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Malcolm Spicer

Malcolm Spicer, Managing Editor – US

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.

Latest From Malcolm Spicer

Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies

Firms also notes in its announcement that FDA typically requires actual use trials for switch NDAs in addition to label comprehension studies, which it has conducted, and self-selection studies.

Prescription To OTC Switch OTC Drugs

US FTC Diagnoses Omicron Symptom: More Fraudulent COVID-19 Treatment Claims

Agency says emergence of Omicron variant spurred marketers of products and services from peptide therapy to herbal remedies, and from nasal irrigation to intravenous drips to make false COVID-19 claims. 

Warning Letters Coronavirus COVID-19

Ordering Starts For Free OTC COVID-19 Tests; USPS Deliveries Expected Within Two Weeks

US consumers can order up to four rapid antigen tests per household through USPS website, or a phone hotline coming soon. Biden administration, which is working to buy another 500m tests soon, notes more OTC tests are becoming available through an accelerated pathway to support FDA reviews of for emergency use authorizations of tests with potential for large-scale manufacturing.

Record Number Of Mergers Forces US Regulatory Agencies’ Hand On Updating Enforcement Guides

Chairwoman Lina Khan says concerns about impact on consumer product markets from mergers prompted FTC, working with DoJ, to seek public input on modernizing federal merger guidelines to better detect and prevent illegal, anticompetitive deals in current markets.

Enforcement Guidance Documents

Unilever Plan To Grow Consumer Health By Acquisition, Meet US Tightening Of Merger Scrutiny

Unilever, which has had three offers for GSK rebuffed, likely notes that the Federal Trade Commission and Department of Justice signal they will tighten scrutiny of deals that merge companies providing consumer-facing products and services.

OTC Drugs Dietary Supplements

Perrigo Steers Through Transportation Obstacles, Soaring Shipping Costs From COVID-19

Perrigo largely has resolved distribution problems, but shipping freight costs still are much higher than pre-pandemic and it must divest a wound-care brand before US regulators sign off on acquisition of HRA Pharma, says CEO Murray Kessler during J.P. Morgan conference.

Coronavirus COVID-19 M & A
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