'Lights are no longer green': Antitrust regulators reassess pharma deals

 Biotech and pharmaceutical executives often describe dealmaking as the industry's lifeblood, arguing that acquisitions build pipelines, drive competition and give investors a reason to fund innovative startups. Drug company opponents dispute those points and their arguments may now have gained powerful allies in global antitrust regulators.

In March, the Federal Trade Commission and its counterparts in Europe, the U.K. and Canada announced they will reassess how they review drugmaker deals, pointing in particular to two recent multi-billion dollar buyouts, Bristol Myers Squibb's takeover of Celgene and AbbVie's purchase of Allergan.

Rebecca Kelly Slaughter, the FTC's acting chair, didn't detail how regulators' views might change. However, antitrust experts expect the agencies will scrutinize whether larger companies use their wider portfolio of drugs to force insurers to accept higher prices, as well as how acquisitions may discourage innovation by thwarting competition.

"This is a pretty clear signal that the lights are no longer green," said antitrust attorney David Balto, who represented unions and consumer groups in objecting to the Allergan deal. "They're now yellow or red, and companies need to be much more cautious about the deals they consider."

Illumina, the dominant provider of DNA sequencing in the U.S., has learned that first hand, as the FTC and the European Commission recently challenged its proposed acquisition of Grail, an up-and-coming rival.

The biotech and pharma sectors have taken notice, although there hasn't yet been a noticeable impact on investment or dealmaking activity. In April, for example, U.S. regulators cleared AstraZeneca's $39 billion buyout of rare disease drugmaker Alexion. 

"We have to treat it as a credible threat," said Bruce Booth, partner in the venture capital firm Atlas Ventures. "[But] as a negative risk, it has yet to be priced into the financing world."

"A more expansive approach"

Currently, the FTC focuses on overlaps between marketed drugs or between marketed and experimental drugs owned by merging companies. The FTC typically accepts divestiture of the marketed drug to resolve its objections.

That may no longer be the case in the future. "Going forward, I hope the commission will take a more expansive approach to analyzing the full range of competitive consequences of pharmaceutical mergers," Slaughter wrote in her dissenting statement on clearance of the Bristol Myers-Celgene acquisition.

"I urge not only the commission, but also researchers and industry experts to think carefully and creatively about these cases, and in particular to study the effects of recent consummated mergers on drug research, development and approval," she added.

Through a spokesperson, Slaughter declined comment for this article.

The FTC's reassessment of pharma mergers might not have happened if not for President Joe Biden's election. Joseph Simons, who was Donald Trump's appointee as chairman, stepped down on Jan. 29, and Biden named Columbia University professor Lina Khan, a critic of concentration among the biggest technology companies, to take Simons' place, giving Democrats a 3-2 majority.

Biden will get a chance to nominate a second FTC commissioner as he nominated Rohit Chopra, who joined Slaughter in dissenting in the AbbVie-Allergan and Bristol Myers-Celgene cases, to become director of the Consumer Financial Protection Bureau. Another nominee could allow Biden to put a stamp on more expansive antitrust policies.

PhRMA, the powerful industry trade group, is unsurprisingly critical of the regulators' efforts to review drugmaker deals. "These mergers and acquisitions can facilitate the transfer of knowledge and expertise required to push the envelope of scientific discovery, support the development of new and lifesaving medicines, and enhance competition," spokesperson Brian Newell said in a statement.

But U.S. antitrust regulators have redefined their views on anti-competitive mergers before. After the FTC lost numerous challenges to hospital mergers in the 1990s, the agency reviewed its approach and later won court rulings based on a more tightly defined analysis of what constituted a market.

Essentially, the FTC narrowed how large it considered those markets to be and redefined which mergers were viewed as anti-competitive, according to Balto. "That's an example of what might come about," he said.

The FTC is currently revising its view of hospital competition in another way, by assessing how mergers affect nurses' wages.

Consolidation and innovation

In the case of pharma consolidation, the FTC's competitive analysis is likely to go in two directions: how bigger companies may have led to higher prices for marketed drugs, and how pharma companies' acquisition of drugs in development may suppress innovation.

Previously, antitrust regulators' review of megamergers largely discounted the possibility they would translate into higher drug prices, aside from instances in which there were product overlaps that risked permitting anti-competitive behavior.

But list prices have often risen faster than inflation in recent years, prompting some experts to suggest the market leverage of increasingly large companies enables them to pry open insurers' wallets.

