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AZ’ Forxiga to be reviewed for diabetes type I

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AZ’ Forxiga to be reviewed for diabetes type I

The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I.

The submission contains data from the Phase III DEPICT clinical programme, which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled diabetes type I, induced significant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo.

On the safety side, the drug’s profile was consistent with that established for its use in patients with type II diabetes, except for a higher number of diabetic ketoacidosis (DKA) events, known to occur more frequently in patients with type I disease, AZ said.

Forxiga is a first-in-class SGLT-2 inhibitor which has been on the market in Europe since 2012 for patients with type II diabetes, as both monotherapy and as part of combination therapy to improve blood sugar levels, with the added benefits of blood pressure reductions and weight loss.

With this submission, the drug could potentially become the first selective SGLT-2 inhibitor approved in the region for the treatment of type I diabetes as an oral treatment adjunct to insulin, “helping to address a significant unmet need in this patient population,” the firm noted.

Source: Pharma Times

Natural doesn’t mean safe – herbal medicines found to contain steroids

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Natural doesn’t mean safe – herbal medicines found to contain steroids

People who may have purchased Yiganerjing Cream are urged to discontinue use immediately as it contains an undisclosed steroid and two antifungal ingredients.

The Medicines and Healthcare products Regulatory Agency is warning people who may have purchased a “natural” Chinese herbal medicine, Yiganerjing Cream, as a treatment for skin conditions to stop using it immediately as it has been found to contain an undisclosed steroid and two antifungal ingredients.

MHRA officials have been acting to stop the sale of this cream and have had it withdrawn from many websites and on-line market places but people may have purchased it in the past and still be using it.

Yiganerjing Cream is not a licensed medicine and has been marketed in the UK as a “natural” Chinese herbal medicine for the treatment of a range of skin conditions, most commonly eczema, psoriasis and rosacea.

Our analysis found the presence of the steroid clobetasol propionate. This steroid is the active ingredient in Prescription-Only Medicines used for the treatment of a range skin conditions such as psoriasis and eczema. Creams containing steroids should be used sparingly and as directed by the prescriber. It is contraindicated in children under 1 year of age.

We are also aware of the use, via a herbal clinic, of a product called Penny Orange Cream which has also been found to contain clobetasol propionate. While this product is no longer available, and we are not aware of its widespread use, it did contain an undisclosed steroid and should not be used.

If you are unsure about the safety of a medicine claiming to be “natural” or “herbal” you should check for a Marketing Authorisation (MA) or Product Licence (PL) number or Traditional Herbal Registration (THR) number / the THR logo. This means the product has been assessed by MHRA for safety and has been manufactured correctly. For more information, visit NHS Choices.

Dr Chris Jones, Manager of the Medicines Borderline Section at MHRA said:

The sale of potent steroid creams directly to the public is illegal for good reason. If used without medical supervision these medicines can be dangerous.

Steroids must be prescribed by healthcare professionals who follow strict criteria when prescribing them and monitoring patients using them. They can suppress the skin’s response to infection, can cause long-term thinning of the skin, and if applied long term over a wide area, particularly in babies and children, can cause other medical problems.

Our advice to anyone who is using Yiganerjing Cream, particularly on young children and babies, is to discontinue use immediately. If you have any questions, please contact your healthcare professional.

If you are aware of Yiganerjing cream being sold, please report it to MHRA at Borderline_medicine@mhra.gov.uk.

MHRA update to pharmaceutical companies on exit preparations

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MHRA update to pharmaceutical companies on exit preparations

The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted guidelines for that second phase.

This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December.

These are important steps forward for both sides and demonstrate the shared interest in managing our exit smoothly, and in moving on with our negotiations.

In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the Withdrawal Agreement. The UK looks forward to continuing these discussions.

The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.

Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018.

Finally, the guidelines reconfirm the EU’s desire to establish a close future partnership with the UK. As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

Preparing for all outcomes
MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

As noted above, the UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership.

We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.

Current regulatory relationship between UK and European network
It is also important to note that the UK’s current regulatory relationship with the European network remains unchanged. The UK has underlined to Member States and to the EMA on several occasions that at present:

the UK continues to be a full member of the EU: we will fulfil our responsibilities, and, in turn expect to be treated as such.

the UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019: we are, for example, putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.

MHRA have committed to complete all assessments under evaluation at the time that the UK departs from the EU and will make assessment reports available to the network.

the UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.

the UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.

UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks
Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals – will be published when appropriate.

As stated above, the UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period, MHRA’s approach would be in line with the following principles:

the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

we would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences.

we would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

We will continue to engage with business, patient groups and other stakeholders to help plan ahead with certainty, and will look to publish more technical detail if appropriate.

Source: MHRA

Dispensing defence one of Hunt’s ‘ground-breaking’ plans to end errors

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Health secretary Jeremy Hunt has set out three “ground-breaking” measures to tackle 200 million medication errors across the NHS each year.
Mr Hunt – who set out the initiatives at the Annual World Patient Safety, Science and Technology Summit in London today (February 23) – said they will help to tackle the “appalling levels of harm and death that are totally preventable”.

