In the news this week, Johnson & Johnson’s (J&J’s) COVID-19 vaccine rollout in Europe halted following blood clot concerns in the U.S. In other news, a biopharma partnership aims to expedite drug development in immunology, and research reveals substantial public funding for the Oxford/AstraZeneca vaccine. 

RESEARCH REVEALS 97% OF FUNDING FOR OXFORD COVID-19 WAS TAXPAYERS AND CHARITABLE SUPPORT – According to a recent research paper, the development of the Oxford/AstraZeneca COVID-19 vaccine was funded at least 97% by the public or charitable trusts including the Wellcome Trust. The paper in question details how “less than 2% of the identified funding came from private industry”. Despite waiting to be peer reviewed, the research team have declared that their data supported the truth that “public investment and international collaboration gave us the Covid-19 vaccines”.

J&J URGED TO CLARIFY CANCELLED DEPLOYMENT OF COVID-19 VACCINE IN EUROPE- Despite aiming to deliver 55 million doses to the EU by the end of June, J&J have temporarily suspended COVID-19 vaccine rollout in europe. The European Commission is now seeking “urgent clarification” from J&J. The suspension of J&J’s vaccine in Europe comes after blood clot concerns in the US, which the European Medicines Agency are currently reviewing. 

TWIST BIOSCIENCE PARTNERSHIP HOPES TO ACCELERATE ANTIBODY-BASED DRUG DISCOVERY – Biopharma Twist Bioscience partnered with Pure Biologics to optimise the discovery of antibody candidates for immunoncological targets. The biopharma division of Twist Bioscience has granted access for Pure Biologics to “select synthetic antibody phage display libraries”. The collaboration is hoping to support the potential of highly selective, potent antibodies in future cancer treatment.

R&D
Promising findings in identification of genetic site in susceptibility of breast cancer 

Manufacturing
UK drug discovery company licenses agreement with Sanofi to develop and commercialise inflammatory drug 

Clinical
Immunotherapy combination therapy shows potential for cancer treatment in clinical trial

That’s all for now. See you next week!

Charlotte Di Salvo, Junior Medical Writer
Proventa International

The post Weekly News Round-up – 16/4/21 appeared first on Proventa International.

In the news this week, Genmab suggests potential investment plans for spin-off biotechs. In other news, alternative COVID-19 vaccines offered to under-30s, and Acadia fails to achieve FDA approval for psychosis drug. 

GENMAB CEO HINTS AT FUTURE INVESTMENT PLANS – CEO of Genmab, Jan van de Winkel, has suggested he would consider branching out with smaller, specialist biotech companies. The application of Genmab’s drugs in many fields, including autoimmune diseases, has shown potential to spin out smaller arms of the company in different disease areas, according to Van de Winkel. He stated he had ambitions for the company “to build an innovation powerhouse on our own.”

ALTERNATIVE COVID-19 VACCINE FOR THE YOUNGER POPULATION – After recent reviews by the Medicines and Healthcare Products Regulatory Agency (MHRA), under-30s in the UK will be offered alternative COVID-19 vaccines to the AstraZeneca jab. The final decision comes from the MHRA, with CEO Dr June Raine emphasising that the risks of the AstraZeneca vaccine were more ‘finely balanced’ with the benefits for the younger population.

ACADIA PSYCHOSIS DRUG DENIED FDA APPROVAL – Disappointment for Acadia as FDA rejects its psychosis drug, Nuplazid, for approval. Despite approval for the drug for Parkinson’s psychosis in 2016, the FDA denied approving Nuplazid for dementia-related psychosis. The decision came from the Division of Psychiatry, FDA, who inferred one of the reasons was that the “study data has had insufficient numbers of patients in the study with certain less common dementia subtypes.”

R&D
Artios Pharma and Novartis Collaboration Brings Hope for Next Generation Radioligand Therapy 

Manufacturing
EMA Classifies Blood Clot Risk of AstraZeneca COVID-19 Vaccine as ‘Very Rare Side Effect’ Linked with Low Blood Platelets 

Clinical
Eli Lily Fails to Reach End Goal with Arthritis Drug of Preventing Mechanical Ventilation in COVID-19 Patients

That’s all for now. See you next week!

