Market Access

ICER says Amgen’s tezepelumab ‘likely to be too expensive’

Amgen and AstraZeneca haven’t won approval or announced a price for their severe asthma therapy tezepelumab should it reach the market, but ICER in the US maintains it will probably not be cost-effective. The cost effectiveness organisation has published a draft evidence report on the first-in-class TSLP inhibitor – which is currently under FDA review …

ICER says Amgen’s tezepelumab ‘likely to be too expensive’ Read More »

Keytruda backed by NICE for late-stage oesophageal cancer

MSD’s Keytruda has become the first immunotherapy cleared by NICE for previously-untreated patients with advanced oesophageal cancer, making it an option for routine NHS treatment. Keytruda (pembrolizumab) has been given the green light for use alongside platinum- and fluoropyrimidine-based chemotherapy in patients with locally advanced or metastatic oesophageal cancer that cannot be treated with surgery. …

Keytruda backed by NICE for late-stage oesophageal cancer Read More »

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung …

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval Read More »

NICE backs BioCryst’s Orladeyo for hereditary angioedema

BioCryst Pharma’s Orladeyo has been recommended by NICE as a treatment for the rare disease hereditary angioedema (HAE) in England, Wales and Northern Ireland. Orladeyo (berotralstat) – which was approved by the EMA and MHRA in April and May, respectively – is set to become the first oral, once-daily therapy that can be used to …

NICE backs BioCryst’s Orladeyo for hereditary angioedema Read More »

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Documents published ahead of the panel by the FDA reviewers suggest that there is some evidence from observational studies that …

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips Read More »

Amylyx preps filing for its ALS drug after FDA feedback

Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug for neurodegenerative disease amyotrophic lateral sclerosis (ALS). It’s now accelerating those plans, citing favourable discussions with the US regulator. The company revealed today that it will submit its marketing application …

Amylyx preps filing for its ALS drug after FDA feedback Read More »

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who …

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant Read More »

Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo

Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The green light covers England, Scotland Wales, as Northern Ireland remains under the EU regulatory framework, and covers once-daily use of the orally-active drug in adolescents aged over 12 …

Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo Read More »

MHRA cuts could affect UK regulatory decisions, say unions

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. In an open letter to Health Secretary Sajid Javid, Prospect, Unite and three other unions say the decision to slash the MHRA’s current …

MHRA cuts could affect UK regulatory decisions, say unions Read More »

NICE changes its mind on J&J’s Erleada in prostate cancer

NICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed or hormone sensitive tumours, backing NHS use of the drug. The change of heart comes after J&J’s Janssen pharma unit offered an improved discount on Erleada (apalutamide), according to the cost-effectiveness watchdog in its final appraisal determination, …

NICE changes its mind on J&J’s Erleada in prostate cancer Read More »

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes …

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab Read More »

NICE backs Cosentyx’ use in thousands of children with psoriasis

NICE has recommended broadening NHS use of Novartis’ IL-17 inhibitor Cosentyx to include children aged six to 17 with severe plaque psoriasis. The cost-effectiveness agency says in draft guidance that Cosentyx (secukinumab) should be offered as an option to patients in this age bracket who either don’t respond to or cannot tolerate other systemic treatments. …

NICE backs Cosentyx’ use in thousands of children with psoriasis Read More »

FDA schedules adcomm for Pfizer’s COVID booster filing

The FDA has said it will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over. The adcomm is scheduled for 17 September and will discuss the Pfizer/BioNTech filing as well as booster …

FDA schedules adcomm for Pfizer’s COVID booster filing Read More »

NICE backs NHS use of Novartis’ cholesterol drug Leqvio

Novartis’ cholesterol-lowering drug Leqvio will be made available on the NHS in England and Wales, and could help to prevent up to 30,000 deaths, according to NICE. The PCSK9-targeting oligonucleotide – which is already available in Scotland – requires dosing just twice a year and has been approved by the health technology assessment (HTA) agency …

NICE backs NHS use of Novartis’ cholesterol drug Leqvio Read More »

NICE rejects J&J’ Darzalex regimen for multiple myeloma

New guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group of previously-untreated patients with multiple myeloma, a type of bone marrow cancer. The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given …

NICE rejects J&J’ Darzalex regimen for multiple myeloma Read More »

AbbVie’s Rinvoq is first JAK drug cleared in EU for atopic dermatitis

The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie’s Rinvoq. The EU regulator has cleared Rinvoq (upadacitinib) as an oral treatment for moderate to severe atopic dermatitis in adults and adolescents 12 years and older, either …

AbbVie’s Rinvoq is first JAK drug cleared in EU for atopic dermatitis Read More »

Cara’s Korsuva is first drug cleared for itching in dialysis patients

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review. The green …

Cara’s Korsuva is first drug cleared for itching in dialysis patients Read More »

IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis

UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. The European Commission has cleared the drug as Bimzelx for the treatment of moderate to severe plaque psoriasis …

IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis Read More »

FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, …

FDA grants full approval to Pfizer/BioNTech COVID jab Read More »

COVID prompts another milestone, as India clears first DNA vaccine

The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. This is the first DNA vaccine to ever receive regulatory authorisation anywhere in the world, the first COVID-19 jab approved in India to treat children …

COVID prompts another milestone, as India clears first DNA vaccine Read More »

After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from …

After FDA snub, EMA backs FibroGen, Astellas’ roxadustat Read More »

NICE says yes to Novartis’ Rydapt for rare blood disorder

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for  treatment with oral, twice-daily drug, …

NICE says yes to Novartis’ Rydapt for rare blood disorder Read More »

Jardiance gets parity with Farxiga in US as FDA clears use in heart failure

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in …

Jardiance gets parity with Farxiga in US as FDA clears use in heart failure Read More »

Amid Actemra shortage, WHO asks Roche to ensure equitable access

Roche’s arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and the World Health Organisation (WHO) wants the company to ensure that supplies don’t just go to wealthy countries. Earlier this week Roche’s Genentech unit said it was facing unprecedented demand for Actemra (tocilizumab) – known as RoActemra …

Amid Actemra shortage, WHO asks Roche to ensure equitable access Read More »

Merck kicks off oral COVID-19 antiviral filing in Canada

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results …

Merck kicks off oral COVID-19 antiviral filing in Canada Read More »

Ipsen hit by new palaver for rare disease drug palovarotene

Just as Ipsen’s $1 billion bet on rare bone disease drug palovarotene seemed to be nearing the finish line, it has fallen at the final hurdle. After a string of setbacks with the programme, Ipsen finally filed palovarotene with the FDA in May, earning a priority review. But the French drugmaker has already withdrawn it, …

Ipsen hit by new palaver for rare disease drug palovarotene Read More »

Health insurer Excellus will not fund Alzheimer’s drug Aduhelm

Health insurer Excellus BlueCross BlueShield has said it will not cover treatment with Biogen and Eisai’s new Alzheimer’s disease drug Aduhelm because it has not been shown to be medically effective. The company – said to be the largest health insurer in New York – said in a statement that Aduhelm (aducanumab) remains an investigational …

Health insurer Excellus will not fund Alzheimer’s drug Aduhelm Read More »

A problem combination?

