R&D

Theravance axes staff as lead pipeline drug flunks phase 3 trial

Theravance has been forced to downsize its business after its lead pipeline drug ampreloxatine missed the mark in a phase 3 trial, cutting 75% of its workforce. The Irish-American biopharma said this morning that ampreloxetine did not meet its objectives in a trial involving patients with symptomatic neurogenic orthostatic hypotension (nOH) – a rare condition …

Theravance axes staff as lead pipeline drug flunks phase 3 trial Read More »

Rome Therapeutics raises $77m for junk DNA-targeting drugs

Startup Rome Therapeutics has raised $77 million in second-round financing to help mine sequences of DNA – which were dismissed for years as ‘junk’ – for hidden treasure. The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the …

Rome Therapeutics raises $77m for junk DNA-targeting drugs Read More »

First subject dosed in psilocybin trial for rare headache disorder

The first patient has received a low dose of Beckley Psytech’s psychedelic medicine psilocybin in a clinical trial for short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare disorder. The UK company says that SUNHA is a debilitating condition that is estimated to affect 40,000 patients in US and Europe. It is characterised by short, extremely …

First subject dosed in psilocybin trial for rare headache disorder Read More »

AbbVie spies potential in Regenxbio eye disease gene therapy

AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The partnership centres on RGX314, which delivers a gene coding for an antibody against VEGF – a well-established approach to treating …

AbbVie spies potential in Regenxbio eye disease gene therapy Read More »

France’s biotech ecosystem is primed for growth – it’s time to feed it

After some years of stagnant funding and growth France is now at an inflection point for health care innovation, says Jeito Capital’s Dr Rafaèle Tordjman. Prior to the pandemic, our homegrown entrepreneurs felt too often they had to go abroad to the United States to get the funding they needed, government support for clinical trials …

France’s biotech ecosystem is primed for growth – it’s time to feed it Read More »

Apellis reports mixed data with eye drug, but plans to file anyway

Apellis Pharma’s has reported mixed results with its lead drug pegcetacoplan in geographic atrophy (GA) – a major cause of blindness – with one hit and one miss in its phase 3 programme. Shares in the company were hit hard after the news was announced, although Apellis insisted that the totality of the data would …

Apellis reports mixed data with eye drug, but plans to file anyway Read More »

Biotech Insight podcast: Overcoming planning challenges in oncology

The first episode of Kantar Health’s new Biotech Insight podcast takes aim at the planning and forecasting challenges that biotechnology companies face, with a particular focus on oncology. Joining Dominic Tyer for this instalment of Biotech Insight are Prithu Somani, senior manager of forecasting and business analytics at Genmab, and Kantar Health’s vice president of …

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Server cans autism hope bumetanide after phase 3 fails

Servier and Neurochlore have been forced to admit defeat in their bid to bring the first drug to market for people with autism spectrum disorder (ASD), after a comprehensive fail for their bumetanide candidate in two phase 3 trials. The French partners said today that there was “no sign of effectiveness” for bumetanide compared to …

Server cans autism hope bumetanide after phase 3 fails Read More »

Applying the 10x Strategy to Clinical Trials: How Every New Treatment Can Move at Warp Speed

By John Potthoff, Ph.D., CEO, Elligo Imagine how many lives would be saved if we were able to develop treatments at warp speed instead of the years it typically takes before a medicine is approved? On March 17, 2020, Pfizer and BioNTech partnered to jointly develop a COVID-19 vaccine. Within a month and a half …

Applying the 10x Strategy to Clinical Trials: How Every New Treatment Can Move at Warp Speed Read More »

Hybrigenics says it wants a merger with Bone Therapeutics

French biopharma company Hybrigenics has made another bid to merge with Belgium’s Bone Therapeutics, a specialist in regenerative medicine that is still recovering from a setback in its lead development programme. Hybrigenics said in a press release today that it had started discussions with Bone Therapeutics, but the Belgian company was quick to come out …

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Bayer’s eliapixant hits the right notes in PAGANINI cough study

Bayer has released the data in its phase 2b trial of eliapixant in refractory chronic cough, as it tries to close the gap with Merck & Co’s rival drug gefapixant. The drugmaker said last month that the PAGANINI study hit its main objective, which was to reduce the average cough frequency compared to placebo after …

Bayer’s eliapixant hits the right notes in PAGANINI cough study Read More »

FDA slaps clinical hold on BioMarin’s PKU gene therapy

BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PKU) on hold while it investigates a safety signal. The biotech said that the US regulator ordered the pause on the study after liver tumours were …

FDA slaps clinical hold on BioMarin’s PKU gene therapy Read More »

Amgen builds case for severe asthma drug tezepelumab

Amgen and partner AstraZeneca have said their recently filed severe asthma drug tezepelumab has shown impressive results in patients who also have nasal polyps, a common complication of the respiratory disease. Tezepelumab reduced the annualised asthma exacerbation rate (AAER) by 86% in a subgroup of people with severe, uncontrolled asthma and polyps in the NAVIGATOR …

Amgen builds case for severe asthma drug tezepelumab Read More »

Novartis’ transplant drug hope iscalimab flunks mid-stage trial

Novartis hopes of improving on tacrolimus as the standard drug for preventing organ rejection in transplant patients have been dashed after its iscalimab candidate failed a mid-phase trial. An interim analysis of data from the CIRRUS-1 trial suggested that iscalimab (CFZ533) was less effective than tacrolimus at preventing rejection in kidney transplant patients when both …

Novartis’ transplant drug hope iscalimab flunks mid-stage trial Read More »

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and …

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial Read More »

Targeting COVID-19 and cancer with immunotherapy advancements

Anna Biosciences’ Dr Anthony Rullo discusses the drug development company’s immunotherapy platform. Over the last 30 years, we have seen dramatic improvements in patient outcomes due to the emergence of biologics – particularly monoclonal antibodies – as therapies for a wide variety of diseases and infections. Monoclonal antibodies (mABs) are highly specific therapies associated with …

Targeting COVID-19 and cancer with immunotherapy advancements Read More »

J&J vaccine fails to protect women against HIV infection

Johnson & Johnson’s HIV vaccine candidate has failed its first major efficacy test, as it was unable to protect women against infection with the virus in a phase 2b trial carried out in sub-Saharan Africa. The Ad26.Mos4.HIV vaccine – which uses the same adenoviral technology as J&J’s COVID-19 vaccine and targets four HIV antigens – …

J&J vaccine fails to protect women against HIV infection Read More »

AC Immune claims half a win for tau drug in Alzheimer’s trial

Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. The Swiss biotech’s Nasdaq-listed shares were up around 66% shortly after the announcement of data from the LAURIET study in patients with mild-to-moderate Alzheimer’s disease, …

AC Immune claims half a win for tau drug in Alzheimer’s trial Read More »

External control arms and debunking real-world data myths

For the healthcare ecosystem to drive research and care, clarity is needed about the opportunities and challenges of ECAs and their value in bringing therapies to patients faster, say COTA Viraj Narayanan and Karla Feghali from ConvergeHEALTH by Deloitte. External control arms (ECAs) – also known as synthetic control arms – are based on real …

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‘Endless RNA’ startup Laronde raises $440m to fuel pipeline

Just a few months after breaking cover with its new take on RNA therapeutics, Laronde has raised an impressive $440 million in second-round financing backed by Flagship Pioneering – which was behind the founding of mRNA specialist Moderna. Laronde is developing what it calls ‘endless’ RNA or eRNA, a circular form of the material that …

‘Endless RNA’ startup Laronde raises $440m to fuel pipeline Read More »

GSK takes SK bio-partnered COVID jab into phase 3

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. The move follows phase 1/2 results with SK bio’s GBP510, which …

GSK takes SK bio-partnered COVID jab into phase 3 Read More »

Data points to big win for Jardiance in hard-to-treat heart failure

The data is now in from the EMPEROR-Preserved study of Boehringer Ingelheim and Eli Lilly’s Jardiance in heart failure with preserved ejection fraction (HFpEF), and suggest the drug performs better than Novartis’ Entresto – currently the only approved option for these patients. SGLT2 inhibitor Jardiance (empagliflozin) reduced a composite of cardiovascular (CV) death or hospitalisations …

Data points to big win for Jardiance in hard-to-treat heart failure Read More »

After Ultomiris stumble, Alexion delivers a rare disease win for AZ

A drug for Wilson disease developed by AstraZeneca’s Alexion rare disease unit has cleared a phase 3 trial, setting up regulatory filings in the coming months. The FoCus study of ALXN1840 showed that once-daily oral drug met its primary objective in improving a key biomarker in Wilson disease, a rare and progressive genetic condition in …

After Ultomiris stumble, Alexion delivers a rare disease win for AZ Read More »

Amplifying the patient voice for better engagement, recruitment and retention

Everyone is familiar with the phrase ‘patient-centricity’ but, where it might once have been seen as a ‘checkbox exercise’, it has gained preeminent status in the era of COVID-19, says Prime Global’s Ross Jackson. The pandemic has transformed many aspects of our industry and one area that change has come to is patient engagement within …

Amplifying the patient voice for better engagement, recruitment and retention Read More »

Merck raises pressure on Pfizer in pneumococcal vaccine tussle

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise. The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which …

Merck raises pressure on Pfizer in pneumococcal vaccine tussle Read More »

Lilly taps Lycia for protein degrader tech in $1.6bn deal

Eli Lilly has bolstered its position the fast-emerging area of protein degrader drugs, agreeing a $1.6 billion-plus deal with Lycia Therapeutics spanning up to five drug targets. The drugmaker has looked close to home for its latest entry into the category, as Lycia’s founder Prof Carolyn Bertozzi has held a seat on its board of …

Lilly taps Lycia for protein degrader tech in $1.6bn deal Read More »

Vertex builds in gene editing yet again, with $1.2bn Arbor deal

Vertex Pharma has ramped up its involvement in gene-editing medicines for the third time in a matter of months, agreeing a partnership with CRISPR specialist Arbor Biotechnologies that could be worth up to $1.2 billion. The latest deal allows Vertex to tap into Arbor’s technology platform to develop cell therapies for diseases like type 1 …

Vertex builds in gene editing yet again, with $1.2bn Arbor deal Read More »

AZ’s Alexion takeover hits a snag, as Ultomiris flunks ALS trial

It has only been a month since AstraZeneca’s $39 billion takeover of Alexion was completed, but the merger has already had a setback. Alexion has dropped development of its Ultomiris drug in amyotrophic lateral sclerosis (ALS), chalking up the first clinical failure for the drug since AZ took control. The phase 3 CHAMPION-ALS trial showed …

AZ’s Alexion takeover hits a snag, as Ultomiris flunks ALS trial Read More »

PROVENT trial puts AZ COVID antibody combo back on track

AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to …

PROVENT trial puts AZ COVID antibody combo back on track Read More »

Does draft RCT guide set the scene for future trials?

