The Pharma Digest

Novel life-saving research, evolving technology, and drug approvals granted – or not. At Teckro, we’re committed to making the complex simple. That’s why we regularly gather the latest highlights from industry-leading clinical research news, all in one place: The Pharma Digest.

Aug 04, 2021

August

New EU Clinical Trial Regulation Set for Early 2022

The European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will replace the Clinical Trials Directive (2001/20/EC) when it comes into effect in January 2022. The CTR will ensure a greater level of synchronization of the rules for conducting clinical trials throughout the EU and will introduce a submission and review process via a single portal. The CTR will also make it easier for pharmaceutical companies to conduct multinational clinical trials, increasing the number of studies conducted within the EU. Learn more here.

AbbVie Announces New Data for Presbyopia Treatment

AbbVie revealed new data from the Phase III trial – GEMINI 1 - evaluating the efficacy and safety of AGN-190584 for presbyopia, a common and progressive eye condition. The study met its primary and key secondary endpoints, demonstrating an improvement in patients’ vision at 30 days. Discover more.

Safety Profiles: AstraZeneca and mRNA COVID-19 Vaccines

A study published in The Lancet last week discovered that the AstraZeneca and mRNA vaccines for COVID-19 have similar safety profiles. The study examined the incidence of thrombosis in over a million vaccinated people. Read more about the study.

Roche’s Evrysdi Shows Improvement in Spinal Muscular Atrophy Infant Trial

Roche’s FIREFISH study in infants aged one to seven months with symptomatic Type 1 spinal muscular atrophy (SMA) met primary endpoints. Almost 29% of infants were able to sit without needing support for five seconds, while 85% did not require continuous ventilation at month 12. Read the full article.

Sanofi’s Dupixent Shows Positive Results for Urticaria

Sanofi reported that Dupixent (dupilumab) met the primary and all key secondary goals at 24 weeks in pivotal Phase III clinical trial (Study A) in moderate-to-severe chronic spontaneous urticaria (CSU) patients. The drug, which targets inflammation pathways, demonstrated a 63% decrease in the severity of itch and a 65% decline in urticaria activity severity. Details here.

July

Lilly Collaboration for Phase III Trial of Alzheimer’s Drug

Eli Lilly entered a collaboration with Banner Alzheimer’s Institute in a placebo-controlled Phase III trial. The trial, named TRAILBLAZER-ALZ 3, will investigate if donanemab can slow the clinical progression of Alzheimer’s disease in patients at risk for cognitive and functional decline. Learn more.

Merck's Keytruda, Eisai's Lenvima Granted Full Approval for Endometrial Cancer

The FDA granted full approval to Merck and Eisai for the combination therapy of Keytruda and Lenvima. The approval follows the Phase III trial which showed that the treatment cut the risk of death by 38% compared to chemotherapy in patients with previously treated endometrial cancer, regardless of their tumor’s mismatch repair status. Discover more about the approval.

Pfizer and Arvinas Announce a $1 Billion Collaboration for Breast Cancer

Pfizer and Arvinas signed an agreement to jointly develop and commercialize an investigational oral protein degrader for breast cancer, currently in a Phase II trial. The investigational treatment – ARV-471 – aims to treat patients with advanced or metastatic breast cancer. Read the full story.

Bluebird Bio’s Gene Therapy Treatment Approved for a Rare Disease in Children

Skysona, Bluebird Bio’s elivaldogene autotemcel, won approval from the European Commission to treat children with the rare neurodegenerative disease early cerebral adrenoleukodystrophy (CALD). This approval was supported by efficacy and safety data from the Phase II/III Starbeam study and follows the EMA’s positive recommendation for Bluebird Bio’s Zynteglo. Go to the article.

Digital Approach from Dopavision to Tackle Myopia Through Gaming

Myopia, or short-sightedness, is a growing health concern. Young people especially are developing myopia at a faster rate, possible due to mobile phone use from an early age. In fact, some studies have suggested that 50% of the global population will have myopia by 2050, which carries with it an increased risk of glaucoma, cataracts, and retinal detachment. Digital therapeutics (DTx) startup Dopavision developed an app designed to slow the progression of myopia in children and adolescents using light therapy administered during a game. Details here.

FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Trials

The FDA issued draft guidance on “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings.” When finalized, this guidance will provide sponsors with recommendations on designing clinical trials to expand eligibility to patients with incurable cancers, including patients who have not received available treatment options. Read the full article.

FDA Advisory Committee Votes Against Approval of Roxadustat

An FDA advisory committee voted against the approval of AstraZeneca and FibroGen’s roxadustat for the treatment of anemia in chronic kidney disease patients over the risk/benefit profile. Although the FDA is not bound to follow the recommendations made by the advisory committee, it usually does so. Learn more here.

