- Trump administration signs up new company to make COVID-19 drugs in U.S. (reuters.com)Trump picks little-known U.S. firm to spearhead $354M pandemic drug pact (fiercepharma.com)How Civica helped under-the-radar Phlow nab a $354M COVID-19 manufacturing deal (fiercepharma.com)HHS-Industry Partnership to Expand US Stockpile of Essential Drug Ingredients During Pandemic (drugtopics.com)
U.S. President Donald Trump’s administration awarded a contract worth up to $812 million for a new U.S. company to manufacture drugs and drug ingredients to fight COVID-19 on American soil, aiming to end dependence on other countries...The administration has been looking to build up the ability to produce drugs and their raw materials in the United States after the global pandemic exposed the industry’s dependence on China and India for its supply chain...The U.S Department of Health and Human Services said it had awarded a four-year, $354 million contract to privately-held Phlow Corp to make COVID-19 drugs, other essential drugs and their ingredients. The contract - which is for generic drugs, not more complicated products like vaccines - can be extended to a total of $812 million over 10 years...READ MORE
- Buprenorphine Dispensing Barriers Among Community Pharmacies in Rural Kentucky (drugtopics.com)New Study Reveals Pharmacy-level Barriers to Treatment for Opioid Use Disorder in Appalachian Kentucky (uknow.uky.edu)
A recent study identified pharmacy-level barriers to treatment for opioid use disorder in rural areas, indicating a need for policy changes regarding buprenorphine access and monitoring...The case study, published in the International Journal of Drug Policy, looked at buprenorphine dispensing practices in 12 rural Kentucky counties across 15 community pharmacies. The investigators aimed to determine whether dispensing patterns were influenced by features of the rural risk environment...“Concerns about exceeding a ‘Drug Enforcement Administration cap’ on opioid dispensing stifled dispensing,” the investigators wrote. The other factors that influenced dispensing were distrust of pharmaceutical companies and prescribers of opioid analgesics and a general stigma against individual who use drugs and/or against the medications to treat substance use disorder...READ MORE
- Expanding The Tent: Improving Trial Participation Among Under-Represented Patient Populations (invivo.pharmaintelligence.informa.com)
The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later...New Research from the Tufts Center for the Study of Drug Development reveals the extent to which minority groups are absent from clinical trials supporting new drug and biologic approvals...Additional tools are emerging to help sponsors effectively recruit and enroll underrepresented patient populations in clinical trials...READ MORE
- Buy American Proposals Rile Manufacturers and Trading Partners (pharmtech.com)
Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs...Efforts to shift more production of pharmaceuticals and APIs to the United States as a strategy for reducing drug shortages and ensuring access to needed medicines...The recent $2-trillion COVID economic stimulus legislation...supports exploration of federal “Buy American” policies, ostensibly to reduce US dependence on drugs and medical products imported from overseas...READ MORE
- With drugmakers clamoring, FDA looks to restart facility inspections delayed by COVID-19 (fiercepharma.com)
The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate...The agency is working with the U.S. Centers for Disease Control and Prevention to develop a "phased approach" to restarting inspections of domestic and foreign drug manufacturing facilities, the administration said...the plan would likely continue the agency's focus on high-priority inspections taken on a "case-by-case" basis...READ MORE
- COVID-19 restrictions send generic drug shipping costs through the roof: survey (fiercepharma.com)
Global restrictions spawned by the coronavirus pandemic have sent transport costs skyrocketing for generics and biosimilar makers, a trade association finds. But despite the dire report, COVID-19 might not be all bad news for the industry...Average shipping costs have jumped by 224% as the pandemic added new kinks to the global drug supply chain, a survey from the Association for Accessible Medicines found..."The global pharmaceutical ecosystem is built on a highly complex supply chain,” AAM interim CEO Jeff Francer said in a release. “This ongoing crisis illustrates the importance of developing new strategies and policies that enhance the pharmaceutical supply chain in the U.S. and increase our nation’s self-sufficiency.”...READ MORE
- Las Vegas hospital blazes own path with malaria drug to treat COVID-19 (reviewjournal.com)
University Medical Center…began prescribing hydroxychloroquine to high-risk emergency room patients who test positive for COVID-19 but do not require immediate hospitalization…In doing so, UMC became the first Las Vegas-area hospital to dispense it on an outpatient basis, taking a cutting-edge position nationally in the use of the controversial experimental drug… Dr. Thomas Zyniewicz, an emergency medicine physician at UMC, said the drug, which is frequently used to treat malaria and autoimmune diseases, has shown promising results in thwarting the progression of COVID-19… Dr. Thomas Zyniewicz, an emergency medicine physician at UMC, said the drug, which is frequently used to treat malaria and autoimmune diseases, has shown promising results in thwarting the progression of COVID-19…READ MORE
- Gilead, working on its own remdesivir ramp-up, scouts licensing partners for global production (fiercepharma.com)
Gilead Sciences can only produce so much of its newly authorized COVID-19 drug remdesivir, so it’s scouting other companies to bolster global supply...Even as it presses ahead with its own remdesivir ramp-up, Gilead says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022...Remdesivir manufacturing relies on “scarce” raw materials that command their own “lengthy” production timelines, Gilead has said. Moving forward, coordination on producing the drug will be “critical,” the drugmaker says. Disruptions could reduce output or increase manufacturing time...READ MORE
- COVID-19 lockdown in India hub leaves pharmas scrambling to keep up supply (fiercepharma.com)India pharma manufacturing hub back up and running after COVID-19 lockdown: report (fiercepharma.com)
With a major Indian production hub now locked down in a COVID-19 containment zone, the spotlight on pharma's emerging markets suppliers will likely shine even hotter...Drug manufacturing facilities in Baddi, Himachal Pradesh, India—a key source of drug supplies—have shut down or reduced capacity since the region locked down in mid-April...Fifty facilities reportedly have shuttered, including at least one operated by top generics player Sun Pharmaceuticals...A slew of others are hobbled by the lockdown...The U.S. supply of generic and branded medicines, heavily reliant on emerging markets in India and China, has come under close scrutiny as COVID-19 sends shockwaves through the industry...the FDA said it would temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19...READ MORE
- India, hoping to challenge Chinese dominance, plans API production push: report (fiercepharma.com)
The novel coronavirus pandemic has caused a host of problems in the global pharmaceutical supply chain—particularly in China, a major producer of drug ingredients. Now, seeing an opportunity, India is reportedly working on a plan to supersize its own ingredient manufacturing to combat Chinese dominance in the market...The Indian government is planning to escalate domestic production of pharmaceutical ingredients to counteract a perceived over-reliance on Chinese imports now hampered by COVID-19 shutdowns...READ MORE