UK life science competitiveness indicators 2022: measuring what matters most?
The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The indicators did not bring universal […]
Market Access
UK advisors back Moderna’s bivalent shot for autumn COVID booster
The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in […]
Why reshoring drug production means embracing continuous manufacturing
Recent history should have the pharmaceutical industry questioning some of its fundamental assumptions. The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously […]
Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld
Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, […]
Novartis’ Pluvicto gets first European approval in GB
Novartis has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products […]
AZ gets FDA nod for Enhertu in first HER2-low cancer
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that […]
US Democrats’ blockbuster budget bill could spell big changes for drug prices
The Inflation Reduction Act of 2022, a sweeping measure that now looks likely to be passed through budget reconciliation by Senate Democrats in the US, […]
Sanofi looks east with €300m Innovent cancer alliance
Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as […]
Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
Sarepta says early filing for DMD gene therapy is back on
Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy […]
AmerisourceBergen aims to make digital therapeutics access easier
Pharma distributor AmerisourceBergen is working on a platform to make access to digital therapeutics (DTx) easier in the US by providing a unified system for […]
Global comparator data signal “alarm bells” for UK Government, says APBI
Latest UK Life Sciences Competitive Indicators “ought to ring alarm bells across Government,” says ABPI. Despite the UK’s potential as an international life sciences leader, […]
Biogen gets much-needed pipeline lift with speedy ALS drug review
Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its review of amyotrophic lateral sclerosis (ALS) therapy […]
Roche’s fast-growing eye drug Vabysmo set for EU approval
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the […]
CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision
The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma, joining a growing group of […]
The new European Unitary Patent system – What you need to know
The proposed European unitary patent and unified patent court represents one of the largest changes to the European patent system in a generation. It will […]
As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever
The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. However, many firms were hit […]
The big squeeze?
With NHS England highlighting savings of £1.2 billion on medicines in three years coming from both deals on generics and new innovative treatments, Leela Barham […]
Simcere gets China okay for G1’s bone marrow protector Cosela
China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy partnered […]
AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
Byondis cues up US, EU decisions on breast cancer ADC in 2023
Byondis has filed its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the US and Europe, setting up possible approvals next year and a showdown with […]
NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients
Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs to start prescribing the drug in up […]
FDA clears Xalkori for inflammatory myofibroblastic tumours
Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form […]
NICE backs two new breast cancer drugs for NHS use
Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – […]
HRA Pharma bids to bring first OTC contraceptive pill to US
Perrigo’s HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter contraceptive pill. The move comes as access […]
NICE makes J&J’s Tremfya more accessible in England and Wales
NICE has updated its recommendations for NHS use of Johnson & Johnson’s IL-23 inhibitor Tremfya in the treatment of psoriatic arthritis (PsA), expanding the pool […]
BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy
NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of […]
FDA backs pharmacist prescribing of Paxlovid for COVID
Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be […]
Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan
The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that […]
FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the […]
Are timely access and robust safety mutually exclusive?
The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely […]
Omnichannel strategies to revolutionize the healthcare professional experience
Two years into the COVID-19 pandemic, engaging with healthcare professionals about treatments has never been more difficult. Consultants, doctors, and nurses are overworked, stressed, and […]
FDA rejection of Spero’s tebipenem ‘raises resistance threat’
The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of […]
US panel backs Omicron-targeting vaccines for booster campaigns
Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological […]
Pharma’s post-pandemic launch performance problem: what’s the prognosis?
The prescription medicine market has recovered from the wild swings of the early pandemic with renewed growth. COVID vaccines and treatments have created a substantial […]
Gilead tries again with twice-yearly HIV drug lenacapavir
Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after […]
Celebrations for ASMD community as EU clears Sanofi’s Xenpozyme
Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment […]
Basilea preps key US filing for MRSA antibiotic ceftobiprole
Basilea Pharmaceutica may finally be able to bring its antibiotic ceftobiprole to the US market – 13 years after its first attempt was turned down […]
BioMarin gene therapy for haemophilia on course for EU approval
The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the […]
How the US’s pending PIE Act will improve patient access to medication
Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) […]
GSK pledges £1bn drive for infectious disease R&D
GSK will invest around £1 billion ($1.2 billion) over a 10-year period to speed up R&D on infectious diseases that mainly impact lower-income countries. The […]
US frets over pharma supply chain security
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. […]
ICSs: improving patient and market access at a local level
Integrated Care Systems (ICSs) – 42 partnerships of health and care organisations who will plan and deliver more joined-up services for their locality in England […]
Evaluate’s Orphan Drug Report 2022
Paul Verdin, VP of consulting and analytics, and Andreas Hadjivasiliou, managing analyst at Evaluate, tell us about the company’s Orphan Drug Report 2022, which highlights […]
Lilly’s Verzenios gets NICE blessing for early-stage breast cancer
Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE […]
FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis
Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related psychosis have suffered another major setback. Nuplazid […]
Six months after authorization, what do we know about Paxlovid?
