Tag Archives: approved

Immunotherapy Combo Now Approved for First-Line Mesothelioma in EU

Combination therapy with the immunotherapies nivolumab (Opdivo) and ipilimumab (Yervoy) is now approved in the European Union for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).

This is the first new treatment for mesothelioma in more than 15 years.

This aggressive and often deadly disease is frequently associated with asbestos exposure. “Mesothelioma can be a devastating diagnosis for patients and their families, and the disease has a significant impact throughout Europe, which has the highest incidence rate of mesothelioma globally,” said Stefania Vallone, board member, Women Against Lung Cancer in Europe.

The European Commission’s approval of the combination drug regimen allows for its use in 27 European Union member states, as well as Iceland, Liechtenstein, and Norway.

The regimen has thus far been approved in six other countries, including the United States, where it received US Food and Drug Administration approval in October 2020, as reported by Medscape Medical News.

The approvals are based on findings of superior overall survival (OS) versus standard-of-care chemotherapy with pemetrexed and cisplatin or carboplatin among patients with unresectable MPM in the open-label, multi-center, randomized phase 3 CheckMate 743 trial. Prespecified interim analysis data from the trial were published in January 2021 in The Lancet.

“After many years of limited progress in the treatment of malignant mesothelioma, we saw an important clinical benefit for patients with nivolumab plus ipilimumab in the CheckMate 743 trial,” lead study author Paul Baas, MD, PhD, department of thoracic oncology, Netherlands Cancer Institute and the University of Leiden, said in a press statement from the drugs’ maker, Bristol Myers Squibb.

Improved Survival and Other Outcomes

Baas initially reported the findings from CheckMate 743 — the first positive phase 3 trial of an immunotherapy in unresectable malignant mesothelioma — during the presidential symposium of the World Conference on Lung Cancer 2020, as reported by Medscape Medical News at the time. He noted that the trial “met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis,” and also said the regimen should be considered a new standard of care.

The CheckMate 743 trial compared the immunotherapy regimen with chemotherapy in a cohort of 605 treatment-naïve patients. Participants were randomized 1:1 to nivolumab and ipilimumab for up to 2 years or six cycles of combination chemotherapy.

OS at 2 years was improved by 26% (hazard ratio [HR], 0.74) with the immunotherapy regimen compared with chemotherapy (41% vs 27%, respectively). Median OS was 18.1 months versus 14.1 months (HR, 0.74).

Median progression-free survival was 6.8 months and 7.2 months in the immunotherapy and chemotherapy arms, and the confirmed overall response rates were 40% and 43%, respectively.

Median response duration was 11.0 months versus 6.7 months, and at 2 years, the response was ongoing among 32% versus 8% of patients in the immunotherapy and chemotherapy arms, respectively.

The recommended doses are 360 mg every 3 weeks for nivolumab and 1 mg/kg for ipilimumab every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression.

Acceptable Safety

Adverse reactions occurring in at least 10% of patients treated with the immunotherapy combination were fatigue (43%), diarrhea (31%), rash (30%), musculoskeletal pain (27%), nausea (24%), decreased appetite (24%), pruritus (21%), constipation (19%), and hypothyroidism (13%).

“The safety profile…in first-line MPM was manageable using established adverse event management protocols and consistent with previous studies of the combination in other tumor types,” Bristol Myers Squibb notes in its press release.

This latest approval is the fourth for combination nivolumab plus ipilimumab treatment for an advanced cancer type. The dual immunotherapy is also indicated in the European Union for non-small cell lung cancer, melanoma, and renal cell carcinoma.

Sharon Worcester is an award-winning reporter for MDedge News, part of the Medscape Professional Network.

For more news, follow Medscape on Facebook, Twitter, Instagram, YouTube, and LinkedIn.

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This post originally appeared on Medscape Medical News Headlines

Novel Drug Approved by FDA for Some Bile Duct Cancers

A novel drug, infigratinib (Truseltiq), is now available in the United States for adults with previously treated unresectable bile duct cancer harboring a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

The agent is an orally administered, ATP-competitive tyrosine kinase inhibitor of FGFR.

