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Monday, September 20, 2021

Verrica Pharma Gets Complete Response Letter from FDA

 No Specific Deficiencies Related to the Manufacturing of VP-102 Identified by FDA in its General Inspection of a Facility of the Contract Manufacturer

No Clinical, Safety or CMC Issues Specific to VP-102 Identified

Verrica Pharmaceuticals Inc. (the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA by three months to September 23, 2021 to allow the Agency additional time to review information submitted by the Company in response to comments from the Agency regarding the Company’s human factors study.

According to the CRL, the FDA has identified deficiencies at a facility of a contract manufacturing organization (CMO), which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility. At no time prior to the CRL was the Company notified by the FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that their general investigation of the facility would have any impact on the Company’s NDA. More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.

The Company understands from the CMO that it has implemented corrective actions to address the Agency’s concerns and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days. During this timeframe, the Company will engage with the Agency to demonstrate that the Company’s good manufacturing practices, controls and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety or quality of VP-102.

https://www.marketscreener.com/quote/stock/VERRICA-PHARMACEUTICALS-I-44247380/news/Verrica-Pharmaceuticals-Receives-Complete-Response-Letter-from-the-FDA-identifying-deficiencies-at-36470594/

Merck KGaA to Invest More Than $3.5B in Electronics Business

 Merck KGaA said Monday that it will invest in its electronics business over the coming years, as it looks to capitalize on global growth in demand for semiconductor and display materials.

The German company plans to invest more than 3 billion euros ($3.52 billion) in its electronics division by the end of 2025. Money will go into research and development, as well as into capital expenditure on long-term fixed assets, Merck KGaA said.

The company aims for compound annual growth of between 3% and 6% to 2025 in the business, which makes memory chips and processors.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Merck-KGaA-to-Invest-More-Than-3-5-Billion-in-Electronics-Business-36464007/

Illumina expects EU order to keep Grail a separate company

 

Illumina Inc expects an EU order to keep recently acquired Grail Inc as a separate company, the U.S. life sciences company said on Monday, hours after EU antitrust regulators warned of interim measures for closing the deal before their approval.

The company is likely to face other measures on top of the hold separate order, however, with the EU competition enforcer sending a warning to other companies.

Illumina finalised the Grail takeover last month and said it would hold the company separate while waiting for a European Commission decision on the deal, defying EU merger rules against gun-jumping.

Previous instances of gun-jumping have resulted in companies being hit with million-euro fines. Sanctions can be as much as 10% of a company's global turnover.

"We had anticipated that the Commission would seek to impose a hold separate order, and this is the reason why it has already voluntarily agreed to such an arrangement; their proposals are based on Illumina's voluntary undertakings," Illumina said in a statement.

It said it would discuss certain changes suggested by the EU in the coming days.

The EU competition enforcer earlier on Monday said it had sent a statement of objections or charge sheet to the companies, setting out the interim measures it plans to take. It did not provide details.

Under EU merger rules, the competition watchdog can order companies to unwind their deals or sell off shares or assets acquired for violations.

Commission Vice-President Margrethe Vestager underlined the seriousness of Illumina's actions, saying it was the first time companies had openly implemented a deal while regulators were still investigating.

"The standstill obligation is a cornerstone of our ex-ante merger control regime which aims at preventing harmful effects to competition while our review is ongoing," she said in a statement.

The Commission said the interim measures aim to restore and maintain effective competition pending a final decision on the deal.

The Commission will make a final decision on the measures after receiving the companies' response.

https://www.marketscreener.com/news/latest/Illumina-expects-EU-order-to-keep-Grail-a-separate-company--36468664/

Medtronic's Latest Recall Linked to 2 Deaths, 10 Serious Injuries

 At least two people have died, and 10 others have been seriously injured after a procedure to treat brain aneurysms resulted in a piece of a medical device made by Medtronic fractured and broke off inside their bloodstream.

Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk that the delivery system's wires and tubes will fracture and break off during placement, retrieval, or movement of the device. There have been 59 reported device malfunctions associated with the recall, which Medtronic initiated in July. The recall includes 8,825 devices that were distributed between April 18, 2019 and August 13, 2020.

