- Fierce Pharma Politics—Pushback escalates after drug companies restrict 340B drug discounts (fiercepharma.com)
After AstraZeneca’s move to stop selling discounted drugs to safety net providers through contract pharmacies, patient advocates took the drugmaker to task...protestors blasted the company’s recent decision to restrict the sale of discounted meds through contract pharmacies under the federally mandated 340B Drug Pricing Program. The program requires companies to discount medicines to hospitals and clinics that serve disadvantaged communities...But AstraZeneca isn’t alone in cracking down on drugs sold under the 340B program. Eli Lilly, Sanofi, Novartis and Merck & Co. have also implemented new restrictions or initiatives...seven hospital and pharmacy groups asked U.S. Department of Health and Human Services...to enforce the 340B rules following new moves from the companies...READ MORE
- The Booming Biosimilar Market of 2020 (drugchannels.net)
The biosimilar market is finally beginning to fulfill its promise...The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products...manufacturers of reference products are cutting drug prices to defend their market shares...Twenty of the 28 FDA-approved biosimilars are provider-administered products covered primarily under a patient’s medical benefit. Many innovator drugs now compete with multiple biosimilar versions, including Herceptin and Remicade...READ MORE
- Eli Lilly faces FDA crackdown for manufacturing issues at plant handling COVID-19 antibody (fiercepharma.com)
Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody...The FDA cited Lilly's Branchburg, New Jersey, facility on two counts of inadequate "control of computer systems," Lilly confirmed in an email. Those two findings included deleted data on the company's manufacturing processes and failed quality control over audit paper trails...FDA investigators flagged the quality control deficiencies in a notice...The investigators' findings qualified as official action indicated (OAI) in the notice, the highest enforcement priority level from the FDA for its observations...READ MORE
- Celebrate the Pharmacy Profession (drugtopics.com)
October is American Pharmacists Month. This celebration—recognizing pharmacists’ contributions to health care and all they do for their communities—includes Women Pharmacist Day (October 12); Pharmacy Week (October 18-24), acknowledging the invaluable contributions of pharmacists and technicians to patient care; and Pharmacy Technician Day (October 20)...Pharmacists are busier than ever with flu season and the coronavirus disease 2019 (COVID-19) pandemic, making it particularly important this year to take the time to celebrate and acknowledge our pharmacy staff’s contributions...Let’s take a look at a few ways that pharmacists are celebrating the value of the profession this month...READ MORE
- Nursing homes to get free COVID-19 vaccines under Trump plan with CVS, Walgreens (usatoday.com)CVS, Walgreens make deal with Trump admin to quickly distribute COVID-19 vaccines to nursing homes (fiercehealthcare.com)
Americans living or working in long-term care facilities, including nursing homes and assisted care living centers, will receive COVID-19 vaccinations for free if and when they become available, the Trump administration said...The administration announced a partnership with the nation's two largest drug store chains, CVS and Walgreens, "to provide and administer" the vaccines with "no out-of-pocket costs" for the recipients...READ MORE
- Johnson & Johnson adds $1B to opioid lawsuits settlement pool, bringing total to $5B (fiercepharma.com)
Johnson & Johnson appears to be nearing a final deal that could settle more than 2,000 lawsuits brought by states and cities that claim the company contributed to the opioid crisis by overselling the benefits of its painkillers...The U.S. drugmaker will pour an additional $1 billion into a potential settlement that would resolve those opioid lawsuits, on top of the $4 billion the company set aside a year ago.,,READ MORE
- Mexico targets a group of Indian generics makers for homeland pharma hub (fiercepharma.com)
The human cost of the COVID-19 pandemic has been a strain on countries' ability to obtain medicines produced abroad...Mexico...aims to build its own drug supply chain on home soil...Six Indian generics makers have signed letters of intent with the state of Hidalgo, Mexico, to establish a pharma hub for manufacturing and logistics...The drugmakers targeted in the effort—Dr. Reddy's, Zydus Cadila, Glenmark, Torrent and Hetero—will have access to a $10.6 billion Mexican drug market, among the largest in the Latin American region..READ MORE
- FiercePharmaPolitics—Pfizer Vyndaqel copay lawsuit could bring drug pricing shockwaves (fiercepharma.com)
Pfizer’s fast-growing and costly heart meds Vyndaqel and Vyndamax have been the subject of drug pricing scrutiny since their launch in 2018. Now, they’re at the center of a Medicare copay lawsuit that could reverberate around the industry...meds list with prices of $225,000 per year, the company is suing the U.S. Department of Health and Human Services in an attempt to help with Medicare patients with their copays...kickbacks laws prohibit drugmakers from assisting with Medicare patient copays; companies can financially help patients on commercial insurance. The laws are designed to keep a check on drug prices, and one expert told Barron’s a ruling in Pfizer's favor “would be a major earthquake” for the industry...READ MORE
- Gilead signs remdesivir agreement with European Commission (outsourcing-pharma.com)
...Gilead will supply the EC with up to half a million treatment courses of Veklury to treat COVID-19 patients...The European Commission has signed a joint procurement contract from the EC’s Emergency Support Instrument, worth a total of EUR 70 million with pharma giant Gilead, with the opportunity to extend the supply beyond the initial 500,000-treatment level if necessary. Participating countries now can place orders to procure the drug directly with the company...READ MORE
- As Trump touts his ‘great’ COVID-19 drugs, the pharma cash flows to Biden, not him (fiercepharma.com)
Reversing a trend in which contributions from drugmakers’ political committees and their employees have gone largely to Republican candidates for president and Congress, so far for 2020 the industry has tilted toward Democrats...The shift may reflect industry expectations that Democratic presidential candidate Joe Biden will win...Pharma companies may see campaign largesse as leverage if Biden follows through on promises to address high drug prices...donors with ties to pharma manufacturers have given around $976,000 to Biden...“Traditionally the industry tends to favor Republicans,”...“But this cycle, we’re seeing that flipped,” partly reflecting Democrats’ overall greater success in fundraising...Pharmaceutical companies and their trade groups have a history of supporting Trump and other Republicans indirectly through hard-to-trace “dark money” nonprofits. ...READ MORE