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Johnson & Johnson

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Latest From Johnson & Johnson

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

OTC Drugs FDA

Biopharma Quarterly Dealmaking Statistics, Q2 2019

Biopharma companies raised $12.4bn in Q2, largely from follow-on public offerings. In the latest mega-merger of the year, AbbVie spent $63bn on Allergan and its established portfolio. Many of the higher-valued alliances focused on the area of protein degradation.

Market Intelligence Deals

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

OTC Drugs FDA

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

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