Leela Barham takes stock of past NICE decisions for combinations to explore the scale of the reimbursement challenge for combination therapies. Combination therapies are now common in therapy areas like cancer. There have been cases where even if a new treatment used in combination were offered at zero cost to the NHS that it would …

A problem combination? Read More »

NICE changes stance on Lilly’s breast cancer dug Verzenio

After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast …

NICE changes stance on Lilly’s breast cancer dug Verzenio Read More »

FDA rejects FibroGen/AZ’s roxadustat, asking for new trial

The FDA has demanded another clinical trial of FibroGen and AstraZeneca’s roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a lengthy delay to the programme. The need for a new trial is something of a worst-case scenario for roxadustat, although a rejection was expected after an FDA …

FDA rejects FibroGen/AZ’s roxadustat, asking for new trial Read More »

Axsome faces delay for depression drug, hitting shares hard

The FDA was supposed to be delivering its verdict on Axsome Therapeutics’ depression therapy AXS-05 in less than a fortnight – but instead has delivered the company a letter outlining deficiencies in its marketing application. The problem for the company is that it doesn’t yet know what those deficiencies are, and that uncertainty weighed heavily …

Axsome faces delay for depression drug, hitting shares hard Read More »

Collaborate to simplify cancer trials and accelerate post-pandemic recovery

How could simplifying the administration of clinical trials help cancer diagnosis, care, and treatment levels to exceed pre-pandemic levels? Amanda Barrell reports from the ABPI Scotland cancer roundtable discussion. Work to get Scotland’s cancer services back to full strength following the pandemic has already begun, and the pharmaceutical industry has pledged to play its part. …

Collaborate to simplify cancer trials and accelerate post-pandemic recovery Read More »

Scotland backs Bavencio for bladder cancer after NICE says no

Patients with bladder cancer in Scotland will be the first in the UK to claim access to maintenance treatment with Merck Serono and Pfizer’s Bavencio, ahead of their counterparts in England and Wales. The Scottish Medicines Consortium (SMC) has cleared NHS funding for Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial …

Scotland backs Bavencio for bladder cancer after NICE says no Read More »

Sanofi extends its Pompe range with first Nexviazyme OK

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. The US regulator has approved Nexviazyme (avalglucosidase alfa) for the treatment of patients aged one year of age and older with late-onset Pompe disease, which progressively attacks the heart and …

Sanofi extends its Pompe range with first Nexviazyme OK Read More »

Lilly sets out its stall on donanemab as filing approaches

The FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, although it has acknowledged it will have to overcome reservations about anti-amyloid drugs. Lilly’s chief scientific officer Dan Skovronsky said on the company’s second-quarter results call that the results of …

Lilly sets out its stall on donanemab as filing approaches Read More »

UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme

UCB’s bimekizumab hasn’t been approved for marketing in Europe yet, but has already been given the nod for NHS use in England and Wales under a new fast-track scheme introduced by NICE. The IL-17 inhibitor is the first to go through a new process aimed at accelerating appraisals for drugs deemed to be low-risk, which …

UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme Read More »

FDA approves AZ’s anifromulab, ending 10-year lupus drug drought

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. Anifrolumab was all-but written off in 2018 after failing the phase 3 TULIP-1 trial, but bounced back with positive data from a second study …

FDA approves AZ’s anifromulab, ending 10-year lupus drug drought Read More »

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict Read More »

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Mylan’s Semglee has been approved for over a year as a regular biosimilar to Lantus (insulin glargine), meaning that it could be used in …

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar Read More »

Boost for AZ as Ultomiris gets CHMP nod for expanded label

Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of the main assets behind the $39 billion merger. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has backed the approval of Ultomiris (ravulizumab) for children and adolescents with …

Boost for AZ as Ultomiris gets CHMP nod for expanded label Read More »

NHS sets aside £340m for new Innovative Medicines Fund

NHS England has matched its financial backing of the Cancer Drugs Fund (CDF) with an equivalent pot of money for a new Innovative Medicines Fund (IMF) that will provide early access to cutting-edge medicines like cell and gene therapies. It has proposed that the IMF will work in the same way as the CDF, funding …

NHS sets aside £340m for new Innovative Medicines Fund Read More »

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout

Phase 3 results with Roche’s amyloid-targeting Alzheimer’s drug gantenerumab may not be due until the second half of last year, but the company is already in discussions with the FDA about a route to approval. There has been speculation since the unexpected approval of Biogen and Eisai’s Aduhelm (aducanumab) last month that other amyloid therapies …

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout Read More »

NICE changes its mind on rare bile duct cancer drug from Incyte

Incyte’s Pemazyre has become the first targeted therapy available for NHS patients with cholangiocarcinoma or bile duct cancer, after NICE concluded it provided value for money. The green light for Pemazyre (pemigatinib) has been hailed by cholangiocarcinoma charity AMMF, which said it was a “major milestone” in the fight against the “Cinderella” cancer, which for …

NICE changes its mind on rare bile duct cancer drug from Incyte Read More »

Bluebird claims EU nod for rare disease therapy Skysona

Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the nod from the EU regulatory authority. The EMA has cleared Skysona (elivaldogene autotemcel) for use in CALD patients aged under 18 who have an ABCD1 genetic mutation and no matched …

Bluebird claims EU nod for rare disease therapy Skysona Read More »

Novartis eyes New Year verdict from FDA on delayed Leqvio

Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022. The drugmaker refiled its application for Leqvio (inclisiran) earlier this month, trying to get the programme back on track in …

Novartis eyes New Year verdict from FDA on delayed Leqvio Read More »

EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK …

EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine Read More »

Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. The US regulator had extended its review of the drug by three months – setting …

Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor Read More »

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time. Those …

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy Read More »

FDA okays Merck’s would-be Prevnar rival Vaxneuvance

The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Merck’s Vaxneuvance – formerly known as V114 – is the first major competition to Pfizer’s franchise in the big market for conjugate pneumococcal …

FDA okays Merck’s would-be Prevnar rival Vaxneuvance Read More »

FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia

Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after FDA advisors voted comprehensively against the drug yesterday. Just one of the 14-member panel thought that roxadustat should be approved for non-dialysis-dependent CKD patients, and only …

FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia Read More »

Merck’s targeted lung cancer drug tepotinib wins early access in UK

The UK drugs regulator has backed Merck KGaA’s MET inhibitor for the treatment of some patients with non-small cell lung cancer under the early access to medicines scheme (EAMS). The EAMS – first introduced in 2014 – provides a route for drugmakers to provide earlier availability of promising new unlicensed medicines to patients with few …

Merck’s targeted lung cancer drug tepotinib wins early access in UK Read More »

NICE feedback?

The National Institute for Health and Care Excellence (NICE) is quite far along a NICE-led process to review its methods and processes for evaluating technologies. As part of that work, NICE is engaging widely with stakeholders, including patient organisations. Leela Barham provides an independent view of patient organisations responses to a NICE online survey and …

NICE feedback? Read More »

US starts review of Aduhelm coverage amid fears of Medicare hit

The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 …

US starts review of Aduhelm coverage amid fears of Medicare hit Read More »

Bayer’s finerenone gets FDA nod for diabetic kidney disease

Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market.  The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market …

Bayer’s finerenone gets FDA nod for diabetic kidney disease Read More »

Aduhelm approval controversy dials up as FDA seeks probe

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the …

Aduhelm approval controversy dials up as FDA seeks probe Read More »

How digital pathways are changing healthcare

As demonstrated throughout COVID, digital health is no longer experimental. Digital technologies are proving their value by allowing for better care, improved adherence and a more connected ecosystem between doctors, patients and pharma. Ampersand Health has been working in the space since 2015 and has seen it evolve from a niche approach with limited acceptance …

How digital pathways are changing healthcare Read More »

NICE rejects Orchard’s gene therapy for rare childhood disease MLD

Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200), assumptions about its long-term effects are uncertain, making it unclear whether it will offer …

NICE rejects Orchard’s gene therapy for rare childhood disease MLD Read More »

Eyeing delta surge, Pfizer will file COVID-19 booster next month

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases.  The two companies have revealed data from an ongoing trial of …

Eyeing delta surge, Pfizer will file COVID-19 booster next month Read More »

FDA whittles back Aduhelm approval amid concern over broad label

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients than was included in clinical trials. Now, it has backtracked on that decision. The updated label for Aduhelm (aducanumab) says it …

FDA whittles back Aduhelm approval amid concern over broad label Read More »

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by …

AZ, Amgen get speedy FDA review for asthma drug tezepelumab Read More »

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

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

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

FDA rejects Provention’s type 1 diabetes drug teplizumab

The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, the agency has rejected the application entirely, sending the company’s shares into a steep slide. The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 …

FDA rejects Provention’s type 1 diabetes drug teplizumab Read More »

Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at …

Novartis tries to rescue stalled inclisiran filing with FDA Read More »

Zydus Cadila nears world-first human plasmid DNA vaccine approval

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans.  Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could …

Zydus Cadila nears world-first human plasmid DNA vaccine approval Read More »

ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

Turning words into actions with patient engagement

Boehringer Ingelheim’s Carinne Brouillon tells us how the company co-created its recent Global Patient Partnership Summit with patients and how the meeting brought representatives together to design actionable projects for pharma-patient engagement. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read a preview below: As pharma seeks new and better …

Turning words into actions with patient engagement Read More »

Turning words into actions with patient engagement

Boehringer Ingelheim’s Carinne Brouillon tells us how the company co-created its recent Global Patient Partnership Summit with patients and how the meeting brought representatives together to design actionable projects for pharma-patient engagement. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read a preview below: As pharma seeks new and better …

Turning words into actions with patient engagement Read More »

NICE backs Novartis’ Cosentyx for underdiagnosed back condition

NICE has extended the range of indications that Novartis’ Cosentyx can be prescribed for by the NHS in England, giving a green light for its use in non-radiographic axial spondyloarthritis (nr-axSpA), a form of arthritis affecting the joints of the spine. IL-17 inhibitor Cosentyx (secukinumab) is already approved by NICE to treat ankylosing spondylitis or …

NICE backs Novartis’ Cosentyx for underdiagnosed back condition Read More »

Blueprint’s latest approval for Ayvakit sets up clash with Novartis

Blueprint Medicines has claimed its second FDA approval for Ayvakit, getting the nod for advanced systemic mastocytosis (SM), a group of rare blood cancers currently treated mainly by Novartis’ Rydapt.  The FDA has cleared Ayvakit (avapritinib) for adults with SM, including the three major subtypes – aggressive disease with or without an associated haematological neoplasm, …

Blueprint’s latest approval for Ayvakit sets up clash with Novartis Read More »

Consumer group seeks resignation of top FDA staffers over Aduhelm okay

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director …

Consumer group seeks resignation of top FDA staffers over Aduhelm okay Read More »

Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO

NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of …

Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO Read More »

A roadmap for adopting New Science 

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

A roadmap for adopting New Science  Read More »

How the patient voice is becoming vital for drug approval

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for …

How the patient voice is becoming vital for drug approval Read More »

And then there were three: another FDA adcomm member quits over Aduhelm

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest.  The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David …

And then there were three: another FDA adcomm member quits over Aduhelm Read More »

Ocugen gets a black eye as FDA denies emergency OK for COVID jab

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share …

Ocugen gets a black eye as FDA denies emergency OK for COVID jab Read More »

Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day …

Double resignation over Aduhelm approval depletes FDA’s CNS adcomm Read More »

Aduhelm approval could signal new era for CNS drugs; analysts

The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the broader implications for the industry as a whole? Analysts at RBC Capital Markets say that the decision points to an unprecedented shift in position for the FDA when it comes …

Aduhelm approval could signal new era for CNS drugs; analysts Read More »

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s …

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag Read More »

Country focus: China & APAC’s growing medical needs bring opportunities and challenges

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and …

Country focus: China & APAC’s growing medical needs bring opportunities and challenges Read More »

Scotland backs rare blood cancer drug Poteligeo rejected by NICE

A north-south divide has emerged in UK medicines access after the Scottish Medicines Consortium (SMC) okayed Kyowa Kirin’s Poteligeo for two rare blood cancers, a few weeks after the drug was turned in England by NICE. Poteligeo (mogamulizumab) has been backed by the SMC for adults living with mycosis fungoides (MF) and Sézary syndrome (SS), …

Scotland backs rare blood cancer drug Poteligeo rejected by NICE Read More »

Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The accelerated approval from the US regulator has been given even though its own advisory committee comprehensively voted down the main study filed in support of the drug last …

Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab Read More »

“A long way to go” for digital health reimbursement

A recent analysis delves into the challenges companies face in getting digital health technologies reimbursed and presents recommendations for how these products can find a smoother path to market. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read a preview below: In many ways, the healthcare sector is still wrestling …

“A long way to go” for digital health reimbursement Read More »

Time for a NICE change

The National Institute for Health and Care Excellence (NICE) is world-renowned for their work assessing the clinical and cost-effectiveness of new treatments. In recognition of how the world has changed over its history, NICE is coming to the end of a period of review and consultation on their processes and methods. Leela Barham takes stock. …

Time for a NICE change Read More »

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its …

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi Read More »

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a surprise to patient association SMA UK. The cost-effectiveness agency’s initial assessment is that Evrysdi is simply too expensive at its current price to be provided to the roughly 1,500 people …

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group Read More »

Janssen COVID jab cleared in UK as fears of third wave mount

With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson’s Janssen division. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision …

Janssen COVID jab cleared in UK as fears of third wave mount Read More »

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3

GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response …

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3 Read More »

Rethinking access barriers to innovation

Market access issues don’t stop once a product has passed HTA – and this is especially true for disruptive therapies like ATMPs. Experts from Executive Insight discuss how a holistic, multi-stakeholder approach can help companies overcome access barriers at all stages. This article appears in our digital magazine Deep Dive: Market Access 2021. Read on …

Rethinking access barriers to innovation Read More »

Belgium halts dosing of J&J COVID vaccine in under 41s after death

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition.  The unnamed woman – who was under the age of 40 – died on 21 May after being admitted …

Belgium halts dosing of J&J COVID vaccine in under 41s after death Read More »

New Cell & Gene Therapy Collective seeks to boost UK adoption

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

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

AI meets RWE: The future of drug assessment?

Savana’s Dr Ignacio Medrano explains how machine learning and natural language processing technology is opening up huge amounts of previously-inaccessible real-world evidence (RWE) for pharma and regulators. This article appears in out digital magazine Deep Dive: Market Access 2021. Read below for a preview: Real world evidence (RWE) is rapidly evolving. Having gone from being …

AI meets RWE: The future of drug assessment? Read More »

CHMP backs bluebird bio’s gene therapy for rare disease ALD

US biotech bluebird bio has had a challenging time in the last few months, so a recommendation for EU approval of its gene therapy for adrenoleukodystrophy (ALD) will give it a lift. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given the go-ahead to bluebird’s therapy – known as Skysona (elivaldogene autotemcel) …

CHMP backs bluebird bio’s gene therapy for rare disease ALD Read More »

Listening to ultra-rare disease communities

When it comes to ultra-rare diseases, the smaller the patient population, the bigger the challenges. As a global commercial biopharmaceutical company pioneering therapies for ultra-rare diseases, PTC Therapeutics is familiar with the challenges. The company prides itself on a patient-centric approach to treatment but there can be significant hurdles in patients accessing potentially life-changing treatments. …

Listening to ultra-rare disease communities Read More »

Japan approves two more COVID vaccines as fourth infection wave hits

Japan has approved two more coronavirus vaccines, while expanding a state of emergency to cover the southern island of Okinawa. The two newly approved vaccines are from Moderna and AstraZeneca and will be added to a vaccine drive that began in mid-February using the Pfizer/BioNTech shot. However Reuters reported that the AstraZeneca vaccine will not …

Japan approves two more COVID vaccines as fourth infection wave hits Read More »

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. The cost-effectiveness body is assessing Erleada, plus androgen deprivation therapy (ADT), for prostate cancer in adults who have hormone-relapsed non-metastatic disease at high risk of metastasising and hormone-sensitive metastatic disease. Hormone …

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance Read More »

How to improve payer engagement with tailored value communication

Pharmaceutical drug success rests on being able to achieve market access. Brands are facing increasing pressure to demonstrate strong value propositions in increasingly crowded therapeutic areas. However, value can mean different things to different payers. In this article, Cecilie Alstad, senior analyst at Research Partnership, discusses how an approach established in the world of marketing …

How to improve payer engagement with tailored value communication Read More »

From representation to empowerment: Putting patients at the centre of medicine reimbursement

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. This article appears in full in our digital magazine Deep Dive: Market Access 2021. Read below for a sneak-peak: The reimbursement landscape in Europe is complex. There …

From representation to empowerment: Putting patients at the centre of medicine reimbursement Read More »

Apellis set to take on Alexion as FDA clears PNH drug Empaveli

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly.  There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see …

Apellis set to take on Alexion as FDA clears PNH drug Empaveli Read More »

How will NICE fare in a post-Brexit world?

NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage. This article appears in our digital magazine, Deep Dive: Market Access …

How will NICE fare in a post-Brexit world? Read More »

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis

NICE has issued a final “no” to Bristol-Myers Squibb’s oral MS drug Zeposia (ozanimod), in a decision that prevents access for patients in England and Wales. This ruling means that there will be a divide in access to Zeposia in the UK, after the Scottish Medicines Consortium allowed funding in February for the drug in …

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis Read More »

Research predicts the post-COVID landscape for HCP engagement

IQVIA’s Liz Murray takes us through the company’s latest research into HCPs’ attitudes to pharma engagement, and asks how pharma sales forces can adapt for future changes. This article appears in full in Deep Dive: Market Access 2021. Read a preview below: Recent ChannelDynamics data from IQVIA shows that while there has been a marked …

Research predicts the post-COVID landscape for HCP engagement Read More »

Alvotech files lawsuit challenging AbbVie’s Humira patent thicket

Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Alvotech is challenging the patent thicket surrounding Humira, a common ploy in pharma that seems to be particularly effective in the US. Several biological drugs have remained unchallenged on the US market thanks to …

Alvotech files lawsuit challenging AbbVie’s Humira patent thicket Read More »

NICE says ‘no’ to Pfizer’s Vyndaqel for rare heart condition

NICE has rejected regular NHS funding for Pfizer’s Vyndaqel (tafamidis) for a rare heart condition, although it has left the door open for negotiations if the pharma decides to drop its price. Pfizer had appealed against draft guidance from NICE that rejected Vyndaqel for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) on cost grounds. The pharma unsuccessfully …

NICE says ‘no’ to Pfizer’s Vyndaqel for rare heart condition Read More »

FDA authorises Pfizer/BioNTech vaccine for adolescents

The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s Emergency Use Authorization to include the new age group. The vaccine was first approved under the emergency protocols on 11th December, for people aged 16 years of age and older. …

FDA authorises Pfizer/BioNTech vaccine for adolescents Read More »

Scotland backs NHS use of Alexion’s Ultomiris for rare disease aHUS

NHS patients in Scotland with the rare disease atypical haemolytic uremic syndrome (aHUS) will now be able to access treatment with Alexion’s Ultomiris, ahead of their counterparts in England and Wales.  aHUS is an ultra-rare disease that can cause progressive injury to the kidneys via damage to the walls of blood vessels and blood clots …

Scotland backs NHS use of Alexion’s Ultomiris for rare disease aHUS Read More »

A year on: pandemic driven trends in HCP engagement

IQVIA’s John Procter explores why the industry should be paying attention to the changing HCP customer experience in the wake of COVID-19. This article appears in full in this month’s Deep Dive digital magazine on Market Access. Here is a preview: As we reach the end of the first quarter of 2021, our customers continue …

A year on: pandemic driven trends in HCP engagement Read More »

EU starts rolling review of GSK’s antibody for COVID-19

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU.  Sotrovimab (VIR-7831) – also known as GSK4182136 – is being assessed as a treatment for patients with SARS-CoV-2 infection aged 12 and …

EU starts rolling review of GSK’s antibody for COVID-19 Read More »

Patients in England get fast access to AZ’s Tagrisso in early lung cancer

The UK’s drugs regulator has swiftly granted a licence extension for AstraZeneca’s Tagrisso in certain patients with early stage lung cancer, with NICE allowing fast access to patients on England’s NHS. The arrangements under Project Orbis, a global project run by the FDA that the Medicines and Healthcare products Regulatory Authority is supporting, aim to …

Patients in England get fast access to AZ’s Tagrisso in early lung cancer Read More »

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver

Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost global supplies of the life-saving shots. Waiving the patent on proprietary knowledge would allow it to be shared with other manufacturers and the matter is being discussed by the World …

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver Read More »

Hidden compliance risks for life sciences companies

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target …

Hidden compliance risks for life sciences companies Read More »

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA

AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD).  The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure …

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA Read More »

Galapagos UK’s Michael Smyth on RNA-based tech: the pharmaphorum podcast

Episode 35 of the pharmaphorum podcast hears from Michael Smyth about Galapagos UK and joining the company as medical director just as COVID-19 hit. With RNA-based technology hitting the headlines in recent months due to its use in Covid vaccines, he also discusses the version of it that Galapagos uses and how it can produce …

Galapagos UK’s Michael Smyth on RNA-based tech: the pharmaphorum podcast Read More »

Deep Dive: Market Access

It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks. …

Deep Dive: Market Access Read More »

Indivior pays $300m to settle Suboxone marketing allegations

Indivior has paid out $300 million to resolve civil claims from US states after it was last year found guilty against criminal charges of improper marketing of the opioid addiction drug Suboxone. Last year, Indivior reached a $600 million settlement plea deal to settle criminal fraud charges, after US authorities found the company’s conduct had …

Indivior pays $300m to settle Suboxone marketing allegations Read More »

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine

The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the autumn. Health secretary Matt Hancock made the announcement in a press briefing, revealing that officials think they may have to boost protection for the population during the winter. The UK …

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine Read More »

FDA sets September review date for Calliditas’ rare kidney disease drug

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN).  The Swedish biotech says the IUS regulator has set an action date of 15 September for its review of Nefecon, a novel …

FDA sets September review date for Calliditas’ rare kidney disease drug Read More »

European Commission legal battle with AZ over COVD vaccines contract

The European Commission has officially begun legal proceedings against AstraZeneca over supplies of COVID vaccines. The legal action marks an escalation in the dispute between the EU and AZ over the supply of coronavirus vaccines. Under pressure to roll out vaccinations, the European Commission has accused AZ of failing to live up to a contract …

European Commission legal battle with AZ over COVD vaccines contract Read More »

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD

Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the life-threatening rare disease.  The CHMP has backed the drug in patients aged 12 or more with NMOSD that tests positive for aquaporin-4 (AQP4) antibodies, a biomarker seen in around 80% …

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD Read More »

Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

Calliditas Therapeutics is on course to launch its first product, Nefecon for rare disease primary IgA nephropathy (IgAN), in the first half of 2022 after getting the green light for an accelerated review by the EMA.  The Swedish biotech is planning to file Nefecon for approval in the second quarter to the EU regulator, which …

Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon Read More »

Jazz lifted by third EU approval for GW Pharma’s Epidyolex

GW Pharmaceuticals’ Epidyolex has been approved in the EU for a third epilepsy indication, giving a boost for the company ahead of its $7.2 billion takeover by Jazz Pharma.  The cannabis-derived drug has been cleared by the EMA to treat seizures associated with tuberous sclerosis complex (TSC), a condition in which mostly benign tumours grow …

Jazz lifted by third EU approval for GW Pharma’s Epidyolex Read More »

FDA pens stinging report on Emergent COVID vaccine plant

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine.  The US regulator says it completed an inspection of the Bayview plant run by the contract manufacturing organisation (CMO) which uncovered …

FDA pens stinging report on Emergent COVID vaccine plant Read More »

EU safety regulators clear J&J COVID shot despite tiny clot risk

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with …

EU safety regulators clear J&J COVID shot despite tiny clot risk Read More »

Hikma shares rally after US launch of Advair generic resumes

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. Advair …

Hikma shares rally after US launch of Advair generic resumes Read More »

The next five years of NICE: Challenges, opportunities, and the future of technology assessment

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. NICE is about to undergo a complete transformation in a bid to get ready – and stay ready – …

The next five years of NICE: Challenges, opportunities, and the future of technology assessment Read More »

Enhertu cleared for NHS use via Cancer Drugs Fund

NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European country.  The UK health technology assessment (HTA) agency has backed Enhertu (trastuzumab deruxtecan) as a therapy for HER2 positive breast cancer which can’t be surgically removed or which has spread …

Enhertu cleared for NHS use via Cancer Drugs Fund Read More »

NICE unveils five year plan promising faster access to medicines

NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations. The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said …

NICE unveils five year plan promising faster access to medicines Read More »

NICE unveils five year plan promising faster access to medicines

NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations.  The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said …

NICE unveils five year plan promising faster access to medicines Read More »

