Merck’s potential Covid-19 treatment molnupiravir will not be used in France, French regulators said Friday.
The French National Authority of Health cited the potential impact of the Omicron variant, the fact that Regeneron’s mAb cocktail is more effective, and the pill’s own lack of efficacy as reasons for denying early access of the drug to patients experiencing mild to moderate cases of Covid-19. France has already pre-ordered hundreds of thousands of the pills, with the goal of treating 50,000 patients.
In the US, the FDA’s antimicrobial drugs advisory committee last month voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. Bu the FDA has yet to authorize the pill.
Brii claims China’s first antibody is effective against Omicron
Brii Biosciences is standing by its Covid-19 antibody cocktail’s ability to fight against the Omicron variant, the Chinese biotech announced Monday, even though one of the antibodies showed a drop in activity when it was tested alone.
The cocktail was the first approved in China last week, but will not be available for purchase until data is published in a scientific journal. Results from three different labs showed similarities, CEO Zhi Hong said.
‘We believe the amubarvimab/romlusevimab combination has the potential to be a best-in-class treatment option for a broad range of high risk COVID-19 patients. These latest findings underscore that our combination antibody therapy holds up well against the Omicron variant that pose a significant public health threat worldwide,’ he said in a statement.
The company has secured manufacturing deals for 1 million doses a year over the next two years, and 80,000 doses are already in inventory. No purchase deals have been announced so far.
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.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
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.
Jacob Van Naarden (Lilly Oncology)
Jake Van Naarden, who rules the oncology roost at Eli Lilly, is back in the dealmaking game.
Monday morning he uncorked a deal to provide Flagship-backed Foghorn Therapeutics $380 million — $300 million in cash and $80 million for a premium equity deal — to jump on board the biotech’s development platform. The deal gives him co-development and co-commercialization rights to their BRM selective program — which uses protein degradation and enzymatic inhibition — directed against BRG1 mutations. Those mutations are aligned along 5% of all tumors and 10% of NSCLC.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
James Xue, CANbridge Pharmaceuticals CEO
Though IPO activity has slowed in the US significantly, a Qiming Venture-backed biotech took the public leap in a Hong Kong debut Friday.
CANbridge Pharmaceuticals began trading on the HKEX after raising about $77.4 million in its IPO, according to a Qiming release. The move comes a little less than two years after CANbridge’s last raise, when it pulled in $98 million from a global syndicate joined by RA Capital.
Precision CMO Alan List (Diane Bondareff/AP Images for Moffitt Cancer Center)
The next generation of cell therapies have focused in large part on the development of allogeneic — better known as ‘off-the-shelf — drugs that can cut manufacturing times and hopefully evade a patient’s immune system. One of the early players in that race has new data at #ASH21 that show deep responses but will also raise fresh concerns about these therapies’ durability.
Precision Biosciences’ PBCAR0191, a CD19-directed allogeneic CAR-T cell therapy, posted a complete response rate of 59% in 22 heavily pretreated patients with various forms of relapsed or refractory non-Hodgkin’s lymphoma and acute lymphocytic leukemia, six of whom had previously received an autologous CAR-T before dosing, the biotech said.
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
The bulk of this week’s report is brought to you by Endpoints editors Nicole DeFeudis and Max Gelman, who are covering for me as I take a few days off after the big Women in Biopharma R&D event. We are really proud of both the special report and the live panel, which featured some great stories from trailblazing leaders and insights on gender diversity in biotech. Do check them out below if you haven’t had a chance.
Unlock this story instantly and join 125,400+ biopharma pros reading Endpoints daily — and it’s free.
Stéphane Bancel, Moderna CEO (Endpoints JPM20/Jeff Rumans)
Last fall, as their Covid-19 vaccine crossed the finish line, Moderna unveiled plans to take its newly proven mRNA platform and use it to effectively change how the world blocks humanity’s most persistent viral foes.
In addition to their pre-existing vaccine programs, executives announced new ones for flu, where vaccines have chronically underperformed, and HIV, which has eluded every inoculation effort over nearly 40 years. In flu, the other mRNA vaccine companies — BioNTech (with Pfizer), Translate Bio (under Sanofi), and CureVac (with GSK) — all had similar ambitions, hoping to make shots that were as high as 80% effective.
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.
https://endpts.com/covid-19-roundup-french-regulators-not-ready-to-give-molnupiravir-the-ok-chinas-first-antibody-cocktail-proves-effective-against-omicron/
