“Maybe this is not their final offer and maybe they’re not digging as deep as they perhaps could or should,” Michael Abrams, managing partner and co-founder of Numerof & Associates, said of the biopharma industry’s counteroffer to U.S. President Donald Trump on drug pricing. But the offer “is not inconsequential,” he told BioWorld, noting that it reportedly could deliver $100 billion in savings over 10 years. The proposal also offers the president the opportunity to say he delivered on his promise to lower prescription drug prices as he campaigns for re-election, whereas his threatened executive order granting Medicare and other federal programs “most favorable nation pricing” for prescription drugs would still be in the rulemaking process when voters head to the polls or their mailboxes in November.

The U.S. FDA has given the green light to a new type of treatment to help smokers quit, clearing the way for the first time the use of deep transcranial magnetic stimulation (Deep TMS) for short-term smoking cessation in adults.

The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.

Medical device cybersecurity seems to have taken a back seat to the COVID-19 pandemic, but a new internet connection protocol vulnerability has been identified that affects health care along with a wide range of other industries.

As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.

The U.S. Administrative Procedures Act (APA) has proven controversial for device makers in that the associated requirements for rulemaking have been the subject of regulatory end-runs, by some accounts. The Department of Justice (DOJ) said in an Aug. 11 statement, however, that it is time to update the APA because the it has ossified in the 74 years since passage, while an attached report estimated that government regulation adds as much as $2 trillion in compliance costs to the economy every year.

The COVID-19 pandemic has had an enormous impact on elective and nonessential procedures, and with them the medical device companies they depend on, but early signs of recovery are encouraging, according to Raghav Tangri, of (DRG), which is part of Clarivate. That said, Tangri told BioWorld that while the second quarter is expected to be the most strongly impacted period this year, the speed of recovery will depend on a number of factors, including the possibility of a second wave of the coronavirus outbreak and how soon a vaccine is available.

Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.

A Sino-U.S. collaborative study has demonstrated that acupuncture regulates inflammation by activating pro- or anti-inflammatory signaling pathways, while mitigating cytokine storms in mice with systemic inflammation, the study authors reported in the Aug. 12, 2020, edition of Neuron. The study also found that the acupuncture site, intensity and timing determined how it affected response, which has important implications for acupuncture use in inflammatory diseases and as adjunctive cancer therapy.