Controversial Biogen approval; Plus Biden’s global vaccine push

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TThis week, the FDA approved conditional approval of Biogen’s aducanumab, the first new Alzheimer’s drug to hit the market in nearly two decades. The decision is controversial, however, as the drug’s Phase 3 trials had mixed results. While one showed a 22% reduction in Alzheimer’s-related cognitive decline, a second showed no benefit. The FDA said Biogen would need to complete post-approval studies, but in the meantime, the drug will soon hit the market priced at around $ 50,000. While Biogen stock skyrocketed on the news, there are concerns that it will set a risky precedent for future drug approvals and the necessary evidence for a drug’s effectiveness.

The FDA also recently approved a new drug used to treat obesity, Wegovy, but it could likely face reimbursement issues, reports Forbes employee Joshua Cohen. Sales of weight loss drugs have disappointed for decades, along with several high profile withdrawals from the market. Similarly, the newly approved Brexafemme, a drug used to treat vaginal yeast infections, may face admission hurdles as its price of $ 350 and $ 450 is 10 times higher than that of its main competitor, Fluconazole.


Venture funding for mental health startups hits record high

In 2019, about 11% of adults in the US reported having symptoms of anxiety or depression, which increased to 42% by December 2020. While some venture capital investors had started looking into mental health in recent years, they put a record $ 1.5 billion in funding to meet rapidly growing demand. There are now seven mental health unicorns in the US, up from two a year ago carried by the spate of digital health IPOs, SPAC deals, and M&A activity. But experts warn that technology alone cannot solve long-standing problems such as low reimbursement rates and provider shortages. Read more here.


Remarkable

Medicare Advantage insurers Clover health hits a record high and then falls as the Reddit trading mania builds.

Strateos raises $ 56 million to help realize its vision of scientific automation and remote laboratories.

Virtual care startup Health of Babylon will go public later this year with a $ 4.2 billion SPAC deal as the British company plans a major expansion into the United States

Medline Industries, a family-owned medical device manufacturer, sold to a consortium of private equity firms for approximately $ 30 billion.

Coronavirus updates

TThe US has issued more Covid-19 vaccines than most countries in the world – which is both good and bad. Good, because people in the USA are safer from the Covid-19 virus and the number of illnesses is steadily declining. However, global experts fear that the severe inequalities in vaccine distribution could actually lead to new variants in low-income countries that prolong the pandemic for everyone. President Biden’s administration has been criticized in recent weeks for the number of vaccines the US has bought, including millions of doses that are about to expire. In keeping with his promise to help lower-income countries, the president announced today that the federal government will buy an additional 500 million doses of the Pfizer vaccine and ship it to low-income countries. However, it is still unclear when these doses will arrive in other nations, and it may not happen until 2022.


Public-private partnerships are essential to pandemic prevention

Experts say tapping into the private sector can help provide valuable disease surveillance technologies locally and globally. Here are the companies that make up these essential partnerships. Read more here.

More coronavirus news

The EU has approved the use of a new digital Covid-19 certificate showing a traveler’s vaccination or Covid-19 test status.

Hong Kong billionaires hand out coupons and cash as an incentive to get more people vaccinated.

Can Long-range Covid Cause depression? Here’s what science says.

Herd immunity is a concept that got tossed around a lot during the pandemic – but there are some common misconceptions about what it actually means.

A new study is examining whether Psychedelics could help frontline healthcare workers fight covid burnout.

About Forbes

Jeff Bezos and the other multi-billion dollar space cowboys

Confident women are taking the helm in the autonomous technology industry

Employers, do not be afraid of the “great resignation” – it is already there

What else we read

Neuroscientists Discovered a Phenomenon They Can’t Explain (The Atlantic)

FDA Expert Panel Member Resigns Due to Controversial Approval of Alzheimer’s Therapy (STAT)

Facebook plans first smartwatch with two cameras, heart rate monitor (The Verge) for next summer



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