EMA starts review of GSK/Vir COVID-19 antibody

The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its type cleared for early use in the EU.  The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 …

EMA starts review of GSK/Vir COVID-19 antibody Read More »

World Orphan Drug Congress USA Virtual 2021

On Wednesday, April 28th, the World Orphan Drug Congress USA is being held online for free! The conference brings together pharma, biotechs, government, payers, investors and patient/patient advocates in the rare disease space to discuss the latest developments that will lead to the future of orphan drug development. We are thrilled to announce some amazing speakers …

World Orphan Drug Congress USA Virtual 2021 Read More »

Three pillars of post-pandemic launch excellence

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines. The launch environment was directly impacted by the COVID-19 pandemic, which hit …

Three pillars of post-pandemic launch excellence Read More »

NICE recommends Alexion’s long-acting Ultomiris for PNH

NICE has recommended Alexion’s long-acting Ultomiris (ravulizumab) for the rare disease paroxysmal nocturnal haemoglobinuria (PNH) in final draft guidance. Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for  an eight-week dosing schedule after a loading phase. This is more patient-friendly than Soliris, which requires infusions every two weeks, a considerable …

NICE recommends Alexion’s long-acting Ultomiris for PNH Read More »

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots

The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using it because of concerns about rare blood clotting side-effects. Czech deputy prime minister Jan Hamacek said on twitter that he had instructed the country’s ambassador in Denmark to try to …

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots Read More »

Global impact: How regulatory affairs is shaping development of cutting-edge pharma innovation

When it comes to developing cutting-edge innovations, Astellas aims to be at the forefront. The pharma organisation prides itself on having an open, collaborative, “science first” approach to help ensure breakthrough discoveries have the very best chance of long-term success in bringing new treatment options to patients worldwide. “Our mission is to turn innovative science …

Global impact: How regulatory affairs is shaping development of cutting-edge pharma innovation Read More »

England begins Moderna vaccine rollout as lockdown eases

England is beginning its rollout of the Moderna COVID-19 vaccine, offering an alternative to the AstraZeneca/Oxford University jab following a potential link to a very rare kind of blood clot. The Moderna shot is the third vaccine to become available in the country, which has made considerable progress with its inoculation campaign. Its arrival is …

England begins Moderna vaccine rollout as lockdown eases Read More »

Scotland opens door to Translarna for Duchenne muscular dystrophy

A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of PTC Therapeutics’ Translarna for the first time.  The Scottish Medicines Consortium (SMC) says that Translarna (ataluren) can be provided by NHS Scotland for a period of three years, once PTC …

Scotland opens door to Translarna for Duchenne muscular dystrophy Read More »

Provention faces delay in FDA review of diabetes prevention antibody

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data …

Provention faces delay in FDA review of diabetes prevention antibody Read More »

Gilead scores US approval for breast cancer drug that wowed ESMO

Gilead’s $21 billion purchase of Immunomedics and its potential blockbuster Trodelvy continues to pay off, as the drug has now been approved by the FDA for triple-negative breast cancer.  Trodelvy (sacituzumab govitecan) was granted accelerated approval by the FDA in April last year, and is now indicated for adults with triple-negative breast cancer who have …

Gilead scores US approval for breast cancer drug that wowed ESMO Read More »

Acadia puts blame on FDA as Nuplazid rejected for dementia

Acadia Pharmaceuticals is butting heads with US regulators again, this time over the FDA’s decision to reject its Nuplazid (pimavanserin) for use in dementia-related psychosis (DRP) – with the company bemused by the agency’s apparent pivot on an agreed trial design.  The FDA has rejected the expansion of the drug – originally approved to treat …

Acadia puts blame on FDA as Nuplazid rejected for dementia Read More »

NICE backs Sobi’s Kineret for rare inflammatory disease

The UK’s cost-effectiveness agency NICE has recommended that Sobi’s Kineret can be used to treat NHS patients with Still’s disease, a rare form of arthritis affecting children and adults. The final guidance concludes that interleukin-1 receptor antagonist Kineret (anakinra) can be used as a treatment for two forms of Still’s, namely systemic juvenile idiopathic arthritis …

NICE backs Sobi’s Kineret for rare inflammatory disease Read More »

World leaders call for international pandemic preparedness treaty

More than 20 world leaders have called for an international treaty for pandemic preparedness to protect the world from future health crises. Backed by the World Health Organization, the treaty would “dispel the temptations of isolationism and nationalism” in the event of another crisis such as COVID-19. In a commentary backed by the 24 leaders, …

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NICE methods and process review aims to create fertile ground for innovation

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? Amanda Barrell spoke to Dr Paul Catchpole, director of value and access policy at the ABPI, to find out. From COVID-19 and Brexit, …

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Moderna COVID-19 shot available in UK next month

The Moderna COVID-19 vaccine will be added to the UK’s arsenal of coronavirus vaccines in April, when the country will focus on handing out second doses to those already vaccinated. Minister for vaccine deployment Nadhim Zahawi said that supplies of the Moderna shot will become available during a near-pause of the first dose programme. The …

Moderna COVID-19 shot available in UK next month Read More »

CHMP backs Celltrion’s regdanvimab antibody for COVID-19

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting.  Regdanvimab (CT-P59) – which is currently under a rolling review at the EMA – can be used for the treatment of COVID-19 in adults who don’t …

CHMP backs Celltrion’s regdanvimab antibody for COVID-19 Read More »

The Brexit deal; shot in the arm or kick in the teeth for the pharma sector?

The UK Government and EU Commission trumpeted their Brexit trade deal, struck at the end of December, as ‘comprehensive’, the ‘biggest yet’.  But a closer inspection of the EU-UK Trade and Cooperation Agreement (TCA) renders these statements largely illusory for the pharma sector. While pharma companies grapple with the effects of Brexit, there are undoubtedly …

The Brexit deal; shot in the arm or kick in the teeth for the pharma sector? Read More »

EU stops short of vaccine export controls after summit

The European Union has stopped short of export controls on vaccines after leaders met at a summit to discuss the issue of shortfalls in supply. At the meeting of the European Council leaders said that toughening export controls was an option but a post-summit statement emphasised the importance of global supply chains to produce vaccines. …

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Boris Johnson slammed for saying “greed” is behind UK vaccine success

Boris Johnson’s sense of humour seems to have got him into trouble again, at the most delicate of times. The Prime Minister reportedly told Conservative backbench MPs on a Zoom call that “capitalism” and “greed” was behind the success of the UK’s COVID-19 vaccination programme, before backtracking after realising he had made a blunder and …

Boris Johnson slammed for saying “greed” is behind UK vaccine success Read More »

NICE backs ovarian cancer and multiple myeloma combination drugs

NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer that have responded to platinum chemotherapy. Early results from the …

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NICE backs ovarian cancer and multiple myeloma combination drugs

NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer that have responded to platinum chemotherapy. Early results from the …

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Novartis says £1.8m Zolgensma is model for gene therapy pricing

Novartis has said its gene therapy pricing model, involving a steep one-off payment, could be a template for the hundreds of similar treatments that could follow its Zolgensma for Spinal Muscular Atrophy (SMA).  Zolgensma (onasemnogene abeparvovec) has a list price of £1,795,000 excluding VAT in the UK, but Novartis says the price is justified by …

Novartis says £1.8m Zolgensma is model for gene therapy pricing Read More »

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

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

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

J&J’s COVID-19 shot backed for emergency use in EU

The EU’s medicines regulator has recommended granting conditional approval to a fourth COVID-19 vaccine – a single-dose shot from Johnson & Johnson’s Janssen unit – after a review by its human medicines committee.  The CHMP has concluded that the Ad26.COV2.S vaccine can be used in people aged over 18, saying that “the data on the …

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Pharma must adapt to embrace the opportunities of a new-look NHS

Fundamental changes to the way the NHS is structured and funded are afoot – and pharma needs to adapt to this new way of working. A new focus on “place” and the introduction of medicines registers are among the proposals in a new government white paper on the future of NHS England. Such changes may …

Pharma must adapt to embrace the opportunities of a new-look NHS Read More »