Booth doesn't believe the data supports that claim, pointing to how even the biggest companies like Pfizer and Novartis account for very little of the $1.2 trillion in global pharmaceutical sales.

"We're an incredibly fragmented sector despite the scale of the top 20 big pharmas," he said in an interview.

In 2019, the 10 largest drugmakers accounted for 42% of worldwide prescription drug sales, according to numbers from EvaluatePharma. Roche, at 5.5% market share, was the largest, followed by Novartis and Pfizer.

On large drugmaker innovation, meanwhile, Slaughter appears to be moved by analysis from two economists, Justus Haucap and Joel Stiebale of the Düsseldorf Institute for Competition Economics. Slaughter cited their work in her dissenting statement on Bristol Myers' acquisition of Celgene.

The two scholars analyzed 65 major pharma deals subjected to review by European competition authorities. Companies were headquartered in the U.S. as well as Europe. They found that innovation activities, as measured by patents issued and R&D expenditures, shrunk not just for the merging firms but also for their competitors.

"Especially with pharmaceuticals, it's very important to be the first one to come up with a new product. It's a winner-takes-all or a winner-takes-most market," Stiebale said in an interview. "So then if you buy one of your main competitors, there's less risk that somebody overtakes your research."

The remaining rivals to merged companies "seem to have reduced their innovation efforts, so that this is very suggestive that competition is the driver," he said. The analyzed firms cut back their research and development activities by more than 20% over the four years following each deal, Stiebale and Haucap found. 

Killer acquisitions

Other economists have looked at the fate of experimental drugs being developed by small biotechs that were acquired by bigger companies.

In describing "killer acquisitions," Colleen Cunningham of the London School of Business and Florian Ederer and Song Ma of the Yale School of Management estimated that drugs acquired through the buyout of small biotechs were modestly less likely to be taken forward if the larger company had overlapping projects.

The economists calculated that between 5% to 7% of acquisitions each year fit the description of a killer acquisition.

The FTC appeared to be considering this question in its 2019 review of Roche's acquisition of gene therapy developer Spark Therapeutics.

The commission considered whether the Swiss pharma had an incentive to abandon or delay Spark's hemophilia A gene therapy to defend the market share of its top-selling drug for the condition, Hemlibra. In the end, the FTC concluded that, because other biotechs were developing hemophilia A gene therapies, Roche still had an incentive to develop Spark's.

While the work of Cunningham and her colleagues hasn't taken a prominent role in commissioner's analyses, the FTC appears aware of them and cited their paper in describing its retrospective reviews of mergers and acquisitions.

Booth, of Atlas Venture, argues acquisitions are a positive, allowing research, talent and money to be recycled into new projects.

He also disputes the claim that big pharma frequently buys out companies to shut down competition. Target companies should be able to determine whether that could happen when negotiating a sale, he said.

"I've never heard of pharma buying something and just shooting it for anti-competitive reasons," he added.

https://www.biopharmadive.com/news/ftc-pharma-biotech-deal-scrutiny-slaughter/601577/

Vertex Pharmaceuticals Seen as Buying Opportunity as Stock Plunges

 Vertex Pharmaceuticals  (VRTX) - Get Report shares fell on Friday after the company nixed a closely watched effort to develop a therapy for a rare genetic disorder that affects the lungs and liver, though analysts took the price drop as reason to potentially jump in.

Vertex announced on Thursday that it halted its efforts to develop a drug to treat alpha 1 antitrypsin deficiency, also known as AATD, an inherited disorder that can lead to liver transplants in children.

The study, called VX-864, met its primary endpoint and was well tolerated, Vertex said, and the drug's mechanism was proved to work, but the "magnitude of the treatment effect observed [was] unlikely to translate into substantial clinical benefit.”

Analysts were quick to focus on the Boston-based company’s existing pipeline of cystic fibrosis and other treatments, as well as its plans to continue efforts to develop treatments for AATD, calling the knee-jerk selloff a buying opportunity.

Barclays analyst Gena Wang cut her price target on Vertex to $285, though said she sees a buying opportunity in the stock weakness, even if the company’s future pipeline remains “… a show-me story,” especially given Vertex’s other drugmaking efforts in development, and its intellectual property. She has an overweight rating on the shares.

Piper Sandler analyst Edward Tenthoff also sees the recent share price drop as an opportunity to step forward, noting Vertex’s cystic fibrosis franchise remains strong and its medicated kidney disease treatments also appear promising. He also has an overweight rating on the stock with a price target of $347.