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make …

Does draft RCT guide set the scene for future trials? Read More »

Welcome to the COVIDome, a new tool for COVID-19 R&D

Take a cohort of people hospitalised with COVID-19 and a group of negative controls, carry out extensive biological profiling of both groups and place all the information in a database. What do you get? A new R&D toolkit called the COVIDome, which has been shared by its developers in the hope that it could accelerate …

Welcome to the COVIDome, a new tool for COVID-19 R&D Read More »

Health Innovators: PureTech Health’s Daphne Zohar

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board …

Health Innovators: PureTech Health’s Daphne Zohar Read More »

With Alzheimer’s market opening up, Lilly forms neuroscience unit

Eli Lilly is one of the front runners in the bid to follow Biogen and Eisai onto the market with an anti-amyloid drug for Alzheimer’s disease, and its preparing the ground with a restructuring of its business units. As of 5 September, Lilly’s BioMedicines division will be split in two to form Lilly Neuroscience and …

With Alzheimer’s market opening up, Lilly forms neuroscience unit Read More »

From start to finish – digitising clinical trials

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. This shift to digitised approaches has been triggered by some persistent challenges faced by those companies still reliant on applying manual processes. “A few …

From start to finish – digitising clinical trials Read More »

Beckley Psytech raises $80m for psychedelic meds development

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing …

Beckley Psytech raises $80m for psychedelic meds development Read More »

Look out Dupixent, Lilly’s lebrikizumab is on the march

Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. The company has claimed across-the-board wins against primary and secondary measures of efficacy in the studies, and while the data hasn’t been revealed yet, …

Look out Dupixent, Lilly’s lebrikizumab is on the march Read More »

Organicell on regenerative medicine: the pharmaphorum podcast

In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they …

Organicell on regenerative medicine: the pharmaphorum podcast Read More »

More malaria hope as antibody protects against infection

A single dose of a monoclonal antibody developed by scientists at the US National Institutes of Health (NIH) has provided protection for people exposed to malaria parasites for up to nine months. The results of the phase 1 trial suggest that antibodies could be used to protect travellers, military personnel and health care workers traveling …

More malaria hope as antibody protects against infection Read More »

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab

South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been …

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab Read More »

Predicting and improving clinical trial enrolment: A problem for psychiatry

Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. The reasons behind this problem, however, are rarely studied or understood. Despite this, new strategies devised over the last five years are beginning to reverse the …

Predicting and improving clinical trial enrolment: A problem for psychiatry Read More »

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer

Gilead Sciences’ Kite Pharma has mapped out another route to the development of allogeneic or ‘off-the-shelf’ cell therapies for cancer, using technology developed by Appia Bio, a US startup focusing on haematopoietic stem cells (HSCs). The partnership will combine Kite’s experience in chimeric antigen receptor (CAR) therapies with Appia’s platform, which involves using HSCs to …

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer Read More »

Medicines Discovery Catapult relaunches Wolfson Radiochemistry facility in Manchester

Medicines Discovery Catapult (MDC) today announces the relaunch of radiochemistry at the Wolfson Molecular Imaging Centre (WMIC) in Manchester. The facility, which was closed in 2020, includes the multi-million pound cyclotron, one of only a handful in the UK. It will supply hard-to-make radiochemicals to drug discovery biotechs and academic innovators – increasing the UK’s …

Medicines Discovery Catapult relaunches Wolfson Radiochemistry facility in Manchester Read More »

Evaluating methods targeting Protein-Protein Interactions

Protein-protein interactions (PPIs) are becoming increasingly relevant in the pathology of many diseases, including cancer. The issue, however, is developing an effective way of targeting them.  The latest advancements in methods targeting PPIs are designed to overcome the challenges limiting the conventional methods. Targeting PPIs offers another potential therapeutic target for diseases with complex biological …

Evaluating methods targeting Protein-Protein Interactions Read More »

Bayer bolsters R&D platform with $2bn Vividion takeover

Bayer headlined its second-quarter results this morning by unveiling a deal to buy Vividion Therapeutics, saying it will boost its ability to develop medicines against targets once considered “undruggable.” Bayer is paying $1.5 billion upfront to claim ownership of Vividion‘s drug discovery platform, which uses chemoproteomics to identify new binding sites on proteins and find …

Bayer bolsters R&D platform with $2bn Vividion takeover Read More »

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia

Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair regrowth in a late-stage trial. In the phase 2b/3 ALLEGRO trial, JAK inhibitor ritlecitinib hit its primary objective of improving the area of scalp covered by hair in people with …

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia Read More »

Chasing Merck & Co, Bayer builds case for cough drug eliapixant

Bayer says its drug candidate for chronic cough – eliapixant – has hit the mark in a phase 2b trial, putting it in hot pursuit of Merck & Co’s gefapixant, which was filed for approval in March. The orally-active P2X3 receptor antagonist, also known as BAY1817080, hit the main objective of the study, which was …

Chasing Merck & Co, Bayer builds case for cough drug eliapixant Read More »

Novartis cleared to restart trials of new Zolgensma delivery route

The FDA has relaxed a clinical hold on clinical trials of Novartis’ intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get underway. Zolgensma (onasemnogene abeparvovec) is already approved as an intravenous treatment in babies and very young children for the rare muscle-wasting disease, but the new …

Novartis cleared to restart trials of new Zolgensma delivery route Read More »

Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn

Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours …

Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn Read More »

Ipsen forges $1bn alliance with Exicure on neurodegenerative diseases

Ipsen’s new chief executive David Loew pledged to ramp up spending on the company’s pipeline when he took the helm last year, and a flurry of licensing deals in the last few weeks shows that push is starting to gather momentum. The French company – which focusing on cancer, neuroscience and rare diseases – has …

Ipsen forges $1bn alliance with Exicure on neurodegenerative diseases Read More »

Takeda spins norovirus vaccine out into separate company

Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The Japanese drugmaker has partnered with venture capital company Frazier Healthcare Partners to form HilleVax, which comes into being with full and exclusive ex-Japanese development and commercial rights to TAK-214 (now …

Takeda spins norovirus vaccine out into separate company Read More »

Biogen adds real-world test for Aduhelm to its confirmatory trial

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the …

Biogen adds real-world test for Aduhelm to its confirmatory trial Read More »

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

Regeneron, AZ team up on drugs for obesity “superpower” gene

AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists at the Regeneron Genetics Centre. AZ’s buy into the programme comes a few weeks after Regeneron published findings in the journal Science suggesting that people with certain GPR75 mutations have …

Regeneron, AZ team up on drugs for obesity “superpower” gene Read More »

BioNTech’s mRNA vaccine drive now includes malaria, TB shots

Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. Human testing of the malaria shot should get underway by the end of 2022, according to the German biotech, …

BioNTech’s mRNA vaccine drive now includes malaria, TB shots Read More »

First published data backs CanSino’s inhaled COVID vaccine

Early-stage clinical data with CanSino Biologics’ inhaled COVID-19 vaccine show that it was able to stimulate neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration. Published in The Lancet, a phase 1 study conducted in China showed that a two-dose regimen of aerosolised Ad5-nCoV was similar to that achieved with …

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Boehringer takes alteplase to phase 3 for COVID, but drops antibody

Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the …

Boehringer takes alteplase to phase 3 for COVID, but drops antibody Read More »

Oncology R&D: the patient insights we’re still missing, and how to catch up

Imagine you are a pharma executive working in oncology R&D. The landscape is rapidly becoming more competitive and overcrowded. You are under pressure to bring solutions now, and for your entire career, you have been taught that things must be done a certain way. Patient engagement is viewed by many as a nice-to-have rather than …

Oncology R&D: the patient insights we’re still missing, and how to catch up Read More »

Allergen builds case for first drug therapy for presbyopia

If you are in middle aged and find you have to hold your phone at arm’s length to read, you may have presbyopia – a difficulty focusing on close objects that is usually corrected using glasses, contact lenses or laser eye surgery. Now, there could be another alternative, in the form of eye drops administered …

Allergen builds case for first drug therapy for presbyopia Read More »

Virtual reality therapy: The future of chronic pain management?

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? pharmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain …

Virtual reality therapy: The future of chronic pain management? Read More »

COVID-19: Celltrion’s therapeutic option

In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of …

COVID-19: Celltrion’s therapeutic option Read More »

Look out BMS, Cytokinetics has its eye on mavacamten’s turf

Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October. In HCM, the heart muscle become thickened and in some patients can obstruct blood …

Look out BMS, Cytokinetics has its eye on mavacamten’s turf Read More »

Complex Medicines: A multi-billion-pound addition to the UK life sciences industry

 A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK   ‘Shaping the UK into an epicentre for complex medicines’ is a report by the Medicines Discovery Catapult (MDC) in partnership with the CPI showcasing the extensive potential for the UK in …

Complex Medicines: A multi-billion-pound addition to the UK life sciences industry Read More »

Ipsen tries again in Parkinson’s disease with $363m IRLAB deal

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront.  The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, …

Ipsen tries again in Parkinson’s disease with $363m IRLAB deal Read More »

GSK unveils plan for life sciences cluster at Stevenage campus

GlaxoSmithKline wants to sell more than a third of the space at its R&D campus in Stevenage, UK, to a new bioscience cluster that it says could become one of the largest in Europe. The drugmaker says it is seeking a development partner for the project, and hopes to unlock £400 million ($553 million) in …

GSK unveils plan for life sciences cluster at Stevenage campus Read More »

Virtual GP clinics – are they accessible as they need to be?

