21 Jun 2022
Acer Therapeutics and Relief Therapeutics announce update on U.S. FDA review of new drug application for ACER-001
21 June 2022 - Citing the need to inspect a third-party contract packaging manufacturer, the U.S. FDA has issued a complete ...
Posted by Michael Wonder on 21 Jun 2022
Tebentafusp for treating advanced (unresectable or metastatic) uveal melanoma
21 June 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using tebentafusp ...
Posted by Michael Wonder on 21 Jun 2022
European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...
Posted by Michael Wonder on 21 Jun 2022
Prescription medicines: applications under evaluation
21 June 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 20 Jun 2022
FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
Posted by Michael Wonder on 20 Jun 2022
EMA publishes agenda for 20-23 June 2022 CHMP meeting
20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Jun 2022
HIRA reviews reimbursing antidiabetic combo therapies
15 June 2022 - HIRA has been analysing how new reimbursements for anti-diabetic combination therapies mixing oral SGLT-2 and DPP-4 ...
Posted by Michael Wonder on 20 Jun 2022
Zeposia is included in the high-cost protection with limitation
17 June 2022 - Zeposia (ozanimod) is included in the high-cost protection with limited subsidy from 17 June 2022. ...
Posted by Michael Wonder on 20 Jun 2022
Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...
Posted by Michael Wonder on 20 Jun 2022
Givlaari is included in the high-cost protection with limitation
17 June 2022 - Givlaari (givosiran) is included in the high-cost protection with limited subsidy to reduce attacks in patients with ...