Senate finance chair to HHS: Wait on Biogen’s Aduhelm NCD prior to enforcing historically steep Medicare premium hikes

Sen. Ron Wyden (D-OR) (Graeme Sloan/Sipa via AP Images)

It’s no longer a secret that the US government is going to have to pay for Biogen’s new and expensive Alzheimer’s drug Aduhelm on the backs of huge increases in Medicare premiums.

CMS explained last month that Medicare Part B will have to increase (by the largest amount ever) its standard monthly premium — from $148.50 in 2021 to $170.10 in 2022 — in part because of the massive spending that could occur should CMS sign off on a national coverage decision for Aduhelm, and its $56,000 annual price tag next year.

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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.

Now Pfizer wants to give the pharma rival a run for its money.

Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.

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Harpreet Singh, Immatics CEO (Credit: Allogeneic Cell Therapies Summit)

Just a few weeks after offering a positive readout on its first early clinical-stage offering, the transatlantic biotech Immatics is back with news that the research crowd around Rupert Vessey at Bristol Myers Squibb has anted up $150 million in cash to get on at the ground floor with one of their still-preclinical efforts.

This time the news is centered on IMA401, Immatics’ most advanced bispecific, which uses one binder to latch on to MAGEA4/8 while another is used to whip up T cell activity against tumor cells where that’s a common antigen. For now, that’s still a preclinical effort, with the first human trial set to launch in the first half of next year.

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AnHeart Therapeutics co-founder and CEO Jerry Wang (L); co-founder and CBO Lihua Zheng (R)

In China, the character 安, pronounced An in English phonics, has a few different translations — yet they all come to the same general meaning: calm, safe, comfortable.

And for precision oncology biotech AnHeart Therapeutics, that Chinese character helps to define the company’s objective.

‘In Chinese, the pronunciation actually means something — [it] has special meaning: calm, safe, comfortable. So it’s really — you have a very calm heart, comfortable heart full of patients. So we try to make medicine so the patient can feel comfortable, feel safe. Feel calm,’ AnHeart CBO and co-founder Lihua Zheng told Endpoints News.

Australia’s CSL is plopping down $11.7 billion to acquire Vifor Pharma, the Swiss biotech best known for its iron products and kidney drugs.

While the buyout comes as little surprise — rumors have swirled since early December, and Vifor actually confirmed the deal talks to media on Monday — the final price could raise some eyebrows.

At $179.25 per share, CSL’s offer comes in much higher than the ‘more than $8.5 billion’ price tag cited in reports.

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Albert Bourla, Pfizer CEO (Getty Images)

A new private study by South Africa’s largest insurer, Discovery Health, suggests that Pfizer and BioNTech’s Covid-19 vaccine is just 33% effective against infections by the Omicron variant.

However, the variant appears to cause less severe disease, the company reported. The data, based on 211,000 positive Covid cases, showed that risk of hospitalization was 29% lower than in South Africa’s first wave back in mid-2020.

House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)

Back in January 2019, the late House Oversight Committee chair Elijah Cummings kicked off a nearly 3-year-long drug pricing investigation that culminated today in a major new report detailing how prices for vital drugs have risen substantially since their launch, while calling on the Senate to pass a bill that will allow Medicare to negotiate some prices.

The committee’s investigation focused on 12 of the most expensive drugs for Medicare, showing massive price spikes that have accumulated over the years and made some drugs, like insulin, entirely unaffordable for some, to the point where some diabetics have had to ration their life-saving insulin, and some have died.

The Senate Finance Committee on Saturday released the latest text of President Joe Biden’s $2 trillion spending package, paid for at least in part with new negotiating power for Medicare and inflation rebates drugmakers will have to pay if their drug prices rise too quickly each year.

But now, generic drugs at risk of shortage and biosimilars have been cut out of the rebates, as their industry lobbying groups had sought. They’d said the inclusion of such rebates and negotiations could increase the likelihood of drug shortages and create barriers to competition.

Quick response or QR codes are having a moment. Restaurant menus, scan-and-pay retail shopping, hotel check-ins and even vaccination status QR codes are spurring a resurgence in the once-derided technology.

For pharma, the resurgence of QR codes is also fueling marketing opportunities. QR codes on materials in doctor’s waiting rooms can be pointed at to watch videos, get more information about a treatment or follow a brand on social media.

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