A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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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%).
We will now have to wait until 2022 to find out whether Sanofi and GlaxoSmithKline have an effective recombinant vaccine against Covid-19.
The two pharma giants revealed that their Phase III trial isn’t quite ready for a readout. Meanwhile, they seem to have more hope in the booster application of their candidate, touting positive preliminary data suggesting that it spurred an increase in neutralizing antibodies in all patients — whether they received mRNA or adenovirus-based shots as the primary vaccines.
Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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Albert Bourla (Evan Vucci, AP Images)
After a post-marketing trial for Pfizer’s Xeljanz turned concerning safety results at the beginning of the year, thwarting the whole JAK class, the FDA is finally rolling out some new approvals — but with added warnings and a key label change.
Both Xeljanz and AbbVie’s Rinvoq got cleared for new indications on Tuesday, but on one condition: They can only be taken after a patient has failed on one or more tumor necrosis factor (TNF) blockers, like Humira or Enbrel.
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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The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.
But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:
Tillman Gerngross, Adagio CEO
Since the pandemic began in the spring of 2020, Tillman Gerngross has raised more than half a billion dollars for his startup Adagio and their promise to develop a so-called broadly neutralizing coronavirus antibody that could snare any variant.
When Omicron broke out over Thanksgiving, bringing a strain that threatened to evade widely-used antibody treatments from Eli Lilly and Regeneron, Adagio’s $ADGI soared 34% as Gerngross’ predictions appeared to come true. Early computational analyses suggested Adagio’s antibody, ADG20, currently in pivotal trials, should retain full efficacy against the variant.
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Though it’s already publicly traded in the US and Hong Kong, BeiGene went and triple-listed itself in Shanghai’s stock exchange as well. But early returns have reportedly been far from promising.
BeiGene shares in Shanghai fell more than 16% after debuting Wednesday, following a $3.5 billion raise for the biotech. It had been the year’s biggest IPO on the Shanghai stock exchange, known as STAR, as well as the largest IPO offering by any Chinese healthcare firm in at least the last two decades, according to the report.
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Soon after San Francisco-based Genentech won an EUA for tocilizumab as a treatment for hospitalized Covid patients last summer, the company announced a shortage of the drug while pointing to the emergence of the Delta variant and the slowing of vaccination rates across the US.
‘This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV– well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase,’ the company said in August.
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