Charlotte Di Salvo, Junior Medical Writer
Proventa International

The post Weekly News Round-up – 9/4/21 appeared first on Proventa International.

In the news this week, GSK agrees to support NOVAVAX vaccine production to meet UK targets. In other news, Amgen Inc. confirms its agreement to acquire Rodeo Therapeutics, and COVID-19 vaccine production is boosted by expansions in production with BioNtech and Pfizer. 

GSK SUPPORTS NOVAVAX COVID 19 VACCINE MANUFACTURING – In collaboration with NOVAVAX and the UK’s Vaccines Task Force, GSK has agreed to support the manufacturing of up to 60 million COVID-19 vaccines. The recent partnership could increase production capacity and meet the April 15 deadline to offer a first dose to all over 50’s. 

AMGEN TO ACQUIRE RODEO THERAPEUTICS – Under a new agreement, Amgen Inc. will acquire Rodeo Therapeutics Corporation. The strategic move by Amgen seeks to collaborate with Rodeo’s enzyme programme (15-PGDH) to develop ‘first-in-class’ therapeutics alongside Amgen’s inflammation research. Any outstanding shares of Rodeo will be acquired by Amgen in exchange for an upfront payment of $55 million. 

2021 VACCINE TARGET BOOSTED BY BIONTECH-PFIZER – With further manufacturing capacity, expansion BioNTech and Pfizer could deliver 2.5 billion COVID-19 doses by 2022. The recent addition of BioNTech’s latest facility in Marburg, Germany, has resulted in expansion of the manufacturing and supply network to accelerate commercial production. 

R&D
IBM unveils next steps in AI technology with quantum computer

Clinical
First cell-based gene therapy approved for Adult Multiple Myeloma by FDA

Manufacturing 
Human error costs J&J 15 million COVID-19 vaccines

That’s all for now. See you next week!

Charlotte Di Salvo, Junior Medical Writer
Proventa International

The post Weekly News Round-up – 1/4/21 appeared first on Proventa International.

In the news this week, reports urge pharmaceutical companies to exploit the benefits of synthetic data in clinical trials. In other news, FDA fears over the safety of tanezumab compromises approval for the Pfizer/Lilly pain drug, and the COSMIC database promises great advancements in better matching treatment to patients’ cancer profiles.

FDA FEARS OVER SAFETY OF PFIZER/LILLY PAIN DRUG – Approval for tanezumab painkiller injection continues to be disputed with fear over the drug’s safety profile. This is not the first-time issues have been raised, with development suspended in 2012 due to issues with joint destruction. FDA reviewers are primarily focusing on the risk of Rapidly Progressive Osteoarthritis Rheumatology (RPOA) which has developed during trials with the pain drug. There is additional concern with mild nerve pain.

LATEST REPORTS REINFORCE BENEFITS OF SYNTHETIC DATA IN TRIALS – One of the main issues for clinical trials, especially in oncology, is the challenging and expensive recruitment process. According to a report by Accenture, synthetic data offers the opportunity to create a ‘synthetic patient profile’ as a virtual cohort. Using real-word evidence, synthetic data has the potential to accelerate progression of clinical trials by removing placebo effects. 

EXCITING DEVELOPMENTS IN PRECISION ONCOLOGY WITH COSMIC DATABASE – The launch of the Actionability tool for the COSMIC database allows clinicians and researchers to search over 37 million mutations across 1500 cancer types for the first time. Users can search for drugs that target specific mutations throughout the stages of drug development. With the addition of Actionability, clinicians can not only identify the mutations of a cancer, but how to precisely tailor the treatment for patients according to the genetic profile, from diagnosis through to therapy.

In other news:

R&D: 
Daiichi Sankyo digital partnership confirmed for Atrial Fibrillation research

CLINICAL:
Moderna initiates paediatric COVID-19 vaccine study

MANUFACTURING:
Vaccine rollout by J&J delivers only 22% of March target  

That’s all for now. See you next week!