It was granted an accelerated approval by the US Food and Drug Administration (FDA) on the basis of response rate data from a single arm, open label phase 2 trial, dubbed CBGJ398X2204. This trial involved 108 patients with locally advanced or metastatic cholangiocarcinoma — including 107 with stage IV disease, the FDA noted in a press release.

These types of bile duct cancers, which affect about 20,000 people in the United States and European Union each year, are aggressive and often diagnosed in later stages when treatment options are limited and prognosis is poor. The median 5-year survival rate is 9%, the drug’s maker, BridgeBio Pharma affiliate QED Therapeutics, and its partner, Helsinn Group, noted in their joint press release.

The FDA also approved the FoundationOne comprehensive diagnostic (CDx) genomic profiling test as the registrational companion CDx device for identifying patients with FGFR2 fusion or other rearrangement who might benefit from treatment with infigratinib.

FoundationOne CDx is a comprehensive genomic profiling (CGP) test for solid tumors, currently approved as a CDx test for 26 unique therapies. It is the only tissue-based CGP test approved as a companion diagnostic test for infigratinib, according to the device maker, Foundation Medicine

Details of Infigratinib Results

Patients enrolled in CBGJ398X2204 received infigratinib at a once-daily dose of 125 mg for 21 consecutive days followed by 7 days off therapy, in 28-day cycles until disease progression or unacceptable toxicity.

The overall response rate was 23%. One patient experienced complete response and 24 had partial response.

The duration of response was 5 months, and in eight of the 23 responders the response was maintained for 6 months or more.

The study results were reported at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium by lead investigator Milind Javle, MD, professor of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center, Houston.

Adverse reactions occurring in at least 20% of patients included hyperphosphatemia, increased creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting.

“Serious risks include hyperphosphatemia and retinal pigment epithelial detachment and monitoring for these adverse reactions during treatment is recommended,” the FDA notes in its press release, adding that “[c]ontinued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).”

In addition to the pivotal second-line trial of infigratinib for bile duct cancer, QED Therapeutics is also enrolling patients in the phase 3 PROOF trial comparing the agent with gemcitabine plus cisplatin in the first-line setting.

Enrollment is also ongoing in trials looking at infigratinib for bladder and urinary tract cancers and achondroplasia.

The company has also launched ForgingBridges, a “comprehensive patient support program designed specifically to provide education, access and affordability resources for patients during their TRUSELTIQ journey.”

Sharon Worcester is an award-winning reporter for MDedge News, part of the Medscape Professional Network.

For more news, follow Medscape on Facebook, Twitter, Instagram, YouTube, and LinkedIn.

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This post originally appeared on Medscape Medical News Headlines

City delays release of approved Austin homeless encampments, citing too many restrictions

AUSTIN (KXAN) — Austin’s Homeless Strategy Manager says the city needs to relax some of its restrictions on sanctioned homeless encampments if it hopes to find any city-owned land that could work as an approved homeless camp.

Dianna Grey sent a memo to the mayor and City Council on Tuesday, saying in part that Council added too many secondary restrictions at its May 18 meeting and that’s made it difficult to find suitable sites.

Under council’s criteria, factors like being too close to a school, lacking access to utilities or restricting citizen access to high-use public amenities or programming would be disqualifiers for any potential sites.

“Applying all of the Secondary Criteria articulated by Council Members at the May 18
presentation and thereafter severely limits the use of City-owned land as an option for
consideration,” Grey wrote in the memo.

“If Council modifies the Secondary Criteria to allow for some City-owned land options to be
considered for encampments, staff will continue our analysis of any identified properties and will build the framework for a community engagement process.”

That means on June 1 — exactly one month after Austin voters overwhelmingly chose to reinstate the city’s camping ban — Austin still has approved no location to tell those people experiencing homelessness where they can legally camp. And the city doesn’t have enough shelters to house them all.

