- AllianceRx Walgreens Prime unveils new patented process for delivering specialty medicine (chaindrugreview.com)
A new patented process for delivering specialty medicine will assure AllianceRx Walgreens Prime patients receive their medicine delivered at the correct temperature...It is the only specialty pharmacy to offer a patented cold-chain shipment packaging process...Maintaining the right temperatures is critical to ensuring the efficacy of specialty medications, including costly biologics and injectables, which have special storage or temperature requirements...The new patented process also reduces waste and eliminates reship needs...AllianceRx Walgreens Prime anticipates a significant annual savings in reship costs...READ MORE
- The Gross-to-Net Bubble Hit $175 Billion in 2019: Why Patients Need Rebate Reform (drugchannels.net)
Last Friday’s Executive Orders revived the government’s effort to reform rebates in federal programs. Whether that effort succeeds, today's update reminds us what's still at stake in reforming rebates within the U.S. drug channel...For 2019, Drug Channels Institute estimates that the gross-to-net bubble—the dollar gap between sales at brand-name drugs' list prices and their sales at net prices after rebates and other reductions—reached $175 billion...The bubble reflects—and drives—many of patients’ problems and misunderstandings of U.S. drug prices...However, the political and practical challenges to rebate reform remain daunting. Few people grasp the complex economic interplay of patient out-of-pocket spending, cost-shifting, premiums, and payer incentives...READ MORE
- Reno doctor says hydroxychloroquine has helped dozens of his patients (kolotv.com)
Whether or not the anti-malarial drug hydroxychloroquine helpful in treating patients with COVID-19 has been a topic of debate for months now...“Recommendations of many of the people including doctors. many think it is extremely successful,” the President said...In Reno, one local doctor says the drug has helped several dozen of his patients...“Frankly, everyone that I have treated has gotten better”...Doctor Bruce Fong is Medical Director at Sierra Integrative Medical Center in south Reno. He says when paired with azithromycin and zinc, hydroxychloroquine has been effective...Many of the nation’s top medical experts do not agree, and Fong feels he knows why...“There was nobody bothering us about it and trying to put up regulations about it prior to President Trump saying something about it. It seems like his political enemies try to make him look bad.”...READ MORE
- Kodak Pharmaceuticals lands $765m US loan (outsourcing-pharma.com)
The Eastman Kodak Co. (traditionally associated with cameras, film, printers and other imaging technology) announced the launch of its new Kodak Pharmaceuticals arm, which will produce various pharmaceutical ingredients. The $765m funding is the first action occurring under the president’s executive order, which authors the International Development Finance Corp. (DFC) and Department of Defense (DoD) to collaborate on COVID-19 response...”Kodak is stepping up to help onshore pharmaceutical production and this DPA action will allow the modernized Strategic National Stockpile to have domestic resiliency. Once Kodak ramps up we will have the ability to tap into that capacity for domestic use."...READ MORE
- Following court ruling, NIH warns drug and device companies to post missing trial data (statnews.com)
Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week...New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to ClinicalTrials.gov, a public database, meaning a decade of data about approved drugs and medical devices has never been made public...The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data...READ MORE
- Next big COVID-19 treatment may be manufactured antibodies (reuters.com)
As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders - antibodies designed specifically to attack this new virus...Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease...READ MORE
- Seqirus begins shipping 2020/21 influenza vaccines to U.S. market (chaindrugreview.com)Vaccine sales driven down by pandemic's effects on doctor visits Vaccine sales driven down by pandemic's effects on doctor visits (biopharmadive.com)
Seqirus announced Thursday it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world’s largest influenza vaccine companies and is well-positioned to supply up to 60 million doses* for the U.S. market this year, depending on demand...“Influenza vaccination is critical every year, and it is more important than ever this season as it can help reduce the risk of co-infection from seasonal influenza and COVID-19 and minimize the burden of flu on the healthcare system to preserve capacity for patients with COVID-19 and other serious disorders,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “Our cell-based and adjuvant vaccine technologies are designed to address influenza prevention challenges...against seasonal influenza.”...READ MORE
- Gilead’s COVID med remdesivir is scarce and costly, AGs say, urging feds to sidestep its patents (fiercepharma.com)
Unhappy with the price and availability of Gilead’s remdesivir—the only drug with FDA clearance to treat COVID-19—dozens of state attorney generals have called for the federal government to exercise march-in rights to allow for broader production of the medicine...In a letter to the heads of the FDA, HHS and NIH, 34 attorneys general wrote that Gilead has been unable to ensure “sufficient” supply and has priced the medicine out of reach for many patients who need it. Gilead is charging $3,120 per treatment course for patients with commercial insurance, Medicare or Medicaid, and $2,340 for patients on certain smaller federal programs...READ MORE
- Special Report: COVID opens new doors for China’s gene giant (reuters.com)
As countries scramble to test for the novel coronavirus, a Chinese company has become a go-to name around the world...BGI Group, described in one 2015 study as “Goliath” in the fast-growing field of genomics research, is using an opening created by the pandemic to expand its footprint globally. In the past six months, it says it has sold 35 million rapid COVID-19 testing kits to 180 countries and built 58 labs in 18 countries. Some of the equipment has been donated by BGI’s philanthropic arm, promoted by China’s embassies in an extension of China’s virus diplomacy...But as well as test kits, the company is distributing gene-sequencing technology that U.S. security officials say could threaten national security. This is a sensitive area globally. Sequencers are used to analyse genetic material, and can unlock powerful personal information...READ MORE
- A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast (statnews.com)The coronavirus vaccine frontrunners are advancing quickly. Here's where they stand (biopharmadive.com)
Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19...The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits...Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far...READ MORE
A familiar family
An acute, not chronic infection
Cutting-edge approaches
Money, money, money
Regulatory nimbleness
The challenges ahead