Few drug patent infringement cases go to court in China, where a murky and lengthy process deters many from pursuing litigation. But a newly enacted Patent Law with patent linkage provisions is spurring a rise in infringement lawsuits, with one recent case involving a major Japanese pharma firm underscoring the remaining challenges.

In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.

Janssen went against EMA’s advice on the choice of secondary endpoints for its multiple sclerosis drug Ponvory (ponesimod), but still enjoyed a relatively brisk review. The hierarchical order of endpoints did not seem to ruffle any feathers among US FDA reviewers.

The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.

A growing role in dealing with medicines shortages, COVID-19-related pressures and the costs of relocating to new premises are among the factors behind the TGA’s proposal to raise the fees it charges pharma firms for its regulatory services.

Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.

New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

The ex-GSK supply head Ian McCubbin will join the independent UK organization aimed at advancing cell and gene therapies, but notes issues with scale and manufacturing ahead.

The 4 February entry deadline is looming for the inaugural Informa Pharma Intelligence Awards Japan, which will be held in Tokyo on 12 May 2022 to recognize and reward the very best innovations and achievements in pharma and biotech, highlighting Japan's integral role in the global healthcare market.

Daily notebook from the virtual J.P. Morgan Healthcare Conference: Updates from Galapagos, Ipsen, LG Chem and Hanmi; experts discuss deal and financial outlook at Biotech Showcase, plus the impact of RMAT and the changing landscape for rare diseases. 

Biogen’s Alzheimer’s drug may not cause as much of a financial headache to American seniors as expected, which could dampen criticism of Medicare’s upcoming coverage determination. But questions remain about what exactly HHS will be able to do about Part B premiums.

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.

Report says agencies took steps to use DPA more effectively, but HHS still working on a strategy for DPA use that will strengthen domestic supply chains and manufacturing.