UK to Study Long Covid in £20 Million Research Drive

The UK Government announced a £19.6m research drive into long Covid to help fund 15 new clinical studies across the UK. Selected projects include University College London’s STIMULATE-ICP which will be the largest long Covid trial to date, recruiting more than 4,500 people. Read more about the research drive.

Atopic Dermatitis Applications from AbbVie and Lilly hit with more Delays

The FDA deferred decisions on AbbVie and Lilly’s applications for Rinvoq and Olumiant in moderate to severe atopic dermatitis. The FDA halted verdicts on Janus kinase (JAK) class of medicines due to safety concerns while more investigations take place. Learn more.

FDA Grants Priority Review for Severe Asthma Treatment

The FDA has accepted AstraZeneca and Amgen’s submission for their investigational asthma drug tezepelumab and has granted a priority review for the therapy. The submission included data from the Phase III NAVIGATOR trial, which demonstrated the potential to successfully treat patients with severe asthma by preventing inflammation. Discover more here.

Oxford University Begins Phase I Trial of HIV Vaccine

HIVconsvX, the Oxford University candidate for a HIV vaccine, has entered Phase I clinical trials. The trial is analyzing the safety, tolerability and immunogenicity of the vaccine in 13 healthy, HIV-negative individuals aged 18 to 65 years who are not at high risk of HIV infection. Results are expected next year. Read the full article.

Diabetes Drug first to Succeed in hard-to-treat Heart Failure

A diabetes drug from Eli Lilly and Boehringer Ingelheim reduced the risk of heart-related death or hospitalization for heart failure. The results came from two large Phase III studies focused on preserved ejection fraction, in which the heart is able to contract but does not pump normal amounts of blood. Details here.

Moderna enters the Clinic with mRNA flu Vaccine, mRNA-1010

Moderna has dosed the first participants in a Phase I/II study for the prevention of influenza. Advancing on the success of the mRNA COVID-19 vaccination, Moderna is applying the technology to a range of new indications, including a combination flu/ COVID-19 jab. Learn more.

Merck & Co withdraws Keytruda’s US Approval in third-line Stomach Cancer

Merck & Co (known as MSD outside of the US and Canada) will voluntarily withdraw a US FDA accelerated approval for Keytruda in third-line stomach cancer, beginning in six months’ time. This decision follows an FDA announcement earlier this year that it would convene an advisory committee meeting to discuss six oncology indications with accelerated approvals, amid a major review of cancer drugs that have failed to meet post-marketing requirements. Read the full article.

GSK and Alector to Develop Antibodies for Neurodegenerative Diseases

GlaxoSmithKline (GSK) and Alector entered a strategic global alliance to develop and market two monoclonal antibodies, AL001 and AL101. Trials are currently underway for various neurodegenerative diseases, including frontotemporal dementia owing to a progranulin gene mutation and amyotrophic lateral sclerosis. Details here.

Sanofi to Invest in a Vaccine mRNA Center of Excellence

Following the success of the COVID-19 mRNA vaccines, Sanofi plans to invest $473 million annually to establish a vaccine mRNA Center of Excellence. Through its collaboration with Translate Bio, the company has already made headway in the mRNA field, focusing on “current and future infectious diseases.” Discover more.

Roche remains focused on Phase III trial of Alzheimer's Drug

Roche dismissed rumors that it would seek early FDA approval for its Alzheimer’s disease candidate, gantenerumab. The company is continuing with the Phase III trial and is expecting data from the late-stage trial to arrive in the second half of the year. This news follows the FDA’s approval of Biogen's Aduhelm for Alzheimer's disease through the accelerated approval lane. Learn more here.

Gilead Submits New Drug Application to FDA for HIV Treatment

Gilead recently submitted a new drug application to FDA seeking approval for lenacapavir, its investigational, long-acting HIV-1 inhibitor for HIV treatment. In a Phase II/III trial, a higher proportion of patients who received the HIV treatment achieved a clinically meaningful viral load reduction compared to those who received a placebo. If approved, Lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered every six months. Discover more.

June

Cancer Research UK spin-out gets US approval to trial unique T-cell Therapy

GammaDelta Therapeutics, a spin-out of Cancer Research UK, has been given approval from the FDA to trial its unique T-cell therapy in humans with acute myeloid leukaemia. The trial is expected to begin later this year in the US. Learn more.

Blood test that finds 50 types of cancer is accurate enough to be rolled out

Developed using a machine-learning algorithm, a blood test that can detect more than 50 types of cancer before clinical symptoms of the disease emerge is now ready to be rolled out as a screening test. The test, which is also being piloted by NHS England in the autumn, is aimed at people at higher risk of the disease, including patients aged 50 or older. Read more.