The recalled devices are permanent mesh cylinders (stents) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires. These devices are intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel. The devices include a guidewire-based delivery system used to place the implant inside the patient.

Medtronic inherited these devices through its $49.9 billion Covidien deal in early 2015, and Covidien had previously acquired the devices when it bought ev3 in 2010 for $2.6 billion. The subsidiary's offical name is Micro Therapeutics but it is doing business as ev3 Neurovascular.

According to the FDA notice issued Monday, fractured pieces of these devices could be left inside the patient's brain bloodstream. It is also possible that attempts to retrieve the fractured pieces may make the patient’s condition worse, the agency noted. The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.

This represents the ninth Medtronic recall that FDA has issued a notice about this year. Four of those recalls were related to the now-discontinued HeartWare HVAD system. Other Medtronic recalls this year include the recall of seven of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to the risk of a shortened battery life; and a recall of the Valiant Navion thoracic stent graft systems due to patient safety issues observed in a global cinical trial. FDA has issued a total of 45 recall notices so far this year.

https://www.mddionline.com/regulatory-quality/medtronics-latest-recall-linked-2-deaths-10-serious-injuries

NYC to conduct weekly random COVID-19 tests in schools

 New York City will begin conducting weekly, random COVID-19 tests of unvaccinated students in the nation’s largest school district in an attempt to more quickly spot outbreaks in classrooms.

New York City Mayor Bill de Blasio made the announcement Monday, and said the changes followed U.S. Centers for Disease Control and Prevention guidelines and would keep students from missing vital classroom time.

The changes come after the first full week of the school year in which nearly 900 classrooms, including those in charter schools, were fully or partially closed in the city’s 1,876 schools because of reports positive COVID-19 cases. One school entirely closed for 10 days after a cluster of cases.

Unlike other school districts, New York City is not offering any remote instruction this school year, despite concerns about the highly contagious delta variant’s ability to spread. De Blasio has said children need to be back in school for their mental and physical health and social development.

The new rules take effect on Sept. 27. That day is also the deadline for the city’s public school teachers and staff to get at least their first shot of the COVID-19 vaccine under a city-wide schools mandate.

https://apnews.com/article/business-health-new-zealand-pandemics-coronavirus-pandemic-43f1a4ed6992fded2dac7d269f92d5db

US easing virus restrictions for foreign flights to America

 The U.S. said Monday it will ease airline restrictions this fall on travel to the country for people who have vaccination proof and a negative COVID-19 test, replacing a hodgepodge of rules that had kept out many non-citizens and irritated allies in Europe and beyond where virus cases are far lower.

The changes, to take effect in November, will allow families and others who have been separated by the travel restrictions for 18 months to plan for long-awaited reunifications and allow foreigners with work permits to get back to their jobs in the U.S.

Airlines, business groups and travelers cheered.

“It’s a happy day. Big Apple, here I come!” said French entrepreneur Stephane Le Breton, 45, finally able to book a trip to New York City that had been put on hold over the virus restrictions.

The new policy will replace a patchwork of travel bans first instituted by President Donald Trump last year and tightened by President Joe Biden that restrict travel by non-citizens who have in the prior 14 days been in the United Kingdom, European Union, China, India, Iran, Republic of Ireland, Brazil or South Africa.

White House COVID-19 coordinator Jeff Zients announced the new policies, which still will require all foreign travelers flying to the U.S. to demonstrate proof of vaccination before boarding, as well as proof of a negative COVID-19 test taken within three days of flight. Biden will also tighten testing rules for unvaccinated American citizens, who will need to be tested within a day before returning to the U.S., as well as after they arrive home.

Fully vaccinated passengers will not be required to quarantine, Zients said.

There will be no immediate change to U.S. land border policies, which restrict much cross-border travel with Mexico and Canada.

The travel bans had become the source of growing geopolitical frustration, particularly among allies in the UK and EU. The easing comes ahead of Biden meeting with some European leaders on the margins of the United Nations General Assembly this week.

“This is based on individuals rather than a country-based approach, so it’s a stronger system,” Zients said.