One of these is the legal defence from criminal sanctions for pharmacists and staff who make an inadvertent dispensing error, which could become law as early as April.

This “will ensure the NHS learns from mistakes and builds a culture of openness and transparency”, the Department of Health and Social Care (DH) said today.

Another is a new system “linking prescribing data in primary care to hospital admissions”, which will help identify “if a prescription was the likely cause of a patient being admitted to hospital”, Mr Hunt said.

This will initially focus on how different medicines may be contributing to hospital admissions linked to gastrointestinal bleeding, and will be rolled out to “a broader range of medicines” following an evaluation in the spring.

Mr Hunt also plans to “accelerate the introduction of electronic prescribing systems” across “more NHS hospitals”, which “could reduce errors by up to 50%”, the DH said in a statement ahead of his speech.

237m medication errors a year
Mr Hunt’s announcement came in response to new research published today by the Universities of Sheffield, York and Manchester, which estimates that “237,396,371 medication errors occur at some point in the medication use process in England” per year. Prescribing errors and dispensing errors account for 21% and 16% respectively, while 54% were “administration errors”, the report’s authors said.

However, of the 237m errors, 72% have little or no potential for harm and “not all these errors would have reached the patient”, the authors stressed.

These medication errors account for 1,708 “definitely avoidable” deaths, according to the research.

The findings, based on 36 studies of “error rates in primary care, care homes and secondary care, and at the various stages of the medication pathway” are “at least 10 years old, so may not reflect current patient populations or practice”, the authors added.

Read a full copy of the report here.

Community pharmacy prevents errors
Responding to the research, National Pharmacy Association (NPA) chief pharmacist Leyla Hannbeck said patient safety is “deeply ingrained in the minds of community pharmacists, who dispense more than a billion prescription items each year”.

“It’s estimated that pharmacists query about 6.6m of those items, helping resolve many incidents that might otherwise have resulted in serious harm,” she added.

Janice Perkins, chair of the Community Pharmacy Patient Safety Group – which consists of representatives of all of the larger pharmacy chains, as well as the NPA – said the organisation is “committed to supporting healthcare leaders” implement Mr Hunt’s initiatives.

“Community pharmacists and their teams play a vital role in preventing medication errors, intervening on prescriptions and minimising risks to patients every day,” she said.

Greater access to patient records
“Discharge medication reviews taking place in community pharmacies, and community pharmacy read/write access to the GP patient record, would be significant enablers” to closer working between general practice and pharmacy teams, Ms Perkins said.

Royal Pharmaceutical Society (RPS) English pharmacy board chair Sandra Gidley also called for pharmacists to receive greater access to “vital information from a patient’s record, to enhance safety”.

“Pharmacists can and have been playing a vital role in reducing medication errors through transfer of patients between care settings,” she added. “We strongly believe that every care home should have a named pharmacist dedicated to improving medicine safety.”

C+D clinical editor Kristoffer Stewart appeared on BBC News this morning calling for pharmacy to have read/write access to patient records.

GPhC: We want to play our part
The General Pharmaceutical Council (GPhC) said it “strongly agrees” that “it is vital to have a learning culture across healthcare”.

“We will continue our work to promote a culture of openness, honesty and learning across pharmacy, and we will be urging everyone who employs pharmacy professionals or works within pharmacy to do the same,” chief executive Duncan Rudkin said.

Numark managing director Jeremy Meader said: “Pharmacy takes great pride in dispensing prescriptions accurately, as evidenced by the significantly low numbers of dispensing errors that occur.”

Mr Meader commended Mr Hunt’s support of the legal defence for dispensing errors, and said Numark “will be seeking further dialogue with Jeremy Hunt to continue to promote the vital role that community pharmacy plays”.

Source : C&D

Aquilon Medical Nebulisers: people urged to stop use immediately

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People and healthcare organisations are being urged to check if they have the affected Aquilon series of nebulisers.

Following withdrawal of CE certification for the Aquilon series of nebulisers, the manufacturer has continued to place the nebulisers on the market. We have issued a Medical Device Alert today to all relevant healthcare professionals.

The affected nebulisers and packaging do have a CE mark placed on them, however this has not been obtained through appropriate regulatory oversight and therefore, their safety cannot be assured.

A medical device cannot be marketed in Europe without carrying a CE mark. It is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.

This issue affects Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series medical nebulisers manufactured since 01 April 2015. MHRA believes that more than 8,000 Aquilon nebulisers, which have been on the market since 2015 are affected in the UK.

If there is suspicion that a nebuliser is affected, people are advised to stop using immediately, dispose of the device and to use an alternative nebuliser where available. It is advisable that you speak to your healthcare professional or GP who can help you find out if your device is affected, give you advice on how to dispose of it and provide a replacement.

John Wilkinson, MHRA’s Director of Medical Devices said:

We have been made aware that the manufacturer has continued to sell nebulisers even after their CE certification was withdrawn. We cannot guarantee they have been manufactured to an appropriate standard.

These devices deliver potential life-saving treatment and it is vital they operate correctly when needed.