J&J manufacturing delays hit US vaccine rollout

The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & Johnson vaccine are available. The White House said on Tuesday that the government will distribute around 18.5 million doses of COVID-19 vaccines this week, fewer than last week because of …

J&J manufacturing delays hit US vaccine rollout Read More »

ExeVir ready for clinic with variant-targeting llama antibody

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

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Lymphoma Action – championing the patient voice in cell therapy

Lymphoma Action is the only UK health charity dedicated to people affected by lymphoma. Chief Executive Ropinder Gill and Director of Operations and External Affairs Stephen Scowcroft believe it is essential to champion the patient voice in cell therapy. This thought leadership series has been paid for and developed with Kite, A Gilead Company. Lymphoma …

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Austria safety officials suspend batch of AZ vaccines after death

Austrian health officials have withdrawn a batch of Oxford University/AstraZeneca’s COVID-19 vaccine after two cases of severe coagulation, one of which was fatal. Both patients were treated from the same batch, codenamed ABV 5300, in the district of Zwettl. In a statement the Austrian Federal Office for Safety in Health Care (BASG) said a 49 …

Austria safety officials suspend batch of AZ vaccines after death Read More »

NICE says NHS should fund Novartis’ £1.79m SMA gene therapy

The NHS should pay for Novartis’ £1.79 million one-off gene therapy for Spinal Muscular Atrophy (SMA) NICE has said, the most expensive treatment ever approved for funding. In first draft guidance NICE said Zolgensma (onasemnogene abeparvovec) should be made available for babies up to 12 months with type 1 SMA, although the age restriction is …

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EMA backs emergency use of Lilly’s COVID antibodies

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The CHMP says bamlanivimab (LY-CoV555) can be given alone or administered together with etesevimab (LY-CoV016) to treat at-risk patients aged 12 …

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NICE says no to AZ’s Lynparza for prostate cancer

NHS patients in England will not be able to get access to AstraZeneca’s PARP inhibitor Lynparza if they have BRCA-positive advance prostate cancer, according to draft guidance from NICE. The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the …

NICE says no to AZ’s Lynparza for prostate cancer Read More »

Teva faces EU antitrust probe over MS drug Copaxone

The European Commission has formally opened an antitrust investigation into Teva, which will assess whether the pharma company illegally delayed launches and use of generic versions of its blockbuster multiple sclerosis drug Copaxone. Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing …

Teva faces EU antitrust probe over MS drug Copaxone Read More »

EMA starts rolling review of Sputnik V COVID vaccine

With EU countries breaking ranks in order to get access to the Russian Sputnik V COVID-19 vaccine, the EMA has started a rolling review of the shot.  “EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time …

EMA starts rolling review of Sputnik V COVID vaccine Read More »

Germany backtracks on AZ COVID vaccine age restriction

Germany has decided that AstraZeneca’s COVID-19 vaccine should be approved for use in the over-65s after all, reversing its earlier restriction in that age group.  The country’s drugs regulator previously limited use of the vaccine to the under-65s only, claiming that the data in the older age group was inadequate, even though the European Commission …

Germany backtracks on AZ COVID vaccine age restriction Read More »

Lilly’s Olumiant is first JAK drug backed by NICE for eczema

Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE  to treat moderate to severe atopic dermatitis in adults who haven’t …

Lilly’s Olumiant is first JAK drug backed by NICE for eczema Read More »

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

A US court has upheld AstraZeneca’s patents on its respiratory drug Symbicort, blocking cheaper competition for the ageing blockbuster. The US District Court for the Northern District of West Virginia has decided in favour of AZ in litigation against Mylan Pharmaceuticals and Kindeva, the company said in a statement. Mylan, which is now part of …

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic Read More »

2021 market access prospects for France

In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in France. In September 2020, the French government published the draft of their annual review of spending on health and social care, which will form the basis of …

2021 market access prospects for France Read More »

FDA clears third emergency COVID-19 vaccine from J&J

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Janssen’s Ad26.COV2.S vaccine has been authorised for use in people aged 18 or over after a “comprehensive evaluation of available safety, effectiveness and manufacturing quality …

FDA clears third emergency COVID-19 vaccine from J&J Read More »

NICE okays regular NHS funding for Novartis’ breast cancer drug Kisqali

NICE has recommended moving Novartis’ Kisqali (ribociclib) from interim funding arrangements to regular NHS reimbursement for certain previously treated breast cancer patients. In the final draft guidance, NICE recommended Kiskali be taken out of the Cancer Drugs Fund, which has been providing interim reimbursement since 2019 until further trial data emerged addressing uncertainties about overall …

NICE okays regular NHS funding for Novartis’ breast cancer drug Kisqali Read More »

COVAX vaccine-sharing scheme delivers first COVID shots to Ghana

The first deliveries of vaccines from the World Health Organization-backed COVAX initiative, which aims to ensure access in low income countries,  has arrived. A shipment of 600,000 doses of the AstraZeneca/Oxford University vaccine to Accra in Ghana is seen as milestone for a scheme. It aims to address the imbalance that has seen the world’s …

COVAX vaccine-sharing scheme delivers first COVID shots to Ghana Read More »

FDA reviewer backs J&J COVID jab for emergency OK

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. In a briefing document published ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the FDA says the Ad26.COV2.S vaccine – developed …

FDA reviewer backs J&J COVID jab for emergency OK Read More »

2021 market access prospects for Spain

2021 will be the year when big market access changes – including the far wider use of health economic evaluation – are implemented in Spain. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Spain. Higher …

2021 market access prospects for Spain Read More »

AZ to divert COVID-19 vaccines from global supply chain to meet EU target

AstraZeneca has said it will be able meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. The company released a statement saying it will meet the EU’s targets by using its global supply chain to make up for …

AZ to divert COVID-19 vaccines from global supply chain to meet EU target Read More »

2021 market access prospects for Germany

The market access landscape in Germany is particularly interesting in 2021, as a key component – AMNOG – is ten years old, and that milestone prompts reflections on what has worked well and what needs reform. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock …

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AZ withdraws Imfinzi in US bladder cancer use after trial failure

AstraZeneca has suffered a setback after it voluntarily withdrew its cancer immunotherapy Imfinzi (durvalumab) in a bladder cancer indication in the US. AZ’s share price ticked downwards after the announcement that it will stop marketing Imfinzi, a PD-L1 class immunotherapy, for previously treated adult patients with advanced or metastatic bladder cancer. It’s news that will …

AZ withdraws Imfinzi in US bladder cancer use after trial failure Read More »

Novavax provides 1.1 billion COVID shots to global vaccine drive

Novavax has signed a deal to provide 1.1 billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. This week UK prime minister Boris Johnson …

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Haven: The strategy that didn’t fix healthcare

John Singer discusses the disbanding of Haven, the joint healthcare venture by Amazon, JP Morgan and Berkshire Hathaway, and the strategies that can help fix US healthcare.  “The market” was terrified when Warren Buffett, Jamie Dimon and Jeff Bezos got together to disrupt healthcare three years ago with the launch of Haven – in response …

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Europe orders another 200m doses of Pfizer/BioNTech COVID shot

The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under the latest deal the commission has an option for a further 100 million doses to be supplied to the 27 European member states. This new agreement is in addition to …

Europe orders another 200m doses of Pfizer/BioNTech COVID shot Read More »

UK health chiefs urge caution over lockdown as COVID deaths fall

UK health chiefs have urged caution over any relaxation of lockdown rules amid signs that the impact of vaccination and social distancing regulations are beginning to work. Latest figures from the Office for National Statistics (ONS) covering England and Wales showed that for the week ending 5th February there were 7,320 deaths registered mentioning coronavirus, …

UK health chiefs urge caution over lockdown as COVID deaths fall Read More »

bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy

It’s back to the drawing board for bluebird bio and its discussions with NICE, which has rejected its beta thalassaemia gene therapy Zynteglo for regular NHS use in first draft guidance. NICE is assessing Zynteglo (betibeglogene autotemcel), a one-off gene therapy for the condition, which can have life-threatening consequences and is associated with a curtailed …

bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy Read More »

