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Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval...Johnson & Johnson chief scientific officer Paul Stoffels said the company has seen “strong” preclinical data, and it's now ready to kick off human testing...A phase 1/2a study in more than 1,000 adults ages 18 to 55 will start by enrolling in Belgium next week and open to U.S. participants the week after...READ MORE

USP has announced the release of six new Reference Standards to support manufacturers and regulators in analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain...in 2018, nitrosamine impurities were found to be present in some angiotensin II receptor blockers used to treat high blood pressure and heart failure...exposure to this class of chemical compounds, nitrosamines have the potential to cause cancer. Nitrosamine impurities have since been found in ranitidine and metformin, leading to major recalls and efforts by regulators and industry worldwide to reduce or eliminate the presence of these impurities in the drug supply...READ MORE

Nearly one in five diabetes drugs and one in 20 asthma drugs experienced a significant price increase in the past year or two, with average one-year increases about 11.2 percent and 19.3 percent, respectively, according to the third annual drug pricing report released by the Nevada Department of Health and Human Services last week...The state identified 117 essential diabetes drugs and 13 essential asthma medications that had a significant price increase over the previous one or two years, meaning that their costs increased by more than the rate of medical inflation. Manufacturers attributed the price increases to a number of factors, including changes in marketplace dynamics, research and development and manufacturing cost...the findings of the report continued to be consistent with the results of the first two diabetes drug pricing reports...Here are some of the key findings of the report:...READ MORE

Accused of favoring profits over patients’ lives, French pharmaceutical company Servier Laboratories is facing millions of euros in potential fines and damages after a huge trial involving 6,500 plaintiffs who say the company allowed a diabetes drug to be widely and irresponsibly prescribed as a diet pill — with deadly consequences...The popular drug, called Mediator, became one of France’s biggest modern health scandals, and the trial is wrapping up Monday after more than six months of proceedings targeting both Servier and France’s medicines watchdog. Servier says it didn’t know about the drug’s risks...Servier is accused of manslaughter, involuntary injury, fraud, influence trading and other charges. Investigating magistrates concluded that Servier for decades covered up Mediator’s effects on patients. The national medicines agency is suspected of colluding in masking its dangers...READ MORE

In the global race to make a coronavirus vaccine, a state-owned Chinese company is boasting that its employees, including top executives, received experimental shots even before the government approved testing in people...“Giving a helping hand in forging the sword of victory,” reads an online post from SinoPharm with pictures of company leaders it says helped “pre-test” its vaccine...Whether it’s viewed as heroic sacrifice or a violation of international ethical norms, the claim underscores the enormous stakes as China competes with U.S. and British companies to be the first with a vaccine to help end the pandemic — a feat that would be both a scientific and political triumph...READ MORE

To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said...That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines...But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research...READ MORE

South Korea has asked Gilead Sciences Inc’s to supply enough of its anti-viral drug remdesivir to treat more than 5,000 COVID-19 patients in preparation for a potential second wave of infections...remdesivir is in high demand, but there are concerns about its availability after Gilead allocated nearly all of its supply to the United States over the next three months..In a letter sent to Gilead on June 3, South Korea had requested doses for 360 patients who are in urgent need of the drug, and for enough to have ready for an additional 5,000 patients in the event of a second wave of infections...READ MORE

DYNALABS, in St. Louis, Missouri, announced the new policy after Reuters published an investigation...that named some of the companies involved in a secret supply chain to make and test a drug ahead of the first federal executions in 17 years...DYNALABS, told Reuters they did not know the samples of the drug, pentobarbital, belonged to the Justice Department, nor that it was intended for executions...“It will be our policy going forward to require a statement from our client indicating their preparation will not be used for execution,” Michael Pruett and Russell Odegard, DYNALABS’ co-founders, said in a statement published on Friday on their website. “Clients that decline to make that declaration will not be allowed to submit their pentobarbital preparations to DYNALABS for testing.”...READ MORE

A U.S. judge, skeptical of how Bayer plans to resolve future Roundup claims, says he's "tentatively inclined" to reject that part of the $10 billion-plus settlement...Looks like Bayer’s Roundup litigation headache may not be over after all, even after the company committed nearly $11 billion to a settlement...U.S. District Judge Vince Chhabria...said in a court filing...that he’s ready to reject part of the deal centered on potential future claims that the popular Monsanto weedkiller causes cancer...“[T]he Court is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion,” Chhabria wrote...READ MORE

The FDA called for five drugmakers to voluntarily withdraw their metformin products in May...Diabetes med metformin has been in the FDA's crosshairs since the agency found high levels of a probable carcinogen, NDMA...an Indian drugmaker will expand its own metformin recall after confirming the FDA's testing...Lupin Pharmaceuticals has pulled all lots of metformin after discovering unacceptably high levels of a probable carcinogen, N-Nitrosodimethylamine (NDMA), in tested samples...READ MORE