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Michigan AG Seeks to Investigate Lilly for ‘Grossly’ Excessive Insulin Prices

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Michigan’s Attorney General is pursuing court approval to begin an investigation into Eli Lilly over the high insulin prices the company charges. Source: Drug Industry Daily

Continue ReadingMichigan AG Seeks to Investigate Lilly for ‘Grossly’ Excessive Insulin Prices

COVID-19 Boosters Slash Risk of Omicron-Related Death in Older People

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Protection against Omicron-related death in people 50 and older reached as high as 95 percent after a booster dose of a messenger RNA (mRNA) vaccine, the UK Health Security Agency…

Continue ReadingCOVID-19 Boosters Slash Risk of Omicron-Related Death in Older People

Keytruda Unmasks Hiding HIV, Wins EU Approval for Kidney Cancer

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Merck’s Keytruda (pembrolizumab) has made a couple of headlines this week, drawing attention as a potential weapon against latent HIV infections, and winning approval in Europe as a kidney cancer…

Continue ReadingKeytruda Unmasks Hiding HIV, Wins EU Approval for Kidney Cancer

Responding to Real-World Data Guidance, Industry Calls for Flexibility and Further Clarity

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Prominent industry figures have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in trials, but they hope it will acknowledge issues inherent…

Continue ReadingResponding to Real-World Data Guidance, Industry Calls for Flexibility and Further Clarity

FDA Approves Immunocore’s Kimmtrak for Rare Eye Cancer

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Source: Drug Industry Daily

Continue ReadingFDA Approves Immunocore’s Kimmtrak for Rare Eye Cancer

Generic Drug for CHB Stayed Expensive Despite Competition, Says Analysis

  • Post author:PacConAdmin
  • Post published:January 27, 2022
  • Post category:Drug Industry Daily

Researchers from the University of Minnesota and 46brooklyn Research have shown in a new analysis that prices of entecavir, a generic drug that’s one of the first-line treatments used to…

Continue ReadingGeneric Drug for CHB Stayed Expensive Despite Competition, Says Analysis

Institutions Still Sluggish to Report Clinical Trial Results, Analysis Finds

  • Post author:PacConAdmin
  • Post published:January 26, 2022
  • Post category:Drug Industry Daily

A number of academic and medical institutions are still not reporting their trial results as required by federal law, a new analysis shows. Source: Drug Industry Daily

Continue ReadingInstitutions Still Sluggish to Report Clinical Trial Results, Analysis Finds

COVID-19 Woes Continue to Plague Generic Drug Approvals

  • Post author:PacConAdmin
  • Post published:January 26, 2022
  • Post category:Drug Industry Daily

Fiscal 2022 is already setting a dismal pace for generic drug approvals, which sunk to a record low last year under the full brunt of COVID-19 supply-chain and clinical trial…

Continue ReadingCOVID-19 Woes Continue to Plague Generic Drug Approvals

Sierra Oncology Records Success in Late-Stage Study of Blood Cancer Drug

  • Post author:PacConAdmin
  • Post published:January 26, 2022
  • Post category:Drug Industry Daily

Sierra Oncology has announced that its experimental blood cancer treatment has reached all primary and key secondary endpoints in a phase 3 study, including maintaining platelet counts. Source: Drug Industry…

Continue ReadingSierra Oncology Records Success in Late-Stage Study of Blood Cancer Drug

FDA Issues Final Guidance on Submitting ANDAs, Highlighting Recurring Deficiencies

  • Post author:PacConAdmin
  • Post published:January 26, 2022
  • Post category:Drug Industry Daily

The FDA, as part of its Drug Competition Action Plan, has released final guidance for companies preparing to submit abbreviated new drug applications (ANDAs) to the agency for generic products.…

Continue ReadingFDA Issues Final Guidance on Submitting ANDAs, Highlighting Recurring Deficiencies
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