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Scientists have developed a technique that could significantly reduce the time of discovering potential new antibody-based drugs to treat disease...New research...has resulted in a technique that allows fragments of antibodies to be screened for susceptibility to aggregation caused by structure disruption much earlier in the drug discovery process...a significant problem has been the failure rate of candidates upon manufacturing at industrial scale. This often only emerges at a very late stage in the development process -- these drugs are failing at the last hurdle...READ MORE

How the target proteins are screened

Directed evolution

As global demand intensifies for an old malaria drug that some believe can combat Covid-19, a distributor that supplies the key active pharmaceutical ingredient to compound pharmacies in the U.S. has raised prices by huge amounts over the past week...Spectrum Chemical boosted the wholesale price for a 100-gram container of hydroxychloroquine sulfate by about 350%, to approximately $1,160, while a 1,000-gram container jumped 230% to $5,932. And the price for a 5,000 gram container roughly tripled to almost $30,000...Spectrum explained the sudden clamor for the drug has made it more difficult to obtain the active ingredient, sometimes causing its own suppliers to ship partially filled orders or cancel them outright...READ MORE

A federal judge increased to $1.2 billion the damages that Gilead Sciences Inc must pay to Bristol-Myers Squibb Co in a patent infringement case regarding technology for treating cancer...The judgment was entered against Gilead’s Kite Pharma unit on its “counterclaims of non-infringement and invalidity”, according to a ruling by U.S. District Judge Philip Gutierrez...The new total of $1.2 billion includes $778 million awarded by a federal jury in December plus enhanced damages of $389 million and a pre-judgment interest on the jury’s verdict in the amount of $32.8 million, the judge said in his ruling...The patent at issue in the lawsuit, which Juno (subsidiary of BMS) licenses from the Memorial Sloan Kettering Cancer Center...relates to CAR T-cell immunotherapy for cancer...READ MORE

The decades-old drug that President Donald Trump has persistently promoted as a potential weapon against COVID-19 has within a matter of weeks become a standard of care in areas of the United States hit hard by the pandemic — though doctors prescribing it have no idea whether it works...Doctors and pharmacists from more than half a dozen large healthcare systems in New York, Louisiana, Massachusetts, Ohio, Washington and California told Reuters they are routinely using hydroxychloroquine on patients hospitalized with COVID-19. At the same time, several said they have seen no evidence that the drug, used for years to treat malaria and autoimmune disorders, has any effect on the virus...READ MORE

U.S. eyes have turned abroad as the coronavirus crisis raises concerns about the safety of the global drug supply. In moves that could shore up confidence, the FDA has given a trio of overseas generics plants the all-clear to produce...Lupin Pharmaceuticals, Dr. Reddy's Laboratories and Biocon all received clean FDA reports at manufacturing facilities in India and Malaysia...With the novel coronavirus pandemic continuing its march, focus has turned to the stability of the supply chain, including for generic medicines...READ MORE

This week, the top managed care news includes a report on how CDC lacks data to tell the full story on disparities in the COVID-19 pandemic, Medicare Advantage gets a pay bump amid COVID-19 rule changes, and the nation’s top infectious disease expert speaks with the editor-in-chief of JAMA.

Mylan is one of a group of drugmakers that have joined the global effort to supply doses of generic hydroxychloroquine, an antimalarial touted as a possible COVID-19 therapy, to ongoing clinical trials. Now, after ramping up production, Mylan is ready to dole out its stockpile faster than expected...After announcing last month it would restart production of hydroxychloroquine to meet global demand, Mylan plans to donate millions of doses of the drug "ahead of schedule,"...Mylan will give away 10 million hydroxychloroquine tablets to the U.S. Department of Health and Human Services to supplement investigational trials for COVID-19 and bolster the FDA's emergency use program...READ MORE

As we’ve seen with COVID-19, the response speed of supply chains is critical in helping slow down and even prevent the total number of casualties in a global health emergency. The sooner solutions can be assembled — whether it is a hospital being built or getting PPE into the hands of medical teams — the sooner people can be treated and the less spread that occurs...A model simulation cited in Nature shows that, “…if China had implemented its control measures a week earlier, it could have prevented 67 percent of all cases in the country. Implementing the measures three weeks earlier...would have cut the number of infections to 5 percent of the total.” Similarly, Italian officials estimate that if they had acted 10 days sooner, they could have avoided tens of thousands of fatalities. Supply chains play an important role in implementing response measures and building out a local healthcare system’s capacity...READ MORE

Pfizer, AbbVie, Novartis and other pharma companies are pledging millions in COVID-19 relief funds to help healthcare workers, patients and communities...Pfizer announced $40 million in both cash and grants for medical and community needs in the U.S. and around the world. In the U.S., emergency relief funds will go to government public health organizations and nonprofit community health organizations, while grants will be awarded to community health clinics for immediate and long-term needs of healthcare workers involved the COVID-19 response. Pfizer, along with Eli Lilly and Merck, previously announced a program to allow employees with medical and lab expertise to volunteer with local healthcare systems...AbbVie pledged $35 million in a COVID-19 relief package—its largest disaster donation to date—and encouraged other companies follow suit...READ MORE

With pharmaceutical supply chains under immense pressure due to the novel coronavirus, China's role as a global ingredient producer has come under scrutiny. Despite fears the East Asian nation could shut off the tap for U.S. drugs, the FDA said it hasn't yet noticed major signs for concern...The FDA hasn't seen a shortage of active pharmaceutical ingredients (APIs) sourced from China due to the ongoing novel coronavirus outbreak but is "closely monitoring the situation," FDA Commissioner Stephen Hahn told Fox News...Hahn highlighted reported spot shortages of certain drugs due to increased demand but said China's API tap is still running, despite escalating rhetoric between the Chinese and U.S. governments. Hahn highlighted the Trump administration's push to develop "advanced" manufacturing stateside to help drive greater redundancy in the supply chain...READ MORE