UK government mulls lockdown review as it hits 15m COVID vaccine target

More than 15 million people in the UK have had their first coronavirus vaccine, described as a ‘significant milestone’ by prime minister Boris Johnson. While the UK was slow to react to the first wave of the pandemic a year ago, it has mounted one of the fastest vaccination programmes in the world. The first …

UK government mulls lockdown review as it hits 15m COVID vaccine target Read More »

Ireland is open: The biologics boom boosting the Irish economy

The life sciences industry has an important role in the Irish economy, with sectors such as biologics booming across the country. Rory Mullen, head of biopharma at Ireland’s economic development agency IDA Ireland tells pharmaphorum why business is blossoming in the Emerald Isle. With an attractive corporate tax rate and the youngest workforce in the …

Ireland is open: The biologics boom boosting the Irish economy Read More »

Stay calm and carry on: How to implement the updated ABPI code

Don’t panic – that’s the message from one ABPI code expert who tells Amanda Barrell it’s time to take stock and prioritise. Compliance managers have less than six months to rewrite processes and procedures in line with the updated ABPI code of practice before it becomes enforceable in July. But it doesn’t all have to …

Stay calm and carry on: How to implement the updated ABPI code Read More »

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots

The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission spokesperson, Reuters reported the EU had finalised a preliminary contract for 300 million doses that was first announced a month ago. This is on top of the 300 million doses …

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots Read More »

Labour accuses government of cronyism in COVID-19 contracts

The UK government’s massive spending on the coronavirus pandemic response has been “rife with conflicts of interest”, says the opposition Labour Party, and an independent watchdog should be set up to oversee procurement contracts. That was the message delivered by shadow Cabinet Office minister Rachel Reeves in a speech yesterday which claimed almost £2 billion …

Labour accuses government of cronyism in COVID-19 contracts Read More »

ViiV’s Rukobia cleared in EU as rescue HIV therapy

The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART).  The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not …

ViiV’s Rukobia cleared in EU as rescue HIV therapy Read More »

BMS’ MS pill gets funding in Scotland after rejection in England by NICE

Scotland’s drugs cost-effectiveness body has recommended Bristol-Myers Squibb’s Zeposia multiple sclerosis pill, setting a potential north-south access divide following a draft rejection in England by NICE last month. There are a range of MS drugs on the market but Zeposia does not have the common unpleasant gastrointestinal side effects that can occur with Biogen’s Tecfidera. …

BMS’ MS pill gets funding in Scotland after rejection in England by NICE Read More »

VPAS: Achievement so far on objectives for the economy and innovation

In the third part of this series taking stock of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access objectives, Leela Barham looks at the third VPAS objective that relates to the economy and innovation. The objectives for the economy and innovation are to: deliver a net benefit to the UK economy overall; and support the …

VPAS: Achievement so far on objectives for the economy and innovation Read More »

J&J asks FDA for emergence clearance for single-shot COVID-19 vaccine

Johnson & Johnson’s Janssen unit has filed its single dose COVID-19 vaccine candidate with the FDA, asking for an Emergency Use Authorization (EUA). The EUA will be based on the data from the phase 3 ENSEMBLE trial that Janssen announced last week. The European Medicines Agency (EMA) has already begun a rolling review of the …

J&J asks FDA for emergence clearance for single-shot COVID-19 vaccine Read More »

VPAS: Achievements so far on affordability

In the second part of this series taking stock of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access objectives, Leela Barham looks at the second VPAS objective that relates to affordability (spoiler alert: government gets millions in payments). The affordability objective is broken down further to: ensure that the Voluntary Scheme contributes to …

VPAS: Achievements so far on affordability Read More »

NICE backs NHS funding for MSD’s Keytruda combination in lung cancer

NICE has backed regular NHS funding England and Wales for Merck, Sharp and Dohme’s Keytruda in combination with pemetrexed and platinum chemotherapy in certain lung cancer patients. In draft guidance NICE said the Keytruda (pembrolizumab) and chemo combination can now be reimbursed by the NHS in adults with untreated non-squamous non-small cell lung cancer (NSCLC) …

NICE backs NHS funding for MSD’s Keytruda combination in lung cancer Read More »

UK reaches 10 million landmark with COVID-19 vaccination programme

The UK has reached a major landmark with its COVID-19 vaccination programme, with more than 10 million people receiving their first shot. After almost a year of restrictions to prevent the virus spreading, there is now hope that normal life may begin to return as data collected separately in Israel showed that vaccination also helps …

UK reaches 10 million landmark with COVID-19 vaccination programme Read More »

UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular …

UK patient group warns COVID could limit access to Novartis’ new eye drug Read More »

Competition for Neurocrine as Gocovri picks up new Parkinson’s indication

Adamas Pharmaceuticals’ Parkinson’s drug Gocovri has a new indication as an adjunctive treatment for levodopa/carbodopa in patients with Parkinson’s disease experiencing ‘off’ episodes. The new indication brings the drug into direct competition with Ongentys from rival Neurocrine Biosciences, which was approved for the same use last year. Adamas noted that Gocovri (amantadine extended release) already …

Competition for Neurocrine as Gocovri picks up new Parkinson’s indication Read More »

Assessing the impact of prevalence on pricing of rare disease drugs in Germany

In this first article of a three-part series exploring pricing in Europe, CRA’s Life Sciences Practice team discuss the role that disease rarity plays in reimbursement decisions among payers in Germany. Historically, payers have accepted factors including small target patient populations and high clinical development costs as justifications for the high prices of rare disease …

Assessing the impact of prevalence on pricing of rare disease drugs in Germany Read More »

BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis

Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a second indication for the would-be blockbuster. Orally-active S1P agonist Zeposia (ozanimod) has been submitted to the FDA as a treatment for adults with moderately to severely active ulcerative colitis (UC), …

BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis Read More »

2021 market access prospects for Italy

Italy was working up big changes in market access throughout 2020 which will be implemented in 2021. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Italy. AIFA, the Italian Medicines Agency and the agency tasked …

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AstraZeneca to supply nine million more vaccines to EU

The diplomatic row that broke out last week over the supply of AstraZeneca’s vaccine to Europe appears to have cooled after the UK pharma agreed to supply an extra nine million doses. At the end of last week, the European Commission was forced into an embarrassing U-Turn when it tried to impose restrictions on COVID-19 …

AstraZeneca to supply nine million more vaccines to EU Read More »

EMA approves AZ’s COVID-19 vaccine – including for over-65s

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. The conditional marketing authorisation makes AZD1222 the third coronavirus vaccine to be approved for EU use after the Pfizer/BioNTech and Moderna shots, and …

EMA approves AZ’s COVID-19 vaccine – including for over-65s Read More »

AZ has ‘constructive talks’ with EU leaders after vaccine row

AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU. The vaccine is expected to be approved by European regulators tomorrow, but this has been overshadowed by an announcement that the company will not be able to produce the 300 million …

AZ has ‘constructive talks’ with EU leaders after vaccine row Read More »

The US biosimilar market: Predictions for 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. As we’ve seen over those five years, biosimilars are critical in continuing to provide …

The US biosimilar market: Predictions for 2021 Read More »

NICE reverses stance on Celgene’s Revlimid for myeloma maintenance

NHS patients in England with newly-diagnosed multiple myeloma can be treated with Celgene’s Revlimid as maintenance therapy after a stem cell transplant, after new guidance from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund (CDF), which provides temporary reimbursement for medicines until further data …

NICE reverses stance on Celgene’s Revlimid for myeloma maintenance Read More »

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot

Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. In a statement Sanofi …

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot Read More »

EU eyes tighter COVID-19 vaccine exports as access gets ugly

The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where supplies have been delivered so far.   Moreover, it plans to rush through legislation requiring that all companies producing vaccines against COVID-19 in the EU have to notify the Commission …

EU eyes tighter COVID-19 vaccine exports as access gets ugly Read More »

Biden administration – What can the healthcare industry expect?