Charlotte Di Salvo, Junior Medical Writer
Proventa International

The post Weekly News Round-Up – 26/3/21 appeared first on Proventa International.

In the news this week,real-world data has found the Pfizer vaccine to have high effectiveness against asymptomatic COVID-19. In other news, the EMA has advised continued use of AstraZeneca’s vaccine despite blood clot scares, and Zolgensma is set to be available on the NHS in England for the first time. 

EU COUNTRIES SUSPEND AZ VACCINE OVER BLOOD CLOTS – The EMA has declared the AZ/Oxford University COVID-19 vaccine can continue production as they begin an investigation into possible blood clots caused by the product. 30 cases have so far been reported, with several countries suspending inoculations at the time. AZ noted the vaccine had been extensively studied in human trials, and were subject to rigorous quality controls. 

PFIZER VACCINE GIVES HIGH PROTECTION AGAINST COVID-19, STUDY FINDS – Real-world data from Israel suggests the Pfizer/BioNTech vaccine grants high protection against asymptomatic COVID-19. The as-yet un-peer reviewed study found the vaccine is 97% effective against disease and death, and 94% effective against infection without symptoms. The data does not specify how effective the vaccine is yet against South African and Brazilian variants, however. 

NHS TO STOCK MOST EXPENSIVE DRUG IN THE WORLD FOR FIRST TIME – Zolgensma, the most expensive drug in the world, is to be made available on the NHS in England for the first time later in 2021. The drug, designed to halt progression of spinal muscular atrophy, would benefit around 80 infants a year in England. This is the most expensive treatment yet approved by the National Institute for Health and Care Excellence.

In other news:

R&D
Takeda buys Maverick Therapeutics for $525 million

Clinical
Bluebird Bio hoping to restart LentiGlobin trials after cancer scare

Manufacturing
Rollout of US COVID vaccine complicated by J&J manufacturing difficulties
Roche withdraws US bladder cancer indication for Tecentriq

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 12/3/21 appeared first on Proventa International.

In the news this week, Merck & J&J team up to boost COVID vaccine supply, while Novavax hopes to have its vaccine approved in May. In other news, Pfizer’s COVID vaccine may less effective in obese individuals, and Merck buys head & neck cancer drug xevinpant for $1 billion.

MERCK & J&J MAKE PARTNERSHIP TO BOOST COVID VACCINE SUPPLIES – President Biden is expected to announce a ’historic’ partnership between Merck & J&J as the two companies work to boost COVID vaccine supplies. Biden has previously promised to create enough vaccines for all Americans by July 2021. 

NOVAVAX COULD RECEIVE COVID VACCINE APPROVAL IN MAY – Novavax has released a statement that its COVID-19 vaccine could receive regulatory approval in May 2021. It is currently using data from a UK study. Should a US study be needed instead, the approval data would be moved to late summer. 

PFIZER VACCINE LESS EFFECTIVE IN THE OBESE – New data suggests the Pfizer/BioNTech vaccine could have less effect in the obese. A currently non-peer reviewed study found those with obesity produced only half the amount of antibodies of healthy individuals in response to a second dose of the vaccine. This could mean the obese need an additional booster dose for full protection. 

In other news:

R&D
Merck buys head & neck cancer drug xevinpant for $1 billion
ISA Pharma completes pre-clinical work for novel COVID-19 immunotherapy product

Clinical
Takeda buys Ovid’s epilepsy inhibitor soticlestat for up to $856 million

Manufacturing
Merck axe Ketruda from metastatic small cell lung cancer niche over FDA requirements

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 5/3/21 appeared first on Proventa International.

In the news this week, Moderna is set to make a profit for the first time with huge profit expectations for 2021. In other news, Icon acquires PRA for $12 billion to create a ‘mega-CRO’, and the first variant of the South African COVID variant specifically is shipped for trials.

