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EMA Panel Calls for Safety Updates for J&J’s, Moderna’s COVID-19 Vaccines

  • Post author:PacConAdmin
  • Post published:March 20, 2022
  • Post category:Drug Industry Daily

The European Medicines Agency’s (EMA) safety committee has recommended revised product safety information for Johnson & Johnson’s (J&J) and Moderna’s COVID-19 vaccines. Source: Drug Industry Daily

Continue ReadingEMA Panel Calls for Safety Updates for J&J’s, Moderna’s COVID-19 Vaccines

AstraZeneca Reaches $775 Million Settlement Resolving Ultomiris Patent Dispute

  • Post author:PacConAdmin
  • Post published:March 17, 2022
  • Post category:Drug Industry Daily

AstraZeneca (AZ) has agreed to pay Chugai Pharmaceutical $775 million to resolve allegations that AZ’s rare disease immunotherapy, Ultomiris (ravulizumab), infringed on the Tokyo-based company’s patents. Source: Drug Industry Daily

Continue ReadingAstraZeneca Reaches $775 Million Settlement Resolving Ultomiris Patent Dispute

Gilead Becomes 15th Major Drugmaker to Limit Its Participation in the 340B Drug Discount Program

  • Post author:PacConAdmin
  • Post published:March 17, 2022
  • Post category:Drug Industry Daily

Gilead Sciences has become the 15th major drugmaker to limit its involvement with the 30-year-old 340B Drug Discount Program that was designed to serve low-income patient populations in the U.S.…

Continue ReadingGilead Becomes 15th Major Drugmaker to Limit Its Participation in the 340B Drug Discount Program

New Alzheimer’s Prevention Trial Combines Anti-Tau and Antiamyloid Antibodies

  • Post author:PacConAdmin
  • Post published:March 17, 2022
  • Post category:Drug Industry Daily

Esai’s investigational anti-tau antibody E2841 grabbed some air time yesterday in Barcelona, Spain, with the first detailed look at a phase 2/3 study in people who are genetically predestined to…

Continue ReadingNew Alzheimer’s Prevention Trial Combines Anti-Tau and Antiamyloid Antibodies

Alnylam Pharmaceuticals Sues Pfizer and Moderna Over LNP Technology, Moderna Pushes Back

  • Post author:PacConAdmin
  • Post published:March 17, 2022
  • Post category:Drug Industry Daily

Alnylam Pharmaceuticals is suing both Pfizer and Moderna in separate suits, alleging that both companies’ COVID-19 vaccines infringe on one of Alnylam patents for technology that allows RNA-based therapeutics or…

Continue ReadingAlnylam Pharmaceuticals Sues Pfizer and Moderna Over LNP Technology, Moderna Pushes Back

New Jersey Compounding Pharmacy Cited for Lax Quality, Sterility

  • Post author:PacConAdmin
  • Post published:March 17, 2022
  • Post category:Drug Industry Daily

Drug compounding pharmacy Ideal Specialty Apothecary of Parsippany, N.J., has received a Form 483 detailing quality deficiencies observed during an FDA inspection from Sept. 13 through Nov. 18, 2021. Source:…

Continue ReadingNew Jersey Compounding Pharmacy Cited for Lax Quality, Sterility

Senate Finance Committee Examines High Prescription Drug Prices as Lawmakers Respond to PhRMA

  • Post author:PacConAdmin
  • Post published:March 16, 2022
  • Post category:Drug Industry Daily

Senators lambasted the pharmaceutical industry yesterday in a hearing by the Senate Finance Committee on the high price of drugs in the U.S. Source: Drug Industry Daily

Continue ReadingSenate Finance Committee Examines High Prescription Drug Prices as Lawmakers Respond to PhRMA

FDA Issues Warning Letter for Website Making Unapproved Hydroxychloroquine Claims

  • Post author:PacConAdmin
  • Post published:March 16, 2022
  • Post category:Drug Industry Daily

The FDA has sent a warning letter to Ivermectin24h.com, a website the agency said is marketing hydroxychloroquine as a COVID-19 treatment. Source: Drug Industry Daily

Continue ReadingFDA Issues Warning Letter for Website Making Unapproved Hydroxychloroquine Claims

FDA Approves First Generic of AstraZeneca’s Symbicort

  • Post author:PacConAdmin
  • Post published:March 16, 2022
  • Post category:Drug Industry Daily

The FDA has approved the first generic version of AstraZeneca’s Symbicort, a blockbuster drug-device combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Source: Drug Industry…

Continue ReadingFDA Approves First Generic of AstraZeneca’s Symbicort

FDA Expediting Pfizer’s/BioNTech’s EUA Request for a Second COVID-19 Booster

  • Post author:PacConAdmin
  • Post published:March 16, 2022
  • Post category:Drug Industry Daily

The FDA is asking its vaccines advisory committee to meet next month to make a recommendation on Pfizer’s and BioNTech’s March 15 request to amend its Emergency Use Authorization (EUA)…

Continue ReadingFDA Expediting Pfizer’s/BioNTech’s EUA Request for a Second COVID-19 Booster
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