Connect with us


Emergent BioSolutions Latest to Receive U.S. Contract for Potential COVID-19 Vaccine

U.S. awards new contract for potential COVID-19 vaccine



This article was originally published by PharmaLive.

U.S. awards new $628 million contract to boost output of potential COVID-19 vaccine (Reuters) – The U.S. government on Monday entered into a $628 million contract with drugmaker Emergent BioSolutions (EBS.N) to boost manufacturing capacity for a potential COVID-19 vaccine. As drugmakers race to develop vaccines, tests and therapies for the disease, the United States is looking to secure manufacturing capacity under its “Operation Warp Speed” program announced in May to accelerate vaccine development. “Securing more manufacturing capacity here in America for candidates that make it to the final stages of Operation Warp Speed will help get a vaccine to American patients without a day wasted,” Department of Health and Human Services (HHS) Secretary Alex Azar said in a statement. The HHS task order with Emergent falls under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology. Under the contract, Emergent will commit its manufacturing facilities, valued at $542.7 million, to produce COVID-19 vaccine candidates through 2021. The BARDA award secures capacity for drug manufacturing at the company’s Baltimore Bayview facility, established in 2012 with HHS, and designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies, the company said in a statement. The task order also includes an investment of $85.5 million to expand Emergent’s viral and non-viral drug manufacturing capacity. So far, BARDA has invested more than $2 billion in COVID-19 vaccines and funded over 30 projects, including for diagnostics and treatments.
The agency has awarded grants to Moderna Inc (MRNA.O), the first in the United States to begin human trials of a coronavirus vaccine, Sanofi (SASY.PA), Johnson & Johnson (JNJ.N) and British drugmaker AstraZeneca Plc (AZN.L). Emergent has been working with Johnson & Johnson, Novavax Inc (NVAX.O) and Vaxart Inc (VXRT.O) to develop and manufacture their COVID-19 vaccine candidates.

Reporting by Vishwadha Chander in Bengaluru; Editing by Saumyadeb Chakrabarty and Shinjini Ganguli

Reuters source:

Read More

Continue Reading


How we’re using evidence to tackle net zero, slow economy and new hybrid working – sign up for Conversation partnership events and reports

With its IPPO partners, The Conversation is addressing some of the biggest policy challenges.




Civil servants around the world are wrestling with a vast web of incredibly complex social problems.

From meeting net zero targets in cash-strapped economies, with often low levels of political support, to managing ageing populations, sluggish productivity levels and handling the repercussions of soaring inequality, there are no easy answers.

But a growing body of detailed academic research can help. The biggest challenge is assessing and then effectively communicating this research to governments so they can use it to inform and shape policy.

In December 2020, as the UK was about to enter its third pandemic lockdown, The Conversation partnered on the £2 million, ESRC-funded International Public Policy Observatory (IPPO), a collaboration of UK academic institutions – including UCL, the Welsh Centre for Public Policy (WCPP), Queen’s University Belfast, and the University of Glasgow – and the International Network for Government Science Advice (INGSA) to help make sense of the flood of COVID-related evidence and then report it usefully to policymakers across the UK.

Three years later, IPPO is now a third of the way through its second two-year phase, and has extended its focus to include the challenges of net zero, socio-economic inequalities, place and spatial inequality and COVID-19 recovery.

It has also been engaging with national and local policymakers to find out what kinds of evidence would be of most use to them. After all, to provide impactful answers, researchers need to know what questions people are asking.

What’s coming up?

Since June 2023, our team has been reviewing the new normal of hybrid and remote work, and how these changes are affecting workers with disabilities and long-term health conditions. In our next report, we’ll look at what policymakers can do to ensure that potential gains from more flexible working conditions are embedded into work spaces.

Read more: Sunak should be wary of backtracking on net zero – what history tells us about flip-flopping on the environment

IPPO has also focused its attention on the challenges posed by net zero goals, and highlighted the pathways and barriers to change when it comes to people making their homes more energy efficient. It has also suggested the novel idea of home upgrade agencies to offer bespoke, data-driven advice to households and help everyone make a positive difference.

This month, the team is holding a public event on the best ways to engage society in how we meet net zero goals, as countries across the world face increased opposition to green policies.

In Northern Ireland and Scotland, the team has also been exploring policy interventions to reduce high levels of economic inactivity. It now intends to expand this research to look at what different geographic areas around the UK can learn from one another.

Innovations in evidence

As part of its remit to challenge and improve how evidence is gathered and used, IPPO recently launched a new series of public, online events on new methods for mobilising evidence for greatest impact, to guide researchers, policymakers and intermediaries.

Our next events on “How to Commission Rapid Evidence Assessments for Policy” and “Systems Mapping: Best Approaches and What Works for Policy Design” will bring together experts in evidence and policy to discuss best practice for evidence-informed decision making.

Read more: The UK's four-day working week pilot was a success – here's what should happen next

We’ll also be welcoming David Halpern, chief executive of the behavioural insights team at Nesta, to discuss how to gauge whether an approach that works in one place and time, will work in others, during a public, online event.

Unlocking potential in a crisis

On November 21, IPPO will launch its first evidence review of 2023 looking at how local authorities can accelerate policy change under pressure.

Over the last four months, IPPO and its partner RREAL have looked at the COVID-19 recovery plans developed by local authorities across the country.

During our launch event, the report’s authors will discuss key takeaways from their research, reveal what mechanisms help unlock and deliver progressive policies, and share in-depth case studies of the experiences of those involved in the design and implementation of recovery plans at the local authority level. You can sign up here.