Austin was supposed to release new list of sanctioned homeless sites Tuesday

City staff said they would release a narrower list of city-sanctioned homeless camping sites on Tuesday, but that has now changed in light of Grey’s memo. She asked for new guidance from Council by June 10 as well as how much money the Homeless Strategy Office will have to spend before city staff moves forward with potential locations.

The city released a first draft of 45 potential sites on May 18 with slightly more than half of those sites in east and southeast Austin. Officials called the release a “snapshot” after reviewing more than 70 sites initially.

Almost immediately, Council members started exploring alternative sites that weren’t on that initial list.

State camping ban cut list of proposed Austin homeless sites in half

Separately, at the State Capitol, lawmakers saw the City of Austin’s potential locations and then amended and passed a statewide camping ban bill to also prohibit cities from using parkland for permanent homeless camps.

At least 24 of the 45 locations the City of Austin released appear to be on parkland.

City warning people at homeless sites about ban — but no evictions yet

Even though city officials don’t yet know where to tell homeless people to legally camp, they have been to at least 42 current encampments to inform those there about the camping ban and a timetable for leaving.

This “education phase” of the ordinance is the first of a four-phase plan the city and the Austin Police Department instituted to help prepare people experiencing homelessness for their eventual eviction.

The first phase is supposed to end June 12. After that, those found in violation of the ordinance could be subject to written warnings and later potential fines. It’s unclear how the delay of city-sanctioned sites will impact the rollout of that four-phase plan.

Author: Wes Wilson
This post originally appeared on KXAN Austin

Texas elections overhaul approved by senate — is it security or voting restriction for people of color?

AUSTIN (KXAN/Texas Tribune) — Very early Sunday morning, the Texas Senate voted to approve a bill that would overhaul voting rules in the Lone Star State. While approval by the Texas House is still needed, the legislation could head to the desk of Governor Greg Abbott to be signed into law very soon.

Senate Bill 7 will make several changes to voter registration, voting by mail, early voting and ballot counting.

Republican lawmakers in Texas have pushed the legislation. It comes amid a nationwide push by the GOP to crack down on alleged voter fraud. Major parts of the “election security” of the bill include a requirement to live stream counting of ballots and verification of signatures.

Earlier this week, and throughout the legislative session, Abbott has stressed urgency in securing Texas’ elections. Although there is no evidence of widespread voter fraud in the 2020 Election, Abbott nonetheless has made laws like SB 7 emergency priority.

SB 7 would create these changes:

  • Ban mail-in ballot drop boxes
  • Ban most drive-thru voting
  • Limit extended early voting hours
  • Require voters with disabilities to prove they can’t get to polls in order to get mail-in ballots
  • Allow partisan poll watchers to record voters who receive help filling out their ballots
  • Forbid local election officials from encouraging voters to fill out applications to vote by mail — even if they qualify

The Legislature is up against a Sunday night deadline to approve conference committee reports, like the compromise version of SB 7. Had the Senate waited until later Sunday to consider it, it could have left it in reach of a filibuster that could’ve killed the bill. The House is expected to vote on the final version of the bill later today.

Senate discussion on SB 7 regularly landed on the detrimental effect Democrats feared the legislation would have on voters of color and the significant portions of the bill that were written to outlaw some of the voting initiatives Harris County used in the last election.

SB 7 would ban drive-thru voting and the day of 24 hours of uninterrupted early voting the county offered — both of which proved particularly successful in reaching voters of color. An analysis by Harris County’s election office estimated that Black and Hispanic voters cast more than half of the votes counted both at drive-thru sites and during extended hours.

Other controversial changes include a new window of 1 to 9 p.m. for early voting on Sundays. State Sen. Royce West, D-Dallas, raised the possibility that change could hamper “souls to the polls” efforts meant to turn out voters after church services and questioned the justification for 1 p.m. start time.

“We’re going to be able to buy beer at 10 o’clock in the morning but we can’t vote until 1 p.m.,” West said.

But President Joe Biden has called the bill an attempt at voter restriction, saying in part:

“It’s part of an assault on democracy that we’ve seen far too often this year — and often disproportionately targeting Black and Brown Americans. In the 21st century, we should be making it easier, not harder, for every eligible voter to vote.”
President Joe Biden

Meanwhile, those in Texas have been vocal in their approval or condemnation of the legislation.

