Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 'Put up or shut up': Biden, Dems have one last chance to resurrect drug pricing reforms ahead of elections ( Endpoints ) Medicare could have saved billions on drugs if it paid what Mark Cuban charges at his new pharmacy ( STAT ) ( Endpoints ) Merck touts new data for breakthrough pneumococcal vaccine as it heads to PhIII trials ( Endpoints ) U.S. Supreme Court...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...

As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...

The US Food and Drug Administration (FDA) on Tuesday approved the 22 nd and 23 rd biosimilars: Pfizer’s Ruxience (rituximab-pvvr), which is the second biosimilar to Roche’s Rituxan (rituximab), and Samsung Bioepis’s Hadlima (adalimumab-bwwd), which could end up being the ninth biosimilar to AbbVie’s Humira (adalimumab). Ruxience is approved as a treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combin...

Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds of pages of written responses to more specific questions. The lackluster biosimilar market in the US is addressed in nearly all their comments, with some executives explaining in detail as to why their biosimilars have yet to gain market share, while undertones of biosimilar fear-mongering linger in others’ comments. Merck CEO Kenneth Frazier expla...

With the acting solicitor general set to participate in oral arguments before the Supreme Court on 7 January, the high court will be deciding a contentious case centered on who has the final say in warning labels on pharmaceuticals. The case, known as Merck v. Albrecht , presents the question of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempting to change the warning label and having FDA reject its...

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...

In its third quarter earnings report, US pharmaceutical company Merck said that manufacturing disruptions tied to a cyberattack last June led to $135 million in lost sales and caused the company to borrow from a US Centers for Disease Control's (CDC) strategic stockpile to meet demand for one of its vaccines. On 27 June, a cyberattack involving ransomware known as "Petya" or "NotPetya" infected government and business computer systems in Ukraine before spreading to other...

Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector. Background On 27 June, a cyberattack involving ransomware known as "Petya" or "NotPetya" infected government and business computer systems in Ukraine before spreading to other corporate networks around the world. M...

The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. The immunotherapy Keytruda is approved by FDA for the treatment of melanoma, lung cancer and other cancers but it is not approved to treat multiple myeloma. On 3 July, FDA required that all patients in these two trials b...

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels...

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker. FDA noted in a statement : "This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated." Keytruda, an anti-PD-1 therapy that has been approved to treat a variety of cancers dating back to 2014 ...