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 […]
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 […]
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 […]
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 […]
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 has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products […]
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 […]
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 is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as […]
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
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 […]
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 […]
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, […]
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 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 […]
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 proposed European unitary patent and unified patent court represents one of the largest changes to the European patent system in a generation. It will […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 – […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely […]
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 […]
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 […]
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 […]
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 Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after […]
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 Pharmaceutica may finally be able to bring its antibiotic ceftobiprole to the US market – 13 years after its first attempt was turned down […]
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 […]
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 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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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) […]
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 […]
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 […]
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 Pharmaceuticals’ efforts to bring its amyotrophic lateral sclerosis therapy AMX0035 to market in the US have run into some roadblocks, so an approval by […]
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 […]
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 […]
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 […]
It is a fact of life that most – if not all – patients will require some form of prescription medication during their lifetime. Generally, […]
June 7, 2022, Washington DC – Fishawack Health (FH) announces the acquisition of leading healthcare consulting and advisory firm Avalere Health (Avalere) from Inovalon, which […]
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 […]
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 therapies are fast becoming the cornerstone of cancer treatment: not just in the UK, but across the world. With strong evidence to support how […]
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. […]
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 […]
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”. […]
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 […]
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 and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its […]
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, […]
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 […]
After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first […]
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 […]
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 […]
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 […]
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 – […]
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 […]
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 […]
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 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 […]
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 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 […]
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). […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, […]
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 […]
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 […]
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’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. […]
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 […]
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 […]
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 […]
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – […]
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 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 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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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) […]
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 […]
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 […]
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 Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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’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 […]
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 […]
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 […]
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 […]
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 has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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’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 has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for […]
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 […]
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 […]
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 England has agreed a confidential deal with Orchard Therapeutics that will allow access to Libmeldy – a gene therapy for a rare childhood disease […]
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 […]
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 […]
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 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 […]
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 […]
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’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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from […]
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 […]
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 […]
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 […]
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 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 […]
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’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 […]
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 […]
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 […]
Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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-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 […]
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 […]
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 […]
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 […]
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, […]
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 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. […]
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 […]
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 […]
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 Sciences has submitted its marketing application for bulevirtide, its antiviral therapy for rare hepatitis delta virus (HDV) infections, to the FDA. If approved, bulevirtide […]
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 […]
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 […]
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 […]
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 […]
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 – […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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’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 […]
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 […]
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 […]
Merck & Co and Ridgeback’s oral antiviral molnupiravir has been approved in its first market – the UK – as a treatment for people with […]
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 […]
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 […]
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 & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
As expected, Merck & Co has moved ahead swiftly with an emergency use application for its oral antiviral molnupiravir, aiming to protect people with mild […]
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 […]
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. […]
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 […]
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 […]
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