Eurovision Song Contest to Allow COVID-Tested Audiences at Semi-Finals, Finals

 The Dutch government has granted permission for up to 3,500 fans to attend the popular Eurovision Song Contest semi-finals and finals in Rotterdam in May.

The semi-finals are scheduled for May 18 and 20 and the finals on May 22 at Rotterdam’s Ahoy Arena. The Dutch city was due to host the contest in 2020 before the event was canceled due to the ongoing COVID-19 pandemic.

There will be nine shows in total, including six rehearsals, the two semi-finals and the final. A maximum of 3,500 spectators, or half the venue’s capacity are allowed to be present after a negative coronavirus test.

“We welcome this decision by the Dutch government and the possibility that we can invite fans to join us as we bring the Eurovision Song Contest back in May,” said Martin Österdahl, executive supervisor of the Eurovision Song Contest. “We will consider the options now available and announce more details in the coming weeks on how we can safely admit audiences to the Ahoy venue in Rotterdam should the situation allow. The health and safety of all those attending the event remains our top priority.”

The contest is organized by the European Broadcasting Union (EBU). “All delegations, artists and production crew will be following a strict protocol and would not come in contact with potential members of the audience under any circumstances,” the EBU said.

Chantal Janzen, Jan Smit, Edsilia Rombley and Nikkie de Jager will be the presenters.

The Netherlands is not completely out of the woods as far as COVID-19 is concerned, with the current lockdown being extended to Apr. 20. The Eurovision Song Contest organizers have contingency scenarios in case the situation worsens, including no audiences and pre-recorded acts.

In recent weeks, the Dutch government has held a series of test mass events including concerts, music festivals, theater performances and soccer games, admitting COVID-negative audiences.

According to the country’s National Institute for Public Health and Environment, 51,866 people tested positive for COVID-19 over the last week, with 171 deaths.

https://variety.com/2021/music/global/eurovision-song-contest-covid-tested-audience-1234942329/

Pfizer, BioNTech eye full FDA OK with COVID-19 vaccine data

 Pfizer and BioNTech offered an updated look at the efficacy of their COVID-19 vaccine, BNT162b2. The overall efficacy figure remained high at 91.3%, and the shot showed it can protect against a notoriously hard-to-tackle variant first identified in South Africa.

The pair’s mRNA vaccine is 91.3% effective against symptomatic COVID-19 disease as measured in people who have been immunized with the second dose of the shot for up to six months, the companies said Thursday.

The new efficacy data, plus a safety analysis comprising data from more than 12,000 people who were fully immunized for at least six months, allow the companies to file a drug application with the FDA to turn the shot’s emergency use authorization into a full approval, Pfizer CEO Albert Bourla, Ph.D., said in a statement.The efficacy level is slightly down from the 95% number the vaccine first posted in the trial. With those data, Pfizer secured an FDA emergency use authorization in December. Since that initial analysis, more COVID-19 cases have accrued, increasing to 927 as of March 13 from the previous 170.

Of the total cases, investigators recorded 850 in the placebo group compared with 77 in the vaccine cohort. Thirty-two severe COVID-19 cases were recorded, all in the placebo group, translating into a 100% efficacy against severe disease for the vaccine.

The emergence of new variants of the novel coronavirus, especially one dubbed B.1.351 that was first identified in South Africa, raised concerns over the efficacy of existing vaccines. Previous studies in labs found significantly reduced neutralizing ability of the Pfizer-BioNTech shot against the B.1.351 variant as compared with an earlier virus isolate, though BioNTech CEO Ugur Sahin has said the level is still enough to offer protection.

In the newly released data, the South Africa branch of the trial showed the vaccine to be 100% efficacious in the B.1.351-dominant region. Among the 800 participants enrolled there, nine cases of COVID-19 were observed, all in the placebo group. Six of the nine were confirmed to be caused by B.1.351.

“These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population,” Sahin said in a statement Thursday.

Demand for the Pfizer-BioNTech shot, also known as Comirnaty, has soared thanks to the strong efficacy it has demonstrated thus far. Pfizer expects $15 billion in 2021 sales from existing orders of the vaccine. The companies have so far inked supply deals for 1.4 billion doses.

The companies are working around the clock to try to meet demand. This week, BioNTech said the partners aim to churn out 2.5 billion doses this year.

Meanwhile, Pfizer and BioNTech have recently launched a new study to evaluate the effect of a third, booster shot against circulating and potential new variants. They said it would offer a “flexible solution for rapidly adapting the vaccine” for use against potential new virus strains.