The EU and UK had previously moved to allow vaccinated U.S. travelers in without quarantines, in an effort to boost business and tourism. But the EU recommended last month that some travel restrictions be reimposed on U.S. travelers to the bloc because of the rampant spread of the delta variant of the coronavirus in America.

The Centers for Disease Control and Prevention will require airlines to collect contact information from international travelers to facilitate tracing, Zients said.

It was not immediately clear which vaccines would be acceptable under the U.S. system and whether those unapproved in the U.S. could be used. Zients said that decision would be up to the CDC.

Monday’s announcement was met with applause by the air travel industry, which has lost significant revenue from declines in international travel.

Delta Air Lines spokesman Morgan Durrant said, “Science tells us that vaccinations coupled with testing is the safest way to re-open travel, and we are optimistic this important decision will allow for the continued economic recovery both in the U.S. and abroad and the reunification of families who have been separated for more than 18 months.”

Worldwide, air travel is still down more than half from pre-pandemic levels, and the decline is much sharper for cross-border flying. By July, domestic travel had recovered to 84% of 2019 numbers, but international travel was just 26% of the same month two years ago, according to figures this month from the airline industry’s main global trade group, the International Air Transport Association.

The numbers are similar but not quite as stark for the U.S., where international travel in August was 46% of that in August 2019, according to Airlines for America. Arrivals by non-U.S. citizens were only 36% of the 2019 level.

British Prime Minister Boris Johnson tweeted that he was “delighted” by the news. He said: “It’s a fantastic boost for business and trade, and great that family and friends on both sides of the pond can be reunited once again.”

Airlines hailed the U.S. decision as a lifeline for the struggling industry. Tim Alderslade, chief executive of industry body Airlines U.K. said it was “a major breakthrough.”

Shai Weiss, chief executive of Virgin Atlantic, said it was “a major milestone. ... The U.K. will now be able to strengthen ties with our most important economic partner, the U.S., boosting trade and tourism as well as reuniting friends, families and business colleagues.”

The changes also drew praise from business groups, who have been contending with labor shortages as the economy bounces back with unexpected strength from last year’s coronavirus recession. U.S. employers have been posting job openings — a record 10.9 million in July — faster than applicants can fill them.

Myron Brilliant, head of international affairs for the U..S. Chamber of Commerce, said in a statement, “Allowing vaccinated foreign nationals to travel freely to the United States will help foster a robust and durable recovery for the American economy.”

https://apnews.com/article/biden-easing-foreign-travel-restrictions-requiring-vaccines-5d78d14dab51389b02fd70228a5b55b9

India to resume exports of coronavirus vaccines in October

 India, the world’s largest vaccine producer, will resume exports and donations of surplus coronavirus vaccines in October after halting them during a devastating surge in domestic infections in April, the health minister said Monday.

Mansukh Mandaviya said the surplus vaccines will be used to fulfill India’s “commitment towards the world for the collective fight against COVID-19,” but vaccinating Indians will remain the government’s “topmost priority.”

India was expected to be a key supplier for the world and for the U.N.-backed initiative aimed at vaccine equity known as COVAX. It began exporting doses in January but stopped doing so to inoculate its own population during a massive surge in infections in April that pushed India’s health system to the breaking point.

The halt in exports left many developing countries without adequate supplies and delayed vaccines for millions of people.

Before halting exports, India donated or sold 66 million vaccine doses to nearly 100 countries.

Mandaviya did not specify how many doses would be exported. He said India’s monthly coronavirus vaccine production has more than doubled since April and is expected to increase to 300 million doses in October.

“We will help the world and fulfil our responsibility to COVAX,” he said.

Serum Institute of India, the world’s largest maker of vaccines, is now producing an estimated 150 million doses of the AstraZeneca vaccine each month, a more than twofold increase since April.

India’s inoculations have risen in recent months.

A country of nearly 1.4 billion people, India has administered more than 800 million vaccine doses. It has given at least one dose to more than 62% of the eligible adult population and two doses to about 22%.

https://apnews.com/article/business-health-india-coronavirus-pandemic-global-trade-dd27157bb33e91ec7d11ffa5589f89c7