Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD).
In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks.
Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year.
“These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche.

Read more: http://www.pharmatimes.com/news/roches_faricimab_hits_primary_endpoint_in_two_wet_amd_studies_1361940

Roche’s faricimab hits primary endpoint in wet AMD studies - PharmaTimes

Bispecific antibody met non-inferiority measure compared to Regeneron's Eylea - News - PharmaTimes

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the publication of a peer-reviewed study that shows BD's antigen test may be more selective than PCR (polymerase chain reaction) molecular tests at detecting people who are contagious and able to spread COVID-19 disease.

The study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth in the cell culture test indicates the presence of live virus in the patient sample, which may indicate the presence of infectious virus at the time the sample was taken. If no growth is present in the viral cell culture test, it is likely that there wasn't enough viable virus for the patient to be contagious at the time the sample was taken.

Out of 38 positive PCR result specimens tested, only 28 were positive using the cell culture technique.



Read more: https://www.prnewswire.com/news-releases/new-clinical-data-shows-bd-antigen-test-may-be-more-selective-in-detecting-infectious-covid-19-patients-than-molecular-tests-301213568.html

New Clinical Data Shows BD Antigen Test May Be More Selective In Detecting Infectious COVID-19 Patients Than Molecular Tests

/PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the publication of a peer-reviewed...

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL).
In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study.
AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica.
In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence.
“With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/.

Read more: http://www.pharmatimes.com/news/calquence_tops_imbruvica_in_chronic_lymphocytic_leukaemia_study_1361843

Calquence tops Imbruvica in chronic lymphocytic leukaemia study - PharmaTimes

BTK inhibitor demonstrated non-inferior progression-free survival compared to Imbruvica - News - PharmaTimes

French pharma company Servier has entered into a research partnership with UK biotech MiNA Therapeutics to develop small activating RNA (saRNA) therapies for the treatment of neurological diseases.

Under the terms of the deal, MiNA will engage its saRNA platform to identify new potential treatments with the aim of restoring normal cell function in neurological disorders.

Meanwhile, Servier will be responsible for preclincial and clinical development of the lead candidates and will retain the rights for the commercialisation of any products resulting from the partnership.

Although details of the specifics of the deal are sparse, the companies disclosed that MiNA would receive an upfront payment and exclusivity fee for certain ‘targets of interest’.

MiNA will also be entitled to research and development, regulatory and commercial milestones and royalties.



Read more: http://www.pharmatimes.com/news/servier_and_mina_therapeutics_ink_neurology_pact_1361757

A new research institute at the University of Oxford has been established to fight against antimicrobial resistance (AMR).

The Ineos Oxford Institute (IOI) will be based between two sites in Oxford, linking the university’s Department of Chemistry and the Department of Zoology.

It will build on Oxford’s expertise and legacy in the field of AMR and antibiotic research and drug discovery – scientists at the university made progress in making concentrated penicillin after it was discovered by Alexander Fleming in the early 20th century.

The new institute has initially received funding from Ineos, a British chemical company, totalling £100m, which will enable research into the development of new drugs tackling AMR for animals and humans.

The institute will also aim to spread awareness of the responsible use of existing antibiotic medications. The IOI plans to partner with other global leaders in AMR research to achieve this goal.



Read more: http://www.pmlive.com/pharma_news/new_oxford_research_institute_established_to_tackle_antimicrobial_resistance_1361614

New Oxford research institute established to tackle antimicrobial resistance - PMLiVE

New Oxford research institute established to tackle antimicrobial resistance - PMLiVE

UK biotech company ConserV Bioscience will collaborate on the development of a broad-spectrum coronavirus vaccine with Lawrence Livermore National Laboratory (LLNL).

The vaccine has been designed to enable broad-spectrum protection against coronavirus pathogens originating from humans and animals, including MERS, SARS and SARS-CoV-2.

The vaccine candidate consists of conserved immunoreactive regions from external and internal coronavirus proteins encoded in messenger RNA (mRNA).

LLNL will use its proprietary nanolipoprotein particle (NLP) technology to formulate the mRNA constructs prior to injections.

This will allow for the freeze drying of both components of the vaccine separately, with the aim of improving storage and transport conditions compared to other mRNA vaccine products.