RBC Capital analyst Brian Abrahams also sees value in Vertex’s cystic fibrosis franchise and called the share price at current levels an “…attractive long-term entry point on price weakness, even if market will be looking for VRTX to prove themselves.” He too has an outperform rating on the stock, though cut his price target to $242.

At last check, shares of Vertex were down 9.12% at $196.99.

https://www.thestreet.com/investing/vertex-vrtx-analysts-buying-opportunity

Novel target shows promise in treating Alzheimer's and related dementias

 Researchers remain perplexed as to what causes dementia and how to treat and reverse the cognitive decline seen in patients. In a first-of-its-kind study, researchers at the Medical University of South Carolina (MUSC) and Beth Israel Deaconess Medical Center (BIDMC), Harvard Medical School discovered that cis P-tau, a toxic, non-degradable version of a healthy brain protein, is an early marker of vascular dementia (VaD) and Alzheimer's disease (AD). Their results, published on June 2 in Science Translational Medicine, define the molecular mechanism that causes an accumulation of this toxic protein. Furthermore, they showed that a monoclonal antibody (mAb) that targets this toxic protein was able to prevent disease pathology and memory loss in AD- and VaD-like preclinical models. Additionally, this treatment was even capable of reversing cognitive impairment in an AD-like preclinical model.

"We believe our findings have not only discovered cis P-tau as a previously unrecognized major early driver of VaD and AD but also identified a highly effective and specific immunotherapy to target this common disease driver for treating and preventing AD and VaD at early stages," said Onder Albayram, Ph.D., co-lead author and assistant professor in the Division of Cardiology in the Department of Medicine at MUSC.

Aging is a normal part of life -- we experience weakening of our bones and muscles, stiffening of our blood vessels and some memory lapses. But for around 50 million people worldwide, these memory lapses become progressively more severe, ultimately leading to a diagnosis of dementia.

Dementia is an umbrella term that covers AD, which accounts for 60% to 80% of cases; VaD, the second most common cause; and other less common pathologies. Currently, there are no effective treatments for AD. Interestingly, most AD cases have a vascular component, suggesting a broader relationship between cognitive function and healthy brain vasculature. A better understanding of that relationship could provide a platform to discover novel therapeutic targets.

"Our work provides evidence that cis P-tau may be a pathogenic factor that explains VaD, which is not generally linked to other dementias," added Chenxi Qiu, Ph.D., co-lead author and a postdoctoral research fellow at BIDMC, Harvard Medical School.

In a preclinical model of VaD, young mice showed signs of brain inflammation and memory loss within one month. However, treating these mice with the cis P-tau mAb prevented neural degradation and cognitive decline out to six months. In a separate preclinical model of AD, old mice showed severe cognitive impairment. Excitingly, this severe impairment was significantly reversed when mice were given the cis P-tau mAb.

"These data show that cis P-tau could be an early upstream pathogenic factor common to both diseases," said Albayram.

Translating information gained from preclinical models to humans is often difficult, but this study offers reasons to be optimistic. Accumulation of cis P-tau caused dramatic changes in the genetic architecture of affected cells in a VaD model; these changes were consistent with those seen in human AD patients. The researchers went on to show that treatment with the cis P-tau mAb reversed 85% to 90 % of those changes suggesting the power of this potential therapy.

"The genomic landscape really adapts after the silencing of this toxic protein," said Albayram. "That was a big discovery."

Not only are Albayram and Qiu excited about these findings, but colleagues at MUSC are already quite enthusiastic about this work.

"I can go on and on about this paper," said Adviye Ergul, M.D., Ph.D., professor in the College of Medicine, Department of Pathology and Laboratory Medicine at MUSC. "They provide robust evidence that there is accumulation of a specific form of the tau protein -- cis P-tau -- that highlights a different tau protein pathology in VaD research."

This groundbreaking research has opened the door for new potential immunotherapies and highlighted several new areas of research that need to be explored. While the researchers delineated a pathway that leads to the accumulation of cis P-tau, the underlying linkage between vascular abnormalities and activation of the pathway needs to be identified. A better understanding of how toxic cis P-tau interacts with the healthy trans P-tau could provide further insights into the progression of AD disease.

AD and VaD might not be the only diseases affected by high levels of cis P-tau. Other brain disorders with a vascular component might also arise from this toxic protein, but further study will be required to establish such a link.

