Customer data is a precious and now highly regulated corporate asset. As a result, companies need regular security audits to make sure they are properly protecting their clients’ private information, complying with federal regulations, and avoiding liability and costly fines.

Not surprisingly, the market for compliance management software is large and growing, valued at $32.1 billion in 2020 and projected to reach $74.8 billion by 2028, according to Tested Market Research.

Drata is a relatively newly launched and fast-growing company providing an advanced security and compliance automation platform with the mission to help companies maintain the trust of their users, customers, partners, and prospects.

Founded in 2020 by Adam Markowitz, Daniel Marashlian, and Troy Markowitz, the San Diego-based company helps companies streamline their SOC 2 (a voluntary compliance standard developed by the American Institute of CPAs, which specifies how organizations should manage customer data) compliance audit process through continuous, automated control monitoring and evidence collection, resulting in lower costs and time spent preparing for annual audits.

“Trust is kind of the theme of my career,” says Drata Co-Founder and CEO Adam Markowitz. He landed his dream job in 2008 at Aerojet Rocketdyne working on NASA’s space shuttle engine program after graduating from college by creating a portfolio of his accomplishments and capabilities for his job interview to prove his skill and earn the trust of his employers. He would later help build the CV portfolio idea into a program NASA would use to help students prove their skills to employers.

When that program was discontinued at NASA in 2011, Markowitz would team up with Daniel Marashlian, and Troy Markowitz to form their own company called Portfolium in 2013 that would further build on the CV portfolio idea into a separate company. Portfolium quickly found market traction selling into universities and grew to a network of more than 5 million students. The company was acquired in 2019 by Instructure.

“To sell to Universities, we had to prove that their data was safe and secure and we took the time, resources and effort to build a system to automate the process. After the acquisition, myself and the same co-founders came back together in 2020 to start Drata and basically help companies stand up and maintain their security compliance posture, so they could earn the trust of those they want to do business with,” says Markowitz.

Today, Drata is one of the fastest growing SaaS companies. Within the first two months of formally launching in January of 2021, they brought on their first 100 customers. Over the next 18 months they would count 1,000s of customers and bring on over 250 employees in both the US and globally as they expand internationally.

“It's definitely the rocket ship that people describe made possible by the muscle memory of the early team coming back together, having solved a similar problem for ourselves in our prior life. The speed at which we've been able to execute, I think, is 100% attributed to trust as the foundation of our core values. We’re in the business of trust and our product helps companies build trust with their customers. We breathe, live and sleep trust here,” says Markowitz.

That growth trajectory has allowed the company to attract $128.2 million in venture funding to date. Its latest Nov. 8, 2021 $100 million B Round led by ICONIQ Growth, with additional investments from Alkeon Capital and Salesforce Ventures, already valued the company at $1 billion. Additional investors include GGV Capital, Cowboy Ventures, Leaders Fund and others. “We're also able to attract investors like SDCI, a group of about 50 CISOs from Silicon Valley's top tech companies, so that extra endorsement helps show the world what we're up to, and this new way of doing things,” says Markowitz.

Markowitz grew up in Los Angeles. His father worked in special effects for the film industry. He grew up playing competitive team sports, which helped shape his competitiveness and learning the importance of teamwork and leadership. “I attribute the obsessive, kind of relentless mentality to my mother. My dad provided the perspective and appreciation for the selflessness aspect of being a CEO. My dad always said he's never worked a day in his life. He loves what he does. I also have two older siblings, which I think helped a lot growing up. Watching them gave me the confidence to try anything and starting a company is one of the hardest things you can do,” says Markowitz.

He moved to San Diego where he graduated from the University of California, San Diego with a degree in structural engineering and aerospace structures and later earned his masters in astronautical engineering from the University of Southern California. After graduating he was hired by Aerojet Rocketdyne as an aerospace engineer in 2008 after creating the CV Portfolio program that would serve as the basis for the future development of the two companies he co-founded.

