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Pfizer upgrades Biohaven alliance to a takeover bid

Not content with a $1.2 billion licensing deal for Biohaven Pharma’s oral migraine therapy rimegepant, Pfizer has just
The post Pfizer upgrades Biohaven…

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Not content with a $1.2 billion licensing deal for Biohaven Pharma’s oral migraine therapy rimegepant, Pfizer has just offered to buy the company outright – for a cool $11.6 billion.

Pfizer’s earlier buy-in only gave it ex-US rights to rimegepant, already approved and on sale in the US as Nurtec ODT, so taking control of the entire company will give it full ownership of the blockbuster-in-waiting, which pulled in $462 million in sales from the US market alone last year.

The big pharma has made its moved shortly after securing approval for the oral CGRP inhibitor in the EU, where it will be sold as Vydura and has become the first drug in the class to be approved for both treatment and prevention of episodic migraine attacks.

Pfizer is paying $148.50 for each Biohaven share under the terms of the deal, and shareholders will also receive half a share in what has been dubbed ‘New Biohaven’ – a new publicly-traded company that will own the company’s non-CGRP pipeline.

Non-CGRP assets including troriluzole for obsessive compulsive disorder and spinocerebellar ataxia and verdiperstat for amyotrophic lateral sclerosis will transfer to Pfizer’s internal pipeline.

Shares in Biohaven rocketed more than 70% to more than $142 after the takeover deal was announced, and investors reacted to the biggest biopharma M&A deal of 2022 after a desultory start to the year.

Pfizer’s move comes as the company is sitting on a healthy pile of cash coming from sales of its BioNTech-partnered COVID-19 vaccine Comirnaty, which made a whopping $37 billion in sales last year to become the top-selling pharmaceutical product worldwide.

It’s worth noting that Biohaven has just reported that sales of Nurtec ODT came in at $124 million in the first quarter – below analyst projections and the $190 million made in the last quarter of 2021.

That raises the question of whether the company is looking to tap into Pfizer’s marketing muscle in the US to maintain momentum, particularly as it faces what seems to be a strong competitive challenge from rival oral CGRPs notably AbbVie’s prevention drug Qulipta (atogepant).

According to GlobalData, Qulipta has the edge when it comes to data on migraine prevention rates and has a broader range of available doses.

Biohaven said in its first quarter statement that it is predicting full-year sales for Nurtec ODT of $825-$900 million. Meanwhile, Pfizer also claims total rights to follow-up CGRP zavegepant, which is in late-stage trials for chronic migraine.

Pfizer has made a couple of smaller acquisitions this year, closing a $6.7 billion deal for Arena Pharma and its late-stage ulcerative colitis drug etrasimod in March, and a $525 million takeover of respiratory syncytial virus (RSV) drug developer ReVIral last month.

The company said it expects the Biohaven deal to close by early next year.

The post Pfizer upgrades Biohaven alliance to a takeover bid appeared first on .

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Is Plan B The New Baby Formula?

After the Roe v. Wade reversal, some grocery stores are limiting the number of products one can purchase.

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After the Roe v. Wade reversal, some grocery stores are limiting the number of products one can purchase.

The ripple effects of the Supreme Court's overturning Roe v. Wade are just starting to trickle through into a wide range of industries and fields.

One such ripple effect is the widespread purchasing of emergency contraception -- drugstore chain CVS  (CVS) - Get CVS Health Corporation Report recently announced that it was placing caps on the number of Plan B and Aftera products customers can buy at a time to "ensure equitable access and consistent supply on store shelves."

The two are some of the most common brand names of the "morning after pill," which is commonly taken after an unprotected sexual encounter or failure of one's regular birth control.

The active drug in them is Levonorgestrel, which prevents ovulation or eggs from attaching to the uterus. Plan B and Aftera cost a respective $49.99 and $39.99 and are available over the counter.

"We have ample supply of Plan B and Aftera across all of our CVS Pharmacy stores and CVS.com," CVS Health Spokesperson Ethan Slavin said in a statement. "To ensure equitable access and consistent supply on store shelves, we’ve implemented a temporary purchase limit of three on these products."

This Is Very Different From Baby Formula

Most recently, CVS and other drug store chains Target  (TGT) - Get Target Corporation Report and Walgreens  (WBA) - Get Walgreens Boots Alliance Inc. Report placed similar limits on how many boxes of baby formula customers could buy at a time.

Back in April, out-of-stock rates for formula reached 31% nationwide and over 50% in states like Texas, North Dakota, South Dakota, and Tennessee amid pandemic-related supply chain issues and one of the country's largest producers closing a plant due to an FDA recall.

But while shortages of baby formula can be attributed to external factors that limited the numbers of available products, morning after pill limits appear directly linked to the panic coming from the Supreme Court's decision. 

According to CVS, the limits were put in place to prevent panic-buying and profiteering rather than due to a product shortage.

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The repeal of Roe v. Wade, which was put in place in 1973, gives states individual power to ban or severely restrict abortion.

Analysts expect this to happen in roughly half of all states (the divide, as with many other things, will likely take place between "red" and "blue" states) while 13 states with "trigger bans" are already enacting laws to prohibit abortion in the next 30 days.

In one abortion clinic in Texas, providers fearful of violating the law were calling to cancel appointments within hours of the Supreme Court ruling. 

As a result, many women in states most at risk of strict bans may be feeling panicked about the future.

As seen during the pandemic and the numerous shortages that came up in the aftermath, panic-buying can impact the supply chain and create very real shortages.

What Will Demand Be Like In A Post-Wade Future?

