Bluebird trumpets long-term data from beta-thalassaemia gene therapy
bluebird bio has presented long-term data from its Zinteglo one-time gene therapy for the blood disorder beta-thalassaemia, as the company continues talks with payers in […]
Market Access
Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, […]
First COVID-19 vaccinations begin in UK hospitals
A 90-year-old woman has become the first person given a COVID-19 vaccine as part of the UK’s mass vaccination programme. Margaret Keenan was given the […]
Scotland says no to Daiichi Sankyo’s cholesterol drug Nilemdo
The Scottish Medicines Consortium (SMC) has rejected Daiichi Sankyo’s new cholesterol-lowering drug Nilemdo for use by NHS Scotland, saying the evidence backing the drug isn’t […]
UK faces “V-Day” and largest ever vaccination programme
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a […]
Latin America: How pharma can navigate a complex market
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and […]
Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval
In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine […]
A history of Pfizer
Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest […]
Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world […]
AstraZeneca sells rights to cholesterol drug Crestor to Grunenthal
AstraZeneca is to sell European rights to its cholesterol drug Crestor (rosuvastatin) to Germany’s Grunenthal. Crestor is a statin and at its peak generated annual […]
Moderna seeks COVID vaccine okay as data backs 94% efficacy
Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results […]
UK appoints COVID-19 vaccine rollout minister as country preps for launch
The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to […]
EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme
The European Union has fined Teva and its neurology unit Cephalon €60.5 million for an elaborate “pay for delay” scheme that prevented cheaper generic competition […]
Vertex gets EU okay to treat younger cystic fibrosis patients
A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have […]
UK’s Salient Bio launches robotic COVID-19 testing platform
UK diagnostics firm Salient Bio has launched a robotics-driven COVID-19 mass testing platform after spinning out from Imperial College. The company says the technology is […]
Brexit could hinder access to coronavirus vaccines, says pharma group
The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other […]
The calm after the storm: How COVID-19 is making pharma more resilient
COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 […]
FDA approves Alnylam’s ultra-rare disease drug Oxlumo
The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. Oxlumo […]
Regeneron’s COVID-19 antibody cocktail gets US emergency licence
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become […]
Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing
Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The […]
Lilly’s baricitinib granted US emergency use in COVID-19
Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. […]
Gene Therapy Medical Affairs
The inaugural Gene Therapy Medical Affairs Summit is dedicated to exploring the pivotal internal and external role that Medical Affairs plays in delivering gene therapies to patients. Industry pioneers […]
NICE says yes to Braftovi combination for colorectal cancer
Two months after rejecting Pierre Fabre’s Braftovi for a rare form of metastatic colorectal cancer (mCRC), NICE has changed its mind, and now says the […]
FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and […]
COVID-19: Helping to support momentum on antimicrobial innovation
To mark World Antimicrobial Awareness Week NovaBiotics’s Deborah O’Neil tells us why 2021 might be the year anti-infective drugs finally demonstrate their economic value. COVID-19 […]
NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival
UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the […]
Pfizer begins US pilot delivery programme for COVID-19 vaccine
Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by […]
Vertex Pharma’s vision for reimbursement innovation
As regional vice president for Northern Europe & Australia, Simon Lem led the digital launch of Vertex Pharma’s novel cystic fibrosis drug Kaftrio. He tells […]
Guido Rasi steps down, handing the running of EMA to Emer Cooke
EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and […]
Hungary steps out of line with EU to order Russia’s COVID-19 vaccine
Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports, […]
Janssen combines Darzalex with COVID drug in new multiple myeloma submission
Janssen has submitted a new combination regimen for its blockbuster multiple myeloma drug Darzalex for approval with the FDA and EMA, hoping to give the […]
EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine
The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% […]
NICE backs chemo-free CLL combination from AbbVie and Roche
Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of […]
Lilly to ship COVID-19 drug straight away after FDA green light
Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered […]
NHS set to roll out COVID-19 shot in New Year, says health secretary
The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In […]
Divided Congress paves way for drug price reforms on Biden’s watch
Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but […]
After NICE okay, Scots denied access to Vifor’s Veltassa
The Scottish Medicines Consortium (SMC) has ruled that there’s not enough evidence to support NHS funding of Vifor Pharma’s Veltassa for excess potassium in the […]
FDA panel unimpressed with data for Alzheimer’s drug aducanumab
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for […]
After two decades, NICE begins consultation on drug assessment methods
The UK’s drug cost-effectiveness body NICE has launched a public consultation, presenting the case for change about how it assesses medicines, medical devices and diagnostics. […]
Enabling innovation by connecting an ecosystem of partners
COVID-19 has been a shock to the system for every industry, not least pharma, but the sector is already looking at new ways to build […]
Pharma may avoid worst-case drug pricing scenario as US elections deadlocked
Pharma may have avoided a worst case scenario amid the political upheavals in the US elections with the threat of tough drug price legislation lowered, […]
Trials and tribulations in Biogen’s Alzheimer’s drug reviews
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data […]
Price cut leads NICE to back Novo Nordisk’s obesity drug Saxenda
Novo Nordisk’s Saxenda has been recommended by NICE as a treatment for obesity, ending a 10-year drought in new drug therapies for weight management. The […]
NICE talking to you: Trends in early HTA engagement
With exclusive data from Freedom of Information (FOI) requests sent to the National Institute for Health and are Excellence (NICE), Leela Barham takes a look […]
US buys Lilly COVID antibody, as effectiveness questions remain
The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation […]
FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug
Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert […]
Russia’s COVID-19 vaccine filed with WHO, as MHRA reviews Moderna shot
Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for […]
AZ, J&J COVID-19 vaccine trials okay to restart in US
US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious […]
Gilead’s remdesivir finally gets US approval
Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA. As an antiviral drug, remdesivir works […]
Headache for Zosano as FDA turns down migraine patch
Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta takes the […]
Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved
Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery […]
Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug
Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma […]
Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn
Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a […]
Regeneron’s antibody cocktail approved by FDA for Ebola
An antibody cocktail from Regeneron has been approved by the FDA as the first treatment for Ebola, offering hope that a similar approach could be […]
Scynexis bids to end novel antifungal drought, filing ibrexafungerp in US
Scynexis has filed for FDA approval of its novel drug ibrexafungerp which – if approved – would be the first broad-spectrum antifungal to reach the […]
Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody
Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the […]
EU ramps up supply of COVID-19 vaccine, drugs
The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to […]
Pharma’s response to COVID: GSK
A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping […]
FDA gives COVID-19 vaccine ‘advice’ after White House blocks guidance
The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed […]
Why intelligent automation is the future for regulation
There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available […]
Older people first to receive COVID-19 vaccine in UK, says government
As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any […]
EMA starts rapid review of Bluebird’s gene therapy for rare disease CALD
Bluebird bio could be just a few months away from approval of its gene therapy for rare disease cerebral adrenoleukodystrophy (CALD) in the EU, after […]
FDA hands Cassiopea its first approval, for acne drug Winlevi
Italian biotech Cassiopea has won US approval for Winlevi, a topical therapy it says is the first new approach to treating acne in nearly 40 […]
Teva charged in US price-fixing investigation
The US Department of Justice has charged Teva with conspiring with other pharma companies to fix prices for generic drugs. According to an indictment filed […]
COVID plasma treatment gets emergency license from FDA after Trump criticism
The FDA has allowed a blood plasma treatment for COVID-19 to be administered under an Emergency Use license – but some have decried the move […]
Mission successful for Novartis after FDA approves ofatumumab in MS
It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The […]
NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy
NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection. The new guidance recommends […]
Coronavirus pharma news roundup – 14/08/20
Catch up on the latest coronavirus vaccine and digital tech news in our roundup of this week’s biggest stories. Consumer advocacy group Public Citizen has […]
J+D Forecasting strike the balance for the liquid tumour market
J+D Forecasting strike the balance between simplicity and complexity when modelling for the liquid tumour market The Challenge Identify a clear, transparent, and logical way […]
Regeneron’s cholesterol drug evinacumab claims February FDA date
The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease. […]
NS Pharma takes on Sarepta as FDA approves DMD drug
The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and […]
Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine
The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 […]
Chiesi’s flagship Fabry drug heads for FDA verdict in early 2021
The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by […]
Novo Nordisk: Prevention, digital tools and collaboration to define the future of diabetes
In our latest UK Leaders article Pinder Sahota, UK general manager at Novo Nordisk, tells us how he hopes to bring the NHS and pharma […]
Roche takes on pricey rivals as FDA approves SMA drug
Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is the third […]
Coronavirus pharma news roundup – 07/08/20
Pharma’s reputation has soared due to the COVID-19 pandemic – but coronavirus is starting to bite companies’ sales. Find out more in our roundup of […]
DBV craters on FDA’s peanut allergy immunotherapy rejection
DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end. The France-headquartered biotech […]
How does HTA for orphan drugs differ across europe?
New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always […]
Preparing for an influx of cell and gene therapy approvals
Cell and gene therapies offer some of the most groundbreaking advancements in patient care the pharma industry has ever seen. However, to fully realise the […]
NICE backs kidney cancer combination from Merck KGaA and Pfizer
NICE has said a combination of Merck KGaA’s Bavencio and Pfizer’s Inlyta should be available as a first line option for kidney cancer patients for […]
Coronavirus pharma news roundup – 31/07/20
Vaccines, AI-driven drug discovery and llamas all hit the headlines this week as the search for a way to end the COVID-19 pandemic continues. Here […]
Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge
Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs […]
UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine
The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline. […]
Gilead’s Kite gains some height after second CAR-T approval in US
Gilead’s $11.9 billion purchase of Kite Pharma in 2017 didn’t follow the script, with two big write-downs in the value of the asset since then, […]
CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, […]
Country focus: Iraq’s pharma industry sees upward trajectory
After decades of turmoil, Iraq’s healthcare sector is growing fast – but the country still holds some unique challenges for companies looking to enter its […]
Coronavirus pharma news roundup – 24/07/20
With coronavirus vaccine trials finally showing positive results, analysts are starting to wonder what access challenges might lie ahead. We highlight the top R&D, digital […]
US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine
The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, […]
MSD’s David Peacock on moving UK healthcare forward
David Peacock has worked across the world for MSD and other companies, and has now taken the helm of MSD’s UK & Ireland operations. In […]
Controversy as pharma execs predict profits from COVID-19 vaccines
Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products […]
Pandemic hits sales at Novartis after strong launch for SMA gene therapy
The COVID-19 pandemic has bit into sales at Novartis, the big Swiss pharma said in second quarter results, after orders fell back following a period […]
Coronavirus pharma news roundup – 17/07/20
Coronavirus vaccine trials continue – but experts warn that it’s too early to get hopes up. Meanwhile, the rise in digital health looks like it’s […]
NICE backs NHS use for Astellas’ Xospata after rethink
NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia. In final draft guidance NICE said that the drug is recommended […]
UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran
The UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria type 1 to gain access ahead of […]
Mallinckrodt’s liver disease drug terlipressin edges FDA advisory panel
An FDA advisory committee has narrowly voted in favour of approval of Mallinckrodt’s terlipressin for hepatorenal syndrome type 1 (HRS-1), after the agency questioned the […]
