COVID cases break records across Europe as winter takes hold

  Soaring cases prompt debate over new curbs before Christmas

* Spread exacerbated by more transmissible Delta variant, WHO says

* China steps up restrictions ahead of Winter Olympics

* Some Asian countries reopening tourism to rest of world

By Krisztina Than and Nikolaj Skydsgaard

BUDAPEST, Nov 4 (Reuters) - Coronavirus infections are hitting record levels in many countries across Europe as winter takes hold, prompting a call for action from the World Health Organization which described the new wave as a "grave concern".

Soaring numbers of cases, especially in Eastern Europe, have prompted debate on whether to reintroduce curbs on movement before the Christmas holiday season and on how to persuade more people to get vaccinated.

That conversation comes as some countries in Asia, with the notable exception of China, reopen their tourism sectors https://www.reuters.com/world/asia-pacific/asia-tourism-reopens-with-big-spending-chinese-stuck-home-2021-11-03 to the rest of the world.

"The current pace of transmission across the 53 countries of the European Region is of grave concern," regional WHO head Hans Kluge said, adding that the spread was exacerbated by the more transmissible Delta variant.

The virus spreads faster in the winter months when people gather indoors.

Kluge warned earlier that if Europe followed its current trajectory, there could be 500,000 COVID-related deaths in the region by February.

"We must change our tactics, from reacting to surges of COVID-19, to preventing them from happening in the first place," he said.

The region saw a 6% increase in new cases last week, with nearly 1.8 million new cases, compared to the week before. The number of deaths rose 12% in the same period.

Germany, Europe's biggest economy, reported 33,949 new infections, the highest daily increase since the start of the pandemic last year. Cases in Russia and Ukraine are soaring.

Austria's daily new coronavirus infections surged towards a record set a year ago, making a lockdown for the unvaccinated ever more likely.

COVID-19 prevalence in England rose to its highest level on record in October, Imperial College London said, led by a high numbers of cases in children and a surge in the southwest.

Slovakia reported 6,713 new cases, also a record, while daily new cases in Hungary more than doubled from last week to 6,268. Poland, Eastern Europe's biggest economy, reported 15,515 daily cases on Thursday, the highest figure since April. Croatia and Slovenia on Thursday both reported record daily infections.

CHINA ON ALERT AHEAD OF OLYMPICS

China is also on high alert at ports of entry to reduce the risk of COVID-19 cases entering from abroad, and has stepped up restrictions amid a growing outbreak less than 100 days before the Beijing Winter Olympics.

Authorities have also tightened curbs in the capital ahead of a major gathering of the top members of the Communist Party next week.

Since mid-October, over 700 locally transmitted cases with confirmed symptoms have been reported in China. While the number is tiny compared with other countries, it has led to a growing wave of restrictions under Beijing's zero-tolerance policy.

In Central Europe, Hungary has trimmed its 2021 GDP growth projection to 6.8% from 7.0-7.5% due to a rise in inflation, energy prices, and the risks stemming from COVID-19, the finance minister said, flagging the possibility of some new restrictions in a country where there are currently hardly any curbs in place.

Slovakia's Finance Ministry cut its forecasts for 2021 and 2022 growth in September, saying a new wave of COVID-19 cases will hit consumer demand and the labour market at the end of the year although the impact will not be as strong as earlier in the pandemic. Poland's central bank left its projections unchanged.

FRESH CURBS

The Hungarian government has urged people to take up vaccines and last week announced mandatory vaccinations at state institutions, also empowering private companies to make jabs mandatory for employees if they believe that is necessary.

Romania - where hospitals cannot cope with a surge in COVID-19 patients - the Czech Republic, Slovakia and Poland have all tightened rules on mask wearing and introduced measures to curb infections.

The Czech Republic has introduced a requirement for restaurant customers to show proof of vaccination or a test. It also has tough mask regulations and some children are again being tested in schools in areas where cases are higher.