Texas reactions

On Sunday morning, the Texas Senate Democratic Caucus issued a statement, saying in part: “Shortly after 6 a.m., the Texas Senate passed Senate Bill 7 (S.B. 7), the most significant voter suppression legislation our state has seen in half a century. We aggressively fought this bill because it will disenfranchise racial and ethnic minority voters and voters with disabilities, including veterans.”

Texas Democrats said the bill reads like “the Jim Crow laws of the South,” and is in violation of the Voting Rights Act. State Democrats say it will result in a lawsuit against Texas.

“Every eligible Texan deserves to have their voice heard at the ballot box — regardless of their race, ethnicity, disability, gender, age, income, or party. SB 7 makes it harder for every Texan to vote.”

Texas Democrats, along with Julián Castro and Beto O’Rourke, held a briefing to condemn the bill’s passage on Sunday.

But Texas Republican Senator Dawn Buckingham called the bill a “significant step in the right direction for Texas towards election integrity. I’m happy to vote for it.”

Meanwhile, the Texas Legislative Black Caucus and the Texas NAACP held a joint conference Sunday afternoon at the Texas Capitol — to discuss how the bill’s passage would disproportionately affect people of color.

“Instead of now having a poll tax or a literacy test, they’re instituting measures like [eliminating] “Souls to the Polls” — who do you think uses that?” said State Rep. Ron Reynolds. “It’s Black and brown communities. And they’re doing it with surgical precision. What they’re doing is nothing more than modern-day Jim Crow, 2.0.”

‘The New Jim Crow’

Nationally, there have been over 250 similar bills introduced in the majority of states. They’re all aim to narrow voting rules. It spurred U.S. House Democrats to pass the “For the People Act” voting protections bill. It’s headed for the Republican-controlled Senate, where it’s unlikely to have an easy ride.

Back in March, the state of Georgia passed a sweeping elections bill, which was called by the state’s own Governor — a Republican — “Jim Crow in the 21st Century.”

The rewrite of Georgia’s election rules come after the state played a critical role in handing Biden the presidency and control of the U.S. Senate to Democrats.

Portions of this article originally appeared in The Texas Tribune at www.texastribune.org. The Texas Tribune is a nonprofit, nonpartisan media organization that informs Texans – and engages with them – about public policy, politics, government and statewide issues.

Author: Russell Falcon
This post originally appeared on KXAN Austin

UK slashes jab order by 10 million – why?

There has been no clear reason as to why, however, Britain’s vaccine rollout has been progressing at speed, and the company also faces issues with its supplies to Europe and reports of rare blood clots.

Trials found it prevented serious illness but was 67 percent effective overall when moderate cases were included.

The Belgian made vaccine is produced by the pharmaceutical company Janssen.

Health Secretary Matt Hancock said: “This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus.

“As Janssen is a single-dose vaccine, it will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year.”

The UK regulator MHRA was initially concerned about the use of the vaccine in the UK after concerns were raised in the US about potential links to highly rare blood clots.

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This post originally appeared on Daily Express :: UK Feed

What existing Virgin Media and O2 customers need to know as £31bn merger is approved

Well, that’s it. After months of consultation, the Competition and Markets Authority (CMA) approved the £31 billion merger between Virgin Media and O2 to go ahead on Thursday May 20, 2021. Despite some early concerns the Virgin Media-O2 merger could result in either higher costs for customers, or an incentive to reduce service for rival networks (like Sky Mobile) that rely on the infrastructure created by O2, the CMA has decided to allow the deal to proceed unimpeded. This isn’t wholly surprising.

After all, Virgin Media and O2 execs have been pretty boyish about the chances of the multi-billion deal getting the stamp of approval ahead of the summer (even naming the new CEO of the merged firm). And right on time, the companies can move to the next stage of their joint venture.

So, for anyone who currently has a contract with Virgin Media and O2 …what does all this mean?