MODERNA FORECASTS $18 BILLION IN VACCINE SALES FOR 2021 – Moderna has announced an expected $18.4 billion in profit from its coronavirus vaccine in 2021, much higher than the $11.2 billion predicted by analysts. This figure would give the company a profit for the first time. This number could also rise further given Moderna’s current discussions with governments about distributing the COVID vaccine worldwide. 

ICON ACQUIRES PRA IN $12 BILLION DEAL – Contract R&D company Icon has announced the acquisition of competitor PRA Health Services for around $12 billion. The acquisition will create a ‘mega-CRO’. This will have partnerships already cemented with a number of major pharma organisations. Icon claimed the merger would create a company with a top spot in several key markets. 

MODERNA SHIPS SOUTH AFRICA VARIANT VACCINE CANDIDATES OFF TO TRIALS –  Moderna has sent several doses of its vaccine candidate designed to combat the South African variant of COVID-19 to the US National Institutes of Health (NIH). Manufacturing of clinical trial material for the candidate has also been completed, it announced. In addition to this phase 1 study, the company is evaluating booster doses of its current vaccine, to increase neutralising immunity against high-risk variants of the virus.

In other news:

Clinical
FDA set to approve J&J’s one-shot COVID vaccine for emergency use
Sanofi’s immunotherapy drug Libtayo receives regulatory approval in first line lung cancer

Manufacturing
Australia could follow US in approving Pfizer vaccine for standard cold storage
UK COVID vaccine numbers drop by a third as supply slows

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 26/2/21 appeared first on Proventa International.

PFIZER AND MODERNA VACCINES LESS POTENT AGAINST AGGRESSIVE COVID VARIANTS – Further evidence has arisen suggesting Pfizer and its partner BioNTech must update their current vaccines to defeat newer variants of COVID-19. In a letter published in the New England Journal of Medicine, Pfizer said its vaccine appeared around two thirds less potent against the South African variant than against the initial virus. Against a full panel of mutations, including the Denmark and UK variants, they found a sixfold decrease in neutralising antibodies. Analysts examining the data predicted “significant numbers of breakthrough cases in vaccinated individuals” to the South African variant. 

NOVAVAX STRIKES 1.1 BILLION DOSE VACCINE DEAL WITH VACCINE ALLIANCE – A memorandum of understanding has been signed between COVID-19 vaccine maker Novavax and Gavi the Vaccine Alliance for 1.1 billion doses of Novavax’s vaccine to be supplied to COVAX, the global collaboration ensuring equitable access to vaccines. Under the COVAX agreement, Novavax expects to provide doses for high-income markets, while the Serum Institute will manufacture doses for other countries.

PRESIDENT BIDEN TO PROVIDE $1.6 BILLION FOR IMPROVED COVID TESTING – The Biden administration is set to provide $1.6 billion in order to expand and improve COVID-19 testing and sequencing. The government announced regional co-ordinating centres will be set up to identify lab testing capacities and match them to specific areas of need. The government has pledged to invest $815 million to build US manufacturing of testing supplies. The US Centers for Disease Control and Prevention will also invest around $200 million to expand genomic sequencing for the virus and detect emerging variants. 

In other news: 

R&D
GSK expanding COVID antibody collaboration with VIR to include possible flu therapies

Clinical
UK gives approval to controversial COVID-19 vaccine trials

Manufacturing
AZ’s Mexico vaccine partner forced to overhaul factory, slowing production

EU orders further 200 million doses of Pfizer/BioNTech COVID vaccine

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 19/2/21 appeared first on Proventa International.

In the news this week, the ongoing dispute between the UK and European Commission over vaccines entering the UK could lead to two months’ delay in herd immunity and thousands of deaths if EU plans go through. In other news, a report has found the pharma industry still underprepared for the next global pandemic; and Sanofi backs Pfizer in producing 

EU COULD PREVENT MILLIONS OF VACCINES ENTERING UK – The European Commission could block millions of vaccines from entering the UK. Following a vaccine shortage in several Member States, the Commission announced plans to allow regulators new powers to block export requests.