"Cis P-tau may be a common, early and pathogenic factor underlying traumatic brain injury, VaD and AD," said Qiu.

As we get older and our memory begins to lapse -- misplacing our car keys or forgetting the name of a new acquaintance -- we fear the possibility that these are the first signs of dementia. And while there is currently no approved treatment to reverse the physiological effects of dementia, this new research may provide hope that new therapies are around the corner.

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Story Source:

Materials provided by Medical University of South Carolina. Original written by Matthew Greseth, Ph.D.. Note: Content may be edited for style and length.

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Journal Reference:

1. Chenxi Qiu, Onder Albayram, Asami Kondo, Bin Wang, Nami Kim, Ken Arai, Cheng-Yu Tsai, Mahmoud A. Bassal, Megan K. Herbert, Kazuo Washida, Peter Angeli, Shingo Kozono, Joseph E. Stucky, Sean Baxley, Yu-Min Lin, Yan Sun, Alexander Rotenberg, Barbara J. Caldarone, Eileen H. Bigio, Xiaochun Chen, Daniel G. Tenen, Mark Zeidel, Eng H. Lo, Xiao Zhen Zhou, Kun Ping Lu. Cis P-tau underlies vascular contribution to cognitive impairment and dementia and can be effectively targeted by immunotherapy in mice. Science Translational Medicine, 2021; 13 (596): eaaz7615 DOI: 10.1126/scitranslmed.aaz7615

https://www.sciencedaily.com/releases/2021/06/210610162350.htm

Effects of COVID-19 on human kidney cells

 Researchers have studied human kidney cells in the lab to examine the effects of COVID-19 on kidney health. The findings appear in an upcoming issue of JASN.

Many individuals who develop COVID-19 also experience kidney damage, but it's unclear if this is a direct result of viral infection or a consequence of another condition or the body's response to the infection. To investigate, a team led by Benjamin Dekel, MD, PhD (Sheba Medical Center, in Israel) cultivated human kidney cells in lab dishes and infected them with the virus that causes COVID-19.

The researchers found that although the virus that causes COVID-19 could enter, infect, and replicate in human adult kidney cells, this did not typically lead to cell death. Prior to infection, the cells contained high levels of interferon signaling molecules, and the infection stimulated an inflammatory response that increased these molecules. In contrast, infection of kidney cells deficient in such molecules resulted in cell death, suggesting a protective effect.

The cells in these experiments were grown as a three-dimensional spheroid that imitates the healthy kidney or as a two-dimensional layer that mimics the cells of an acutely injured kidney. Cells that mimicked an acutely injured kidney were more prone to infection and additional injury but not cell death.

"The data indicate that it is unlikely that the virus is a primary cause of acute kidney injury seen in COVID-19 patients. It implies that if such injury takes place in the kidney by any cause, the virus might jump on the wagon to intensify it. Therefore, if we're able to limit the common scenario of acute kidney injury in the first place, then there might be the possibility to minimize potential damage caused by the virus," Dr. Dekel explained.

Study co-authors from the Sheba Medical Center and the Israel Institute for Biological Research include Dorit Omer, PhD, Oren Pleniceanu, MD, PhD, Yehudit Gnatek, MSc, Michael Namestnikov, Osnat Cohen-Zontag, PhD, Sanja Goldberg, PhD, Yehudit Eden Friedman, MD, Nehemya Friedman, PhD, Michal Mandelboim, PhD, Einat B. Vitner, PhD, Hagit Achdout, PhD, Roy Avraham, PhD, Eran Zahavy, PhD, Tomer Israely, PhD, and Haim Mayan, MD.

Disclosures: Dr. Dekel is a co-founder and shareholder at KidneyCure Ltd.

Story Source:

Materials provided by American Society of Nephrology. Note: Content may be edited for style and length.

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Journal Reference:

1. Dorit Omer, Oren Pleniceanu, Yehudit Gnatek, Michael Namestnikov, Osnat Cohen-Zontag, Sanja Goldberg, Yehudit Eden Friedman, Nehemya Friedman, Michal Mandelboim, Einat Vitner, Hagit Achdout, Roy Avraham, Eran Zahavy, Tomer Israely, Haim Mayan, Benjamin Dekel. Human Kidney Spheroids and Monolayers Provide Insights into SARS-CoV-2 Renal Interactions. Journal of the American Society of Nephrology, 2021; ASN.2020111546 DOI: 10.1681/ASN.2020111546

https://www.sciencedaily.com/releases/2021/06/210610173952.htm

Punjab govt decides to block SIM cards of people refusing vaccines

 The Punjab government on Thursday decided to block the SIM cards of people refusing to get vaccinated against the coronavirus, an official said.