As the the pandemic accelerates a move towards remote doctors appointments, work still needs to be done to ensure that digital healthcare is easy and accessible. Sam Jansen explores the practical steps needed to ensure people are comfortable with virtual clinics and the tech involved. Behind the swathe of headlines lauding the way in which …

Virtual GP clinics – are they accessible as they need to be? Read More »

Trials leave Galapagos’ SIK programme looking under the weather

Galapagos has had to send its SIK inhibitor programme back to the drawing board after its lead compound GLPG3970 has failed two of three clinical trials, adding to a string of disappointments for the Belgian biotech.  Results from a phase 1b study in psoriasis and two phase 2a studies in ulcerative colitis and rheumatoid arthritis …

Trials leave Galapagos’ SIK programme looking under the weather Read More »

First US patient gets total heart replacement with CARMAT device

An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. The Aeson bioprosthetic device has already been implanted in a number of European patients with end-stage biventricular heart failure – affecting both sides of the heart – …

First US patient gets total heart replacement with CARMAT device Read More »

Lilly grabs glucose-sensing insulin tech, buying Protomer in $1bn deal

Eli Lilly bought a stake in Protomer Technologies and its glucose-sensing insulin platform last year, and it must like what it has seen in the programme since then – it has just agreed to buy the company outright.  Pasadena, California-based Protomer is working on proteins that can sense molecular activators in the body and only …

Lilly grabs glucose-sensing insulin tech, buying Protomer in $1bn deal Read More »

AZ, J&J tweaking COVID shots to reduce clotting risks; report

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help …

AZ, J&J tweaking COVID shots to reduce clotting risks; report Read More »

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar

Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with its ASP3772 candidate – plus a new breakthrough designation from the FDA. Last year, Pfizer made almost $6 billion from its Prevnar 13 vaccine, which covers 13 common serotypes of …

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar Read More »

Biogen builds MS pipeline via $125m deal with China’s InnoCare

Biogen has moved to shore up its besieged multiple sclerosis franchise by licensing a BTK inhibitor from Chinese biotech InnoCare currently in mid-stage clinical testing. InnoCare gets $125 million upfront in return for sharing rights to orelabrutinib, an orally-active BTK drug that is able to cross the blood-brain barrier and penetrate the central nervous system. …

Biogen builds MS pipeline via $125m deal with China’s InnoCare Read More »

Novo Nordisk bulks up in rare diseases with $1.2bn Prothena deal

Diabetes giant Novo Nordisk has opened a new front in its rare disease R&D, thanks to an acquisition agreement with Prothena focusing on drugs for ATTR amyloidosis. The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a …

Novo Nordisk bulks up in rare diseases with $1.2bn Prothena deal Read More »

Taking steps towards a data-driven future for health and social care

A new policy paper promises to make it easier for innovators and developers to build and deploy tech and AI solution. So, will it help make the vision of a data-driven health service a reality? COVID-19 “revolutionised” the health and care data space, and we have a duty to apply what we have learnt to …

Taking steps towards a data-driven future for health and social care Read More »

Rare disease: industry, patients and tech join forces on diagnosis

Takeda’s Adam Zaeske discusses how cross-sector collaboration is shaping a brighter future for rare disease diagnosis. Diagnosis can sometimes be the most difficult part of a rare disease patient’s journey, and it’s with good reason that the process is often referred to as an ‘odyssey’ in these communities. “We’re dealing with very small populations of …

Rare disease: industry, patients and tech join forces on diagnosis Read More »

Accelerating the adoption of innovation in the NHS

Spreading innovation in the NHS is as much about fostering collaboration and building relationships as it is about designing new interventions and launching new technologies. Scaling up the adoption of new interventions and technologies in the NHS has always been something of a challenge. But a review of approaches used by the Academic Health Science …

Accelerating the adoption of innovation in the NHS Read More »

Moderna plans triple vaccine targeting flu, COVID and RSV

Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains.  The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 …

Moderna plans triple vaccine targeting flu, COVID and RSV Read More »

Dementia, cancer headline UK’s 10-year plan for life sciences sector

The UK’s long-awaited Life Sciences Vision strategy has been published, setting out the government’s stall as it tries to deliver on its promise to keep the country at the forefront of the sector. The document published today lays out seven healthcare “missions” for the UK’s industry as it tries to double down on the success …

Dementia, cancer headline UK’s 10-year plan for life sciences sector Read More »

A life sciences vision to deliver health, wealth and resilience for the UK

The ABPI’s chief executive Dr Richard Torbett outlines a new ‘vision’ and 10-year strategy for UK life sciences, launched by the government today. After an extraordinary year of science versus disease, the UK has cemented itself at the forefront of the global response to COVID-19. What has been achieved in just 18 months is nothing …

A life sciences vision to deliver health, wealth and resilience for the UK Read More »

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure

Boehringer Ingelheim and Eli Lilly have the results they were hoping for in a large-scale study of Jardiance therapy in heart failure with preserved ejection fraction (HFpEF), a form of chronic heart failure associated with high hospitalisation rates, poor quality of life and increased mortality. The results of the much-anticipated EMPEROR-Preserved trial found that SGLT2 …

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure Read More »

COVID-19 neutralising antibody tests – an integrated approach

Nina Garrett, R&D director at Abingdon Health discusses the key role antibody testing is playing in the pandemic and how an integrated approach with vaccines could help life resume. Millions of tests for COVID-19 are taken worldwide every day, as they become an increasingly important tool for our return to normality. Testing programmes have been …

COVID-19 neutralising antibody tests – an integrated approach Read More »

UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing

The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for …

UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing Read More »

Almirall kicks off another hunt for skin disease therapy partnerships

Spanish drugmaker Almirall has launched another search for early-stage research projects that it can partner in dermatology, its core area of expertise. The latest edition of its AlmirallShare competition – which will take submissions until 31 October this year – is hunting for innovative therapies for skin diseases that are in the research or preclinical …

Almirall kicks off another hunt for skin disease therapy partnerships Read More »

Herd immunity is nice – but what about me?

Shahrokh Shabahang discusses why we need a personalised approach to COVID-19 immunity testing. To-date, the battle against COVID-19 has been waged largely in the field of public health, using a series of binary, black-and-white thresholds to measure progress. The number of positive cases per 100,000 people, yes/no results on PCR tests, absence or presence of …

Herd immunity is nice – but what about me? Read More »

Private equity firms play ‘pass the Parexel’ with $8.5bn handover deal

Four years after being taken private, Parexel has been sold again, with Goldman Sachs’ private equity arm and EQT paying $8.5 billion to claim ownership of the contract research organisation. The handover comes four years after Pamplona Capital Management bought the company for around $5 billion, and just a few weeks after lab tech company …

Private equity firms play ‘pass the Parexel’ with $8.5bn handover deal Read More »

GSK backs CEO Walmsley, rejecting Elliott’s call to change board

GlaxoSmithKline’s board had responded to the broadside attack delivered by activist investor Elliott Management yesterday, saying it stands firmly behind the leadership of chief executive Emma Walmsley. The drugmaker rejected calls by Elliott to change its board and accelerate the complete divestment of its consumer health unit which is due to be split from the …

GSK backs CEO Walmsley, rejecting Elliott’s call to change board Read More »

ABPI launches 2021 Code of Practice

The Association of the British Pharmaceutical Industry (ABPI) has launched its 2021 Code of Practice to help companies operate to high ethical standards.   The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public. It is independently administered by the …

ABPI launches 2021 Code of Practice Read More »

AZ drug for hard-to-treat heart failure has mixed results in trial

AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients.  Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel …

AZ drug for hard-to-treat heart failure has mixed results in trial Read More »

Health Innovators: Eliot Forster, F-Star

In this episode of Health Innovators, pharmaphorum founder Paul Tunnah interviews Eliot Forster, CEO of F-Star – a clinical-stage, NASDAQ-listed biopharmaceutical company focused on transforming the lives of patients with cancer.     About the author Dr Paul Tunnah is chief content officer and UK managing director for Healthware Group, a next-generation integrated consulting group that …

Health Innovators: Eliot Forster, F-Star Read More »

Pharma’s use of synthetic biology could deliver radical innovation

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, …

Pharma’s use of synthetic biology could deliver radical innovation Read More »

Pharma’s use of synthetic biology could deliver radical innovation

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, …

Pharma’s use of synthetic biology could deliver radical innovation Read More »

COVID-19 vaccine development: Safety monitoring continues revolution in RWD

From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve outcomes for patients in need. In today’s feature, Dr. Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality.  Only a year after the emergence …

COVID-19 vaccine development: Safety monitoring continues revolution in RWD Read More »

COVID-19 vaccine development: Safety monitoring continues revolution in RWD

From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve outcomes for patients in need. In today’s feature, Dr. Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality.  Only a year after the emergence …

COVID-19 vaccine development: Safety monitoring continues revolution in RWD Read More »

New hybrid healthcare agency Stirred launches

Healthcare communications specialists Jo Spadaccino and Stuart Hehir have launched a new agency named Stirred which will offer communications, marketing and creative consultancy to healthcare businesses. Spaduccino and Hehir previously worked together at health communications agency Pegasus (recently renamed Mind + Matter). “As the world repairs and responds to the needs of today, health has now …

New hybrid healthcare agency Stirred launches Read More »

White House pledges $3 billion war chest for COVID antivirals

The Biden Administration has said it will allocate $3 billion of its pandemic rescue plan to the development of a new generation of antiviral therapies for COVID-19, as well as future viral threats. The plan was announced today by National Institute of Allergy and Infectious Diseases (NIAID) director and chief medical advisor Anthony Fauci, who …

White House pledges $3 billion war chest for COVID antivirals Read More »

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit …

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss Read More »

