- 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
- Customizable synthetic antibiotic outmaneuvers resistant bacteria (sciencedaily.com)
Antibiotic resistance is one of the world's most urgent public health threats...Researchers at UC San Francisco are tackling antibiotic resistance using a different approach: redesigning existing antibiotic molecules to evade a bacterium's resistance mechanisms. By devising a set of molecular LEGO pieces that can be altered and joined together to form larger molecules, the researchers have created what they hope is the first of many "rebuilds" of drugs that had been shelved due to antibiotic resistance..."The aim is to revive classes of drugs that haven't been able to achieve their full potential, especially those already shown to be safe in humans,"..."If we can do that, it eliminates the need to continually come up with new classes of drugs that can outdo resistant bacteria. Redesigning existing drugs could be a vital tool in this effort."...READ MORE
- FiercePharmaPolitics—Trump unveils favored-nation drug pricing executive order, and pharma hits back (fiercepharma.com)Trump’s Drug Price Controls are a Lousy Deal for Patients (cei.org)
After touting a series of executive orders on drug pricing in late July, President Donald Trump has now unveiled the most significant among them—an order tying Medicare's drug prices to much lower costs in other developed countries. The biopharma industry pushed back hard, and it’s unclear exactly when or how the changes would be implemented...The executive order...says Medicare should not buy certain Part B or Part D drugs unless at prices paid by “at a minimum, the lowest price at which the manufacturer sells that drug to any other developed nation.” In Part D, the plan would apply “where insufficient competition exists” and where “seniors are faced with prices" higher than those in other developed nations...READ MORE
- Access to Rx Drugs is Priority (realclearhealth.com)
Access to medicines and cures should be the priority – the focus – for America right now, not unnecessary complications over trade with the Chinese...If one nation shuts down the production of a good, it impacts the supply for the whole world. With drugs, the U.S. gets many ingredients from China and if the Chinese shut off access to these materials, American patients will suffer...The Chinese are using the threat of withholding necessary drug ingredients if trade obstacles with the U.S. supervene...The Chinese are trying to link the Huawei telecom controversy to the drug issue...if the U.S hurts China by continuing current restrictions on Huawei’s access to American technology, they would answer with the withholding of Rx drugs...READ MORE
- AI Identifies Sex-Specific Adverse Events With High Precision (drugtopics.com)
Researchers have developed an algorithm that is able to accurately predict sex differences in drug response through the implementation of pharmacogenomic data...The study...presented AwareDX, a resource that uses machine learning to understand sex-specific adverse drug effects with the potential for use in drug discovery, repositioning, and pharmacogenetic studies, as well as for further analyses of electronic health records and clinical trials, according to investigators...Women are twice as likely as men to develop adverse drug reactions to a drug, partly due to differences in pharmacokinetics and pharmacodynamics that induce increased drug bioavailability and sensitivity to medication and women [remain] severely underrepresented in clinical trials...READ MORE
- FIP calls for focus on pharmacy remuneration (fip.org)
Pharmacist remuneration models in ever-evolving healthcare settings must be examined if global health is to be supported...“A common concern among pharmacy associations worldwide is the long-term financial viability of professional services delivered by pharmacists. These concerns are first and foremost triggered by the impacts of continued price and margin cuts in dispensing of medicines and the non-allocation of funding in many settings for extended professional services and social care,”...“A successful remuneration model is one that promotes sustainable delivery of professional services. These should be integrated into broader health system strategies and, therefore, funding plans...READ MORE
- AHA analysis touts community benefits made by 340B hospitals as spat with drugmakers continues (fiercehealthcare.com)In 2017 alone, 340B Tax-exempt Hospitals Provided More Than $64 Billion in Total Benefits to Their Communities (aha.org)
Safety net hospitals that participate in the 340B drug discount program generated $64.3 billion in total benefits to community programs and services tailored to help low-income patient populations, a new analysis finds...The analysis, published...from the American Hospital Association, comes as hospitals wage a war with drug companies that have begun restricting sales of discounted products to 340B contract pharmacies. AHA charges the 340B program enables safety net hospitals to help patients in vulnerable communities, but drug companies argue the program has gotten too large and hospitals are not helping patients with the savings...READ MORE
- Gilead Sciences takes back remdesivir distribution as demand drops (fiercepharma.com)
After a somewhat chaotic initial rollout by the U.S. government, Gilead Sciences is now taking distribution of COVID-19 drug remdesivir into its own hands...Starting Thursday, Gilead will directly sell remdesivir, branded as Veklury, to American hospitals, ending a five-month phase when the U.S. Department of Health and Human services was responsible for allocating it...AmerisourceBergen will remain the sole U.S. distributor through the end of the year...READ MORE
- Biosimilars May Lead to Improved Competition and Lower Costs (drugtopics.com)
Biosimilars, which offer the potential for more treatment options and less expensive alternatives, are having a good year in 2020 and may have a significant impact on the prescription product market in 2021. With the approval of more biosimilar medications, experts hope that greater competition may occur and help lower overall costs. “As intellectual property protections for biological products continue to expire in the US, we can expect many more applications for potential biosimilar and interchangeable products, and increased uptake of approved products too,”...Some of the key issues affecting biosimilar uptake involve reimbursement factors and insurance coverage...However...business and intellectual property concerns also have contributed to the delayed launch of some FDA-approved biosimilars. ...READ MORE
- FDA ticks off list of grievances over California drug repackager’s quality issues in warning letter (fiercepharma.com)
Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs?...California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week...FDA investigators found that Calvin Scott used suspect heat-sealed pouches to package its version of hydrochlorothiazide...Investigators also found Calvin Scott had inadequate cleaning procedures in place, which led to its drug products sharing multiple surfaces and potentially being cross-contaminated...READ MORE