Read more: http://www.pharmatimes.com/news/conserv_bioscience_to_develop_broad-spectrum_coronavirus_vaccine_1361587

ConserV Bioscience to develop ‘broad-spectrum’ coronavirus vaccine - PharmaTimes

UK biotech company will collaborate with Lawrence Livermore National Laboratory - News - PharmaTimes

Boehringer Ingelheim has entered a strategic collaboration with UK biotech Enara Bio to research and discover novel targeted cancer immunotherapies.

The agreement will leverage Enara’s Dark Antigen discovery platform to identify and validate novel dark antigens in up to three tumour types across the lung and gastrointestinal cancer areas.

Dark antigens are a new class of cancer-associated antigens that derive from genomic dark matter – the portion of the human genome that is normally not expressed as protein.

In healthy cells, dark antigen-encoding sequences are usually silenced but are activated and presented on tumour cells – they are often associated with specific cancer types and are shared across patients.

Within the collaboration, Boehringer and Enara will aim to discover shared antigens that could lead to the development of vaccines that can be used in a broad group of cancer patients.

Under the terms of the agreement, Boehringer has the option to license dark antigens discovered and validated by Enara.



Read more: http://www.pharmatimes.com/news/boehringer_ingelheim_and_enara_bio_join_forces_to_discover_cancer_immunotherapies_1361363

Boehringer Ingelheim and Enara Bio join forces to discover cancer immunotherapies - PharmaTimes

Agreement will leverage Enara's novel Dark Antigen discovery platform - News - PharmaTimes

AstraZeneca’s (AZ) PD-L1 inhibitor Imfinzi (durvalumab) has been granted approval in the European Union and the UK for a new dosing option in locally advanced, unresectable non-small cell lung cancer (NSCLC).

The additional option extends dosing from every two weeks to every four weeks, enabling patients to reduce their medical visits – an important factor in the current COVID-19 pandemic.

The new dosing regimen is consistent with Imfinzi’s approved dosing in extensive-stage small cell lung cancer (ES-SCLC).

The European Commission (EC) approval is based on data from a number of clinical trials evaluating Imfinzi – including the PACIFIC phase 3 trial which supported the two-week, weight-based dosing of 10mg/kg approval in NSCLC and the CASPIAN phase 3 trial which used a four-week fixed-dose regimen in ES-SCLC.



Read more: http://www.pmlive.com/pharma_news/new_dosing_option_for_azs_imfinzi_approved_in_the_eu_and_uk_1361371

New dosing option for AZ’s Imfinzi approved in the EU and UK - PMLiVE

New dosing option for AZ’s Imfinzi approved in the EU and UK - PMLiVE

Gilead Sciences and Vir Biotechnology have partnered to evaluate novel therapeutic combination strategies aimed at developing a ‘functional cure’ for chronic hepatitis B virus (HBV).

As part of the clinical collaboration, the companies are expecting to launch a Phase II trial evaluating combination therapies for both treatment-experienced and treatment-naïve people living with HBV.

This study will evaluate a number of combinations of Gilead’s investigational TLR-8 agonist selgantolimod, Vir’s small interfering ribonucleic acid (siRNA) candidate VIR-2218 and a marketed PD-1 antagonist.

Study participants who have previously received treatment for HBV may also be given Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF).



Read more: http://www.pharmatimes.com/news/gilead_and_vir_unite_to_find_a_functional_cure_for_hepatitis_b_1361244

Gilead and Vir unite to find a ‘functional cure’ for hepatitis B - PharmaTimes

Companies will collaborate on a combination therapy study - News - PharmaTimes

US pharma Johnson & Johnson (J&J) is planning to launch its single-dose COVID-19 vaccine in March, according to the company’s chief scientific officer Paul Stoffels.

In an interview with Reuters, Stoffels added that the company is expecting to have ‘clear data’ on the efficacy of its COVID-19 vaccine by either the end of January or early February.

J&J initiated a large-scale phase 3 trial of its COVID-19 vaccine in September 2020, following positive interim results from a phase 1/2a clinical study.

The phase 3 ENSEMBLE trial was launched in collaboration with the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) and the US National Institute of Allergy and Infectious Diseases (NIAID).