By Monday, reports started to come in of Walgreens  (WBA) - Get Walgreens Boots Alliance Inc. Report and Rite Aid  (RAD) - Get Rite Aid Corporation Report enacting similar purchase limits. 

Some Plan B boxes on Amazon  (AMZN) - Get Amazon.com Inc. Report are also already being listed for above retail price.

The limit imposed by CVS was, as of June 28, three per customer. While the immediate rush of purchases is likely to die down after immediate news of the reversal, many health care advocates are already preparing for major upheaval in the public health care system, from states that do not ban abortions seeing large rushes of out-of-state women to larger demand for other types of contraception.

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Long COVID: female sex, older age and existing health problems increase risk – new research

A new study has analysed UK data from long-term health surveys and electronic health records to understand how common long COVID is, and who might be at…

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About 2 million people in the UK currently have long COVID, according to the latest data from the Office for National Statistics.

In the UK, long COVID is defined as “signs and symptoms that continue or develop after acute COVID-19”. This definition is further split into people who have symptoms between four to 12 weeks after infection (ongoing symptomatic COVID-19) and for 12 weeks or more (post-COVID syndrome).

Symptoms can include fatigue, breathlessness, difficulty concentrating and many more – but the precise nature of the symptoms is not well understood. There are also gaps in our knowledge when it comes to the frequency of long COVID, and whether there are particular factors that put people at higher risk of developing the condition.

All of this is partly because the symptoms used to define long COVID often vary between studies, and these studies tend to be based on relatively few people. So the results may not apply to the wider population.

In a new study published in the journal Nature Communications, my colleagues and I looked at data from ten UK-based long-term studies, alongside 1.1 million anonymised electronic health records from English general practices. Based on this data, we investigated whether the burden of long COVID (how common it is) differs by demographic and health characteristics, such as age, sex and existing medical conditions.

The studies were established before the pandemic, and have tracked participants over many years. From these surveys, we used data from 6,907 people who self-reported they’d had COVID-19. Comparing this with the data from the electronic health records of people diagnosed with COVID allowed us to examine the frequency of long COVID in those who have seen their GP about it and those who haven’t.


Read more: Long COVID: a public health expert’s campaign to understand the disease


We found that of the people who self-reported having COVID in the studies, the proportion who reported symptoms for longer than 12 weeks ranged between 7.8% and 17%, while 1.2% to 4.8% reported “debilitating” symptoms.

In the electronic health records, we found that only 0.4% of people with a COVID diagnosis were subsequently recorded as having long COVID. This low proportion of diagnoses by GPs may be partly because formal logging of long COVID was only introduced for doctors in November 2020.

COVID-19 National Core Study, Author provided

The proportion of people who reported symptoms for more than 12 weeks varied by age. There was also a lot of variation depending on which definition each study used to capture long COVID. But overall, we found evidence to suggest an increased risk of long COVID was associated with increasing age up to age 70.

The studies include participants across a range of ages, from an average age of 20 to 63. Using a strict definition of symptoms affecting day-to-day function, we found that the proportion of people with symptoms for 12 or more weeks generally rose with increasing age, ranging from 1.2% for 20-year-olds to 4.8% for those aged 63.

We also found that a range of other factors is associated with a heightened risk of developing long COVID. For instance, being female, poorer pre-pandemic mental health and overall health, obesity and having asthma were also identified as risk factors in both the long-term studies and electronic health records.

These findings are broadly consistent with other emerging evidence on long COVID. For example, a recent international review study concluded that women are 22% more likely than men to experience long COVID.


Read more: COVID: long-lasting symptoms rarer in children than in adults – new research


It will be important to understand why these links exist, which is beyond the scope of our research. But identifying who may be at higher risk of long COVID is important, and as we continue to learn more, this could inform public health prevention and treatment strategies.

Ellen Thompson does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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U.S. FDA will decide on redesigned COVID vaccines by early July

U.S. regulators plan to decide by early July on whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of…

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U.S. FDA will decide on redesigned COVID vaccines by early July

By Michael Erman

“The better the match of the vaccines to the circulating strain we believe may correspond to improve vaccine effectiveness, and potentially to a better durability of protection,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a meeting of outside advisers to the regulator.

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration

The committee is scheduled to vote on a recommendation on whether to make the change later on Tuesday.

The updated shots are likely to be redesigned to fight the Omicron variant of the coronavirus, experts say. read more The exact composition of the retooled shots and whether they also will include some of the original vaccine alongside new components will be considered at the meeting.

Pfizer Inc (PFE.N), Moderna Inc (MRNA.O) and Novavax Inc. (NVAX.O) are scheduled to present data at the meeting. All three companies have been testing versions of their vaccines updated to combat the BA.1 Omicron variant that was circulating and led to a massive surge in infections last winter.

Both Moderna and Pfizer with partner BioNTech (22UAy.DE) have said that their respective redesigned vaccines generate a better immune response against BA.1 than their current shots that were designed for the original virus that emerged from China.

They have said that their new vaccines also appear to work against the more recently circulating BA.4 and BA.5 Omicron subvariants, even though that protection is not as strong as against BA.1.

Experts also want to know if the new shots will boost protection against severe disease and death for younger, healthier people or merely offer a few months’ additional safeguard against mild infection.

Scientists who have questioned the value of booster shots for young and healthy people have said a broad campaign is not needed with an updated shot either.

Other experts have championed any additional protection new vaccines may offer.

Reporting by Michael Erman Editing by Bill Berkrot and Bernadette Baum

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters

 

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