The step was among several decisions taken by the provincial government to control the spread of Covid-19 and speed up the vaccination process, including opening walk-in vaccination for all adults from June 12.

"Final decision has been taken to block the mobile SIM cards of people not getting vaccinated," Punjab Specialised Healthcare Department spokesman Syed Hammad Raza said.

A high-level meeting chaired by Punjab Health Minister Dr Yasmin Rashid also decided to set up mobile vaccination camps outside major shrines in the province, and fully open businesses in all districts where at least 20 per cent of the population has been vaccinated.

Vaccinated people will be allowed to go to cinema halls and restaurants and marriage halls will be opened. People suffering from terminal illnesses like HIV/AIDS and cancer will now be vaccinated on priority, according to the spokesperson.

The meeting was given a briefing on the measures taken to control the spread of the virus and it appreciated the health department's performance for the decrease in the number of infections and mortality rate.

“We have seen considerable decrease in [the] number of cases. The government is utilising all our resources for control of Covid-19 under the leadership of Chief Minister Usman Buzdar," Rashid was quoted as saying.

She said the credit for the reduction in case numbers went to the administration, adding that as many as 677 vaccination centres were operating in the province.

After the opening of the walk-in facility for all adults, she said, people would be able to get inoculated upon showing their CNIC.

The Punjab chief secretary said that maximum possible facilities were being provided at vaccination centres. He said in districts where 20pc of the population has been vaccinated, all businesses will be opened subject to compliance with mask-wearing.

Residents of Punjab can contact the toll-free 1033 helpline for complaints or queries regarding vaccination.

The decisions come a day after the National Command and Operation Centre (NCOC) announced that coronavirus vaccines will be mandatory for all public- and private-sector employees, and that government employees must be fully vaccinated by June 30.

Among other drastic measures seen in the country to increase the pace of vaccinations, the Sindh government last week issued directions to stop the salaries of government employees who refuse to get themselves vaccinated from July.

Dawn reported last week that the pace of the Covid vaccination drive in Punjab was "dead slow", with the provincial government vaccinating around 52,000 people daily on average against a daily target of 0.42 million adults set by the NCOC to inoculate all 67m eligible people by the end of the year.

The provincial government had started vaccination in the first week of March to achieve the target by the end of 2021.

However, till June 1, the government had vaccinated only 4.2m people out of 67m total target population in Punjab, which constituted a 6.3pc vaccination rate only, showing desperately low coverage to fight the pandemic.

https://www.dawn.com/news/1628625/punjab-govt-decides-to-block-sim-cards-of-people-refusing-vaccines

Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines

 A group of clinicians and researchers has petitioned the FDA to delay fully approving any COVID-19 vaccines before clinical trials have been completed, calling the notion of approval to stimulate vaccination rates "backward logic."

The group, led by Linda Wastila, BSPharm, MSPH, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, includes 27 petitioners, including 16 experts outside the U.S., primarily based in Europe.

"The message of our petition is 'slow down and get the science right -- there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.' We believe the existing evidence base -- both pre- and post-authorization -- is simply not mature enough at this point," they wrote in a blog post published in The BMJ.

"If the FDA listens to us, they won't give serious consideration to approving a COVID-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed phase III trials -- not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These phase III trials are not simply efficacy studies; they also are necessary and important safety studies," the group wrote.

Full approval is not necessary to address public health, they argued, because the emergency use authorizations that the FDA has already issued for three vaccines are substantial enough to provide adequate vaccine access.

However, full approval may convince more people to get vaccinated, the group tacitly acknowledged. "While approval might lead to increased public confidence in COVID-19 vaccines, as well as provide legal support for employer-instituted vaccine mandates, to approve a medical product for these reasons is outside FDA's regulatory purview. Approval decisions must be driven by the safety and efficacy data," they wrote in the blog post.