Read more: http://www.pmlive.com/pharma_news/j_and_j_could_launch_its_single-dose_covid-19_vaccine_in_march_1361272

J&J could launch its single-dose COVID-19 vaccine in March - PMLiVE

J&J could launch its single-dose COVID-19 vaccine in March - PMLiVE

Bayer has scored a US Food and Drug Administration (FDA) priority review for its investigational drug finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
Finerenone – also known as BAY 94-8862 – is a selective mineralocorticoid receptor antagonist (MRA). Overactivation of the mineralocorticoid receptor is believed to play a key role in kidney and cardiovascular damage, through inflammatory and fibrotic processes.
The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D. The participants were randomly assigned in a 1:1 ratio to receive either Bayer’s investigational drug or a placebo.
In this trial, patients with CKD and T2D who received finerenone treatment experienced lower risks of CKD progression and cardiovascular events compared to placebo.
On the primary endpoint of kidney failure outcomes, patients treated with finerenone an 18% relative risk reduction compared to the placebo group.
The key secondary endpoint, which measures cardiovascular outcomes, found that the finerenone treatment group had a relative risk reduction of 14% compared to the placebo group.

Read more: http://www.pmlive.com/pharma_news/bayers_finerenone_scores_fda_priority_review_for_chronic_kidney_disease_1361314

Valneva has chosen UK-based diagnostics company Oxford Immunotec to perform T cell testing on participants receiving its COVID-19 vaccine candidate (VLA2001) in a Phase I/II study.

Valneva’s VLA2001-201 study is designed to investigate the safety, tolerability and immunogenicity of its inactivated SARS-CoV-2 virus vaccine in healthy subjects.

Oxford Immunotec’s T-SPOT Discovery SARS-CoV-2 test will evaluate if vaccination with Valneva’s vaccine candidate induces a T cell response in study participants.

In previous studies, Oxford Immunotec’s test has demonstrated that SARS-CoV-2 responsive T cell numbers were associated with protection from COVID-19.

The aim of collecting T cell data from the VLA2001-201 study is to potentially gather additional information for assessing the efficacy of Valneva’s COVID-19 vaccine candidate.



Read more: http://www.pharmatimes.com/news/valneva_partners_with_oxford_immunotec_on_t_cell_analysis_for_covid-19_vaccine_1361243

Valneva partners with Oxford Immunotec on T cell analysis for COVID-19 vaccine - PharmaTimes

Oxford Immunotec will perform T cell testing on participants receiving Valneva's vaccine candidate - News - PharmaTimes

Biogen and Apple have announced that they will collaborate on a new virtual research study investigating the role of smart devices could have on monitoring cognitive health.

The multi-year, observational study will evaluate the role that Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health, including mild cognitive impairment.

The study will launch later in 2021 and is set to enrol participants including young and ageing adults with a range of cognitive performance.

Its primary objectives are to develop digital biomarkers to help monitor cognitive performance over time and to identify the early signs of mild cognitive impairment.



Read more: http://www.pharmatimes.com/news/biogen_and_apple_partner_on_cognitive_health_study_1361112

Biogen and Apple partner on cognitive health study - PharmaTimes

Study will evaluate the role of smart devices on monitoring cognitive health - News - PharmaTimes

Angelini Pharma has acquired Swiss biopharmaceutical company Arvelle Therapeutics for a total consideration of up to $960m.

Arvelle specialises in developing treatment for patients with central nervous system (CNS) and mental health disorders.

The key focus of the acquisition is Arvelle’s CNS asset cenobamate, which has been deemed a Promising Innovative Medicine by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of drug-resistant focal-onset seizures in adults.

Following Angelini’s acquisition of Arvelle, the company will gain exclusive licensing rights to commercialise cenobamate in the European Union and other countries in the European Economic Area (including Switzerland and the UK).

In a clinical study of cenobamate, the drug’s clinical efficacy was demonstrated after it showed a significant greater reduction in seizure frequency.

In addition, more patients achieved a 50% or greater reduction in seizure frequency compared to the placebo group.

http://www.pharmatimes.com/news/angelini_pharma_acquires_cns_specialist_arvelle_therapeutics_1360759

Angelini Pharma acquires CNS specialist Arvelle Therapeutics - PharmaTimes

Key focus of the deal is focal-onset seizure treatment cenobamate - News - PharmaTimes

The European Commission (EC) has authorised Janssen’s Rekambys (rilpivirine injection) in combination with ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to treat HIV-1 infections in adults who are virologically suppressed.

This approval marks the first time that people living in the EU with HIV can receive a long-acting injectable treatment without having to take daily oral tablets, Janssen said in a statement.

The marketing authorisation is based on the phase III ATLAS, FLAIR and ATLAS-2M studies, which includes over 1,200 participants from 16 countries.