In Poland, mask wearing is mandatory in enclosed public spaces while cinemas, theatres and hotels have a 75% capacity limit. The Hungarian government has not replied to Reuters questions on potential measures.

https://finance.yahoo.com/news/wrapup-1-covid-cases-break-122940628.html

U.K. becomes first country to approve Merck's Covid-19 antiviral pill

 The U.K.'s medicines regulator has approved the world's first pill designed to treat symptomatic Covid-19, the British government announced on Thursday. 

Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme, the antiviral medication, molnupiravir, was found to be "safe and effective" at reducing the risk of hospitalization and death in people with mild to moderate Covid-19 who are at heightened risk of developing severe disease, the government said.

Britain’s Medicines and Healthcare products Regulatory Agency has approved the pill, which will be called Lagevrio in the U.K., for use for those who have a mild to moderate case of the disease, and at least one risk factor for developing serious illness, including older age, obesity, diabetes mellitus or heart disease.

The pill’s approval makes it the first oral antiviral Covid-19 medication in the world to get the green light, the British government said.

In a statement published online, British health secretary Sajid Javid said the approval marked a "historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for Covid-19."

"This will be a gamechanger for the most vulnerable and the immunosuppressed," Javid said.

The health secretary said the British government was "working at pace" with the U.K.'s National Health Service to deploy the antiviral medication to patients through a national study "as soon as possible."

“This antiviral will be an excellent addition to our armoury against Covid-19," he said, adding that it still "remains vital everyone comes forward for their life-saving Covid-19 vaccine," as well as for booster shots.

How does it work?

Lagevrio has been found to work in symptomatic cases by interfering with the Covid-19 virus's replication, the British government said.

By preventing the virus from multiplying, the medication helps keep virus levels in the body low, reducing the severity and impact of the disease.

Clinical trial data suggests that the medication is most effective when administered during the early stages of infection.

As a result, Britain's medicines regulator is recommending patients take it as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms.

The pill's approval comes amid widespread concerns in the U.K. over high rates of Covid-19, with Britain seeing tens of thousands of cases confirmed each day.

On Wednesday alone, more than 40,800 new cases were identified, with the daily death toll reaching 217, according to Johns Hopkins University’s Covid-19 tracker. The seven-day average for the week was at 39,216 and 163 deaths per day.

British Prime Minister Boris Johnson has so far resisted calls to implement a "Plan B" approach that would see the return of mask mandates and social distancing following his government's lifting of restrictions in England in July.

https://www.nbcnews.com/news/world/uk-approves-mercks-covid-19-antiviral-pill-lagevrio-rcna4534

Moderna Cuts Full-Year 2021 Revenue Outlook

 Moderna Inc. on Thursday lowered its outlook for full-year revenue.

The Cambridge, Mass.-based pharmaceutical company said it now expects product sales of $15 billion to $18 billion this year. Previously, it had said its advance purchase agreements could account for sales of $20 billion this year.

Some doses for delivery in 2021 have now been shifted to early 2022, the company said. Moderna said it is prioritizing deliveries to low-income countries.

Moderna expects sales of $17 billion to $22 billion in 2022, the company said.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Cuts-Full-Year-2021-Revenue-Outlook-36899786/

Lipocine Gets FDA Fast-Track Designation for LPCN 1144 in Non-Cirrhotic NASH

 

Lipocine Inc. on Thursday said the U.S. Food and Drug Administration granted fast-track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis, a chronic liver condition commonly known as NASH. The Salt Lake City, Utah, clinical-stage biopharmaceutical company said LPCN 1144 showed improvement of liver injury markers with no observed tolerability issues in a Phase 2 study. The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs. Lipocine said it believes the designation will enable the company to work closely with the FDA on its development program for NASH, including the design of a Phase 3 program. https://www.marketscreener.com/quote/stock/LIPOCINE-INC-16085349/news/Lipocine-Gets-FDA-Fast-Track-Designation-for-LPCN-1144-in-Non-Cirrhotic-NASH-36901409/

Hims & Hers Health to Sell Products at Walgreens

 Hims & Hers Health Inc. said it will collaborate with Walgreens Boots Alliance Inc. to provide greater access to health and wellness solutions.