Well, to be honest, it’s hard to tell at the moment. Virgin Media and O2 have both promised huge investment into their infrastructure to the tune of £10 billion over the next five years. If you’re an O2 customer and have struggled with low signal in certain areas, patchy 5G connectivity, or other issues, you’d hope that lump of cash would go some way to solve those issues. Crucially, if you’re a Virgin Mobile customer and have suffered with the same issues, your mobile network is set to be upgraded before any of that £10 billion is spent.

That’s because Virgin Media doesn’t own a 5G network at the moment. Instead, Virgin Media has struck a deal with Vodafone to piggyback on its 5G network so that its customers don’t miss out. With O2 operating its own 5G infrastructure, we’d have to imagine that one of the advantages of the merger is that Virgin finally gets its own infrastructure of 5G masts across the UK.

If you’re happy with your current SIM-only or phone contract from Virgin Media or O2, we’d hope to see 4G and 5G coverage (and fingers crossed, download speeds) slowly creep up in the coming months and years.

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But what about Virgin Media fibre broadband customers? What benefits will the £31bn merger bring to them?

Well, the green light from the regulators already brings some good news for any Virgin Media broadband customers patiently waiting for an upgrade to the firm’s next-generation gigabit-capable fibre connection. That’s because Lutz Schuler, who currently leads Virgin Media in the UK but will become the Chief Executive Officer (CEO) of the combined Virgin Media-O2 company, has pledged to connect an extra one million homes to this gigabit-capable broadband “within 12 months of the merger closing”.

Virgin Media had already pledged to reach a target of 15 million homes by the end of this year, so now that regulators have given the stamp of approval, the extra commitment will bring the total to 16 million by the end of 2021. That’s seriously impressive. For comparison, BT-owned Openreach – which supplies broadband connections to BT, EE, Sky, TalkTalk, Plusnet, and more – has connected some 4.5 million premises with its gigabit-capable fibre broadband. And Virgin Media-O2 isn’t planning to drop its vast lead over the competition anytime soon.

The newly-merged company has spoken previously about an “ambition to accelerate investments” and connect 7 million more homes to gigabit-capable broadband “in the coming years.” It’s unclear exactly where these homes would be, but it could see smaller towns and villages see these future-proofed connections start to come online. With millions choosing to work from home permanently, these upgrades could make a number of rural towns feasible options for those looking to leave cities behind.

This isn’t completely new. We’ve already seen rivals deploy these types of incentives – BT-owned mobile network EE is currently offering a three-month free subscription to BT Sport (and when watching on EE’s network, you won’t be charged for any of the data used to stream matches). There’s also a “Smart Benefit” available for some pay-monthly and SIM-only customers that bundles a free BT Sport subscription for the length of your contract, for example.

So, if you’ve been a loyal O2 customer and are looking to splash the cash on a new paid-for television subscription with Sky Cinema, Sky Sports, and a super-fast broadband connection… it might be worth holding off a few more weeks to see what Virgin Media has to offer customers from its sister brand before signing up to a two-year contract.

And finally, aside from the potential freebies and perks for existing Virgin Media and O2 customers, it could also be a good opportunity for a career change. That’s because parent companies Liberty Global and Telefonica have pledged to create 4,000 jobs and 1,000 apprenticeships if they receive regulatory approval from the CMA.

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This post originally appeared on Daily Express :: Tech Feed

Virgin Media and O2 approved to merge this summer

Virgin Media and O2 have received the all-clear from UK regulators to proceed with a planned £31 billion merger. So, with these rival firms now set to become a single broadband, television and mobile phone behemoth – what does that mean for existing customers? And when can we expect to see some changes?

Announcing its decision to allow the merger to move ahead unimpeded, Competition and Markets Authority (CMA) inquiry chair Martin Coleman said: “O2 and Virgin are important suppliers of services to other companies who serve millions of consumers. It was important to make sure that this merger would not leave these people worse off. That’s why we conducted an in-depth investigation. After looking closely at the deal, we are reassured that competition amongst mobile communications providers will remain strong and it is therefore unlikely that the merger would lead to higher prices or lower quality services.”