As for the future? “Our mission is to help ensure the future of trust in the cloud, by really leading the way when it comes to continuous automated compliance, which is new. So the vision is to be the trust layer between great companies and those they do business with and to be that real time system of record for a company's security compliance posture. On top of that, we think we could build unlimited applications, all centered around trust,” concludes Markowitz.

DMATS Award

MCLEAN, Va., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Global defense and technologies partner HII (NYSE: HII) has been awarded the Decisive Mission Actions and Technology Services task order under the General Services Administration One Acquisition Solution for Integrated Services multiple award, indefinite delivery/indefinite quantity contract. Support under this task order includes technology, development, integration, collaboration and sustainment support. It also includes threat and specialized analysis and analytics support, as well as operations integration and operational effects support.

This task order has a ceiling value of $826 million with a total period of performance consisting of a one-year base period and four, one-year option periods.

“Advancing U.S. national security is HII’s highest priority,” said Andy Green, president of HII’s Mission Technologies division. “We are proud to partner with the Department of Defense and its mission partners to deliver critical integrated technology services to counter and deter current and emerging global threats.”

A photo accompanying this release is available at: https://hii.com/news/hii-decisive-mission-actions-dod.

Under this task order, HII’s Mission Technologies division will support all DOD service components, component research labs, components of the DOD Fourth Estate, National Intelligence Agencies and Combatant Commands.

“The award of this task order further accelerates HII’s ability to support DOD in developing the next generation of technology innovation,” said Garry Schwartz, president of HII’s C5ISR business group. “We look forward to providing the department integrated services to solve the most challenging security threats facing our nation.”

About HII

HII is an all-domain defense and technologies partner, recognized worldwide as America’s largest shipbuilder. With a 135-year history of trusted partnerships in advancing U.S. national security, HII delivers critical capabilities ranging from the most powerful and survivable naval ships ever built, to unmanned systems, ISR and AI/ML analytics. HII leads the industry in mission-driven solutions that support and enable an all-domain force. Headquartered in Virginia, HII’s skilled workforce is 44,000 strong. For more information, visit:

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Contact:
Greg McCarthy
202.302.1202
gregory.j.mccarthy@hii-co.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/63502672-8e68-4793-bacc-fd3d76c4f5d5

Nasa’s long-awaited return to the Moon could begin as soon as 29 August, and the excitement was hard to miss even in the sober voices of Nasa officials and engineers during a press conference Wednesday.

“The Saturn five took us to the moon, half a century ago,” Nasa Administrator Bill Nelson said. “Now, as we embark on the first Artemis test flight, we recall this agency’s storied past, but our eyes are focused not on the immediate future, but out there.”

Artemis is Nasa’s new Moon program, and the upcoming flight on 29 August is dubbed Artemis I. It will be an uncrewed test flight to test Nasa’s huge Moon rocket, the Space Launch System, or SLS, and the Orion spacecraft, which will fly to, around, and beyond the Moon before returning to Earth 42 days later.

It’s a mission that will pave the way for Artemis II in the spring of 2023, a crewed lunar flyby, and Artemis III in 2025, which will fairly land humans on the lunar surface for the first time since 1972.

“NASA will land the first woman and the first person of color on the moon,” Nelson said in his remarks on Wednesday. “On these increasingly complex missions, astronauts will live and work in deep space. And we’ll develop the science and technology to send the first humans to Mars.”

Nelson and other Nasa officials provided an overview of the Artemis I mission and answered questions from the media about the upcoming test flight.

The SLS rocket and Orion are currently housed in the Vehicle Assembly Building at Kennedy Space Center, but will “roll out” to launch complex 39B around 18 August, according to Nasa Artemis Mission Manager Michael Sarafin.

“That will signal that launch is near,” he said.

The entire 32-story rocket and launch platform will be positioned over the flame trench at the launch complex by 27 August, and tanking operations, loading the rocket with liquid hydrogen fuel and liquid oxygen propellant, will begin the morning of 29 August. If they launch is scrubbed, Nasa has follow up launch windows on 5 and 6 September.