It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric […]
Time is motor neurons – the importance of newborn screening in SMA
Spinal muscular atrophy (SMA) is a devastating, genetic neuromuscular disease caused by a lack of a functional SMN1 gene that results in the progressive and […]
Hansa gets NICE okay for Idefirix in kidney transplant patients
Sweden’s Hansa Biopharma has claimed a positive opinion from NICE for Idefirix, which becomes the first drug cleared for NHS use in a group of […]
Questions linger as England’s Innovative Medicines Fund kicks off
In part one of this two-article series on the latest on England’s Innovative Medicines Fund (IMF), Leela Barham examined what the IMF is and what […]
FDA advisors back COVID jabs for very young children
The FDA’s vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the […]
NICE backs Astellas’ oral therapy Evrenzo for anaemia in kidney disease
Astellas’ oral HIF-PH inhibitor Evrenzo has become the first drug in the class to be recommended for routine NHS use as a treatment for anaemia […]
England’s Innovative Medicines Fund hits another milestone
Leela Barham takes a look at the latest milestone on what will have been a close to three-year journey to an Innovative Medicines Fund (IMF) […]
Alnylam grabs FDA approval for its second amyloidosis therapy
Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a […]
Lilly’s Olumiant okayed in alopecia, with Pfizer, Concert in hot pursuit
Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair […]
FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials
China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment […]
Amylyx bags first approval for ALS drug Albrioza
Amylyx Pharmaceuticals’ efforts to bring its amyotrophic lateral sclerosis therapy AMX0035 to market in the US have run into some roadblocks, so an approval by […]
Second unanimous FDA adcomm vote boosts bluebird bio
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its […]
NICE backs NHS use of Amarin’s Vazkepa for cardiovascular risk reduction
Around 425,000 in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment […]
FDA panel backs bluebird’s CALD gene therapy, despite safety worries
The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far […]
Is it time to rethink electronic prescribing in the US?
It is a fact of life that most – if not all – patients will require some form of prescription medication during their lifetime. Generally, […]
Data-driven policy and market access firm Avalere joins Fishawack Health
June 7, 2022, Washington DC – Fishawack Health (FH) announces the acquisition of leading healthcare consulting and advisory firm Avalere Health (Avalere) from Inovalon, which […]
MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran
The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport‘, a designation designed to speed up NHS access to promising […]
EU first to clear Roche’s lymphoma bispecific mosunetuzumab
Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the […]
Combination pricing: access to the future of oncology treatment relies on collaboration
Combination therapies are fast becoming the cornerstone of cancer treatment: not just in the UK, but across the world. With strong evidence to support how […]
FDA clears GSK’s Priorix, first new MMR vaccine in 50 years
With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. […]
Orphan drugs’ financial success raises questions
R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. However, Ben […]
Closing the digital expectation gap in pharma
Jan Deman is Takeda’s head of digital customer experience for Europe and Canada. But he’d prefer not to refer to what he does as “innovation”. […]
How do we make patient centricity a reality?