BioNTech management also suggest a potential for a booster every six to 18 months based on observations of declining neutralizing antibody titers after the initial two-dose vaccination schedule. But in an investor note Tuesday, SVB Leerink analyst Daina Graybosch argued the third shot “could be more broadly effective and durable in protection than the initial prime/boost of BNT-162b2—limiting the need for long-term re-boosting.”

https://www.fiercepharma.com/pharma/pfizer-biontech-eye-official-covid-19-vaccine-nod-as-efficacy-stands-strong-including

Gilead has sole rights to COVID-19 blockbuster Veklury: GAO

 Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company. 

The federal government, advocates pointed out, has supported research on the medicine over the years. But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report.  

While numerous agencies have supported research on the drug, “federal contributions to the research did not generate new inventions,” the GAO found. 

Between 2009 and 2013, Gilead synthesized the drug compound, conducted preclinical research and “first identified and confirmed the antiviral activity of remdesivir and its parent compound against coronaviruses and other viruses," the GAO says.

Then, between 2013 and 2020, federal agencies chipped in about $162 million in research funding; that research didn’t yield any inventions, the GAO concluded. 

For its part, Gilead estimates its spending on remdesivir as of December totaled $1.3 billion, with about $786 million in R&D costs. The company spent about $1 billion last year in its pandemic response, including its efforts to scale up production.  

In October, Gilead’s med won a full FDA approval as Veklury. Critics have questioned the data supporting the approval, but Gilead has maintained the drug is the standard of care for hospitalized patients. 

In a statement Wednesday, the company said the GAO report “concluded that Gilead alone funded the research that led to the company’s invention and initial synthesis of Veklury."

“The GAO further acknowledged Gilead’s significant investment in Veklury, which exceeded $1 billion in 2020 alone and far outweighed any limited contributions by federal agencies,” the company added. 

As the pandemic wreaked havoc last year and Gilead’s drug showed promise, some called on the federal government to enforce patent rights against the company or break Gilead’s patents altogether. Gilead responded it had developed the drug and invested heavily to expand production capacity.

Meanwhile, Gilead’s efforts on the med have paid off on its income statement. The company collected $2.8 billion in Veklury sales last year, and it expects another $2 billion to $3 billion from the drug this year. Right now, about half of hospitalized COVID-19 patients are treated with the drug, Gilead said.  

https://www.fiercepharma.com/pharma/gilead-has-sole-rights-to-covid-19-blockbuster-veklury-gao-concludes

FDA grew too close to Biogen during Alzheimer’s drug development: Panel

 The FDA got too close to Biogen during the development of the Alzheimer’s drug aducanumab, according to its own expert advisers who are urging the regulator to reject it in the coming weeks.

With the deadline for a regulatory decision approaching for aducanumab in June, three doctors who took part in the expert advisory board meeting that overwhelming voted against approval in November questioned the FDA’s approach to conflicting phase 3 trial data.

Such votes are not binding but it’s rare for the FDA to ignore the advice of its expert advisers.

Finding a therapy that treats the underlying cause of Alzheimer’s has proved elusive, with a series of drugs tackling the amyloid brain plaques associated with the disease failing in the clinic.

It looked like aducanumab had failed too – but Biogen and development partner Eisai hope to revive the drug with an analysis of one of two failed phase 3 trials.

The doctors – Caleb Alexander, Scott Emerson and Aaron Kesselheim – noted in the article from the Journal of the American Medical Association that the data from “study 302” was for patients who took a high dose of the drug in one of the phase 3 trials.

These patients showed a statistically significant 22% relative reduction in a score measuring onset of dementia, although the effect was not seen on the lower dose.

While the doctors said that the FDA does have leeway to approve on the basis of a single trial, the doctors argued that guidelines require “substantial evidence of effectiveness”.

They noted that the FDA worked closely with Biogen to analyse the data from this and other trials.

But according to the experts, “this undertaking reflected an unusual degree of collaboration between the FDA and manufacturer of aducanumab, and the arrangement has been criticised as having potentially compromised the FDA’s objectivity in reviewing the New Drug Application.”

They also raised issues with the statistical analysis that supports approval and could well be a false positive result.

They argued that post-hoc analyses are better used to generate interesting hypotheses that could be tested in future trials.

There were also safety issues flagged, such as amyloid-related imaging abnormalities (ARIA) that could cause symptoms including confusion and disorientation, which was associated with falls.