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If all goes for launch, SLS will list off on a plume fire generating 8.8 million pounds of thrust, 15% more powerful than the Saturn V rocket of the 1960s and 70s, Mr Nelson pointed out.

“The 32-story tall rocket will climb its way up through the atmosphere and in two minutes all the solid propellant the boosters will be consumed and will be jettisoned, as well as all the liquid fuel in eight minutes, and the core stage will be jettisoned,” Mr Sarafin said. The rocket’s upper stage and Orion will make a lap around the Earth as Orion extends its solar arrays to get off battery power, and if all looks good, “At that point the rocket has done its job and now Orion is on its way to the moon.”

Unlike the Apollo missions, which entered an equatorial orbit around the middle of the Moon, Artemis 1 will enter a polar orbit, “an elliptical orbit around the moon that is as if it is the face of a clock facing us,” Mr Nelson said. But it won’t stay there, and will continue out another 38,000 miles from the Moon.

“Orion will be some 270, 275,000 miles from Earth at that point at its farthest point,” Mr Sarafin said. “It’ll be farther than any human capable spacecraft has ever gone.”

All of which will be in service to the four main objectives for the Artemis I mission, according to Sarafin.

One objective is to demonstrate the SLS rocket and Orion can safely fly as intended, another is to collect as much data on the flight as possible. The third is to deploy small satellites to conduct science and take images of the mission to share with the public.

The final, and most important object is to test the Orion Spacecraft’s heat shield.

“After its long flight test, Orion will come home faster and hotter than any spacecraft has before, ‘’ Mr Nelson said. “It’s going to hit the Earth’s atmosphere at 32 times the speed of sound,” using friction to bleed off all the energy imparted to it by the massive SLS rocket at the time of launch.

It will take about 20 minutes from the point of peak heating until Orion slows enough for its parachutes to open, according to Mr Sarafin. “Then it will splash down at about 20 miles an hour in the Pacific,” he said. “A US Navy-NASA team will receive the awaiting spacecraft and will retrieve all the data off of it.”

Nasa will push Artemis I faster and harder than it would a flight with humans aboard, according to Mr Nelson, all in service of learning as much as possible ahead of the first human missions back to the Moon.

And the Artemis program itself is designed as an experimental training ground where Nasa can learn all it can about the technologies and human operations necessary to go far beyond the  Moon in an eventual crewed mission to the Red Planet.

“We’re going back to the moon in order to learn to live and work to survive,” Mr Nelson said. “We’re going to learn how to use the resources on the moon in order to be able to build things in the future as we go not a quarter of a million miles away, not a three day journey. But millions and millions of miles away, on a months and months, if not years journey.”

WASHINGTON (AP) — In a exact closed-door meeting with leaders of the agency's counterterrorism center, the CIA's No. 2 official made clear that fighting al-Qaida and other extremist groups would remain a priority — but that the agency's money and resources would be increasingly shifted to focusing on China.

The CIA drone attack that killed al-Qaida’s leader showed that fighting terrorism is hardly an afterthought. But it didn’t change the message the agency's deputy director, David Cohen, delivered at that meeting weeks earlier: While the U.S. will continue to go after terrorists, the top priority is trying to better understand and counter Beijing.

One year after ending the war in Afghanistan, President Joe Biden and top national security officials speak less about counterterrorism and more about the political, economic and military threats posed by China as well as Russia. There's been a quiet pivot within intelligence agencies, which are moving hundreds of officers to China-focused positions, including some who were previously working on terrorism.

The last week makes clear that the U.S. has to deal with both at the same time. Days after Ayman al-Zawahri was killed in Kabul, China staged large-scale military exercises and threatened to cut off contacts with the U.S. over House Speaker Nancy Pelosi's visit to Taiwan.