For more information about IPPO, its events and upcoming work, please click here.

Read More

Continue Reading


Synaffix joins forces with Sotio on $740M ADC licensing deal, plans expansion after Lonza acquisition

Lonza’s Synaffix is adding another manufacturing licensing partnership by securing a $740 million deal with Sotio Biotech, which would allow Sotio to…



Lonza’s Synaffix is adding another manufacturing licensing partnership by securing a $740 million deal with Sotio Biotech, which would allow Sotio to use the Dutch company’s three-pronged ADC tech.

It’s been a busy year for Synaffix: It was acquired by Lonza in June and the Sotio deal is its fifth new licensing deal of the year. Synaffix CEO Peter van de Sande told Endpoints News the Lonza acquisition will allow the company to bolster its ADC services. This includes plans to increase its personnel count from 35 to 50 in the next year, as well as expand its facilities and increase its manufacturing R&D capacity.

Since its inception in 2014, Synaffix has had at least 15 licensing deals in total and, according to its website, has its hands on three Phase I assets and nine preclinical programs.

In the Sotio deal, the biotech will lead the R&D for one unnamed bioconjugate program, with Synaffix manufacturing relevant assets. The $740 million deal includes signature, target nomination and milestone payments, as well as the potential for royalties once the asset hits the market. The deal has the potential to expand to two more programs.

Jens Hennecke

Sotio chief business officer Jens Hennecke told Endpoints it chose Synaffix as it is “a recognized player” in the ADC field. “We see them as a perfect fit to what we try to achieve to really lead the forefront of the ADC field,” he added in an interview.

On Friday, Sotio signaled it is increasing its focus on ADC products — what Hennecke described as the company’s “internal darling” — and dumped three clinical trials that studied its interleukin-15 superagonist called nanrilkefusp alfa.

Aside from Sotio, Synaffix also licensed its tech to ABL Bio on Sept. 13 for an undisclosed amount. Earlier, On Feb. 6, Synaffix also licensed its tech to South Korea-based Chong Kun Dang Pharm and, on Jan. 5, partnered with Amgen through a $2 billion licensing deal. This year started with a $150 million partnership with Hummingbird Bioscience, which was announced on Jan. 4.

Last week, Lonza revealed it is boosting its in-house ADC manufacturing by extending its partnership with an unnamed “major biopharmaceutical partner.”

Despite Lonza’s reduced CDMO sales outlook for 2023, van de Sande said Synaffix remains largely unaffected, as highlighted by its licensing deals. “We have more deals up our sleeve as well. You see, the funding landscape for ADCs is still good,” he added.

Synaffix’s ADC platform houses three technology products: GlycoConnect converts monoclonal antibodies into ADCs, HydraSpace stabilizes the linker, which attaches the antibody to the drug of choice or payload, and toxSYN provides six linkers with different payloads that have alternative mechanisms of action.

Read More

Continue Reading


BioNTech expects up to $950M in Covid vaccine write-offs after Pfizer lowers expectations

Pfizer’s write-offs for its Covid-19 vaccine are having a ripple effect on partner BioNTech, which is expecting to write off up to €900 million ($950…



Pfizer’s write-offs for its Covid-19 vaccine are having a ripple effect on partner BioNTech, which is expecting to write off up to €900 million ($950 million) related to the shot, Comirnaty.

BioNTech’s Monday update follows Pfizer’s late Friday announcement that it is launching a $3.5 billion company-wide cost-cutting program and writing off some of its inventory because of “lower-than-expected utilization” of its Covid products, including both Comirnaty and the antiviral Paxlovid.

In response to an Endpoints News inquiry about any cost cuts, a BioNTech spokesperson noted the company has been “actively managing our costs,” and pointed to statements from its second-quarter report in August. Notably, Pfizer also made write-offs in Q2, which “significantly reduced” BioNTech’s gross profit share.

Jens Holstein

“With some uncertainty on the revenue line, we are also carefully watching our spending by revisiting our cost base while remaining focused on executing against our strategic goals and providing value to the public and our shareholders,” CFO Jens Holstein said at the time.

Three years into the availability of Covid vaccines and drugs, companies — particularly those who earned the most at the height of the pandemic — have been scrambling to assess the extent of their revenue drop and recalibrate expectations. In the US, September marked the first vaccine season in which private payers, rather than the government, are footing the bill for Comirnaty. Earlier in the year, Pfizer and BioNTech also revised a contract with the European Union, leading to a smaller commitment to purchase doses.

The majority of Pfizer’s $900 million write-offs on Comirnaty has to do with raw materials, according to BioNTech, “mainly formulation-related lipids, purchased during the pandemic, as well as Covid-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk.”

The biotech added that the updated Covid vaccine designed to address the XBB.1.5 variant, which has been approved and distributed on major markets, isn’t part of Pfizer’s write-offs.

It’s still evaluating the exact impact of Pfizer’s new calculations on its own financial results, BioNTech said, noting the €900 million figure is its “current expectation” and represents its half under a gross profit-sharing agreement with Pfizer. The write-offs will reduce the revenues to be reported in its third quarter, although it didn’t specify by how much.

The company previously forecast vaccine revenue of €5 billion for the full year of 2023, after reporting around €1.4 billion for the first half. It is expected to provide an updated estimate in November.

BioNTech shares on the Nasdaq $BNTX are down 5.8% to $97.6 in premarket trading.

Read More

Continue Reading