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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

Prescription medicines: applications under evaluation

21 June 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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 ...

Read more →