CureVac hit hard as its COVID jab fails to make the grade

CureVac has just had a harsh reminder of the perilous nature of drug development, after reporting that its mRNA-based COVID-19 vaccine was just 47% effective in its 40,000-subject phase 3 trial. That is below the threshold efficacy level for a vaccine laid out by the World Health Organisation (WHO) in the early stages of the …

CureVac hit hard as its COVID jab fails to make the grade Read More »

Transforming pharma R&D with a scientist-centric approach to AI & automation

As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to …

Transforming pharma R&D with a scientist-centric approach to AI & automation Read More »

Sage/Biogen’s zuranolone works in depression, but maybe not enough

Sage Therapeutics and Biogen’s antidepressant candidate zuranolone has hit its objectives in a phase 3 trial, but a falloff in efficacy over time has raised concerns about the commercial potential of the drug. The WATERFALL trial of zuranolone showed that a two-week course of the oral GABAA receptor modulator significantly reduced symptoms of depression compared …

Sage/Biogen’s zuranolone works in depression, but maybe not enough Read More »

Regeneron drug saves lives in severe COVID-19, but it’s not for all

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study, which involved around …

Regeneron drug saves lives in severe COVID-19, but it’s not for all Read More »

Biogen’s ambitions in gene therapy hit by another failed pivotal trial

When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category.  Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal. The …

Biogen’s ambitions in gene therapy hit by another failed pivotal trial Read More »

A roadmap for adopting New Science 

The pandemic’s disruption galvanised the biopharma industry into unprecedented action, demonstrating what’s possible when the global scientific community collaborates in exceptional ways and public-private partnerships drive innovation to address a common need. Can the biopharma industry step up again to shatter industry orthodoxy and create new pathways for innovation, access, and affordability? The adoption of …

A roadmap for adopting New Science  Read More »

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US?

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions …

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US? Read More »

EHA21: Study raises BMS’ hopes for Reblozyl in less severe disease

Bristol-Myers Squibb has taken another step towards achieving its blockbuster hopes for beta thalassaemia-associated anaemia therapy Reblozyl, after hitting the target in a phase 2 trial in patients who don’t require regular blood transfusions.  Reblozyl (luspatercept) is already approved to treat thalassaemia patients who depend on transfusions, but getting approval in patients with milder disease …

EHA21: Study raises BMS’ hopes for Reblozyl in less severe disease Read More »

EHA21: Novartis trumpets iptacopan as oral alternative to antibodies in PNH

The mainstay of therapy for the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) is Alexion’s infusion therapy Soliris, but Novartis’ iptacopan could provide an oral option after positive phase 2 trial results. The first-in-class therapy – a targeted factor B inhibitor – was able to “substantially” reduce the destruction of red blood cells (haemolysis) that …

EHA21: Novartis trumpets iptacopan as oral alternative to antibodies in PNH Read More »

EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. The results of the 42-subject CADENZA study – reported at the ongoing European Haematology Association (EHA) – …

EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection Read More »

Bayer’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic

Bayer subsidiary BlueRock Therapeutics has dosed the first Parkinson’s disease patient in a phase 1 trial of its cell-based therapy DA01, which aims to replenish the neurons lost in people with the neurodegenerative disorder. At the same time, the German group’s Asklepios BioPharma (AskBio) unit has started recruiting patients for a phase 1b trial of …

Bayer’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic Read More »

J&J backs out of $1.6bn blood cancer antibody alliance with Argenx

Belgian biotech Argenx has lost its development partner for acute myeloid leukaemia antibody cusatuzumab, after Johnson & Johnson backed away from the alliance after two and a half years. J&J’s Cilag unit – part of its Janssen pharma division – said this morning that it had decided not to continue the collaboration after a “review …

J&J backs out of $1.6bn blood cancer antibody alliance with Argenx Read More »

How Microsoft Teams streamlined cross-country forecasting for biotech pioneers.

J+D Forecasting has worked with one of Europe’s largest, leading biotechnology pioneers, helping to facilitate better, more collaborative forecasting for hundreds of colleagues across the continent. For the company’s most recent forecasting cycle, our experts have worked to incorporate Microsoft Teams as a core software, as well as extending Power BI, to enable regional users, and …

How Microsoft Teams streamlined cross-country forecasting for biotech pioneers. Read More »

The Bloc hires Stuart Goldstein as COO

Stuart Goldstein has been hired as the chief operating officer at New-York-based healthcare creative agency The Bloc. In the newly-created role, Goldstein will oversee the execution of 4,500 projects per year across The Bloc’s US client business. He will be responsible for project management and identifying metrics to increase efficiency and profitability. Goldstein has over …

The Bloc hires Stuart Goldstein as COO Read More »

MorphoSys offers $1.7bn for Constellation, but investors see stars

Shares in German biotech MorphoSys have gone on the slide after it announced a $1.7 billion deal to buy its US rival Constellation Pharma and its pipeline of cancer and haematology therapies. MorphoSys said the $34 per share deal would accelerate growth by adding two clinical-stage drug candidates, namely BET inhibitor pelabresib (CPI-0610) in phase …

MorphoSys offers $1.7bn for Constellation, but investors see stars Read More »

What HCPs think about blood clots linked to COVID-19 vaccines

In the latest edition of What HCPs Think, CREATION.co’s Laura Marsh looks at what healthcare professionals are saying about blood clots linked to COVID-19 vaccines. The formation of blood clots is a necessary process in order for the body to repair damage caused by injury and to slow down bleeding. However, when blood clots form inappropriately, …

What HCPs think about blood clots linked to COVID-19 vaccines Read More »

Amgen pays Kyowa $400m upfront for OX40 eczema drug

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema.  The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of …

Amgen pays Kyowa $400m upfront for OX40 eczema drug Read More »

Sanofi’s venglustat bombs again, but isn’t dead yet

Shortly after failing a Parkinson’s disease study, Sanofi’s venglustat has missed the mark in another trial in autosomal dominant polycystic kidney disease (ADPKD), whittling down the list of possible uses for the drug even further.  Sanofi is still running studies of the glycosphingolipid (GSL) inhibitor in rare lysosomal storage diseases like Gaucher disease type 3, …

Sanofi’s venglustat bombs again, but isn’t dead yet Read More »

Are microtaggants the key to making medicines smarter?

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. The dramatic rise in online drug sales during the COVID-19 pandemic has increased the supply of counterfeit drugs, and many companies are now considering the addition of on-dose authentication for high-risk or high-value products. To implement …

Are microtaggants the key to making medicines smarter? Read More »

Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS …

Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal Read More »

Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia

Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair loss, and says it hopes to report results in the second half of 2022. The two studies – THRIVE-AA1 and THRIVE-AA2 – are testing oral JAK1/2 inhibitor CTP-543 in adults …

Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia Read More »

Novo Holdings leads $200m financing into Esco Lifesciences Group

Life sciences tools company Esco Lifesciences Group has scored $200m in a series A and crossover round co-led by Novo Holdings and Vivo Capital. Funds will be used to expand the company’s presence across Asia and create an innovation hub in Boston for cell and gene therapy technologies. The deal was described by the companies …

Novo Holdings leads $200m financing into Esco Lifesciences Group Read More »

Now what? The future of clinical trials after the pandemic

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. This is definitely a time for the life sciences industry to be proud of our accomplishments. The way in which the industry came together to support the development of the COVID-19 …

Now what? The future of clinical trials after the pandemic Read More »

How diversity can help life sciences advance its lifesaving solutions

Paula Parfitt discusses the importance of workplace diversity and how life science companies can build a thriving, diverse workforce. Diversity, equity and inclusion (D, E & I) is a sensible business choice with significant commercial benefits. A homogenous workforce has a smaller pool of collective experience, meaning that when problems arise, collective creativity and innovation …

How diversity can help life sciences advance its lifesaving solutions Read More »

New Cell & Gene Therapy Collective seeks to boost UK adoption

The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – but there are still many barriers to wider adoption. These challenges often arise because these therapies go through the same value assessment processes as less complex medicines, and the infrastructure …

New Cell & Gene Therapy Collective seeks to boost UK adoption Read More »

NGM craters after dropping mid-stage NASH candidate aldafermin

Shares in NGM Biopharma have plummeted after the US biotech said it would abandon development of aldafermin in non-alcoholic steatohepatitis (NASH), adding to a lengthening list of failed candidates for the fatty liver disease.  The decision was taken after a phase 2b trial of NGM’s lead drug candidate missed its primary target of showing an …

NGM craters after dropping mid-stage NASH candidate aldafermin Read More »

After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine

Takeda has revealed long-term clinical trial results with its dengue vaccine that reinforce its safety and efficacy – and help to differentiate it from Sanofi’s challenged Dengvaxia shot. Updated results from the large-scale TIDES trial of TAK-003 show that three years after dosing it was 62% effective at warding off dengue symptoms and prevented more …

After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine Read More »

Arecor heads for London Stock Exchange with drug reformulation strategy

Arecor Therapeutics is planning to float on the London stock market, to raise funding and awareness for its developmental portfolio of biologic drugs, which are based on already-marketed drugs reformulated to provide extra benefits for patients.  Arecor Therapeutics is the latest company aiming to take advantage of the “feelgood” factor in the biotech sector, which …

Arecor heads for London Stock Exchange with drug reformulation strategy Read More »

Under-pressure GSK sells stake in respiratory diseases partner Innoviva

GlaxoSmithKline has sold its entire stake in its respiratory partner Innoviva, raising $392 million and simplifying its business ahead of a split into two. GSK is pushing ahead with a split into an innovative drugs business and a consumer healthcare firm, while the spectre of activist investor Elliott Management hangs over it. The fund run …

Under-pressure GSK sells stake in respiratory diseases partner Innoviva Read More »

Trial win sets up filings for Lilly’s diabetes blockbuster hope tirzepatide

Eli Lilly has scored five out of five with its phase 3 trials of type 2 diabetes candidate tirzepatide, setting up regulatory filings for a drug that the drugmaker thinks could be the lynchpin of its franchise in the coming years.  In SURPASS-4 – the last of Lilly’s registration studies for the dual GLP-1/GIP agonist …

