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

Ohio lawmakers introduce abortion bill that goes further than Texas law

 Ohio Republicans introduced a bill on Wednesday that calls for a total ban on abortions in the state, reaching farther than the Texas “heartbeat” law that is currently under examination by the Supreme Court.

The bill, called the 2363 Act, which the lawmakers said is the number of children lost to abortion everyday in the U.S., seeks to ban all abortions in Ohio and, like the Texas law, empower “any person” to bring civil action against an individual who performs and abortion or “knowingly engages in conduct that aids or abets the performance or inducement of an abortion.”

Individuals who filed such lawsuits will be permitted to ask for $10,000 or more, according to Cleveland.com.

The legislation does not include exceptions for rape or incest, but it would shield abortion patients from being sued by individuals who may have gotten them pregnant through rape or another form of sexual violence.

The controversial Texas law bans abortion after a fetal heartbeat is detected, something that can occur as early as six weeks into a pregnancy — a point where many women will not know they are pregnant.

The U.S. Supreme Court is currently debating the Texas law, which sparked outrage nationwide when it was enacted in September.

The justices previously denied a request to block the law largely along ideological lines, but they are now giving the text another look.

The Ohio bill, if passed and signed into law, would ban defendants in civil suits from claiming ignorance or mistake of law as a defense, in addition to any personal belief that the legislation is unconstitutional.

Additionally, the text says that defendants cannot point to a court decision’s ruling as a defense if it is later overruled — even if it remained intact at the time of the abortion.

Ohio Rep. Jena Powell (R), who introduced the bill, said it is about protecting life.

“The sanctity of human life, born and preborn, must be preserved in Ohio,” Powell said, according to Cleveland.com. “The 2363 Act is about protecting our fundamental, constitutional right to be born and live. Abortion kills children, scars families, and harms women. We can and must do better.”

Ohio House Minority Leader Emilia Sykes (D) slammed the bill, calling it "an egregious assault on women, a dangerous attack on healthcare rights and an embarrassment for our state,” adding that “Ohio Republicans want to control women, but we won’t be silent.”

“Criminalizing care will disproportionately impact women of color, nonbinary people and those already at a disadvantage in our health and criminal justice system. ...Once again, Republicans are showing that the everyday needs of Ohioans are less important than scoring political points, likes and retweets,” Sykes said, according to Cleveland.com.

The Ohio state House has a 65 to 35 Republican majority.

A number of abortion-rights groups also condemned the bill.

Lauren Blauvelt-Copelin, the vice president of government affairs and public advocacy at Planned Parenthood Advocates of Ohio, said “lawmakers and anti-abortion vigilantes have no business making personal medical decisions for their neighbors.”

“Ohio has once again proved it is one of the most extreme states for abortion access. This bill goes further than Texas Senate Bill 8, the most extreme abortion ban in the country, and would ban all abortions. It allows anyone — including anti-abortion protesters who have no connection to the patient — to act as paid bounty hunters and take doctors, health centers, and anyone who helps another person access abortion to court and get no less than $10,000. Banning abortion would be catastrophic to communities across Ohio,” she added in a statement.

https://thehill.com/homenews/state-watch/579944-ohio-lawmakers-introduce-abortion-bill-that-goes-further-than-texas-law