// Biotech and Pharma Therapeutics
Merck sees up to $7B in coming sales of coronavirus pill
October 28, 2021 / Merck / COVID-19 / FDA
The coronavirus pandemic is turning into a huge business for big pharma. Pfizer and Moderna, for example, have reported roughly $11 billion and $6 billion from sales of their vaccines, respectively, in the first six months of 2021, while Regeneron reported about $3 billion in sales of its antibody drug REGEN-COV.
With approval plans underway, Lilly’s next move is to test its Alzheimer’s drug against Biogen’S
October 26, 2021 / Alzheimer’s / Eli Lilly / Biogen / Drug Approval
One other repercussion of Aduhelm’s approval is that it set somewhat of a standard for the data needed to get an Alzheimer’s drug to market. The FDA noted how it based its decision on Aduhelm’s ability to reduce aggregates of a protein called amyloid beta — an effect which the agency said was “reasonably likely to predict a clinical benefit.”
BioSpace Movers & Shakers, Oct. 29
October 29, 2021 / Biospace / Life Sciences
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Sanofi’s €10B sales target for Dupixent? The ‘megabrand’ is more than halfway there, exec says
October 28, 2021 / Drug Sales / Earnings / Influenza / Dupixent
Shortly after Sanofi CEO Paul Hudson joined the company in 2019, he laid out an ambition to invest as much as necessary to turn the Regeneron-partnered antibody drug Dupixent into a megablockbuster. Two years later, Sanofi is well on its way.
As Lilly gears up for key 2022 launches, Trulicity, Taltz and more drive solid growth
October 26, 2021 / Alzheimer’s / Diabetes / Eli Lilly / Emgality
While Eli Lilly’s Alzheimer’s disease hopeful donanemab stole most of the headlines for the drugmaker Tuesday, the company’s stable of approved drugs continued on their growth path. The company posted a double-digit sales increase in the third quarter and is getting ready for some highly anticipated launches.
// 4th Industrial Revolution
Notable regulatory approvals of emerging technologies over the past 30 days
October 29, 2021 / Regulatory Approvals / New Tech / AI
Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing and visualization, robotics and other innovative technologies changing healthcare delivery.
Teladoc plans to take on risk in primary care, expand program to hospital clients
October 28, 2021 / Teladoc / Hospital Clients / Telehealth
Like other virtual care vendors, Teladoc benefited enormously from surging demand for telehealth last year as COVID-19 spread. Some skeptics questioned whether telehealth companies could keep up the momentum, a concern that’s dinged the stock of publicly traded vendors even as many report sustained utilization.
Bayer, One Drop release digital health program for heart disease
October 27, 2021 / Bayer / One Drop / Digital Health / Heart Disease
The app lets people track their metrics through connected devices, and access health coaching and educational materials. It’s one of multiple that Bayer and One Drop plan to develop together in the future.
Are supercomputers set to transform pharma R&D?
October 28, 2021 / NVIDIA / UK / Supercomputers / New Tech
Advanced technology is now commonplace in pharma, where innovations like artificial intelligence (AI) and machine learning accelerate and improve the accuracy of drug discovery and development efforts. Add to the list the supercomputer – a powerful class of computer, vastly superior to general-purpose computers in terms of speed and performance, that are commonly used for data-intensive scientific purposes.
Digital pharmacy Truepill scores $142M
October 27, 2021 / Digital Pharmacy / Truepill / Digital Health
The company said the new funding brings its total raise to $256 million and its valuation to $1.6 billion. Truepill announced a $75 million Series C in September 2020, just a few months after it brought in $25 million in Series B funding.
// Business & Markets
Hinge Health raises $600M, taps ex-Amazon, Google execs for leadership team
October 29, 2021 / Hinge Health / Amazon / Google
Hinge Health, a digital musculoskeletal clinic in San Francisco, raised &400 million in its latest fundraising round and secured a $200 million secondary investment, the company said Oct. 28.
Takeda reels in a cell therapy research partner with ‘build-to-buy’ deal
October 27, 2021 / Takeda / Cell Therapy / Gene Therapy / ‘Build-to-buy’ Deal
Takeda, which has made cell and gene therapy a research focus, is turning to partnerships and acquisitions to help fill out its pipeline. In addition to the GammaDelta deal, the large drugmaker recently struck a deal with newly launched Ensoma Therapeutics and, earlier this month, Poseida Therapeutics.
Better Therapeutics closes SPAC merger, debuts on Nasdaq
October 29, 2021 / Better Therapeutics / SPAC / Merger / Nasdaq
San Francisco-based Better Therapeutics announced its intention to merge with Mountain Crest, a publicly-traded, special purpose acquisition corporation (SPAC), in April. Last month, the company confirmed its expectations for the $113 million SPAC merger to go through by the end of October, as it has today.
Gilead taps brakes on $4.9B bet after rival’s failure, pushing blood cancer data out to 2022
October 29, 2021 / Blood Cancer / Breakthrough Therapy / Clinical Trial Data / Myelodysplastic Syndrome
The data drop on magrolimab in the blood cancer myelodysplastic syndrome (MDS), which was scheduled for this year, is now penciled in (PDF) for the first quarter of 2022. Analysts at Jefferies said the delay is “in part due to GILD still talking to FDA on filing requirements, particularly after Takeda just failed a Phase III in MDS after strong Phase IB CR rates in MDS.”
Decentralized clinical trials platform Medable now valued at $2.1B
October 26, 2021 / Clinical Trials / Telehealth
Medable recently raised $304 million, its fourth funding round in the past two years. The company’s software can be used to virtually consent patients into clinical trials and run telehealth visits as part of a trial.
