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Novo Nordisk has acquired Embark Biotech, as the larger Danish drugmaker looks to expand its blockbuster obesity drug portfolio in the wake of surging economic demand and rising market shortages of both metabolic and diabetes therapies. Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
The FDA issued three final guidances on Wednesday, one on the use of real-world data (RWD) in noninterventional (observational) studies and two on the Drug Supply Chain Security Act (DSCSA). Read More
Upcoming events in the coming weeks include ten FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Read More
Pharmaceutical companies directly impacted by HHS’ Tuesday announcement of the initial 10 drugs slated for Medicare price negotiations via the Inflation Reduction Act (IRA) have swiftly reacted, with many of them already fighting the law’s provisions in court. Read More
The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Read More
The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization using ethylene oxide (EtO) by March 1, 2024, following the government’s signature on a consent decree that settles a complaint against the EPA filed by multiple groups in December 2022. Read More
Despite customers’ reporting symptoms that included stroke, memory loss, atrial fibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home cranial electrotherapy stimulator (CES) device, the company did not submit the required Medical Device Reporting within 30 days to let the FDA know that serious adverse events (SAE) had occurred. Read More
Pfizer announced Monday that it has reopened its Rocky Mount plant and that efforts to restart production are on track to restart production near the end of the year. Read More
HHS this morning released its list of the top 10 drugs for negotiation through the Inflation Reduction Act, a group that represents $50.5 billion in Medicare Part D prescription drug costs — 20 percent of total gross spent between June 1, 2022, and May 31. Read More
Amgen scored a win in its bid to acquire Horizon Therapeutics with the FTC withdrawing from adjudication of its challenge of the deal until Sept. 18, to allow for discussion of a possible settlement. Read More
The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than 160 comments the agency received. Read More