Trial win sets up filings for Lilly’s diabetes blockbuster hope tirzepatide Read More »

Report calls for better work culture in UK research

Create a positive working culture for the UK’s researchers, or watch the country’s standing as an innovation leader crumble, says new report. From the Oxford vaccine to the RECOVERY trial, all eyes have been on the triumph of British science in recent months. But future success is at risk if we do not create a …

Report calls for better work culture in UK research Read More »

Kintor hits back at press criticism of COVID drug with US trial update

The China-based biotech Kintor has hit back at press criticism of its potential COVID drug proxalutamide, releasing further details of its US phase 3 development plan. Last week Kintor came under fire in a Reuters article, which cast doubt on some of the publicly available information published by the company related to its US development …

Kintor hits back at press criticism of COVID drug with US trial update Read More »

FDA fires broadside at CytoDyn over COVID-19 antibody data

In a rare move, the FDA has publicly accused US biotech CytoDyn of misrepresenting clinical trial results for leronlimab, an antibody being developed for COVID-19.  It’s not uncommon for drug developers put a positive spin on lacklustre clinical data, but CytoDyn’s attempts seems to have irritated the US regulator, specifically relating to its use of …

FDA fires broadside at CytoDyn over COVID-19 antibody data Read More »

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug

Bristol-Myers Squibb has paid $200 million, and promised up to $1.36 billion in “biobucks” for exclusive rights to a cancer antibody still in the labs of US biotech Agenus, which blocks the TIGIT receptor that is emerging as an immunotherapy target. Roche is one of the leaders in research in to TIGIT – short for …

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug Read More »

Elliott Management could force out GSK CEO Walmsley, investor warns

Speculation is mounting GlaxoSmithKline’s CEO Emma Walmsley may pay the price for the company’s lacklustre performance, after the dreaded activist investor Elliott Management built a stake in the struggling pharma. GSK is fast becoming thought of as the UK’s other pharma company following Pascal Soriot’s successful turnaround of AstraZeneca – but according to press reports …

Elliott Management could force out GSK CEO Walmsley, investor warns Read More »

Incyte preps second filing for ruxolitinib cream after vitiligo trial win

Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a key FDA decision in atopic dermatitis. Ruxolitinib is a topical Janus kinase (JAK) inhibitor that could provide an alternative to the steroids commonly used to treat these skin conditions, although …

Incyte preps second filing for ruxolitinib cream after vitiligo trial win Read More »

Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. The Danish pharma said the phase 2 RESCUE trial showed a significant reduction of several inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease …

Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3 Read More »

Medicago, GSK’s plant-made COVID jab clears phase 2

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around …

Medicago, GSK’s plant-made COVID jab clears phase 2 Read More »

Biogen’s eye disease gene therapy fails ahead of FDA Alzheimer’s ruling

Biogen has downbeat news about its gene therapy for the rare inherited eye disease, X-linked retinitis pigmentosa, announcing the shot failed to meet its target in a phase 2/3 study. A final FDA decision on Biogen’s controversial Alzheimer’s drug aducanumab is due before the beginning of next month and the company needs some positive pipeline …

Biogen’s eye disease gene therapy fails ahead of FDA Alzheimer’s ruling Read More »

Arecor hopes London stock market float will raise profile of insulin products

UK biotech Arecor Therapeutics has announced plans to float on the London stock market, to fund plans to develop novel formulations of insulins and other biological drugs with enhanced properties. Based in Cambridge, Arecor has proprietary formulation technology and plans to licence out drugs to big pharma companies, looking for milestone payments and royalties as …

Arecor hopes London stock market float will raise profile of insulin products Read More »

Sanofi/GSK move latecomer COVID-19 shot into phase 3

Sanofi and GlaxoSmithKline seem to be getting somewhere with their COVID-19 vaccine at last, announcing plans to move to phase 3 following supportive mid-stage trial results. In a statement the companies said that if the late-stage trial and regulatory reviews go well, the vaccine is expected to be approved in the fourth quarter of this …

Sanofi/GSK move latecomer COVID-19 shot into phase 3 Read More »

Health Innovators: Teresa Arroyo-Gallego, nQ Medical

In this episode of our Health Innovators series, Paul Tunnah is joined by Teresa Arroyo-Gallego, chief data scientist at artificial intelligence technology company nQ Medical. As a researcher in the biomedical engineering lab of the Massachusetts Institute of Technology (MIT), Teresa leads a team developing the neuroQWERTY technology to detect early signs of motor decline in …

Health Innovators: Teresa Arroyo-Gallego, nQ Medical Read More »

Doubts emerge over Kintor’s COVID-19 US drug trial

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price …

Doubts emerge over Kintor’s COVID-19 US drug trial Read More »

Indian COVID variant puts UK lockdown easing plans in doubt

Concerns are emerging in the UK about the spread of the coronavirus variant that has caused a surge in cases in India, prompting warnings that lockdown easing plans may need a rethink. Latest figures show there are 1,313 cases of the variant in the UK, compared with 520 recorded in the previous week. Known as …

Indian COVID variant puts UK lockdown easing plans in doubt Read More »

Inside MoonLake’s raid on Merck KGaA’s inflammatory disease hopeful sonelokimab

Swiss biotech MoonLake Immunotherapeutics has emerged with what it hopes is one of the hottest drugs in inflammatory diseases, sonelokimab. In an interview with pharmaphorum’s news editor Richard Staines, chief operating officer Arnout Ploos van Amstel revealed how the biotech and its “mystery CEO” managed to swoop for the drug ahead of big pharma rivals. …

Inside MoonLake’s raid on Merck KGaA’s inflammatory disease hopeful sonelokimab Read More »

Biogen taps Envisagenics’ AI to speed up RNA splicing R&D

Biogen has made a further push into RNA-based drug discovery via a collaboration with Envisagenics, which applies artificial intelligence RNA sequencing data to discover new drug targets and therapeutics. Cambridge, Massachusetts-based Envisagenics focuses on using AI to analyse errors in RNA splicing, a process in which a precursor form of messenger RNA (mRNA) – which …

Biogen taps Envisagenics’ AI to speed up RNA splicing R&D Read More »

First UK patient joins Pfizer’s phase 3 DMD gene therapy trial

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. Pfizer’s CIFFREO study began in the US in January this year and has now begun enrolling eligible patients in the UK. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one …

First UK patient joins Pfizer’s phase 3 DMD gene therapy trial Read More »

Biogen bolsters ischaemic stroke pipeline with thrombolytic from TMS

Biogen has licensed a new drug from Japanese biotech TMS that it hopes could provide a big advance on an old treatment approach – using clot-busting thrombolytic drugs to treat ischaemic stroke.  The US company has exercised an option to acquire TMS-007, which it described as a next-generation thrombolytic that could offer safety and efficacy …

Biogen bolsters ischaemic stroke pipeline with thrombolytic from TMS Read More »

Lilly buys into MiNA’s protein-boosting RNA tech in $1.25bn deal

UK biotech MiNA Therapeutics has signed up another big pharma partner for its small activating RNA (saRNA) platform, which upregulates the activity of proteins, with Eli Lilly the latest to get in on the action.  While most RNA-based drugs are intended to reduce the activity of proteins that are over-expressed, saRNAs work in the opposite …

Lilly buys into MiNA’s protein-boosting RNA tech in $1.25bn deal Read More »

Novavax delays COVID vaccine filings until Q3

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data. …

Novavax delays COVID vaccine filings until Q3 Read More »

Moderna’s founder launches Laronde, promising new ‘Endless RNA’ drug class

Flagship Pioneering, the VC fund run by Moderna’s co-founder Noubar Afeyan has launched a new biotech Laronde, with an ambitious plan to create a new class of drugs based on Endless RNA. Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body. This makes the body …

Moderna’s founder launches Laronde, promising new ‘Endless RNA’ drug class Read More »

Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix

Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led the programme from December until he stepped down last week and told the Daily Telegraph that the UK’s vaccination campaign should be enough to protect from the virus and its …

Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix Read More »

CRISPR Therapeutics begins natural killer cell cancer tie-up with Nkarta

Gene editing firm CRISPR Therapeutics has announced a collaboration with US biotech Nkarta to develop natural killer (NK) cell therapies for cancer. This latest agreement follows a major deal with Vertex last month, where CRISPR announced it is to receive $900m in a reworked collaboration, to develop a gene editing therapy for sickle cell disease …

CRISPR Therapeutics begins natural killer cell cancer tie-up with Nkarta Read More »

Why relationships are key in rare disease patient engagement

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards. It is difficult to get data on rare diseases and the people who live with them by their very nature. …

Why relationships are key in rare disease patient engagement Read More »

Small Pharma stock market launch funds DMT-based depression drug trial

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 63 million Canadian dollars (around £37m) to develop medicines based on dimethyltriptylene (DMT) to treat depression. Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of …

Small Pharma stock market launch funds DMT-based depression drug trial Read More »

Tackling diabetes & ALS with cell therapy

Israeli company Kadimastem is developing regenerative medicine therapies based on differentiated cells derived from human embryonic stem cells to treat diseases such as Amyotrophic lateral sclerosis (ALS) and diabetes. Catherine Longworth spoke with Kadimastem’s head of diabetes research, Kfir Molakandov to find out more. In the 1990s, when the first transplant of islets took place, …

Tackling diabetes & ALS with cell therapy Read More »

Sanofi begins three-year immunology R&D tie-up with Stanford

Sanofi has begun a three-year research collaboration with Stanford University School of Medicine, working on better understanding of immunology and inflammation through open scientific exchange. The French pharma said it plans to provide funding and scientific inputs into projects of mutual interest in several therapeutic areas including autoimmune diseases and inflammatory conditions. Sanofi’s success in …

Sanofi begins three-year immunology R&D tie-up with Stanford Read More »

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon

A new drug discovery firm, Eikon Therapeutics, has launched with former Merck & Co research chief Roger Perlmutter at the helm. Eikon is backed with $148 million in Series A financing led by The Column Group, with Foresite Capital, Innovation Endeavors and Lux Capital also joining. The California-based company said it aims to use super-resolution …

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon Read More »