As Joe Biden takes the reins at the White House, pharmaphorum asks experts how his presidential tenure may influence the global healthcare industry. “I think the Biden administration will have only an incremental impact on the healthcare industry as a whole,” said Maxim Jacobs, CFA, managing partner and director of research at Edison Group. “With …

Biden administration – What can the healthcare industry expect? Read More »

ViiV/J&J’s long-acting HIV regimen finally approved in US

The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen. It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC). The …

ViiV/J&J’s long-acting HIV regimen finally approved in US Read More »

NICE rejects BMS’ Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a). But in its first draft guidance NICE said …

NICE rejects BMS’ Zeposia MS pill in provisional guidance Read More »

NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca

Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed by cost-effectiveness agency NICE. Jyseleca (filgotinib) has been recommended for moderate and severe active RA in patients who have responded inadequately to intensive therapy with two or more conventional disease-modifying …

NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca Read More »

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review. Following a press conference on Thursday morning, the Russian Direct Investment Fund (RDIF), which has been bankrolling the vaccine developed by a team in Moscow, said it had already …

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing Read More »

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug. Doptelet (avatrombopag) – an oral thrombopoietin receptor agonist – has been cleared to boost depleted levels of platelets in the blood of patients with ITP, an autoimmune clotting disorder …

Sobi gets EU nod for Doptelet in rare blood disorder ITP Read More »

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in

Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world. Pfizer and BioNTech have responded to this by …

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in Read More »

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England. Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously …

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer Read More »

NHS and Kite sign access deal for Kite’s cancer cell therapy Tecartus

NHS patients in England will be among the first in the world to receive Gilead’s Tecartus cancer cell therapy for certain types of lymphoma, after the company’s specialist Kite unit struck a deal with NICE.  Marketed as Tecartus (autologous anti-CD19-transduced CD3+) in Europe, the drug was approved in the EU in December for adults with …

NHS and Kite sign access deal for Kite’s cancer cell therapy Tecartus Read More »

Fauci backs Biden’s plan for 100 million COVID-19 shots

A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to the US leading infectious diseases expert Dr Anthony Fauci. Biden has announced ambitious initiatives to fight COVID-19 ahead of his inauguration, which is due to take place on Wednesday. While …

Fauci backs Biden’s plan for 100 million COVID-19 shots Read More »

J&J’s Darzalex Faspro is first US therapy for rare blood disorder

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its …

J&J’s Darzalex Faspro is first US therapy for rare blood disorder Read More »

NICE recommends interim funding for GSK’s Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance. Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used …

NICE recommends interim funding for GSK’s Zejula in ovarian cancer Read More »

2021 – UK market access prospects

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Looking back at key market access news …

2021 – UK market access prospects Read More »

EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month. The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting …

EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January Read More »

Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% …

Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label Read More »

Moderna’s COVID-19 vaccine is third approved in UK

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after …

Moderna’s COVID-19 vaccine is third approved in UK Read More »

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer

NICE has rejected Bristol Myers Squibb’s immunotherapy Opdivo as a second-line treatment for head and neck cancer in first draft guidance, unconvinced by evidence unearthed during a three-year NHS trial period. In its latest guidance, NICE said that clinical trial data gathered so far and real-world evidence did not convince about the cost-effectiveness of Opdivo …

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer Read More »

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to …

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine Read More »

Why cell therapy manufacture is a team sport

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work This thought leadership series has been paid and developed by Kite, a Gilead Company. In 2018, we were preparing to build …

Why cell therapy manufacture is a team sport Read More »

FDA and doctors warn against extending COVID-19 vaccine dose gap

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. The regulator made its comments after the UK announced a policy of stretching the gap between doses of the …

FDA and doctors warn against extending COVID-19 vaccine dose gap Read More »

AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday. The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million …

AZ COVID-19 vaccine cleared in UK, dosing to start next week Read More »

NICE backs AZ’s Forxiga for heart failure

Just a few weeks after its EU approval for heart failure, AstraZeneca’s Forxiga has been backed by NICE for this use by the NHS in England and Wales. Forxiga (dapagliflozin) – originally developed as a type 2 diabetes drug – is the first SGLT2 inhibitor to be approved for the treatment of symptomatic chronic heart …

NICE backs AZ’s Forxiga for heart failure Read More »

FDA rejects Novartis’ cholesterol drug after factory inspection issue

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which is preventing an FDA team from visiting the plant in …

FDA rejects Novartis’ cholesterol drug after factory inspection issue Read More »

Moderna’s COVID-19 vaccine is second for US after FDA green light

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved …

Moderna’s COVID-19 vaccine is second for US after FDA green light Read More »

GSK’s Benlysta claims first FDA okay for lupus kidney damage

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the …

GSK’s Benlysta claims first FDA okay for lupus kidney damage Read More »

Operationalize: Expanded Access Programs Summit

Say Goodbye to the Worry & Uncertainty of Setting Up & Managing an Expanded Access Program This inaugural Operationalize: Expanded Access Programs digital event is here to bring you solutions. Dealing with a diverse and confusing global regulatory landscape, on top of an increasing number of access requests from patients, is no easy feat for people working in …

Operationalize: Expanded Access Programs Summit Read More »

Entresto set for big sales hike after FDA panel endorsement

Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously hard to treat effectively, despite missing the mark in a phase 3 trial. An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with …

Entresto set for big sales hike after FDA panel endorsement Read More »

FDA backs Moderna COVID-19 shot ahead of emergency use vote

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency …

FDA backs Moderna COVID-19 shot ahead of emergency use vote Read More »

The critical role of the generics sector during the pandemic

Graeme Duncan from ADVANZ PHARMA explores how successful cross-industry collaboration between pharma and generics companies has helped support supply challenges during the pandemic. While the world has had to come together to fight COVID-19, so too has the pharmaceutical industry in ensuring that essential medicines reach patients in need. Surges in demand have created challenges …

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Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday. Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses …

Pfizer/BioNTech COVID-19 vaccinations start across the US Read More »

Family doctors begin COVID-19 immunisation drive in UK

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot. In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today. Some …

Family doctors begin COVID-19 immunisation drive in UK Read More »

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune …

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months Read More »

CLL patients in England to get AZ’s Calquence after okay from NICE

NHS England is to grant immediate access to AstraZeneca’s cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it in first draft recommendations. NICE recommended regular NHS funding for Calquence in CLL who are considered high-risk due to 17p deletion or TP53 mutations. It is also recommended for adults …

CLL patients in England to get AZ’s Calquence after okay from NICE Read More »

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 Europe to bring the ultra-pricey treatment to market. The European Medicines Agency (EMA) has granted a conditional marketing authorisation for the drug that will be marketed as Zinteglo (betibeglogene autotemcel), …

Bluebird trumpets long-term data from beta-thalassaemia gene therapy Read More »

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, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps …

Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps Read More »

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 injection at 06:31 this morning at University Hospitals Coventry and Warwickshire NHS Trust. Keenan turns 91 next week and the BBC said she described receiving the shot as “the best …

First COVID-19 vaccinations begin in UK hospitals Read More »

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 strong enough. The SMC verdict comes ahead of a decision south of the border by NICE, which was scheduled to discuss Nilemdo (bempedoic acid) at a committee meeting a month …

Scotland says no to Daiichi Sankyo’s cholesterol drug Nilemdo Read More »

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 clinical trial. Health secretary reportedly Matt Hancock came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history. The UK last …

UK faces “V-Day” and largest ever vaccination programme Read More »

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 COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region. Having worked all around the world …

Latin America: How pharma can navigate a complex market Read More »

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 social media activity and lobbying. The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands …

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval Read More »

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 drugmakers in the world. Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set …

A history of Pfizer Read More »

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 to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of …

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval Read More »

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 revenues of more than $7 billion but it lost patent protection in the US four years ago and sales have tumbled. Grunenthal will pay $320 million up front for rights …

AstraZeneca sells rights to cholesterol drug Crestor to Grunenthal Read More »

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 for the shot. The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 …

Moderna seeks COVID vaccine okay as data backs 94% efficacy Read More »

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 press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. According to the Financial Times, …

UK appoints COVID-19 vaccine rollout minister as country preps for launch Read More »

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 for its sleep disorder drug Provigil (modafinil).  In a statement the EU said the scheme prevented generic competition for Provigil, which is used to treat narcolepsy, after its main patents …

EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme Read More »

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 specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies …

Vertex gets EU okay to treat younger cystic fibrosis patients Read More »