- The top 20 pharma companies by 2021 revenue (fiercepharma.com)
It was a good year to be a pharmaceutical company, especially one that came up with a product to combat COVID-19. Of the world’s top 20 pharmas ranked by 2021 revenues, 12 had at least 10% growth, including five that saw their sales boom at least 40%...No company pulled in more revenue from COVID products than Pfizer. Fueled by Comirnaty, Pfizer nearly doubled its top line.Johnson & Johnson needed a healthy 14% increase in revenue to stay comfortably in front of Pfizer and remain in the top spot, where it has resided since 2012. But that reign is in jeopardy this year, as Pfizer is projecting combined sales of $54 billion from Comirnaty and its oral COVID-19 treatment, Paxlovid...READ MORE
- CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots (biospace.com)J&J says delaying rollout of COVID-19 vaccine in Europe (reuters.com)U.S. FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (reuters.com)
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson...That is six cases out of more than 6.8 million doses that have been given in the U.S...The blood clots are cerebral venous sinus thrombosis, which were observed in combination with low levels of blood platelets. All cases were in women between 18 and 48 years of age. The symptoms occurred six to 13 days after vaccination...READ MORE
- FDA plan would ease regulations for prescription drug apps (biopharmadive.com)
The Food and Drug Administration is seeking public comment on a proposed framework for regulating software applications developed by drugmakers for use in conjunction with their prescription drug products...The new approach would treat most prescription drug apps, including dose calculators, symptom trackers and medication reminders, as promotional labeling...drugmakers would need only to submit to the agency copies of the content of what the apps display to consumers, following existing reporting requirements for promotional materials...In other cases, such as when a drugmaker wants to show that software has an effect on a clinical outcome and wants to include information about the software in the FDA-required drug labeling, prior FDA approval would be required...
- China drug scandals highlight risks to global supply chain (cnbc.com)
The drug safety scandals...have underlined the risks to international consumers posed by weak oversight in China, the world's largest supplier of active pharmaceutical ingredients...The European Medicines Agency and the US Food and Drug Administration issued alerts over a cancer-causing ingredient used in a blood pressure medication, supplied by Chinese company Zhejiang Huahai, resulting in a recall of affected drugs...Then Beijing announced that hundreds of thousands of substandard vaccine doses had been sold in China, prompting a public outcry. Senior executives were arrested at the pharma company, Changsheng Biotech, which was also accused by authorities of forging data during the production of rabies vaccines...China is home to thousands of API producers, with exports worth $29bn last year...its producers supply ingredients for generic drugmakers such as Teva Pharmaceutical and multinationals including Johnson & Johnson and Novartis. About 80 percent of APIs used in the US come from China and India…Warnings to Chinese companies published by the FDA and EMA in recent years show that dozens have violated standards, mainly relating to record-keeping during the manufacturing process. In several cases the exporters shipped large volumes of product before the infractions were discovered...
- House panel presses DOJ, Treasury to review drugmakers’ opioid settlement tax breaks (thehill.com)
The House Oversight and Reform Committee...on Monday pressed the departments of Justice and the Treasury to look into the tax deductions of four U.S. drug companies that agreed to a multibillion-dollar settlement last month to end opioid-related lawsuits...In a letter to Treasury Secretary Janet Yellen and U.S. Attorney General Merrick Garland, the panel said it had found four companies that agreed to the $26 billion settlement — Cardinal Health, McKesson Corporation, AmerisourceBergen, and Johnson & Johnson — are possibly trying to "put taxpayers on the hook for billions of dollars in settlement costs."..."We request that you determine whether these tax maneuvers comply with the law, and we urge you to do everything in your power to ensure transparency and accountability for the companies and executives that fueled our country’s deadly opioid crisis," wrote the committee...Read More</strong>
- How to trump the Trump administration? For J&J, it’s putting list prices in ads before it’s forced to (fiercepharma.com)
Johnson & Johnson will put list prices in its drug TV ads. It’s the first pharma to announce that plan, self-regulating ahead of a proposed Trump administration rule that would force all pharma companies to add list prices to TV commercials...J&J pharma arm Janssen will begin with its most prescribed drug, the oral anticoagulant Xarelto, adding both list price and potential out-of-pocket costs to its TV spots later this quarter. It will add prices to its other medicines, too, J&J said in a statement. It’s planning to weigh patient and consumer feedback on the Xarelto changes as it rolls out the follow-ups...J&J’s move combines the Health & Human Services list price mandate with the pricing principle plan that members of the trade association PhRMA agreed upon earlier this year. That plan would offer consumers a broader explanation of costs by linking ads to online or telephone explanations of expected out-of-pocket expenses and insurance coverage.
- Political donations from opioid-related pharma companies slow down in 2018 (thenevadaindependent.com)
Campaign contributions from pharmaceutical companies named in lawsuits filed by the state and several local governments have largely dried up this year...The pharmaceutical industry — long one of the biggest political players in the country, donating tens of millions of dollars to candidates and politicians at all levels of government — has contributed less to state-level candidates this election cycle despite contributing nearly $1 million to various candidates and PACs over the past decade...Seven of the 14 pharmaceutical companies implicated in a Clark County opioid lawsuit that had donated more than $934,000 to state level candidates or party committees have been easing off, and only two named companies — Johnson & Johnson and Purdue Pharma — continued to donate any money after those lawsuits were filed...
- Denmark removes J&J from vaccination program over clot fears (apnews.com)
Denmark...removed the single-dose Johnson & Johnson COVID-19 shot from its vaccination program to investigate reports of rare but potentially dangerous blood clots...Denmark, which has been very cautious with all vaccines, has already taken the AstraZeneca shot out of its vaccination program for the same reason. Both the J&J and AstraZeneca shots are made with similar technology...The Danish Health Authority said in a statement that it “has concluded that the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect.”...READ MORE
- Florida’s opioid lawsuit against CVS and Walgreens takes aim at distributors with deep pockets (cnbc.com)
Florida Attorney General Pam Bondi has added Walgreens and CVS Health as defendants in the state's massive lawsuit against the opioid industry...Legal analysts say Florida and other plaintiffs are targeting the distributors and pharmacies, in part, because they have deep pockets...The...lawsuit accuses the drug stores and pharmaceutical distributors like Cardinal Health, Amerisource Bergen and McKesson of playing as big a role in the proliferation of opioid addiction as drug manufacturers like...Purdue Pharmaceuticals and Johnson & Johnson's Janssen Pharmaceuticals...
- Pfizer joins DOJ probe into claims pharma bribes funded Iraqi terrorists (fiercepharma.com)Veterans' lawsuit claims Big Pharma bribes in Iraq helped finance terrorism (fiercepharma.com)Roche, Johnson & Johnson pulled into Justice Department probe of alleged terrorist bribes (fiercepharma.com)
Pfizer has joined three of its Big Pharma peers in a Department of Justice probe examining allegations that the companies paid bribes to a terrorist-run health ministry in Iraq...The Justice Department's inquiries stem from a lawsuit, filed last fall, in which veterans and their families accused Pfizer, AstraZeneca, Roche and Johnson & Johnson of paying bribes to win business from the Iraqi ministry of health at a time when the ministry was controlled by terrorists...The suit alleges the companies paid bribes to terrorists that "openly controlled the Iraqi ministry in charge of importing medical goods." The plaintiffs contend the drug companies "obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."