For years, the subject of fostering direct connections with patients has been highlighted by notable figures across the healthcare and life sciences industries as a […]
UK grants early access to Argenx’ efgartigimod for myasthenia gravis
The UK regulatory authority has cleared the path for some patients with generalised myasthenia gravis (gMG) to get early access to Argenx’ efgartigimod while it […]
Roche puts pressure on SMA rivals with new FDA approval
Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its […]
At ESMO, three studies show promise of antibody-drug conjugates in breast cancer
The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of cancer researchers just had their own gathering, […]
Leveraging KOL insights to succeed in a data-driven world
For years, key opinion leaders (KOLs) have held a position of authority and respect amongst those working across the life science industry, be it a […]
Angle claims FDA okay for Parsortix liquid biopsy system
After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first […]
Third FDA rejection for Verrica’s molluscum contagiosum drug
Shares in US biotech Verrica Pharma lost half their value today after the FDA declined to approve its candidate treatment for viral skin infection molluscum […]
NICE finds solution to making Keytruda available for TNBC
Around 100 patients in England and Wales with triple negative breast cancer (TNBC) that has spread to other parts of the body could soon access […]
Dermavant claims its first approval as FDA clears psoriasis drug
Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims […]
Pfizer makes non-profit pledge for low-income nations
US pharma giant Pfizer has said it will sell some of its patented medicines at non-profit prices to 45 of the world’s poorest countries – […]
Rethinking value: why diverse viewpoints matter
Value is a tricky concept to capture accurately. Given the diverse and complex world that we live in, different people will often hold contrasting views […]
Nymox slumps as FDA rejects filing for prostate drug
Shares in US biotech Nymox Pharma have plunged after the company announced the FDA had refused to accept its marketing application for its drug candidate […]
Dupixent claims new territory in eosinophilic oesophagitis
Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval in eosinophilic oesophagitis (EoE), which could […]
AbbVie files continuous Parkinson’s therapy ABBV-951 in US
AbbVie has filed for approval of its therapy for Parkinson’s disease, ABBV-951, which promises continuous control of symptoms and would be an alternative to current […]
CHMP backs Sanofi’s Xenpozyme as first drug for ASMD
Sanofi’s Genzyme unit has moved a step closer to securing EU approval for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency […]
PTC gets green light for gene therapy Upstaza in EU
PTC Therapeutic’s Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in the EU, setting up another test of […]
Coalition aims to improve cancer drug access in poorer nations
Several of the top pharmaceutical companies have joined a new coalition that aims to improve access to cancer medicines in low- and lower-middle-income countries (LLMICs). […]
Sleepio app for insomnia backed by NICE
After a non-committal appraisal of Big Health’s Sleepio app for insomnia last November in draft guidance from NICE, the cost-effectiveness agency has come out in […]
NICE endorses Magtrace diagnostic to detect breast cancer spread
Women with breast cancer in England and Wales will soon be able to access a new diagnostic based on an injectable magnetic marker liquid called […]
AstraZeneca, Avillion ‘first-in-class’ combination inhaler shines in Phase 3 trial
An albuterol/budesonide fixed-dose combination rescue medication has been shown to reduce severe exacerbations in patients with asthma for the first time, according to positive Phase […]
Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval
Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. […]
FDA rejects UCB’s psoriasis therapy bimekizumab
The FDA has delivered a blow to UCB’s late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque […]
Gedeon Richter gets NICE nod for uterine fibroids drug Ryeqo
Around 4,500 women in the UK will be eligible for treatment with Gedeon Richter’s once-daily oral therapy Ryeqo, after NICE backed the GnRH antagonist to […]
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which […]
Deep Dive: Market Access
For life science companies around the world, enabling faster access to innovative drugs and therapies is a complicated challenge. As this issue’s contributors discuss, changes […]
Takeda spinout Phathom claims its first FDA approvals
Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a […]
FDA approves first in vitro test for early Alzheimer’s disease
The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer’s disease without the use of PET scans, which expose […]
AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
The FDA has kicked off a priority review of AstraZeneca’s checkpoint inhibitor Imfinzi for biliary tract cancer (BTC), setting up what could be approval for […]
Kymriah is first CAR-T cleared for follicular lymphoma in EU
Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ […]
Idorsia is first to EU market with orexin insomnia drug
Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, […]
FDA says no to two more China-developed cancer drugs
The FDA has declined to approve two more cancer therapies developed by drugmakers based in China, in what may be further evidence of a tough […]
BMS bags FDA okay for cardiomyopathy drug mavacamten
Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator […]
Cara, Vifor get EU okay for drug to treat itching in dialysis patients
Vifor Pharma and Cara Therapeutics’ Kapruvia has become the first drug to be approved in the EU to treat one of the most common and […]
Pfizer/Biohaven migraine drug rimegepant gets EU green light
Pfizer’s $1.2 billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. […]
Enhertu gets breakthrough tag in HER2-low breast cancer
AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients […]
Cidara and Mundipharma prep filings for antifungal rezafungin
Mundipharma and Cidara Therapeutics have reported the results of a phase 3 trial of their new once-weekly antifungal rezafungin, setting up regulatory filings in the […]
AZ closes on FDA verdict on tremelimumab in liver cancer
AstraZeneca’s anti-CTLA4 antibody tremelimumab is moving closer to what once looked like an extremely unlikely regulatory approval, after a string of negative trial results. The […]
CHMP backs Roche’s lymphoma bispecific mosunetuzumab
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – […]
Biogen pulls EU application for Alzheimer’s drug Aduhelm
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it […]
Ampio slumps as FDA delivers knee osteoarthritis shock
Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the […]
Teva’s long-acting schizophrenia drug rejected by FDA
Teva’s long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company’s […]
Gilead wins court order against fraudsters targeting HIV programme
Gilead has won a crucial court order in a wide-ranging lawsuit against a network of clinics, prescribers, medical labs and pharmacies in Florida that it […]
FDA starts speedy review of Enhertu in lung cancer
AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu […]
The largest pharma company in Europe calls for interoperability
Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare […]
GSK goes for gold as FDA starts review of daprodustat
GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two […]
ICER says bluebird bio’s $2.1m gene therapy is cost-effective
US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel […]
NICE backs Biogen’s Vumerity for multiple sclerosis
Patients with relapsing-remitting multiple sclerosis (RRMS) in England, Wales and Northern Ireland can now access treatment with Biogen’s oral therapy Vumerity, after NICE recommended the […]
Why the drug pricing debate is focused on insulin
The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. […]
UK grants early access to Novartis’ prostate cancer radioligand
The UK regulator has said eligible patients with prostate cancer will get early access to a radioligand therapy developed by Novartis’ Advanced Accelerator Applications (AAA) […]
Medical Informatics: a bridge between two worlds
With more than 6,000 different diseases comprising the rare disease (RD) landscape, connecting patients and practitioners with the expertise needed to achieve the correct diagnosis […]
NICE verdict on Trodelvy threatens unequal access to drug in UK
In draft guidance, NICE has said it cannot recommend Gilead Sciences’ Trodelvy in triple-negative breast cancer (TNBC), setting up a disparity in access to the […]
NICE reverses stance on Merck’s Bavencio for bladder cancer
Last year, NICE said that Merck KGaA/Pfizer’s Bavencio was too expensive for routine in NHS use as a first-line maintenance treatment for bladder cancer, even […]
BioXcel gets first approval for agitation drug Igalmi
BioXcel Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with […]
ICSs – an opportunity to improve Patient & Market Access at a local level
With the new Health and Care Bill edging ever closer to receiving Royal Assent, life sciences companies in the UK are preparing to navigate the […]
NICE ends UK access disparity to osteoporosis drug Evenity
NICE has reversed its stance on UCB and Amgen’s severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the […]
Five things to watch as the Biosimilars market heats up in 2022
As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their […]
Patients dismayed as FDA advisors narrowly reject Amylyx’ ALS drug
By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide […]
Amylyx slumps on non-committal FDA reviewer assessment of ALS drug
Shares in Amylyx Pharma slid today after the FDA published a less-than-enthusiastic assessment of its amyotrophic lateral sclerosis (ALS) therapy ahead of an advisory committee […]
FDA restricts GSK’s Xevudy due to lower efficacy against BA.2
GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity […]
CHMP backs J&J’s myeloma CAR-T therapy Carvykti
Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a […]
FDA knocks back MEI’s plans for drug in troubled PI3K class
MEI Pharma and partner Kyowa Kirin have had to abandon plans to file for approval of their PI3K inhibitor zandelisib in B cell lymphoma, after […]
ViiV, J&J get FDA nod for simpler HIV injectable dosing
The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for […]