// Legal & Regulatory
An Allergan psychiatric drug failed late-stage depression studies — but AbbVie is going for approval anyway
October 29, 2021 / Allergan / AbbVie / Clinical Trials
Cariprazine, the Allergan-turned-AbbVie drug for bipolar depression and schizophrenia, had a rocky road through clinical trials before its approvals. And as AbbVie attempts to further expand into major depressive disorder, it’s facing similar challenges.
Dexcom raises guidance ahead of G7 launch, FDA submission imminent
October 29, 2021 / Dexcom / G7 Launch / FDA / San Diego Biotech / Diabetes
Dexcom Chairman, President & CEO Kevin Sayer told Drug Delivery Business News earlier this year that the company expects to launch its next-generation G7 continuous glucose monitor (CGM) in Europe this autumn. During Dexcom’s earnings call yesterday evening, he said the company remains on track for a Q4 launch of the G7 upon receiving CE mark clearance.
Sanofi hit by filing delays for key drugs, drops an early Sangamo thalassemia asset
October 28, 2021 / Breast Cancer / Pipeline / Sangamo BioSciences / Sanofi
Filings have also been pushed back a year for the CEACAM5-targeted antibody-drug conjugate tusamitamab in lung cancer, which will now be into 2023, with venglustat in Gaucher disease type 3 and rilzabrutinib in the rare blood disorder immune thrombocytopenia (ITP), also both pushed into 2024.
Health App Companies May Be Surprised FTC Is Watching Them
October 28, 2021 / FTC / TeleHealth / Health Apps
The Federal Trade Commission recently issued a policy statement related to its health breach notification rule. This “statement” by the FTC comes a few months after the agency reached a settlement with Flo Health, a mobile app that allegedly impermissibly disclosed sensitive health data about millions of users.
Proposed Tax on Billionaires Raises Question: What’s Income?
October, 2021 / New Tax / Democrats / Social Spending Bill
Democrats are homing in on unrealized capital gains raises as a way to help fund their social spending bill.
// Research & Development
Alnylam and AbbVie Each Reveal Influential Phase III Results
October 29, 2021 / Alnylam / AbbVie / RNAi
Nine months after first reporting that its investigational RNAi drug vutrisiran hit its nine-month endpoints in the Phase III HELIOS-A study, Alnylam announced Thursday that the experimental treatment continues to demonstrate positive results at the 18-month mark in patients diagnosed with polyneuropathy associated with hereditary transthyretin-mediated (hATTR) amyloidosis.
Daiichi jettisons ADC after flunking early solid tumor test
October 29, 2021 / Antibody-drug conjugates/ Failed Trials / Gastrointestinal Tumors / Daiichi Sankyo
Daiichi took DS-6157 into the clinic in light of the unmet need in GIST and evidence that GPR20 is selectively and abundantly expressed in the indication. Tyrosine kinase inhibitors such as Gleevec are already used to treat GIST, but many patients progress after developing resistance mutations. Equally, the therapies have limited efficacy in some subsets of GIST patients.
Pfizer, Novartis sign on to accelerate gene therapies for rare diseases with US agencies
October 28, 2021 / Cell & Gene Therapy / Drug Development / FDA Regulation / Gene Therapy
Called the Bespoke Gene Therapy Consortium, or BGTC, the initiative is headed up by the FDA and the National Institutes of Health (NIH) and is designed to accelerate development of gene therapies. The agencies are putting up $76 million over five years.
Novartis looks for silver lining in $2B canakinumab repurposing after 2nd lung cancer failure
October 25, 2021 / Non-small Cell Lung Cancer / Ilaris / Novartis
Adding Ilaris, or canakinumab, to Merck’s Keytruda and platinum-based chemotherapy couldn’t extend the lives of newly diagnosed NSCLC patients, Novartis said Monday. The experimental regimen also failed to show a benefit in slowing tumor progression over the standard immunotherapy-chemo combo.
Mozart Therapeutics makes its official debut, jumping into the hot Treg R&D field with some big-name investors backing it
October 26, 2021 / Mozart Therapeutics / R&D / Treg Cells
Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.
// Politics
Federal security officials warn that ‘Made in China’ could one day go for tech-dependent US healthcare
October 22, 2021 / Healthcare / China
U.S. healthcare may be high on China’s wish list of Western spheres of activity to infiltrate ever more deeply with artificial intelligence and other advanced technologies.
Biden’s HHS to withdraw controversial Trump-era regulatory reform rule
October 29, 2021 / Biden / Trump / SUNSET Rule
The U.S. Department of Health and Human Services issued a proposal this week to withdraw a final rule put forth by the Trump administration that would have required the agency to review its regulations once every ten years.
Drug price restraints dropped as Biden prioritizes other measures
October 29, 2021 / Drug Price / Biden / U.S. Congress
Broad national drug pricing controls aren’t likely to be signed into law this year after President Joe Biden, facing congressional opposition, left them out a legislative negotiating framework for a package that includes health insurance, education and more support for household income.
Pharma campaign cash delivered to key lawmakers with surgical precision
October 27, 2021 / Lawmakers / Surgical Precision / Biden / U.S. Congress
The Biden administration and Congress are embroiled in high-stakes haggling over what urgent priorities will make it into the ever-shrinking social spending bill. But for the pharmaceutical industry there is one agenda: Heading off Medicare drug price negotiation, which it considers an existential threat to its business model.