First up, the green light for the merger spells good news for any Virgin Media customers patiently waiting for an upgrade to the firm’s next-generation gigabit-capable fibre broadband. That’s because Lutz Schuler, who currently leads Virgin Media in the UK but will become the Chief Executive Officer (CEO) of the combined Virgin Media-O2 company, has pledged to connect an extra one million homes to this gigabit-capable broadband “within 12 months of the merger closing”.

Virgin Media had already pledged to reach a target of 15 million homes by the end of this year, so now that regulators have given the stamp of approval, the extra commitment will bring the total to 16 million by the end of 2021. That’s seriously impressive.

For comparison, BT-owned Openreach – which supplies broadband connections to BT, EE, Sky, TalkTalk, Plusnet, and more – has connected some 4.5 million premises with its gigabit-capable fibre broadband. And Virgin Media-O2 isn’t planning to drop its vast lead over the competition anytime soon.

The newly-merged company has previously spoken about an “ambition to accelerate investments” and connect seven million more homes to gigabit-capable broadband “in the coming years.” It’s unclear exactly where these homes would be, but it could see smaller towns and villages see these future-proofed connections start to come online. With millions choosing to work from home permanently, these upgrades could make a number of rural towns feasible options for those looking to leave cities behind.

And when there isn’t a fixed-line broadband connection available, Virgin Media-O2 wants to keep you connected with 5G too. Yes, this £31 billion merger isn’t simply about fibre broadband, but is also designed to allow both companies to compete against BT and EE when it comes to next-generation mobile data speeds too.

Superfast 5G networks are widely expected to become essential to many customers in the coming years, thanks to speedy downloads and low-latency which many believe will accelerate remote working, Augmented Reality (AR) applications, and self-driving cars. As it stands, Virgin Media has struck a deal with Vodafone to piggyback on its 5G network so that its customers don’t miss out.

However, with the O2 merger now going ahead, Virgin Media will finally have its own 5G infrastructure across the UK. Virgin Media owner Liberty Global would be able to invest as it sees fit. It could also leverage the 5G network to power home Wi-Fi connections for those who aren’t currently connected to its fibre broadband infrastructure. So, you could have a 5G-powered hub supplying Wi-Fi to your devices before the road is dug up and your street is connected to the gigabit-capable cables. EE currently offers a similar solution to customers not able to tap into the Openreach broadband network.

In other words, with the merger now moving ahead, Virgin Media customers should expect to see more options around 5G coming online. And O2 customers should begin to see more integration with the services already on offer from Virgin Media, including super-fast home broadband, public Wi-Fi hotspots on the London Underground and elsewhere, and its TV 360 set-top box that competes with Sky TV.

Virgin Media now has a real incentive to tempt its broadband or telly customers to move away from rival mobile contracts, so we should expect to see exclusive deals to entice EE, Three or Sky customers to move their SIM-only plan or pay-monthly phone contract in-house with Virgin Media – like their home broadband. That could be a great way for customers with phone contracts, television, and broadband with three different companies to save some dosh – and make their Direct Debits a little simpler to read on the monthly statement.

As mentioned above, it’s possible we will see the two companies leverage one another’s strengths to compete with rivals. So, O2 could offer streaming of content from your Virgin Media TV V6 box when out-and-about without counting towards your monthly mobile data allowance, for example. This would be a clever way to tempt those who already pay for the telly to move their mobile contract in-house.

We’ve already seen rivals deploy these types of incentives – BT-owned mobile network EE is currently offering a three-month free subscription to BT Sport (and when watching on EE’s network, you won’t be charged for any of the data used to stream matches). There’s also a “Smart Benefit” available for some pay-monthly and SIM-only customers that bundles a free BT Sport subscription for the length of your contract.

Aside from the potential freebies and perks for existing Virgin Media and O2 customers, it could also be a good opportunity for a career change. That’s because parent companies Liberty Global and Telefonica have pledged to create 4,000 jobs and 1,000 apprenticeships if they receive regulatory approval from the CMA.

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This post originally appeared on Daily Express :: Tech Feed