NICE firms up NHS use of Vimizim for Morquio A syndrome
In 2015, NICE said that BioMarin’s Vimizim could be used to treat patients with the ultra-rare disease Morquio A syndrome, while real-world data was collected […]
FDA sets August decision date for Provention’s type 1 diabetes drug
Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Armed with new data […]
FDA clears Marinus’ Ztalmy as first drug for rare epilepsy
People with CDKL5 deficiency disorder (CDD) now have their first FDA-approved treatment, after the US regulator gave the nod to Marinus Pharma’s Ztalmy for the […]
Moderna follows Pfizer in asking FDA for second COVID booster okay
Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech […]
Pfizer makes case for fourth COVID jab dose to FDA
Earlier this week, Pfizer chief executive Albert Bourla said that a second booster of its COVID-19 vaccine will be necessary to keep the pandemic under […]
21GRAMS and McCann Health take top spot at PM Society Awards 2022
After two years of virtual events, the PM Society celebrated its 36th annual awards with an in-person ceremony at London’s Grosvenor House on Friday 11 […]
New bill moves to tighten accelerated approval regulation in US
US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to […]
NICE says no to Keytruda in triple-negative breast cancer
There isn’t enough evidence to support the use of Merck & Co/MSD’s Keytruda in combination with chemotherapy as a first-line treatment for advanced triple negative […]
IWD: Spotlight on women in life sciences
To celebrate International Women’s Day, we speak to design engineer at Envair Technology Darina Shopova; managing director, UK & ROI at Healthcare Business of Merck […]
Jardiance pulls ahead of Forxiga with heart failure approval in EU
Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance has become the first drug in the class to be approved in the EU for all adults […]
Fishawack Health acquires HEOR consultancy PAI
March 3, 2022, London, UK—Fishawack Health (FH), a leading commercialization partner for biopharmaceutical, medical technology, and wellness companies, today welcomes the US-based health economics and […]
After GSK stumble, Pfizer moves forward with RSV vaccine
Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position […]
Janssen, Legend CAR-T therapy CARVYKTI gets FDA nod
The US Food and Drug Administration (FDA) has approved a new cell-based therapy for blood cancer, developed by Janssen and China’s Legend Biotech to treat […]
FDA turns down Amryt’s epidermolysis bullosa drug
Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare […]
Orphazyme ‘looking at options’ after lead drug hits buffers in EU
Orphazyme’s hopes of getting EU approval for its Niemann-Pick disease type C (NPC) therapy arimoclomol after a rejection by the US FDA last year are […]
EU regulator backs Idorsia’s Quviviq for adults with insomnia
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the […]
FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure
Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider […]
FDA knocks back Mallinckrodt’s kidney drug terlipressin
Manufacturing problems seem to have scuppered Mallinckrodt’s hopes of bringing the first approved drug to market in the US for hepatorenal syndrome (HRS), a life-threatening […]
Biosimilars: a rapidly maturing market
Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. […]
AbbVie files Vraylar as add-on therapy for depression in US
AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part […]
FDA expands use of Abbott’s heart sensor with new approval
The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could […]
EU clears Bayer’s chronic kidney disease drug Kerendia
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries […]
GBT claims EU approval for sickle cell drug Oxbryta
Global Blood Therapeutics’ run of positive regulatory news for its oral sickle cell disease treatment Oxbryta has continued with an approval for the drug in […]
AZ’s Saphnelo is cleared in EU, challenging GSK’s Benlysta
lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more […]
Robert Califf confirmed as FDA commissioner in tight vote
It’s official – President Joe Biden’s choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote […]
Lilly bags US okay for rival to GSK’s COVID-19 drug Xevudy
Eli Lilly has been granted an emergency use authorisation from the FDA for bebtelovimab, its second COVID-19 antibody drug and a rival to GlaxoSmithKline and […]
Eisai bites back against restricted coverage plan for Aduhelm
Japanese drugmaker Eisai has published comments filed with the US Centers for Medicare & Medicaid Services over its restrictive coverage proposal for beleaguered Alzheimer’s drug […]
Novo Nordisk gets NICE okay for obesity drug Wegovy
Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients […]
Sanofi claims FDA okay for drug to treat rare blood disorder CAD
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for […]
Novavax COVID jab ‘could save UK money on boosters’
The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future […]
Lilly defers Alzheimer’s drug filing after CMS’ ‘disappointing’ decision
Eli Lilly has backed away from plans to file Alzheimer’s drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement […]
How does rare disease prevalence impact drug pricing in England?