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon

A new drug discovery firm, Eikon Therapeutics, has launched with former Merck & Co research chief Roger Perlmutter at the helm. Eikon is backed with $148 million in Series A financing led by The Column Group, with Foresite Capital, Innovation Endeavors and Lux Capital also joining. The California-based company said it aims to use super-resolution …

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon Read More »

New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy

UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months.  The start-up is focusing on processed and purified extracts from an undisclosed plant source that have been shown in lab studies to kill the …

New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy Read More »

Creating a global life sciences superpower from the lessons of COVID

It’s time to take what the UK has learnt about the “Holy Trinity” of government, academia, and industry and apply it to creating a “life sciences superpower”, says health secretary Matt Hancock. The UK’s life sciences industry has “achieved in months what usually takes years” – and in doing so has built a solid foundation …

Creating a global life sciences superpower from the lessons of COVID Read More »

MDMA on track for 2023 approval as PTSD therapy, says developer

A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it.  The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) is leading the development of MDMA and has just reported top-line results …

MDMA on track for 2023 approval as PTSD therapy, says developer Read More »

EU starts rolling review of Sinovac’s COVID-19 vaccine

Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19. In a statement, the European Medicines Agency said the rolling review is based on non-clinical and clinical studies suggesting the vaccine triggers production …

EU starts rolling review of Sinovac’s COVID-19 vaccine Read More »

MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial. MoonLake has swiftly in-licensed the drug discovered …

MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab Read More »

Engaging Underserved Populations – Improving Diversity and Inclusion

With health equity at the forefront of many conversations today, study sponsors are seeking ways to make clinical trial participation more inclusive. To help facilitate participation of underserved populations, we have outlined strategic guidance that study sponsors can leverage in their efforts. Learn more: http://bit.ly/BBKDI Watch our video: The post Engaging Underserved Populations – Improving …

Engaging Underserved Populations – Improving Diversity and Inclusion Read More »

AZ posts solid Q1 results as Alexion merger looms

AstraZeneca’s not-for-profit coronavirus vaccine has bit into margins in Q1, although revenues were ahead of expectations as the company heads towards completion of its $39bn acquisition of Alexion.  The company posted Q1 product sales of $7.26bn, ahead of consensus forecasts of around $6.84 billion, with total revenues up 15% compared with last year’s Q1 to …

AZ posts solid Q1 results as Alexion merger looms Read More »

GlaxoSmithKline focuses on split after lacklustre Q1 results

GlaxoSmithKline’s CEO Emma Walmsley said the company is focused on pursuing its strategy to spin off its consumer business after downbeat set of first quarter results. Pharma sales were down 12% compared with last year’s Q1 to £3.9 billion and its vaccines business has also been hit by a 32% slump as people put off …

GlaxoSmithKline focuses on split after lacklustre Q1 results Read More »

Crowded psoriasis market cuts Lilly’s mirikizumab ambitions

Eli Lilly has walked away from a major indication for its blockbuster hopeful mirikizumab, shelving plans to file it for psoriasis as the market is getting much too congested.  The decision – announced in the company’s first-quarter results statement – comes shortly after Lilly reported positive phase 3 results with mirikizumab in ulcerative colitis. The …

Crowded psoriasis market cuts Lilly’s mirikizumab ambitions Read More »

Sanofi eyes 2022 filing for haemophilia drug fitusiran, despite safety issue

Sanofi’s much anticipated drug for both haemophilia A and B – fitusiran – could be filed in 2022 despite a problem with blood clots in some patients in late-stage testing.  In its quarterly results update, Sanofi notes that a revised dosing schedule is being tested in its phase 3 programme to try to reduce the …

Sanofi eyes 2022 filing for haemophilia drug fitusiran, despite safety issue Read More »

Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy

Following the success of the coronavirus vaccine developed with AstraZeneca, Oxford University’s Jenner Institute has unveiled trial results showing its experimental malaria shot could be around 77% effective. There is a malaria vaccine on the market – GlaxoSmithKline’s Mosquirix – but this is only around 39% effective in young children and has not been backed …

Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy Read More »

FDA lifts hold on uniQure gene therapy after cancer case review

Dosing can start once again in uniQure’s phase 3 trial of its haemophilia B gene therapy, after the FDA concluded that a case of liver cancer seen in the study was unlikely to be caused by the treatment.  The biotech said that the FDA had concluded that its investigation into the case, conducted in collaboration …

FDA lifts hold on uniQure gene therapy after cancer case review Read More »

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival

Bristol-Myers Squibb has phase 3 data from its deucravacitinib psoriasis pill, showing it outperformed Amgen’s rival Otezla in patients with moderate to severe disease. The company thinks the data from the first-in-class tyrosine kinase 2 inhibitor are strong enough to file with regulators, setting up a potential launch next year. Competition regulators required Celgene to …

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival Read More »

Avillion/Merck psoriasis nanobody hits the mark in phase 2

UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx.  The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was …

Avillion/Merck psoriasis nanobody hits the mark in phase 2 Read More »

Nobel winner Charpentier’s CRISPR Therapeutics gets $900m in reworked Vertex deal

CRISPR Therapeutics is to receive a hefty $900m payment from Vertex after the companies amended a collaboration to develop, manufacture and market a gene editing therapy for sickle cell disease and beta thalassemia. Founded by Nobel prize winner Emmanuelle Charpentier, CRISPR Therapeutics has been at the forefront of gene editing technology and has refined its …

Nobel winner Charpentier’s CRISPR Therapeutics gets $900m in reworked Vertex deal Read More »

UK regulator backs Amarin’s cardiology drug Vazkepa

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March.  The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. These are defined as patients who …

UK regulator backs Amarin’s cardiology drug Vazkepa Read More »

FDA approves under-pressure GSK’s Jemperli for endometrial cancer

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer.  With Jemperli, a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers. Merck & Co’s Keytruda …

FDA approves under-pressure GSK’s Jemperli for endometrial cancer Read More »

Vertex eyes controllable genetic drugs with $1.3bn Obsidian alliance

Vertex Pharma has ramped up its involvement in gene-editing medicines for the second time in a week, paying Obsidian Therapeutics $75 million upfront to access its technology platform.  Vertex is also offering up to $1.3 billion in milestone payments in the deal, which will focus on using small-molecule compounds to “fine tune” the effects of …

Vertex eyes controllable genetic drugs with $1.3bn Obsidian alliance Read More »

Centessa plans $100m IPO to fund R&D and potential acquisitions

Centessa has announced plans for a $100m US IPO just weeks after the company launched with $250m in private backing and an R&D powerhouse driven by the merger of 10 biotechs. In a filing with the Securities and Exchange Commission, Centessa said it plans to use proceeds to fund the development of the 16 drugs …

Centessa plans $100m IPO to fund R&D and potential acquisitions Read More »

Roche axes two pipeline COVID drugs as pandemic hits Q1 pharma sales

Roche has axed two mid-stage COVID drugs from its development pipeline, according to a first quarter results statement showing the pandemic has hit sales in its medicines business. Gone from the pipeline is a phase 2 trial of astegolimab (RG6149), a drug that binds to IL-33 and ST2 in COVID-19 related pneumonia Roche said in …

Roche axes two pipeline COVID drugs as pandemic hits Q1 pharma sales Read More »

Collaboration is key to advancing cell therapy research

Dr. Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe to expand patient access to cell therapy. This thought leadership series has been paid and developed by Kite, a Gilead Company. Cell therapy is a treatment involving the genetic modification …

Collaboration is key to advancing cell therapy research Read More »

Big data and cell therapy development: the pharmaphorum podcast

In the latest episode of the podcast pharmaphorum’s website editor Catherine Longworth speaks with Dr Darrin Disley, who’s the CEO of Mogrify. The UK biotechnology company is aiming to transform the development of cell therapies using a systematic direct cell conversion & maintenance platform powered by big-data. Darrin discusses the story behind Mogrify’s technology and his …

Big data and cell therapy development: the pharmaphorum podcast Read More »

SparingVision to buy GAMUT and potential Luxturna eye gene therapy competitor

French genomic medicines firm SparingVision has agreed to buy GAMUT Therapeutics, a biotech specialising in gene therapies for inherited eye diseases such as retinitis pigmentosa (RP) that could compete against Roche/Spark’s Luxturna in a wider patient group.  GAMUT’s lead product, now SPVN20, is a novel, mutation-agnostic gene therapy, which aims at restoring the function of …

SparingVision to buy GAMUT and potential Luxturna eye gene therapy competitor Read More »

UK Vaccine Taskforce head lifts lid on Novavax deal

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce.  Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in …

UK Vaccine Taskforce head lifts lid on Novavax deal Read More »

2nd Gene Therapy for Neurological Disorders Europe

Returning digitally in 2021, the 2nd Annual Gene Therapy for Neurological Disorders Europe meeting will possibly be your last chance to attend a European meeting without the airmiles! Focusing on the industry’s challenges of developing and delivering gene therapies to the CNS and bringing fresh faces and emerging companies into the conversation, this is not one to miss …

2nd Gene Therapy for Neurological Disorders Europe Read More »

Risk of brain clots higher with COVID than vaccine, study suggests

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either …

Risk of brain clots higher with COVID than vaccine, study suggests Read More »

Magic mushroom compound matches antidepressant in clinical trial

The active compound in magic mushrooms – psilocybin – seems to be at least as effective as a commercially-available antidepressant in a phase 2 trial, and may work more quickly.  Researchers at Imperial College London’s Centre for Psychedelic Research also say that psilocybin may have a stronger effect and was more likely to help patients …

Magic mushroom compound matches antidepressant in clinical trial Read More »

Activist investor Elliott builds stake in GSK after fresh trial upset

Activist investor Elliott Management has built a significant stake in GlaxoSmithKline, after a poor run of clinical trial results this year raised questions about management’s strategy to turn around the company’s fortunes. The news follows another trial disappointment this week, where GSK’s feladilimab, combined with Merck & Co’s Keytruda (pembrolizumab), came up short in a …

Activist investor Elliott builds stake in GSK after fresh trial upset Read More »

