The Federal Trade Commission filed a complaint in federal court against Vyera Pharmaceuticals, the company formerly known as Turing Pharmaceuticals that Martin Shkreli founded, alleging an “elaborate anticompetitive scheme to preserve a monopoly” on Daraprim.
Changes in U.S. Food and Drug Administration procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests.
Eli Lilly and Co. plans to sell two versions of insulin products at half their current U.S. list prices, eight months after the drug manufacturer started selling a half-priced version of the widely used Humalog injection.
Novo Nordisk will offer free, one-time supply of insulin to people in immediate need and at risk of rationing the medication.
Novartis won FDA approval for a long-delayed version of Amgen’s $4 billion seller Neulasta drug, helping the Swiss drugmaker in an uphill battle to sell copies of rivals’ blockbusters in the U.S.
The Canadian government announced final regulations to reduce patented drug prices expected to save Canadians C$13.2 billion over a decade, overriding heavy pharma company opposition.
Mallinckrodt Plc tentatively agreed to pay $15.4 million to resolve a U.S. Justice Department probe into how a drugmaker that the company now owns marketed an expensive treatment for a rare infant seizure disorder and multiple sclerosis.
Expectations were high during 2018 for three new migraine drugs hitting the market from Amgen Inc., Eli Lilly and Co. and Teva Pharmaceutical Industries Ltd. Priced around $7,000 each, the drugmakers called them “breakthrough” treatments designed to prevent migraines when taken year-round, and estimated that millions of patients could benefit. But a small group of medical experts who quietly advise U.S. health insurers on new drugs was not impressed, according to a private meeting held at UnitedHealth Group’s OptumRx offices in Chicago that was attended by Reuters.
FDA Commissioner Scott Gottlieb plans to step down in April 2019, a sudden resignation that calls into question how the regulatory agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs.
Barring a last-minute reversal, 2018 will likely end as a down year for the biotech industry, at least in terms of stock performance.