In this second article of a three-part series exploring pricing in Europe, CRA’s Life Sciences Practice team discusses the role that disease rarity plays in […]
NHS signs deal with Orchard for pricey Libmeldy gene therapy
NHS England has agreed a confidential deal with Orchard Therapeutics that will allow access to Libmeldy – a gene therapy for a rare childhood disease […]
Califf pledges not to use ‘revolving door’ between FDA and industry
Robert Califf has made a series of commitments to try to win over senators reluctant to back his nomination as the next FDA commissioner, ahead […]
Roche grabs FDA okay for would-be blockbuster eye drug faricimab
The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug […]
FDA stifles Merck’s cough drug gefapixant, asking for more data
The FDA has issued a complete response letter (CRL) to Merck & Co’s gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer […]
After FDA setback, Ipsen gets first OK for rare disease drug palovarotene
After regulatory hold-ups in the US and Europe, Ipsen has claimed a confidence-boosting approval in Canada for palovarotene, a rare disease therapy acquired via its […]
Chronic kidney disease: treating a silent killer
In November, NICE backed NHS use of AstraZeneca’s diabetes and heart failure drug Forxiga for the treatment of chronic kidney disease. pharmaphorum caught up with […]
Biliary tract cancer drug granted orphan drug designation in US
The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. There are currently no treatments for this rare cancer, and the US […]
Japan approves Pfizer COVID vaccine for children aged 5 to 11
Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed […]
Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access
Access to medicines is “one of the most challenging policy areas in every country in the European region” – it’s time to develop a solution […]
UK green lights Gilead Sciences, Galapagos ulcerative colitis drug
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jyseleca (filgotinib) 200mg tablets to treat ulcerative colitis (UC) in adults whose UC is […]
Glenmark and Lotus partner on allergic rhinitis spray
The mission to treat people who suffer from allergic rhinitis has been given a boost as two pharma companies join forces. The Swiss subsidiary of […]
Gilead takes legal action against counterfeit HIV drug network
US pharma giant Gilead Sciences has accused a network of unauthorised suppliers and distributors of selling more than $250 million of counterfeit versions of its […]
Poolbeg licences candidate for broad-spectrum respiratory infections
Poolbeg Pharma has licenced a candidate for nasal immunotherapy, developed by the University of Warwick, targeting respiratory infections, such as influenza and coronavirus. The RNA-based […]
Two new drugs added to WHO list of COVID-19 therapies
A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus […]
GSK rejects $68.4bn Unilever bid for consumer health
GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 […]
Parallel Trade 2022
SMi presents its 16th annual Parallel Trade conference on the 21st and the 22nd March 2022. As the only parallel trade conference in Europe, this […]
Senate panel backs Biden’s FDA selection Robert Califf
Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, […]
Third dose of AZ’s COVID jab boosts Omicron antibodies
Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as […]
Dream result for Idorsia as FDA clears its insomnia drug
Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from […]
Nine for 2022: innovation and opportunities in healthcare
In the second part of our examination of issues that will shape the course of 2022, we’ll update the ongoing impacts of the pandemic, which […]
Nine for 2022: International issues that are compelling, new or changed in 2022
The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a […]
After a Scottish aye, NICE says no to Lynparza for prostate cancer
AstraZeneca’s PARP inhibitor Lynparza should not be made available routinely on the NHS n England and Wales as a treatment for prostate cancer, according to […]
Applied Therapeutics slumps as FDA seeks more data on lead drug
Shares in Applied Therapeutics slumped today after it said it would have to delay a US filing for its lead drug programme AT-007, following an […]
Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track […]
The Considered pharmaceutical marketing experiment
COVID-19 has changed everything – at least that’s David Hunt’s plan for pharmaceutical marketing. The former CEO of Havas Lynx recently launched a new agency […]
Pfizer pips Merck to first oral COVID antiviral okay in US
Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for […]
NICE backs Aimmune’s peanut allergy drug Palforzia for children
Children in England with peanut allergies could be among the first in Europe to get access to Aimmune’s oral immunotherapy Palforzia, after the drugmaker agreed […]
Japan looks set to follow EU in rejecting Alzheimer’s drug Aduhelm
The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA […]
2021 in review: Building the framework of a patient-centric industry
Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. […]