The U.S. has long been alarmed by China’s growing political and economic ambitions. China has tried to influence foreign elections, mounted campaigns of cyber and corporate espionage, and detained millions of minority Uyghurs in camps. Some experts also think Beijing will in coming years try to seize the self-ruled democratic island of Taiwan by force.

Intelligence officials have said they need more insights on China, including after being unable to definitively pinpoint the cause of the COVID-19 pandemic. Beijing has been accused of withholding information about the origins of the virus.

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And the war in Ukraine has underscored Russia's importance as a target. The U.S. used declassified information to expose Russian President Vladimir Putin's war plans before the invasion and rally diplomatic support for Kyiv.

Supporters of the Biden administration approach note that the U.S. was able to track and kill al-Zawahri is evidence of its capabilities to target threats in Afghanistan from abroad. Critics say the fact that al-Zawahri was living in Kabul, under the apparent protection of the Taliban, suggests there's a resurgence of extremist groups that America is ill-equipped to counter.

The shift in priorities is supported by many former intelligence officers and lawmakers from both parties who say it’s overdue. That includes people who served in Afghanistan and other missions against al-Qaida and other terrorist groups.

Rep. Jason Crow, a former Army Ranger who served in Afghanistan and Iraq, said he believed the U.S. had been overly focused on counterterrorism over the last several years.

“A far greater existential threat is Russia and China,” said Crow, a Colorado Democrat who serves on the House Intelligence and Armed Services committees. Terrorist groups, he said, “will not destroy the American way of life ... the way China can.”

CIA spokesperson Tammy Thorp noted that terrorism “remains a very real challenge.”

“Even as crises such as Russia’s invasion of Ukraine and strategic challenges such as that posed by the People’s Republic of China demand our attention, CIA will continue to aggressively track terrorist threats globally and work with partners to counter them,” Thorp said.

Congress has pushed the CIA and other intelligence agencies to make China a top priority, according to several people familiar with the matter who spoke on condition of anonymity to discuss sensitive intelligence matters. Pushing resources toward China has required cuts elsewhere, including in counterterrorism. Specific figures were unavailable because intelligence budgets are classified.

In particular, lawmakers want more information about China's development in advanced technologies. Under President Xi Jinping, China has committed trillions of dollars in investment on quantum science, artificial intelligence and other technologies that are likely to disrupt how future wars are fought and economies are structured.

As part of the shift, congressional committees are trying to better track how intelligence agencies spend their funding on China, seeking more detail about how specific programs contribute to that mission, one person familiar with the matter said.

“We are late, but it's good that we're finally changing our focus into that region,” said Rep. Chris Stewart, a Utah Republican who serves on the House Intelligence Committee. “That means in people, in resources, in military assets, and in diplomacy.”

The CIA last year announced it would create two new “mission centers” — one on China, one on emerging technologies — to centralize and Boost intelligence collection on those issues. The CIA is also trying to recruit more Chinese speakers and reduce wait times on security clearances to hire new people faster.

Inside the agency, many officers are learning Chinese and moving into new roles focused on China, though not all of those jobs require language training, people familiar with the matter said.

Officials note that intelligence officers are trained to adapt to new challenges and that many were moved more quickly into counterterrorism roles after the attacks of Sept. 11, 2001. Advances from counterterrorism work — including better use of data and different sources of intelligence to build networks and identify targets — are also useful in countering Russia and China, former officers said.

“It’s the analytics and targeting machine that has become extraordinary,” said Douglas Wise, a former CIA senior officer who was deputy chief of operations at the counterterrorism center.

The CIA's Counterterrorism Center, renamed the Counterterrorism Mission Center in a 2015 reorganization, remains a point of pride for many people who credit its work for keeping Americans safe from terrorism after Sept. 11. CIA officers landed in Afghanistan on Sept. 26, 2001, and were part of operations to displace the Taliban and find and kill leaders of al-Qaida including Osama bin Laden.

And 13 years after a double agent tricked officers pursuing al-Zawahri and blew himself up, killing seven agency employees, the CIA killed him in a strike with no reported civilian casualties.