Read more: http://www.pharmatimes.com/news/eu_authorises_first_long-acting_hiv_injectable_treatment_1360432

EU nod for first long-acting HIV injectable treatment - PharmaTimes

Rekambys plus Vocabria authorised to treat HIV-1 infections in adults who are virologically suppressed - News - PharmaTimes

The Lancet has published peer-reviewed results from an interim analysis of AstraZeneca (AZ) and Oxford University’s phase 3 COVID-19 vaccine programme, confirming the vaccine to be 70.4% effective based on two dosing regimens.

The interim analysis for efficacy of the vaccine, AZD1222, was based on 11,636 participants with 131 symptomatic COVID-19 infections from the phase 3 UK and Brazil trials conducted by Oxford University.

AZ initially announced the interim analysis data in November, revealing that the vaccine candidate had an average efficacy rate of 70% based on two dosing regimens.

The new Lancet data sheds some more light on the exact efficacy for AZ/Oxford’s vaccine programme, demonstrating that AZD1222 is 70.4% effective in preventing symptomatic COVID-19, 14 days after receiving two doses of AZD1222.

Read more: http://www.pmlive.com/pharma_news/the_lancet_confirms_effectiveness_of_azoxford_universitys_covid-19_vaccine_1359763

The Lancet confirms effectiveness of AZ/Oxford University's COVID-19 vaccine - PMLiVE

The Lancet confirms effectiveness of AZ/Oxford University's COVID-19 vaccine - PMLiVE

Novartis has signed a multi-year collaboration agreement with RetinAI to utilise the latter’s IT solutions and artificial intelligence (AI) tools to support multiple projects in ophthalmology and digital health.

RentinAI is a Swiss biotech company focused on developing software solutions to accelerate clinics, research and pharmaceutical workflows using advanced machine learning and computer vision.

The first project to be carried out under the new Novartis agreement will support an international clinical study involving patients with neovascular age-related macular degeneration (nAMD).

The study will investigate the influence of optical coherence tomography (OCT) image solutions using AI on the assessment of disease activity.

This study is set to be conducted in several clinical centres across a number of European countries and candidate and will involve over 500 patients.



Read more: http://www.pharmatimes.com/news/novartis_signs_ai_ophthalmology_pact_with_retinai_1359748

Patients with relapsed or refractory mantle cell lymphoma (MCL) treated with AstraZeneca's Calquence (acalabrutinib) remained progression free for a median of 22 months, with median overall survival not yet reached at three years of follow-up, according to long-term follow-up data from the ACE-LY-004 Phase II trial.

At a median follow up of 38.1 months, 55 patients (44%) either remained on treatment (24 patients) or continued to be followed for survival (31 patients).

The results, presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, also showed a consistent safety and tolerability profile for the drug in this setting, with with only 14 patients (11%) having discontinued treatment due to adverse events.



Read more: http://www.pharmatimes.com/news/calquence_shows_long-term_efficacy_and_tolerability_in_mcl_1359178

Calquence shows long-term efficacy and tolerability in MCL - PharmaTimes

Patients with relapsed or refractory mantle cell lymphoma (MCL) treated with AstraZeneca's Calquence remained progression free for a median of 22 months - News - PharmaTimes

Roche’s Genentech division and its partner Blueprint Medicines have scored a new approval for Gavreto in the US for the treatment of RET-altered thyroid cancer.

The US Food and Drug Administration (FDA) has cleared Gavreto (pralsetinib) for the treatment of adult and paediatric patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer.

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.

This newest approval is based on results from the phase I/II ARROW study, in which treatment with Gavreto led to an overall response rate (ORR) of 60% in 55 people with previously-treated RET-mutant metastatic medullary thyroid cancer (MTC).

In addition, Gavreto treatment led to an ORR of 66% in 29 people with RET-mutant advanced MTC who had not been previously treated with cabozantinib and vandetanib.