FDA knocks back Takeda’s blockbuster hope TAK-721
Japanese drugmaker Takeda has suffered a blow to its late-stage pipeline, after the FDA rejected its marketing application for TAK-721, a drug candidate that is […]
FDA okays ViiV’s Apretude as first injectable for HIV PrEP
GlaxoSmithKline’ majority-owned HIV unit ViiV has scored a key FDA approval, getting approval for its long-acting drug cabotegravir as the first injectable for pre-exposure prophylaxis […]
Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab
The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed […]
Samantha Roberts to replace Gillian Leng as CEO of NICE
Prof Gillian Leng’s replacement as chief executive of the National Institute for Health and Care Excellence (NICE) has been named as Dr Samantha Roberts, currently […]
Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted […]
As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid
The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with […]
NICE gives Keytruda parity with Opdivo for adjuvant melanoma
After three years of availability via the Cancer Drugs Fund (CDF), MSD’s checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery […]
EU gives narrower label to Apellis, Sobi’s PNH drug
Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than […]
Wales is first UK country to fund GW’s Epidyolex for tuberous sclerosis
Patients in Wales with a rare disease that causes epilepsy will be the first in the UK to get access to GW Pharma’s cannabis-based medicine […]
FDA sets April date for verdict on Incyte’s vitiligo drug
Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to […]
Califf breezes through Senate nomination hearing
Robert Califf looks set to take a second term as FDA commissioner after navigating a relatively placid two-hour confirmation hearing in the US Senate, with […]
Intercept’s travails continue as it pulls NASH drug filing in EU
Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for […]
Post-Brexit medicines regulation must have international scope
Post-pandemic, post-Brexit Britain must create a regulatory framework that both defines and aligns with international standards, or risk being left behind. If the UK creates […]
AZ’s antibody first to be cleared by FDA for COVID prevention
AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the […]
EU approves Roche’s Actemra for severe COVID-19
The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours […]
MHRA okays GSK’s Xevudy as data suggest it works against Omicron
The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron […]
Merck’s oral COVID drug squeaks past FDA advisory committee
An FDA advisory committee voted by 13 to 10 to recommend emergency-use authorisation for Merck & Co and Ridgeback’s oral antiviral molnupiravir for mild-to-moderate COVID-19, […]
FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib
The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU […]
Turkey’s home-grown COVID vaccine project nears fruition
Turkey could have its own COVID-19 vaccine Turkovac available for use by the end of the year, according to the country’s Health Minister Fahrettin Koca. […]
After Scotland says no, NICE backs Lilly’s Retsevmo for lung cancer
Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England […]
Innovation and collaboration – the MHRA’s pandemic approach
The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey […]
FDA clears Takeda drug for post-transplant CMV infections
Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased […]
Gilead files first hepatitis delta therapy with FDA
Gilead Sciences has submitted its marketing application for bulevirtide, its antiviral therapy for rare hepatitis delta virus (HDV) infections, to the FDA. If approved, bulevirtide […]
NICE reaches a deal with Roche on access to oral SMA drug Evrysdi
Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached […]
NICE backs ViiV/J&J’s six-per-year injection for HIV
People living with HIV in England and Wales now have an alternative to daily oral tablets, after NICE backed NHS use of two long-acting injectable […]
CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for […]
NICE changes tack on NHS use of BMS’ myelofibrosis drug Inrebic
After turning down routine NHS funding of Bristol-Myers Squibb’s Inrebic for bone marrow disorder myelofibrosis earlier this year, NICE now says the drug can be […]
Pfizer files oral COVID pill in US, signs access deal for 95 countries
Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – […]
Drug-resistant epilepsy drug Ontozry backed by NICE
NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini […]
Biden confirms Califf choice as FDA commissioner
President Joe Biden ended months of speculation by formally nominating Robert Califf as the new commissioner of the FDA, a position he previously held during […]
Novo Nordisk nears EU approval of obesity drug Wegovy
Danish drugmaker Novo Nordisk is hoping to launch its once-weekly injectable treatment for obesity, Wegovy, in the EU next year after getting a green light […]
COVID antibodies from Roche, Celltrion backed for approval in EU
The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to […]
Getting better at measuring international uptake of medicines?