The CIA was also involved in some of the darkest moments of the fight against terrorism. It operated secret “black site” jails to hold terrorism suspects, some wrongly, and was found by a Senate investigation to have used interrogation methods that amounted to torture. Elite Afghan special operations units trained by the CIA were also accused of killing civilians and violating international law.

There's long been a debate over whether counterterrorism pulled intelligence agencies too far away from traditional spying and whether some of the CIA's work in targeting terrorists should instead be done by special forces under the military.

Marc Polymeropoulos is a retired CIA operations officer and former base chief in Afghanistan. He said he supports a greater focus on China and Russia but added, “There’s no reason to diminish what we had to do."

“This notion that somehow all the CT work we did, somehow that was wrong, that we took our eye of the ball — just remember on Sept. 12 what everyone was feeling,” he said.

Re-orienting the agencies toward more of a focus on China and Russia will ultimately take years and require both patience and recognition that the agency’s culture will take time to change, Wise said.

“For decades, we have been doing counterterrorism,” Wise said. “We’ve got to have a rational plan to make this adaptation, which doesn’t take so long that our enemies can exploit a glacial process.”

Nomaan Merchant, The Associated Press

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Published on Friday, 05 August 2022 17:51

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Acquisition Includes TAVNEOS^® (avacopan), a First-in-Class Medicine for Patients With Serious Autoimmune Disease 

Tavneos Adds to Amgen's Decades-Long Leadership in Inflammation and Nephrology

THOUSAND OAKS, CA and SAN CARLOS, CA, USA I August 4, 2022 I Amgen (NASDAQ: AMGN) and ChemoCentryx, Inc., (NASDAQ: CCXI), a biopharmaceutical company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, today announced that the companies have entered into a definitive agreement under which Amgen will acquire ChemoCentryx for $52 per share in cash, representing an enterprise value of approximately $3.7 billion.

"The acquisition of ChemoCentryx represents a compelling opportunity for Amgen to add to our decades-long leadership in inflammation and nephrology with TAVNEOS, a transformative, first-in-class treatment for ANCA-associated vasculitis," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are excited to join in the TAVNEOS launch and help many more patients with this serious and sometimes life-threatening disease for which there remains significant unmet medical need. We also look forward to welcoming the highly skilled team from ChemoCentryx that shares our passion for serving patients suffering from serious diseases."

"A fierce commitment to improving human lives is the bond that unites Amgen and ChemoCentryx today," said Thomas J. Schall, Ph.D., president and chief executive officer of ChemoCentryx. "Last year, after 25 years of proud history, we at CCXI delivered on our founding promise with the approval of TAVNEOS for patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis). It is an honor to now join Amgen's great mission, and together begin a bright new era bringing landscape-shaping medicines like TAVNEOS to those who will benefit most."

TAVNEOS is an orally administered selective complement component 5a receptor inhibitor. It was approved by the U.S. Food and Drug Administration in October 2021 as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA-associated vasculitis), in combination with standard therapy.

ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound injury and dysfunction in the kidneys, lungs and other organs.

Amgen is a leader in inflammation and nephrology. The company's inflammation portfolio includes Otezla^®, ENBREL^®, TEZSPIRE^®, AMGEVITA™ (a biosimilar to HUMIRA^®), RIABNI^™ (a biosimilar to Rituxan^®), and AVSOLA^® (a biosimilar to REMICADE^®). Amgen's pipeline includes four innovative Phase 2 inflammation medicines – efavaleukin alpha for systemic lupus erythematosus and ulcerative colitis, ordesekimab for celiac disease, rocatinlimab for atopic dermatitis and rozibafusap alfa for systemic lupus erythematosus – as well as ABP 654, a biosimilar to STELARA^® that is in Phase 3 development. Amgen's nephrology portfolio includes EPOGEN^®, Aranesp^®, Parsabiv^® and Sensipar^®.