Phase III pivotal trial of once weekly exenatide in adolescents aged 10–17 shows benefit for the treatment of type 2 diabetes

AstraZeneca’s exenatide extended-release 2mg once weekly has shown benefit for the treatment of type 2 diabetes in their phase III clinical trial. The results were presented at the 2021 American Diabetes Association (ADA) Virtual 81st Scientific Sessions. Read the full press release.

Game On! Akili Launches the first FDA-approved ADHD Video Game

It may be offered on prescription, but Akili’s new treatment for ADHD isn’t a drug – it’s a video game. Taking a digital-first approach, patients can leave the doctor’s office, receive a code from the pharmacy and begin playing the same day. Learn more.

CRISPR injected into the Blood treats a Genetic Disease for the first time

Researchers have injected a CRISPR drug (a tool for editing genomes) into the blood of people born with a disease that causes fatal nerve and heart disease. In three of the subjects, the drug nearly shut off the toxic protein produced by their livers. Details here.

Combining Forces in Metabolic Disorders

Altimmune recently announced the results of their early-stage obesity trial. A six-week interim cut of the phase I trial of Altimmune’s ALT-801 far surpassed the pre-established target of 2% weight loss at 1.8mg, the higher of two doses. Discover more about clinical trials and obesity.

BMS and Eisai to Collaborate in Deal Worth up to $3.1 billion

BMS and Eisai will work on developing a drug for endometrial, ovarian, lung and breast cancers. The two companies will co-commercialize and co-develop MORAb-202, an antibody drug conjugate which combines Eisai’s anti-folate receptor alpha (FRα) antibody farletuzumab and anticancer agent eribulin. Learn more.

US announces $3 billion Funding Boost for Antiviral COVID-19 Treatments

The US government announced that it will invest more than $3 billion for the development of “next-generation” antiviral treatments for COVID-19. Funding will go towards the discovery, development and manufacturing of antiviral medicines. As part of this plan, the National Institutes of Health will evaluate, prioritize and advance antiviral treatment candidates to Phase II clinical trials. Discover more.

Getting Under Your Skin: Sorrento Leveraging Novel Drug Delivery Platform to treat Melanoma in tie-up with Mayo Clinic

The biotech firm Sorrento Technologies received FDA clearance for a research collaboration with Mayo Clinic. Together, they will conduct human clinical proof of concept studies using a system that delivers biologic therapies through the skin and directly into the lymphatic system. Read the full article.

Biogen’s Rare Eye Disease Gene Therapy falls short at Phase III

Biogen announced that the Phase III trial of its gene therapy, timrepigene emparvovec, did not meet its primary or key secondary endpoints in patients with the rare inherited eye disease, choroideremia. Details here.

Gene writing: The Future of Genetic Medicine?

Tessera Therapeutics is pioneering gene writing. This new gene engineering technology would allow therapeutic messages to be written into genomes, addressing diseases at their source. Is this the future of genetic medicine? Read more.

Prime Minister's Research Plan to make UK 'Science Superpower'

Sir Patrick Vallance, the chief scientific adviser to the UK government, will lead a new Office for Science and Technology Strategy. The aim is to increase research spending from nearly £15 billion a year to £22 billion by 2025. The prime minister is said to want to build on the success of the UK's coronavirus vaccine program and apply it to other areas, including developing technology to reach net zero carbon emissions and developing cures for cancer. Go to the BBC.

Can Diet and Exercise lower your Risk of Dementia?

Over the past 3 years, around 6,000 people have taken part in a clinical trial called Maintain Your Brain, one of about 30 current or planned studies that eschew pharmaceutical interventions and test whether altering multiple aspects of participants’ lives improves brain health. Learn more.

Johnson & Johnson's New Cancer Drug Leads a Growing Pipeline of Dual-Targeting Antibodies

Johnson & Johnson’s new cancer drug Rybrevant has been approved by the FDA. This is part of a growing pipeline of so-called bispecific antibodies, offering hope that physicians may be better able to treat difficult conditions like lymphoma, multiple myeloma, leukaemia and prostate cancer. Discover more.

Machine Learning takes some of the Guesswork out of Pediatric Dosing

An algorithm is in development for determining drug dosing in children at various stages of maturation, which could one day aid in the design of pediatric clinical trials. Read the full article.

Alzheimer’s Drug Approved, despite doubts about Effectiveness

Aducanumab became the first new Alzheimer’s disease drug approved in the United States since 2003, despite “thin and conflicting evidence.” The FDA will require Biogen to complete a post-approval clinical trial to verify the drug’s benefit. Learn more.

"Digital fabric" could be used to Measure Health Data

Researchers from the Massachusetts Institute of Technology (MIT) have developed a wearable fabric that can sense, store and analyze data that could be used to measure physiological functions or detect illness. Details here.

 

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