Read more: http://www.pharmatimes.com/news/genentechs_gavreto_scores_us_approval_for_ret_thyroid_cancer_1359022

Genentech’s Gavreto scores US approval for RET thyroid cancer - PharmaTimes

Precision therapy is designed to selectively target RET alterations - News - PharmaTimes

http://www.pmlive.com/pharma_news/biogen_signs_$3.1bn_deal_with_sage_for_potential_depression_therapies_1358687

Biogen signs $3.1bn deal with Sage for potential depression therapies - PMLiVE

Biogen signs $3.1bn deal with Sage for potential depression therapies - PMLiVE

http://www.pharmatimes.com/news/azoxford_universitys_covid-19_vaccine_shows_average_efficacy_of_70_1357481

AZ/Oxford University’s COVID-19 vaccine shows average efficacy of 70% - PharmaTimes

Effectiveness ranges from 62% to 90% depending on dosing regimen - News - PharmaTimes

A new trial focusing solely on multiple sclerosis patients who can’t walk is set to begin recruiting participants.
The ChariotMS, which will be funded by government, charity and commercial backers, will enrol MS patients who are reliant on a wheelchair.
The trial funders include the Efficacy and Mechanism Evaluation Programme, which is a partnership between the Medical Research Council and National Institute for Health Research, as well as the MS Society, the National MS Society USA, Barts Charity, and Merck Serono.
It will study the efficacy of Mavenclad (cladribine) tablets – which are already licensed for highly active relapsing MS – in advanced MS patients who can’t walk. It will seek to determine whether this treatment can slow the rate of upper limb disability progression in people with advanced MS.

Read more: http://www.pharmatimes.com/news/multiple_sclerosis_trial_focusing_on_people_who_cant_walk_begins_recruitment_1357342

Multiple sclerosis trial focusing on people who can’t walk begins recruitment - PharmaTimes

Trial will evaluate whether Mavenclad can slow the rate of upper limb disability progression - News - PharmaTimes

As digital levels the customer engagement playing field, what can big pharma learn from smaller, nimble biotechs when agility is key? Hear from Alnylam, Alexion and EY in this webinar: https://bit.ly/32Gzmnb

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With the pandemic putting digital capabilities and virtual engagement front and center, the companies who are hyper-effective at rapid data analysis, content deployment and omnichannel are leapfrogging their competitors

A new vaccine that protects against Covid-19 is nearly 95% effective, early data from US company Moderna shows.

The results come hot on the heels of similar results from Pfizer, and add to growing confidence that vaccines can help end the pandemic.

Both companies used a highly innovative and experimental approach to designing their vaccines.

Moderna says it is a "great day" and they plan to apply for approval to use the vaccine in the next few weeks.

However, this is still early data and key questions remain unanswered.

How good is it?

The trial involved 30,000 people in the US with half being given two doses of the vaccine, four weeks apart. The rest had dummy injections.

The analysis was based on the first 95 to develop Covid-19 symptoms.

Only five of the Covid cases were in people given the vaccine, 90 were in those given the dummy treatment. The company says the vaccine is protecting 94.5% of people.

The data also shows there were 11 cases of severe Covid in the trial, but none happened in people who were immunised.

"The overall effectiveness has been remarkable... it's a great day," Tal Zaks, the chief medical officer at Moderna, told BBC News.

Read more: https://www.bbc.co.uk/news/health-54902908

Moderna: Covid vaccine shows nearly 95% protection - BBC News

The results add to growing confidence that vaccination can end the pandemic.

GlaxoSmithKline (GSK) and Medicago have are set to launch phase 2/3 trials of a plant-derived COVID-19 vaccine candidate, after the shot yielded positive results in phase 1.



The vaccine candidate combines Medicago’s recombinant coronavirus virus-like particles (CoVLP) with GSK’s pandemic adjuvant system.

Medicago’s CoVLPs mimic the structure of the SARS-CoV-2 virus that causes COVID-19, which allows them to be recognised and targeted by the immune system.

In an early study of the vaccine, Canada-headquartered Medicago said that all subjects vaccinated with the experimental shot developed "a promising antibody response after two doses".

The company added that it will use a lower dose of the vaccine, combined with GSK’s adjuvant, in the upcoming phase 2/3 studies. Adjuvants are typically used to boost the immune response of a specific vaccine candidate.

They are of particular use in a pandemic situation, as the boosted immune response can reduce the amount of antigen required per dose, allowing for more vaccine doses to be manufactured and distributed.



Read more: http://www.pmlive.com/pharma_news/gsk,_medicago_launch_phase_23_clinical_trials_of_plant-derived_covid-19_vaccine_1356854

GSK, Medicago launch phase 2/3 clinical trials of plant-derived COVID-19 vaccine - PMLiVE

GSK, Medicago launch phase 2/3 clinical trials of plant-derived COVID-19 vaccine - PMLiVE