U.S. sales of TAVNEOS in the first quarter of 2022, the first full quarter of sales, were $5.4 million. TAVNEOS is also approved in major markets outside the U.S., including the European Union and Japan. Vifor Fresenius Medical Care Renal Pharma Ltd. will retain exclusive rights to commercialize TAVNEOS outside the U.S., except in Japan where Kissei Pharmaceutical Co., Ltd. holds commercialization rights and Canada where Otsuka Canada Pharmaceutical holds commercialization rights.

In addition to TAVNEOS, ChemoCentryx has three early-stage drug candidates that target chemoattractant receptors in other inflammatory diseases and an oral checkpoint inhibitor for cancer.

The transaction has been unanimously approved by each company's board of directors. The transaction is subject to ChemoCentryx stockholder approval, regulatory approvals and other customary closing conditions, and is expected to close in the fourth quarter of 2022.

Amgen management will comment further on the ChemoCentryx transaction on its Q2 earnings call today.

PJT Partners acted as financial advisor to Amgen and Wachtell, Lipton, Rosen & Katz is serving as its legal advisor. Goldman Sachs & Co. LLC acted as financial advisor to ChemoCentryx, and Latham & Watkins LLP is serving as its legal advisor.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that Boost health outcomes and dramatically Boost people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces^™ by Fortune and Great Place to Work^™ and one of the 100 most sustainable companies in the world by Barron's.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. 

About ChemoCentryx

ChemoCentryx is a biopharmaceutical company commercializing and developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. In the United States, ChemoCentryx markets TAVNEOS^® (avacopan), the first approved orally administered inhibitor of the complement 5a receptor as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis. TAVNEOS is also in late-stage clinical development for the treatment of severe hidradenitis suppurativa and C3 glomerulopathy (C3G). Additionally, ChemoCentryx has early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer. For more information about ChemoCentryx visit www.chemocentryx.com.

About TAVNEOS^® (avacopan)
TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS's selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS) and lupus nephritis (LN). The U.S. Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G.

About ANCA-Associated Vasculitis

ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound injury and dysfunction in the kidneys, lungs and other organs. Prior to the approval of TAVNEOS, treatment for ANCA-associated vasculitis was limited to courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.

U.S. PRESCRIBING INFORMATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

Contraindications

Serious hypersensitivity to avacopan or to any of the excipients

Warning and Precautions

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

Adverse Reactions

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

Drug Interactions

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information and Medication Guide.

Additional Information

This report may be deemed solicitation material in respect of the proposed acquisition of ChemoCentryx by Amgen. ChemoCentryx expects to file with the SEC a proxy statement and other relevant documents with respect to a special meeting of the stockholders of ChemoCentryx to approve the proposed merger. Investors of ChemoCentryx are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety when they become available because they will contain important information about ChemoCentryx, Amgen and the proposed Merger. Investors may obtain a free copy of these materials (when they are available) and other documents filed by ChemoCentryx with the SEC at the SEC's website at www.sec.gov, at ChemoCentryx's website at https://chemocentryx.com or by sending a written request to ChemoCentryx at 835 Industrial Road, Suite 600, San Carlos, CA 94070, Attention: Legal.

Participants in the Solicitation

ChemoCentryx and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of ChemoCentryx's stockholders in connection with the proposed merger will be set forth in ChemoCentryx's definitive proxy statement for its special stockholders meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed Merger will be set forth in the definitive proxy statement when and if it is filed with the SEC in connection with the proposed merger.

SOURCE: Amgen

WESTMINSTER, Colo., August 04, 2022--(BUSINESS WIRE)--Maxar Technologies (NYSE:MAXR) (TSX:MAXR), provider of comprehensive space solutions and secure, precise, geospatial intelligence, announced it received a Phase A study contract from NASA for the National Oceanic and Atmospheric Administration’s (NOAA) Geostationary Extended Observations (GeoXO) Spacecraft mission. During the ten-month contract, Maxar will develop the spacecraft concept, mature necessary technologies, conduct analysis on robotic servicing and payload accommodations, help define the potential performance, risks, costs and development schedule for a three-satellite, next-generation constellation of weather monitoring satellites.

