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US FDA Serves One Antacid/Analgesic Question For AdComm, Opens Tap On Hangover Discussion

Presentations at the US nonprescription drugs/drug safety joint advisory committee meeting will come from Bayer, marketer of the OTC brand synonymous with antacid/aspirin formulations, Alka-Seltzer, and from a firm that markets Blowfish, a caffeine/aspirin OTC indicated as a hangover remedy.

FDA is posing a single voting question for the upcoming advisory panel on the safety of OTC antacid/analgesic combinations for pain and acid indigestion from overindulgence with food or alcohol, but also is looking for a broader discussion on whether hangover is an appropriate OTC monograph indication.

In a joint meeting on April 4, the Nonprescription Drug and the Drug Safety and Risk Management advisory committees will consider whether antacid/analgesic combination products are safe given a risk of serious internal bleeding potentially linked to aspirin used as the analgesic in many of the products

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.