In part one of a two-piece series, Leela Barham looks at whether we are getting better at measuring international uptake of medicines. The publication of […]
J&J deal with COVAX grants humanitarian access to COVID shot
Johnson & Johnson has reached an agreement to make its one-dose COVID-19 vaccine available to an arm of the COVAX facility that is focusing on […]
Moderna squares off with US government over COVID jab patent
After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend […]
Germany says only Pfizer COVID jab should be used in under 30s
Germany’s vaccination advisory committee has recommended that people aged under 30 should only be offered Pfizer/BioNTech’s COVID-19 vaccine Comirnaty, saying it seems less likely to […]
Patient and market insights from leading KOLs and life science leaders
Today, there are more than 80 treatments in development for atopic dermatitis and psoriasis. The landscape is booming with treatment innovations. However, the rise in […]
Cautious welcome as NICE backs Forxiga for chronic kidney disease
Tens of thousands of people with chronic kidney disease in England could be eligible for treatment with AstraZeneca’s SGLT2 inhibitor Forxiga, after NICE backed NHS […]
UK first to authorise Merck/Ridgeback’s COVID pill molnupiravir
Merck & Co and Ridgeback’s oral antiviral molnupiravir has been approved in its first market – the UK – as a treatment for people with […]
Novavax gets first authorisation for its COVID-19 jab
Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other […]
FDA delays review of Moderna COVD jab in adolescents
The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to […]
AbbVie claims first FDA okay for presbyopia drug therapy
The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves […]
Merck takes further steps to expand access to oral COVID pill
Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture […]
Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial
Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen […]
Seagen’s breast cancer drug Tukysa turned down by NICE
NICE has decided not to recommend Seagen’s orally-active HER2 inhibitor Tukysa for advanced breast cancer in draft guidance, saying it isn’t a cost-effective use of […]
Sustained healthcare systems need sustainable pharma business models
COVID-19 demonstrated the importance of robust supply chains and the dangers of an over reliance on overseas manufacturing. But can the Pharmaceutical Strategy for Europe […]
EU starts review of Merck’s oral COVID drug molnupiravir
The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics’ much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults. […]
FDA clears Roche’s Susvimo implant for eye disease wet AMD
Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to […]
Alnylam gets NICE backing for porphyria therapy Givlaari
UK cost-effectiveness watchdog NICE is set to recommend NHS use of Alnylam’s gene-silencing therapy Givlaari in England and Wales for the rare disease acute hepatic […]
Biogen, Sage prep 2022 filing for depression drug zuranolone
The renaissance of Biogen and Sage Therapeutics antidepressant zuranolone continues, with the companies indicating they now plan to start a rolling submission for the drug […]
Omeros seeks urgent FDA meeting after it rejects key drug
Shares in Omeros plummeted yesterday after the FDA rejected approval of its narsoplimab drug for a rare and life-threatening complication of haematopoietic stem cell transplants […]
NICE changes stance on Sanofi’s Dupixent for severe asthma
18 months after saying “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed […]
COVID-19 has propelled the regulatory industry years ahead
Janssen’s Saskia De Haes, VP EMEA Regulatory Affairs, looks at how the pandemic response has shaped tomorrow’s regulatory landscape. In my 26 years of industry […]
Califf re-joining FDA would be positive for industry; analyst
With rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden’s nomination to be the next FDA commissioner, at least […]
Merck files pill for milder COVID, as AZ showcases its antibody data
As expected, Merck & Co has moved ahead swiftly with an emergency use application for its oral antiviral molnupiravir, aiming to protect people with mild […]
Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review
Patients in Scotland with newly-diagnosed advanced kidney cancer can now access a therapy combining Bristol-Myers Squibb’s immunotherapy Opdivo with Ipsen’s targeted drug Cabometyx, ahead of […]
Flash FDA approval sends ChemoCentryx spiralling upwards
ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. […]
FDA panel backs Takeda’s CMV drug for transplant patients
Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously […]
Consternation as NICE rejects Janssen MS drug Ponvory
NICE has delivered its first verdict on NHS funding of Janssen’s oral multiple sclerosis drug Ponvory, and it’s not good news for patients with the […]