"Maxar is excited to work on designing NOAA’s next-generation weather monitoring spacecraft," said Chris Johnson, Maxar Senior Vice President and General Manager of Space. "This contract builds on our legacy of manufacturing the first- and second-generation GOES satellites, which operated beyond their expected lifetimes. Maxar is committed to helping customers use spacecraft and space-based data to study weather patterns and mitigate climate change, and this GeoXO study contract is the next evolution of that work."

Maxar’s flight-proven 1300-class platform serves as the basis for the company’s Phase A Study contract. Today, there are 90 Maxar-built spacecraft operating on orbit that use the 1300-class platform. This platform provides the precision, stability, reliability and assured operations that NOAA requires for the GeoXO mission.

The GeoXO program will continue Earth observations from geostationary orbit, providing vital information to address major environmental challenges in the United States. GeoXO will also leverage new capabilities to address emerging climate issues that threaten the security and well-being of every American.

Maxar previously built the first-generation and second-generation Geostationary Operational Environmental Satellites (GOES), which were known for their high performance, longevity and reliability. Contracted to build a constellation of three satellites in the 1970s, Maxar (then Ford Aerospace) built GOES-A, -B and -C for NASA’s Office of Space Science Applications. They were later renamed GOES 1, 2 and 3. Maxar also manufactured five more weather monitoring satellites for NOAA: GOES 8, 9, 10, 11 and 12, which were launched in the late 1990s and early 2000s.

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About Maxar

Maxar Technologies (NYSE:MAXR) (TSX:MAXR) is a provider of comprehensive space solutions and secure, precise, geospatial intelligence. We deliver disruptive value to government and commercial customers to help them monitor, understand and navigate our changing planet; deliver global broadband communications; and explore and advance the use of space. Our unique approach combines decades of deep mission understanding and a proven commercial and defense foundation to deploy solutions and deliver insights with unrivaled speed, scale and cost effectiveness. Maxar’s 4,400 team members in over 20 global locations are inspired to harness the potential of space to help our customers create a better world. Maxar trades on the New York Stock Exchange and Toronto Stock Exchange as MAXR. For more information, visit www.maxar.com.

Forward-Looking Statements

This press release may contain forward-looking statements that reflect management's current expectations, assumptions and estimates of future performance and economic conditions. Any such forward-looking statements are made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company cautions investors that any forward-looking statements are subject to risks and uncertainties that may cause actual results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements, including those included in the Company’s filings with U.S. securities and Canadian regulatory authorities. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as may be required under applicable securities law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005965/en/

Contacts

Investor Relations Contact:
Jonny Bell
Maxar Investor Relations
1-303-684-5543
jonny.bell@maxar.com

Media Contact:
Kristin Carringer
Maxar Media Relations
1-303-684-4352
kristin.carringer@maxar.com

When Sunny Shergill was named technical theater director at Clayton Valley Charter High School (CVCHS), he returned to his alma mater determined to give students the best training possible at the high school level. With an aging wireless intercom system that was struggling to make the grade, Shergill convinced school officials to purchase a CrewCom wireless intercom system from Pliant Technologies (opens in new tab).  

Clayton Valley Charter High School is a tuition-free, public charter school located in Concord, CA. For Shergill, his goal in acquiring the CrewCom system was two-fold. “First, our school wanted to provide the students in our Tech program with industry standard equipment and the best hands-on experience possible,” said Shergill. “Secondly, we required full-campus coverage. We run multiple events on the same day at various locations and we needed to be able to deploy our communication system throughout the campus, which is very large. With our old system, every time we did an event, we needed to disassemble our rack or have a rolling rack, which was difficult. When the decision was made to find something that would fit our needs better; I knew we needed to look at Pliant and its CrewCom system.”