Evrysdi has ‘real world impact’ on lives of babies with severe SMA, says Roche

Roche’s Genentech unit has released further data from a key trial of Evrysdi, its oral treatment for spinal muscular atrophy (SMA), the rare muscle wasting disease that is often fatal in babies that develop it. There are several treatment options now available for SMA, with Novartis’ ultra-pricey Zolgensma offering a one-off gene therapy, while Biogen’s …

Evrysdi has ‘real world impact’ on lives of babies with severe SMA, says Roche Read More »

Romark eyes FDA okay for COVID antiviral despite mixed trial results

A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company.  The Florida-based firm has just released top-line results from the 1,092-patient study, showing that …

Romark eyes FDA okay for COVID antiviral despite mixed trial results Read More »

Pfizer/Myovant take relugolix contraceptive combination pill into phase 3

Pfizer and Myovant have begun a late-stage trial of their potential uterine fibroid drug relugolix, as part of a contraceptive combination tablet.  The FDA is already reviewing data from two phase 3 trials of relugolix as a treatment for fibroids, with a decision due on or before 1 June. Pfizer and Myovant began a collaboration …

Pfizer/Myovant take relugolix contraceptive combination pill into phase 3 Read More »

Gilead’s Trodelvy approved in metastatic urothelial cancer

Gilead’s Trodelvy has another string to its bow after FDA approval in patients with advanced metastatic urothelial cancer.  Trodelvy (sacituzumab govitecan) has been approved for locally advanced or metastatic urothelial cancer, following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor immunotherapy. The US pharma hopes that the drug will be used in those patients who have not …

Gilead’s Trodelvy approved in metastatic urothelial cancer Read More »

Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial

Antios has raised $96 million in Series B financing to support the ongoing phase 2 development of its hepatitis B drug candidate, ATI-2173. There are several competitors developing treatments for hepatitis B in what could turn out to be a competitive market. Most people infected with the disease, which can be spread sexually or by …

Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial Read More »

Akari begins late-stage trial of nomacopan for Bullous Pemphigoid

Akari Therapeutics is to begin a late-stage trial of nomacopan, its potential therapy for Bullous Pemphigoid, the rare autoimmune skin disorder. The company based in New York and London has clearance from the FDA to start development of the drug, with clinical sites due to open midway through this year. BP may last several years …

Akari begins late-stage trial of nomacopan for Bullous Pemphigoid Read More »

South African variant may evade Pfizer/BioNTech vaccine, study finds

The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the variant was found to make up around 1% of all COVID-19 cases across the people studied according to results which have yet to be peer-reviewed. But among patients who had …

South African variant may evade Pfizer/BioNTech vaccine, study finds Read More »

Regeneron to ask FDA to use antibody to prevent COVID-19

Regeneron is to ask the FDA for clearance to use its antibody cocktail as a preventive treatment for COVID-19. The therapy is already authorised by the FDA for adults with mild-to-moderate disease and paediatric patients at least 12 years of age who have tested positive for the virus and are at high risk of serious …

Regeneron to ask FDA to use antibody to prevent COVID-19 Read More »

AstraZeneca’s Farxiga fails phase 3 COVID-19 test

Hope that AstraZeneca’s diabetes and heart failure drug Farxiga might treat patients hospitalised with COVID-19 have been dashed after the drug failed to make an impact in a phase 3 trial.  The DARE-19 trial showed that giving Farxiga (dapagliflozin) to COVID-19 patients at risk of developing severe complications wasn’t able to reduce the risk of …

AstraZeneca’s Farxiga fails phase 3 COVID-19 test Read More »

Sanofi licences in potential oral IL-17 drug from UK’s C4X Discovery

Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). While the headline figure looks significant the UK biotech will receive only €7 million up front, reflecting the fact that the drug has not yet begun clinical testing. The rest …

Sanofi licences in potential oral IL-17 drug from UK’s C4X Discovery Read More »

The next generation of immunotherapy? Innate Pharma targets NK cells

Clinical-stage oncology biotech Innate Pharma is on a mission to harness the power of natural killer cells to fight cancer. Catherine Longworth spoke to CEO Mondher Mahjoubi to find out the science behind this next generation of immunotherapies.  Founded in 1999, Marseille-based company Innate Pharma is on a mission to develop immunotherapies that take advantage …

The next generation of immunotherapy? Innate Pharma targets NK cells Read More »

Merck’s Keytruda demonstrates adjuvant use in kidney cancer

Merck & Co has announced interim data from its pivotal Phase 3 KEYNOTE-564 trial evaluating immunotherapy Keytruda for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following surgery.  The interim analysis carried out by an independent data monitoring committee, revealed Keytruda showed a statistically significant and clinically meaningfully improvement in disease free …

Merck’s Keytruda demonstrates adjuvant use in kidney cancer Read More »

Lilly’s Olumiant flunks COVID-19 trial – or does it?

Eli Lilly’s JAK inhibitor Olumiant has missed its main objective in a phase 3 trial in hospitalised COVID-19 patients, but had a significant effect on mortality, a secondary endpoint.  The perplexing data showed that patients treated with Olumiant (baricitinib) were 2.7% less likely to progress to needing a ventilator or death compared to a placebo …

Lilly’s Olumiant flunks COVID-19 trial – or does it? Read More »

COVID heralds a faster future for drug development (if stakeholders can collaborate)

COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI.  The 2021 WIRED Health conference took a broad view …

COVID heralds a faster future for drug development (if stakeholders can collaborate) Read More »

Jan van de Winkel: Building Europe’s biotech powerhouse at Genmab

Jan van de Winkel has overseen one of biotech’s big success stories since he took over Genmab’s CEO in 2010. He spoke to pharmaphorum’s news editor Richard Staines to outline his plans to create a European biotech powerhouse.  The last ten years has seen Denmark’s Genmab become one of biotech’s big success stories. Under the …

Jan van de Winkel: Building Europe’s biotech powerhouse at Genmab Read More »

Genmab could spin out autoimmune disease unit, says CEO

Genmab’s CEO Jan van de Winkel has said he would consider spinning out a smaller autoimmune diseases biotech, while ruling out any interest in a merger with big pharma.  In an interview with pharmaphorum, van de Winkel noted that the company’s drugs could be used for diseases outside of cancer, where Copenhagen-based Genmab first made …

Genmab could spin out autoimmune disease unit, says CEO Read More »

Safety study pushes back phase 3 trial of Newron’s schizophrenia drug

Switzerland’s neurology specialist Newron must hold off starting a phase 3 study of its schizophrenia drug evenamide to complete a small study to show safety at a higher dose, causing a further delay to development. Clinical development has already been delayed by safety issues that arose unexpectedly in 2019 but the FDA agreed a plan …

Safety study pushes back phase 3 trial of Newron’s schizophrenia drug Read More »

FDA grew too close to Biogen during Alzheimer’s drug development, doctors say

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 …

FDA grew too close to Biogen during Alzheimer’s drug development, doctors say Read More »

Country focus: Hungary carves out a niche in digital pharma

AI simulated cell company Turbine is just one of many digital drug discovery firms on the rise in Hungary. We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. Hungarian company, Turbine, is taking an alternative approach …

Country focus: Hungary carves out a niche in digital pharma Read More »

Novartis builds radio-oncology pipeline with iTheranostics deal

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body.  The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is …

Novartis builds radio-oncology pipeline with iTheranostics deal Read More »

Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week.  The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after …

Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope Read More »

Transformational therapies demand a new mindset

Pharma is moving to a new era of radically new therapies, presenting unexpected and difficult challenges. Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. Chris Gray leads Innovation and Ventures for Adelphi’s …

Transformational therapies demand a new mindset Read More »

Novo Holding launches latest call for antibiotic investment proposals

With the focus on COVID-19 over the last year it’s easy to forget another deadly pandemic caused by antimicrobial resistance (AMR), which could lead to the most innocuous of infections becoming life threatening. The Novo Holding REPAIR Impact Fund is hoping to change this with its latest call for investment proposals to fight AMR. While …

Novo Holding launches latest call for antibiotic investment proposals Read More »

Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial

Regeneron has posted findings from a large trial its COVID-19 antibody cocktail showing it reduced risk of hospitalisation or death by 70%. The US pharma said that the results were a landmark as they “conclusively” demonstrated that REGEN-COV (casirivimab+imdevimab) can significantly reduce death in an outpatient setting. Data from the phase 3 trial will also …

Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial Read More »

Culture changes – FUJIFILM Irvine Scientific’s COO on cell therapy, COVID vaccines and 50 years of the company

From animal processing, to cell therapy and AI, Tim Mullane, president, and chief operating officer tells pharmaphorum how FUJIFILM Irvine Scientific has evolved to become one of the top manufacturers of cell culture media. Although Irvine Scientific joined parent company Fujifilm in 2018, its roots can be traced back to the 1970s, where it started …

Culture changes – FUJIFILM Irvine Scientific’s COO on cell therapy, COVID vaccines and 50 years of the company Read More »

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored]

Cho discusses Bristol Myers Squibb’s research efforts in the field of protein degradation to advance potential treatments for a broad range of diseases. In a recent MedCity Pivot Podcast, he also shared insights on his approach to drug discovery, perspectives on dealing with failure, and some of the work his teams are doing in the …

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored] Read More »

Slaoui exits three more companies amid harassment fallout

Moncef Slaoui has stepped down from positions at three more companies, shortly after being dismissed from a firm owned by GlaxoSmithKline for alleged sexual harassment. In the space of 24 hours, Slaoui (61) exited as chairman of US vaccine developer Vaxcyte at the request of the company, and resigned from his role at chief scientific …

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Thumbs-down from FDA experts for Pfizer/Lilly’s painkiller tanezumab

After more than a decade of fraught clinical development it looks like the end of the line for Pfizer/Lilly painkiller tanezumab, which promised to be an alternative to addictive opioid painkillers. Pfizer has asked the FDA for a licence for tanezumab in moderate to severe osteoarthritis pain, where other painkillers aren’t working or are inappropriate. …

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AZ issues revised efficacy figures for COVID-19 shot

AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim analysis published earlier this week were out of date. The new figures from AZ, which developed the vaccine in partnership with Oxford University, give an efficacy at preventing symptomatic COVID-19 …

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GSK fires former R&D chief Slaoui after sexual harassment allegation

GlaxoSmithKline has fired its former research boss Moncef Slaoui from the board of Galvani Bioelectronics, a company it majority owns, after an internal investigation found he sexually harassed a female employee. Slaoui is noted for his work with Operation Warp Speed, the COVID-19 vaccine project launched by the Trump administration, where he was scientific head …

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COVID-19 drives Boehringer’s R&D spend to record level in 2020

Boehringer Ingelheim invested €3.7 billion on R&D last year, the highest spend in its history, as it mobilised its scientists to seek out new therapies for COVID-19. Not all those efforts have been successful. Boehringer abandoned BI 764198, an inhibitor of TRPC6 in phase 2 for acute respiratory distress syndrome (ARDS) in patients hospitalised for …

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Pfizer begins clinical trials of COVID-19 antiviral pill

Pfizer has begun clinical development of an antiviral pill against COVID-19, which could be prescribed to patients at the first sign of infection. The company was the first to get a vaccine approved against the disease with BioNTech and is now aiming to make a pill that could prevent it escalating once patients are infected. …

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LEO Pharma’s new R&D lead on driving agility in drug development

After 27 years at Bayer, Jörg Möller has moved to LEO Pharma as the company’s EVP, global research and development. We spoke to him about the lessons he’s taking from his prior jobs into the new role and what it means to be an R&D leader in the modern industry. As global head of research …

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Roche stops dosing in trial of Huntington’s disease hopeful tominersen

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts.  The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. There were high expectations for tominersen, which the companies hoped would …

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Doubts emerge over AZ’s ‘outdated’ US vaccine trial data

AstraZeneca has been rebuked by a US health authority after a trial monitoring board said data published from a large study of its COVID-19 vaccine may be out of date and may not give a representative view of its efficacy. The company’s share price ticked down after the statement on Monday from the US National …

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FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later this week.  Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally …

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How do you get all the data quality benefits of eCOA in less time and at lower cost?

Upcoming oncology trial? Which oncology eCOA Package offers the best ability to capture reliable endpoint evidence to increase speed, reduce cost, and ensure consistency across sites and geographies in less time? Find out. Consider these data points: 334 studies 158,000+ patients 67 countries 44,000+ sites 116 languages 30+ indications 33% Faster Design with an Average …

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Roche launches test to monitor emerging coronavirus variants

Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Detecting different variants of the virus can help assess the spread …

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Roche launches test to monitor emerging coronavirus variants

Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Detecting different variants of the virus can help assess the spread …

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bluebird bio announces long-term data from CALD gene therapy

bluebird bio has announced new clinical trial data from its gene therapy for patients with cerebral adrenoleukodystrophy (CALD), including long-term follow-up data. CALD is the most severe form of adrenoleukodystrophy (ALD), a rare, X-linked metabolic disease affecting 1 in 21,000 newborn boys worldwide. Approximately 40% of boys with ALD will develop CALD1, typically between the …

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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers. Following this, more than 40 megabytes of classified …

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The host immune response in COVID-19 and beyond

MeMed CEO Dr. Eran Eden explores the relationship between the host immune response and SARS-CoV-2 infection and how technology could help personalise treatment strategies. The entire healthcare sector experienced a steep learning curve after the outbreak of COVID-19. The pace of work in the industry reached almost ludicrous speeds. Decisions that used to take months …

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EU probes low platelet safety issue with COVID-19 shots

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be …

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Sanofi/Translate start clinical trial of mRNA COVID shot

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. While Pfizer/BioNTech and Moderna have been able to produce mRNA vaccines in a matter of months Sanofi is considerably behind with its collaboration with Translate …

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Life sciences must become cloud-first to seize the science of tomorrow

If the power of the life sciences industry to innovate and collaborate were ever in doubt, the speed at which vaccines for COVID-19 were discovered, developed, trialled, approved and manufactured have confirmed just how dynamic the industry can be. And that dynamism, innovation and collaboration are all qualities that the industry must continue to nurture …

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BCMA Targeted Therapies Summit

Built with thought leaders from Seattle Genetics, Precision Biosciences and Kite Pharma, the inaugural industry-focused BCMA Targeted Therapies Summit will share the field’s cutting-edge and aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and …

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New ways to treat COVID: the pharmaphorum podcast

In episode 31 of the pharmaphorum podcast, Deep Dive editor George Underwood speaks to RedHill biopharma’s chief business officer Guy Goldberg about the potential for new COVID-19 therapeutics to help fight the pandemic and treat patients in the years to come. Prior to joining RedHill, Guy served as senior vice president of business operations at …

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FDA fast tracks type 1 diabetes cell therapy from Vertex

Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes.  VX-880 (formerly known as STx-02) derives from Vertex’ near $1 billion acquisition of Semma in 2019, and has …

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Epigenetic Therapeutic Targets Summit

Join the Epigenetic Therapeutic Targets Summit – the only virtual summit dedicated to the clinical translation and optimization of therapeutic candidates targeting epigenetic mechanisms of gene expression. Hear the latest clinical advancements in therapeutic interventions targeting all areas of epigenetic machinery, including DNA methylation, histone post-translational modifications, chromatin remodelling and non-coding RNAs, with case studies …

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AI, big data and deep real-world evidence – the challenges and opportunities

Real-world evidence (RWE) is emerging as an important area of research to reveal, in real time, new insights and innovations and is accelerating the development of new and innovative therapies and treatments to improve patient outcomes. An important source of RWE has, until recently, been locked in the electronic health record (EHR). Now, artificial intelligence …

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bluebird seeks gene therapy trial restart after cancer scare

bluebird bio is to ask regulators to restart clinical studies of its LentiGlobin for sickle cell disease, after an investigation concluded that a case of acute myeloid leukaemia (AML) was “very unlikely” to be caused by the gene therapy. Known as Zynteglo in Europe where it is approved to treat the rare blood disorder beta-thalassemia, …

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UK data hub to apply AI to health records for COVID-19 and respiratory research

Health Data Research UK’s respiratory hub BREATHE is set to use artificial intelligence (AI) to unlock real-world insights from electronic health records (EHRs) as part of a new partnership. It will apply Savana’s EHRead technology to de-identified EHRs to boost research into COVID-19 and respiratory conditions, work that is also part of the international BigCOVIData study …

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Inside the UK’s leading efforts to restart clinical research

A herculean national effort has seen 69% of paused studies due to COVID restarted under the National Institute for Health Research’s (NIHR) Restart Framework. Experts from the institute tell us how those numbers can be further boosted, and how lessons learned from the sector-wide collaboration will change UK research forever. There has been a remarkable …

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Pfizer/BioNTech COVID jab works against Brazil variant; lab study

A laboratory study suggests Pfizer and BioNTech’s COVID-19 vaccine Comirnaty could be effective against a Brazilian variant of the SARS-CoV-2 virus – known as P.1 – that is worrying health officials around the world.  The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise …

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Takeda buys Maverick as T-Cell engager research hots up

Takeda is taking its option to buy the privately held biotech Maverick Therapeutics and its T-Cell engager cancer therapies for $525 million, as research into the technology gathers pace. San Francisco-based Maverick’s technology is designed to target solid tumours with a T-cell attack that focuses on cancerous tissues while leaving healthy tissue alone. Standard T-cell …

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ExeVir ready for clinic with variant-targeting llama antibody

Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. Regeneron and Eli Lilly have already got antibody therapies on the market following emergency approvals by …

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The Alderley Park Discovery Podcast: The journey to accessing science funding and investment

Episode 3 of the Alderley Park Discovery Podcast covers how to successfully access life science funding and investment, highlighting a range of ways companies can attract investors. In this instalment, Dominic Tyer is joined by Kinomica CEO Jane Theaker, BioCity investment director Claire Brown, Redx Pharma CEO Lisa Anson and Dr Kath Mackay, managing director at Bruntwood …

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Keeping Clinical Trials Moving Forward and On Track

Keeping clinical trials moving forward and on track is imperative now more than ever as we navigate today’s challenges.  Sites are eager to work and continue to support the progress of clinical trials for the benefit of subjects.  Despite the pandemic, TotalCRO has been able to meet 100% of enrollment targets while facilitating the closest …

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Focus on Rare: the invisible burden of rare diseases

Emma Sutcliffe from NexGen Healthcare Communications looks at how patient insights can bring the invisible challenges of living with a rare condition into plain view. Over the past decade there has been considerable investment by pharma into research for rare disease as the patient voice and advocacy movement have done an outstanding job of raising …

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International Women’s Day: The gender gap in clinical trials

For International Women’s Day, Medidata’s global compliance and strategy lead Fiona Maini discusses the importance of increasing female participation in clinical trials and how technology may solve some of the barriers. Although women’s social and political advancement may be progressing across the world, the pharmaceutical industry still has a gender gap at each stage of …

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Could personalised medicine change treatment for migraine?

The concept of personalised medicine is becoming established in cancer, with an increasing number of drugs targeting specific mutations making it to market. Alec Mian, CEO at diagnostics firm Curelator, spoke to pharmaphorum’s news editor Richard Staines about the company’s plans to apply a similar paradigm to other diseases such as migraine.  There has been …

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Amgen in $1.9bn swoop for Five Prime and its gastric cancer drug

Amgen is to buy US biotech Five Prime Therapeutics for around $1.9 billion, adding a potential gastric cancer drug to its pipeline. The big pharma swooped in after the California biotech reported promising phase 2 trial results from bemarituzumab in November. The phase 2 FIGHT trial testing bemarituzumab plus chemotherapy as a front-line therapy for advanced gastric …

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The post-COVID face of pharma research and development

The acute phase of the COVID-19 pandemic not only brought delays, restrictions, and reconfigurations to pharmaceutical research & development in 2020, but also a more flexible response to some long-standing issues with the clinical trials process.  Lockdown rules and safety protocols certainly made it harder for patients to travel to trial sites, while a refocusing …

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