CDER’s 2021 Novel Drugs Report Shows Rising Trend of Approvals
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2021 — slightly fewer than 53 approved in 2020. Source: Drug Industry Daily
Omicron Causes Delay of FDA Inspections, as Well as Planning of In-Person Foreign Inspections
The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in…
No Negotiations Happening for Build Back Better, Says Manchin
Sen. Joe Manchin (D-W.Va.) reiterated his opposition yesterday to President Biden’s nearly $2 trillion social spending package, saying there are currently no negotiations underway — further sinking the Build Back…
NICE Says No to AstraZeneca’s Lynparza for Prostate Cancer
An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for…
Nasal-Spray Maker Amcyte Pharma Hit With Warning Letter Over COVID-19 Claims
The FDA has issued nasal-spray maker Amcyte Pharma of Kirkland, Wash., a warning letter for marketing an unapproved and misbranded product related to COVID-19. Source: Drug Industry Daily
CMS Issues Final Rule Tossing ‘Most Favored Nation’ Drug Pricing Strategy
The Centers for Medicare and Medicaid Services (CMS) has formally rescinded a Trump-era policy seeking to tie what Medicare pays for certain outpatient drugs to the lowest price paid by…
Applied Therapeutics Holds Off AT-007 Regulatory Push
Applied Therapeutics got some coal in its stocking last week, when the FDA said the company needs clinical outcomes data, not just biomarker numbers, to support a New Drug Application…
Senate Committee to Hold Vote Next Week on Nominee for FDA Commissioner
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a…
More Than 450 Brand Name Drugs Have Already Seen Price Hikes in 2022, Though Most are Modest
Already, pharmaceutical companies have increased prices for 456 brand name drugs for 2022, with the median increase coming in at a relatively modest 4.9 percent. Source: Drug Industry Daily
Appeals Court Upholds Ruling on Novartis’ Gilenya Patent
A federal court has upheld the validity of Novartis’ patent covering a dosing regimen for its blockbuster multiple sclerosis therapy, Gilenya (fingolimod), rejecting a challenge from Chinese drugmaker HEC Pharma.…