The group also asked the FDA to hold off approval until the agency:

• Confirms there is substantial evidence that clinical effectiveness outweighs harms among special populations
• Requires a "thorough" safety analysis of spike proteins produced in situ after vaccine administration, including studies on spike proteins' "full biodistribution, pharmacokinetics, and tissue-specific toxicities"
• Completes vaccine biodistribution studies "from administration site and safety implications of mRNA translation in distant tissues"
• Comprehensively investigates all severe adverse reactions reported after vaccination
• Examines the safety of people taking more than two doses
• Includes gene delivery and therapy experts in its Vaccines and Related Biological Products Advisory Committee
• Enforces "stringent conflict of interest requirements to ensure individuals involved in data analysis and decision making" related to Biologics License Applications lack such conflicts with the vaccine manufacturers
• The group submitted their petition June 1, calling on FDA to provide an answer by June 11 in part "to allow Petitioners the opportunity to seek emergency judicial relief should the instant Petition be denied," they stated. Group members also plan to lobby Congress, according to an email from the group to MedPage Today.

"Approving a COVID-19 vaccine now risks setting a precedent of lowered standards for future vaccine approvals. The 'FDA approved' seal must represent a high bar -- and premature licensure of a COVID-19 vaccine could seriously damage public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure," they wrote in the blog post.

One of the petitioners, Joseph Ladapo, MD, PhD, of UCLA's David Geffen School of Medicine, was among the physicians with America's Frontline Doctors publicly praising hydroxychloroquine to treat COVID-19 last summer. Ladapo has written at least two editorials critical of the vaccines for the Wall Street Journal this year. However, while the America's Frontline Doctors group is still in operation and fiercely opposes the vaccines, MedPage Today could not find any clear affiliation between the group and Ladapo since last summer.

Fellow petitioner Donald W. Light, PhD, is a professor at Rowan University School of Osteopathic Medicine in Stratford, New Jersey; Rowan was one of the first medical schools to embrace the vaccines in the U.S., back in December 2020.

https://www.medpagetoday.com/special-reports/exclusives/93035

Facebook escalates Big Tech wars with proposed heart rate-tracking smartwatch

 Because racking up nearly 3.5 billion active users across its social networking platforms each month simply isn’t enough, Facebook is on a mission to further boost its standing in the tech world. The next step in that mission? Building a wearable device to compete with Apple and Google.

Though Facebook has yet to officially announce the launch of such a device, several reports have emerged about the proposed smartwatch, and Andrew Bosworth, vice president of Facebook Reality Labs, seemingly shared a photo of a prototype wearable in March.

The most recent of these reports, from The Verge, suggests the smartwatch will largely serve as a smartphone substitute so Facebook can reach its users directly, without being hosted on a competitor’s device.

To that end, the watch will reportedly be equipped with wireless LTE connectivity and two cameras: one on the front for video calls and one for uploading photos to Facebook and Instagram that will be located on the rear of the device, accessed by detaching it from its stainless steel frame.

Of course, to keep up with its competitors in the space, Facebook’s wrist-worn offering will also work as a health tracker. In addition to standard fitness tracking, the smartwatch will reportedly be equipped with a heart rate monitor.

According to people familiar with the project, Facebook’s wearable is scheduled for release in summer 2022 and will likely be priced around $400—equal to the base price of the latest Apple Watch model.

It’s facing some stiff competition: Apple, for one, has spent the better part of the last decade carving out a niche in the consumer wearables space. Not only does its smartwatch integrate directly with its iOS smartphone and computer operating system, it has also received FDA clearance for its electrocardiogram and sleep tracking capabilities.

The Apple Watch is also rumored to soon be able to measure a wearer’s glucose levels, blood pressure, hydration and more, thanks to Apple’s recently expanded collaboration with sensor maker Rockley Photonics.

Meanwhile, Google is another old pro at wearable tech. In addition to its Wear OS technology integrated into third-party smartwatches, Google recently finalized its $2.1 billion purchase of Fitbit, while its life science-focused sister company has introduced the Verily Study Watch for use in clinical trials, with its own FDA clearance for irregular pulse detection.

Amazon, too, has ventured into consumer health. Last August, the retail giant unveiled its own wellness-focused smartwatch, dubbed Halo, which tracks not only physical fitness but also emotional well-being and stress levels with the help of two microphones and a machine learning algorithm trained to analyze the tone and curtness of a wearer’s voice. Whether that device will end up prescribing retail therapy as a cure for a bad day remains to be seen.

https://www.fiercebiotech.com/medtech/facebook-escalates-big-tech-wars-proposed-heart-rate-tracking-smartwatch