Because the trials were stopped because they weren’t working, the doctors argued “there is no reason to favour the trial with the positive signal in 1 of 2 treatment groups over the trial with the negative outcome in both treatment groups, and there is no persuasive evidence to support approval of aducanumab at this time.”

https://pharmaphorum.com/news/fda-grew-too-close-to-biogen-during-alzheimers-drug-development-doctors-say/

Health tech Spacs drift downwards

 2021 has seen a startling rise in the number of deals between special-purpose acquisition companies and medical technology, digital health and diagnostics groups seeking a fast and easy way to go public. A flurry of these deals in February was followed this week by Somalogic reversing into CM Life Sciences II in a transaction worth $651m, including a $375m Pipe investment. Somalogic specialises in protein analysis, and plays in three industries: clinical diagnostics, with its SomaSignal assays for cardiovascular disease, diabetes and cancer; aiding drug development; and basic research. Its revenues in 2020 were just $55m, but the Spac deal will bring Somalogic’s pro forma enterprise value to $1.2bn. News of the deal pushed CM’s share price up 10%, but this is an outlier among the class of 2021 – most have seen their valuation fall since announcing deals. Indeed the shine is perhaps coming off Spacs, at least in the health tech space. VG Acquisition Corp, the blank-cheque company backed by Virgin, has lost nearly a quarter of its value since announcing its intent to buy 23andMe – a fall rendered all the steeper by the fact that its value had soared 31% on the day of the announcement. 

Health tech Spac deals in Q1 2021
Target	Spac (main backer)	Focus	Deal announced	Share price since announcement
Somalogic	CM Life Sciences II (Casdin Capital and Corvex Management)	Proteomics	Mar 29	10%
Humacyte	Alpha Healthcare Acquisition Corp (AHAC Sponsor)	Bioengineered vascular grafts	Feb 17	4%
Owlet Baby Care	Sandbridge Acquisition Corp (Sandbridge Capital and Pimco)	Digital health	Feb 16	(6%)
Sharecare	Falcon Capital Acquisition Corp (Falcon Equity Investors)	Telehealth	Feb 12	(15%)
Sema4	CM Life Sciences (Casdin Capital and Corvex Management)	Genomics	Feb 10	(4%)
Nautilus Biotechnology	Arya Sciences Acquisition Corp III (Perceptive Advisors)	Proteomics	Feb 8	23%
23andMe	VG Acquisition Corp (Virgin Group)	Genetic testing	Feb 4	(24%)
Talkspace	Hudson Executive Investment Corp (Hudson Executive Capital)	Telehealth	Jan 13	(14%)
Source: company announcements.  https://www.evaluate.com/vantage/articles/news/snippets/health-tech-spacs-drift-downwards

FDA approval tracker: March

 Fibrogen and Astrazeneca had been gearing up for an approval decision on their chronic kidney disease project roxadustat last month, but a surprise advisory panel meeting is now in the works, at a date yet to be determined. Experts will play close attention to cardiac safety issues with the oral HIF-PH inhibitor. Akebia, which recently filed vadadustat, a similarly acting project with its own toxicity problems, will be watching the adcom with interest. Elsewhere, Keytruda got knocked back in neoadjuvant/adjuvant triple-negative breast cancer after a negative vote from an earlier panel meeting. Merck & Co will likely have to wait for data on event-free survival from the Keynote-522 study to get another shot here; these are due in the third quarter. Merck also voluntarily withdrew Keytruda's use in small-cell lung cancer. The anti-PD-1 antibody, alongside Roche's Tecentriq and Bristol's Opdivo, will be the subject of a panel towards the end of April looking at accelerated approvals for six indications in which confirmatory studies have failed (Go or no go? The FDA plays hardball, March 30, 2021).

Notable first-time US approval decisions in March
Project	Company	2026e sales by indication ($m)	Outcome
Evrenzo (roxadustat)	Astrazeneca/Fibrogen/ Astellas	2,656	Adcom planned, no date disclosed
Abecma (ide-cel)	Bristol Myers Squibb/ Bluebird	1,198	Approved
Mirabegron oral suspension	Astellas	579*	Approved
Dostarlimab	Glaxosmithkline	537	No decision yet
DaxibotulinumtoxinA	Revance	356	No decision yet
Rolontis	Spectrum	344	Pre-approval inspection scheduled for May
Zegalogue (Dasiglucagon HypoPal Rescue Pen)	Zealand Pharma	268	Approved
Fotivda	Aveo	155	Approved (~3 weeks early)
Trevyent	United Therapeutics	41	Company discontinued development after receiving FDA comments; CRL in Apr 2020
Azstarys (KP145)	Kempharm/ Aquestive	-	Approved
Ponvory (ponesimod)	J&J/Idorsia	-	Approved
Besremi (ropeginterferon alfa-2b)	AOP/PharmaEssentia	-	CRL (manufacturing inspection delay)
*Includes sales for tablet version (Myrbetriq). Source: EvaluatePharma & company releases.