Herd immunity in the UK could be delayed by two months if it is forced to rely solely on home-produced vaccinations, putting thousands of lives at risk. Beyond this, the European Federation of Pharmaceutical Industries and Associations warned that this plan could also lead to a breakdown in global vaccine supply. 

NOVAVAX CORONAVIRUS VACCINE ALMOST 90% EFFECTIVE IN TRIALS – Novavax’s anti-COVID vaccine has completed phase 3 trials in the UK, showing 89.3% efficacy. It has also been shown to work against both the more infectious UK and South African strains of the virus. In a Phase 2 study in South Africa, the vaccine proved slightly less effective, averaging 60% efficacy. 

Novavax’s vaccine differs from the AZ and Pfizer products, in that it stems from moth cells infected with a genetically altered virus and adjuvant combo. As with the Oxford/AZ vaccine, however, it can be stored at normal temperatures, ensuring easier patient delivery. 

THe UK has so far secured access to 60 million Novavax doses, which should ease some of the tension caused by manufacturing problems faced by both Pfizer’s and AZ’s vaccines.

PHARMA STILL NOT READY FOR NEXT PANDEMIC – The not-for-profit Access to Medicine Foundation has published an independent report claiming that the pharma sector is still underprepared for the next global pandemic. The report identified Nipah and nine other illnesses, out of the 16 currently identified by the W.H.O as major public health risks, as significant dangers for which pharma has no development ongoing in its pipelines. 

The report also warns of antimicrobial resistance (AMR), arguing that an AMR pandemic is “inevitable, unless the pharma industry seriously commits to developing replacement antibiotics”.

In other news: 

R&D
RedX Pharma to focus on pipeline that previously found LOXO-305
GSK forced to cut ulcerative colitis drug trial in research setback

Clinical
Merck drops out of COVID-19 vaccine race

Manufacturing
Sanofi to work with Pfizer on coronavirus vaccine production

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 29/1/21 appeared first on Proventa International.

In the news this week, collaboration within the pharma industry continues to struggle as it is revealed that the WHO’s platform for industry collaboration over COVID-19 goes entirely unused. In other news, Merck finally loses its hepatitis C patent infringement case against Gilead as the Supreme Court fails to take up the challenge, and Eli Lilly brings on board cancer immunotherapy products through a Merus alliance.

W.H.O.’S COVID PLATFORM UNUSED SINCE START OF PANDEMIC  – C-Tap, the World Health Organization’s COVID-19 program to allow pharma companies to share expertise, treatment and technology around the virus, has received no contributions over its eight-month lifespan. C-Tap was created to pool treatment data in order to allow manufacturers to produce equipment, drugs and vaccines without patent challenges or legal issues. This in turn would lower costs and ease drug shortages. Critics of the WHO initiative argued that patent rights have fuelled the speed of COVID-19 vaccines, and that simply ignoring IP rights will not overcome problems around access.

SOUTH AFRICA MUST PAY 2.5x EU PRICE FOR OXFORD/AZ VACCINE – South Africa, the worst-hit country in Africa for COVID-19, must pay nearly 2.5 times the amount countries in Europe are paying for the Oxford University / AstraZeneca vaccine. According to South Africa’s deputy director general of health, Anban Pillay, the increased cost of $5.25 is because other countries contributed more to the vaccine’s R&D.

MERCK LOSES $2.4 BILLION COURT BATTLE AGAINST GILEAD – Merck has lost its $2.4 billion court challenge against Gilead, after the Supreme Court refused to take up the case. Merck’s subsidiary Idenix Pharmaceuticals had initially claimed Gilead had infringed one of its hepatitis C patents with two blockbusters, Sovaldi and Harvoni, a claim that was eventually quashed by federal courts. 

In other news: 

R&D
Eli Lilly allies with Merus in $1.6 billion cancer immunotherapy deal

Clinical
Pfizer/BioNTech’s COVID vaccine works against UK variant
Merck/GSK lung cancer drug bintrafusp fails late-stage trials

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

The post Weekly News Round-up – 22/1/21 appeared first on Proventa International.