The company said the partnership will include the availability of Hims & Hers supplements and sexual health and wellness solutions, which will be offered at Walgreens retail locations nationwide and on walgreens.com.

Hims & Hers said its supplements and sexual health and wellness offerings will be available on walgreens.com beginning in early November and will be in select stores starting in mid-November.

https://www.marketscreener.com/quote/stock/HIMS-HERS-HEALTH-INC-65220697/news/Hims-Hers-Health-to-Sell-Products-at-Walgreens-36902474/

Amgen CEO says U.S. Medicare out-of-pocket cap will improve access

 A proposed cap on out-of-pocket drug costs for Medicare recipients would improve patient access, but allowing the U.S. government health plan for seniors to negotiate prices could limit innovation, Amgen Inc Chief Executive Robert Bradway said in an interview.

"We need to make sure to be very careful not to destroy the very system which is bringing forward the innovation we need," Bradway said in an interview ahead of the Reuters Total Health conference, which will run virtually from Nov. 15-18.

The latest legislation proposed by congressional Democrats and the Biden administration would give the federal government the ability for the first time to negotiate prices for a limited number of drugs paid for by Medicare.

Conventional prescription drugs would be protected from negotiation for the first nine years after they are launched, while biologic drugs, which are made from living cells, would be protected for 12 years.

The agreement would also set a $2,000 annual cap on out-of-pocket costs for Medicare recipients and limit annual price increases to the rate of inflation.

"We're going to look favorably on anything that improves access," Bradway said.

But he warned that allowing the government to "negotiate or in effect set prices," runs the risk of "artificial distortions in the market with the effect that innovators will have to decide whether to reallocate capital away from the drug sector."

Bradway said more also needs to be known about the Biden administration's efforts to agree with other nations on a multinational corporate tax rate.

A group of 136 countries, including the United States, last month set a goal for a minimum global tax rate of 15% for big companies - well below the current average of 23.5% in industrialized countries.

"It will be important if the U.S. wants to continue to be the epicenter of innovation for the U.S. to remain competitive," Bradway said. "Otherwise, we'll see what has been happening for years, which is investors from outside the United States acquiring innovative technology and basing that technology in lower tax jurisdictions."

Amgen, based in Thousand Oaks, California, is one of the world's largest makers of biotechnology drugs, including treatments for cancer, osteoporosis and rheumatoid arthritis.

https://finance.yahoo.com/news/amgen-ceo-says-u-medicare-200102067.html

Novartis sells its Roche stake to Roche for $20.7B

• Novartis has agreed to sell 53.3 million Roche bearer shares for a price of $388.99 per share (356.93 Swiss francs per share).
• “After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,” Novartis Chief Executive Vas Narasimhan said in the statement.

Novartis AG, a shareholder in Roche for more than 20 years, said on Thursday the two Swiss drugmakers had agreed that Roche would buy Novartis’s nearly one-third voting stake in its cross-town rival for $20.7 billion.

Novartis has agreed to sell 53.3 million Roche bearer shares for a price of $388.99 per share (356.93 Swiss francs per share) that reflects the volume-weighted average price of the Roche non-voting equity certificates over the last 20 trading days until Nov. 2, Novartis said in a statement.

“After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,” Novartis Chief Executive Vas Narasimhan said in the statement.

“Today’s announcement is consistent with our strategic focus and we intend to deploy the proceeds from the transaction in line with our capital allocation priorities to maximize shareholder value and continue to reimagine medicine,” he said.

Novartis said it will report a gain from the sale of the stake of approximately $14 billion.

The transaction is subject to the approval by the shareholders of Roche at an extraordinary general meeting on Nov. 26.

Roche said in a separate statement the debt-financed repurchase was conditional upon the approval of a capital reduction by cancellation of the repurchased shares and the approval of the interim financial statements prepared for the purpose of the transaction.

Roche said the “disentanglement” of the two competitors would give it “full strategic flexibility”. It confirmed its outlook for 2021 and said it wanted to increase its dividend for 2021.

https://www.cnbc.com/2021/11/04/novartis-sells-its-roche-stake-to-roche-for-20point7-bln.html