 

Advisory committee meetings in March
Project	Company	2026e sales by indication ($m)	Note
Tanezumab	Lilly/Pfizer	179	Negative, Pdufa estimated in Apr
Source: EvaluatePharma & FDA adcom calendar.

 

Supplementary and other notable approval decisions in March
Product	Company	Indication (clinical trial)	Outcome
Sarclisa	Sanofi	R/r multiple myeloma, combo with Kyprolis & dexamethasone	Approved (~3mth early)
Yescarta	Gilead	R/r follicular lymphoma & marginal zone lymphoma after ≥2 systemics (Zuma-5)	Approved
Arcalyst (rilonacept)	Kiniksa	Recurrent pericarditis (Rhapsody)	Approved
Exparel	Pacira	Postsurgical analgesia in children aged ≥6 (Play)	Approved
Myrbetriq (mirabegron tablets)	Astellas	Neurogenic detrusor overactivity in patients aged ≥3 (NCT02751931)	Approved
Keytruda	Merck & Co	TNBC in combo with chemo as neoadjuvant, also single agent as adjuvant (Keynote-522)	CRL (negative adcom in Feb)
Keytruda	Merck & Co	1L oesophageal/gastroesophageal junction carcinoma (Keynote-590)	Approved
Xolair	Roche/Novartis	Self-administration option across all approved US indications	No decision yet
Vazalore	Plx Pharma	Liquid-filled aspirin capsule (325mg and 81mg doses)	Approved
Lorbrena	Pfizer	1L Alk +ve NSCLC (Crown)	Approved
Kimyrsa/ Orbactiv	Melinta	Acute bacterial skin and skin structure infections, single one-hour infusion	Approved
Source: EvaluatePharma & company releases.

 

Voluntarily withdrawn accelerated approvals in March
Product	Company	Setting (failed confirmatory study)
Keytruda	Merck & Co	3L SCLC (Keynote-604)
Tecentriq	Roche	1L urothelial bladder cancer (Imvigor-211)
Source: company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-march-0

India AstraZeneca shot delay could be 'catastrophic' for Africa: health official

 India’s temporary hold on major exports of AstraZeneca’s COVID-19 shot will undermine Africa’s vaccination plans, and could have a “catastrophic” impact if extended, the head of the continent’s disease control body said on Thursday.

India decided to delay big exports of the shots made in its territory by the Serum Institute of India (SII) to make sure it could meet local demand, two sources told Reuters last week.

The hold “will definitely impact our ability to continuously vaccinate people,” the director of the Africa Centers for Disease Control and Prevention, John Nkengasong, told a news conference in Addis Ababa.

The African Union had planned to vaccinate 30-35% of the continent’s population by the end of the year he said, adding that delays could cause the target to be missed.

Ghana has so far received 600,000 of the 2.4 million AstraZeneca shots it was due to get through COVAX by the end of May. It has been told that more shots will only arrive in June, Kwame Amponsa-Achiano, head of the vaccine roll out, told Reuters.

“To be so reliant on one manufacturer is a massive concern,” a U.N. health official involved in the rollout in Africa told Reuters.

The AU’s target primarily relies on supplies from the global COVAX vaccine-sharing facility, through which 64 poorer countries including many in Africa are supposed to get doses from the SII. COVAX aims to provide enough shots for African countries to inoculate at least 20% of their populations.

“If the delay continues, I hope it’s a delay and not a ban, that would be catastrophic for meeting our vaccinations schedule,” Nkengasong said.

African countries have reported 4.25 million coronavirus infections and 112,000 related deaths, though experts have said the actual numbers could be higher.

The AU has also been negotiating with manufacturers to help member states secure the additional doses they will need to achieve 60% coverage.

On Monday, Johnson & Johnson announced it would supply the AU with up to 400 million doses of its COVID-19 vaccine. Delivery of those doses is due to begin in the third quarter of this year and will continue through 2022.

Those doses are separate from the GAVI/WHO-backed global COVAX facility.

Nkengasong said on Thursday the AU has “pivoted” towards the J&J shot in part as a result of the delay in the delivery of AstraZeneca shots, and also because it is a single-dose shot.

The J&J doses will begin to arrive in June or July, which will ease any shortage caused by the delay in the AstraZeneca doses, Nkengasong said. The gap until the arrival of the J&J doses is a concern, he added.

https://www.reuters.com/article/us-health-coronavirus-africa/india-astrazeneca-shot-delay-could-be-catastrophic-for-africa-health-official-idUSKBN2BO5CA