We are taking action, as a matter of priority, to make sure people are aware the CE mark has been withdrawn and that these devices should not be used and should be disposed of.

Patient safety is our highest priority and we urge anyone with questions to speak to a healthcare professional as soon as possible.

Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU

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Caution in Use – Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)

Product information
MDR number
MDR 147-09/17

Company name
Kyowa Kirin

Product description
Bleo-Kyowa®, Powder for Solution for Injection (Bleomycin sulfate), 15,000 IU

PL number
PL 16508/0046

Batch number/expiry
Batch Number Expiry Date Pack Size First Distributed
X7B240 September 2020 10 February 2018
Brief description of the problem
In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.

Actions for healthcare professionals
While investigations are ongoing, additional measures should be adopted, as follows:

Follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics.

Carefully inspect the reconstituted product under a bright light.

If particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder (details overleaf).

If there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see.

Background
In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.

The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

Company contact information
If you have any questions about this letter or any other enquiry, please contact Kyowa Kirin Medical Information:

Tel: +44 (0)1896 664000

Email: medinfo@kyowakirin.com

Recipients of this Drug Alert should bring it to the attention of all relevant contacts involved with the supply and administration of chemotherapy, including: hospital pharmacists; hospital clinicians; ward staff; chemotherapy unit staff; nursing staff and clinic staff by copy of this letter.

In addition, the relevant Healthcare Professionals should be informed where the product is being used in a domiciliary setting. Local area teams are asked to forward this to relevant clinics and hospital pharmacy departments.

Published 22 February 2018

Batches of Ventolin Accuhaler and Seretide Accuhaler asthma inhalers recalled

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Three specific lots of asthma inhalers are being recalled, including preventer and emergency relief inhalers.

People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a patient level drug alert recalling two specific affected lots manufactured by Glaxo Wellcome UK Limited.

Patients who have used the affected batches of Ventolin may find that their symptoms are not relieved as normal by their Ventolin Accuhaler. If this happens, they should seek medical advice. Affected Accuhalers should be returned to their pharmacist for a replacement.

Additionally, one lot of Seretide Accuhaler, used for the maintenance of preventative treatment of asthma, is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK.

The recall of Seretide Accuhaler is pharmacy level because this is used for maintenance treatment as opposed to a reliever treatment.

The two affected batches of Ventolin Accuhaler and the one affected batch of Seretide were distributed to the UK market.

Only a small proportion of the units are defective (images below). Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected.

Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit said:

It is important people check whether they have an affected inhaler. We want patients and their families to be confident treatment will be safe and effective when required.”

People with a Ventolin Accuhaler from the affected lots should take them to their pharmacy or their dispensing practice and speak to a pharmacist who will provide a replacement.

We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.

Information is also available to patients and healthcare professionals by contacting GSK’s Customer Support Team via customercontactuk@gsk.com or calling on 0800 221 441 (option 4).

Product Description Lot details Final market Expiry Date
Ventolin 200mcg – Accuhaler 1x60D 786G UK 05/2019
Ventolin 200mcg – Accuhaler 1x60D 754P UK 05/2019
Seretide 50/250mcg – Accuhaler 1x60D 5K8W UK 04/2019

 

AstraZeneca’s $1B Imfinzi

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Backed by convincing survival data, AstraZeneca’s Imfinzi is breaking out on its own. Friday, the drug snagged an FDA green light in previously treated, stage 3 lung cancer patients whose tumors can’t be removed, a market without a single competitor in sight.

That’s an entirely new experience for Imfinzi, the fifth-to-market PD-1/L1 immunotherapy, which faces four other contenders in its only other approved indication, bladder cancer.

With those rivals years away from gaining a similar nod in lung cancer, Imfinzi could hit $1 billion in worldwide sales from that indication alone, Leerink Partners analyst Seamus Fernandez has predicted. Bernstein’s Tim Anderson has estimated that the opportunity in the world’s top seven markets tallies about 47,000 patients.

The FDA approved the new use based on phase 3 data showing Imfinzi could stave off disease progression for a whopping 11.2 months longer than chemo achieved, good for a 48% reduction in the risk of disease progression and death. But even before AZ rolled out those numbers at September’s European Society for Medical Oncology (ESMO) annual meeting, its top-line data from that trial, dubbed Pacific, were generating plenty of buzz.

The trial “is the kind of breakthrough that promises to pull upward on the I-O market size,” he wrote to clients in July.

AstraZeneca certainly hopes so. The company is counting on Imfinzi to help it come out of what CEO Pascal Soriot earlier this month called a “really difficult period,” and he ensured investors that there was just one more year to go before “fast growth” sets in.

 

Source- FiercePharma

MHRA cracking down on organised crime worth £200m

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The Medicines and Healthcare Regulatory Agency (MHRA) is cracking down on the diversion of Prescription-Only Medicines (POM) onto the criminal market, after first becoming aware of a significant diversion of benzodiazepines and other hypnotics/anxiolytics in 2016.

During 2017 MHRA expanded operations to 19 active investigations and have made more than 40 arrests. Our investigations have revealed an extensive network of criminality involving businesses such as wholesale dealers and a small number of registered pharmacies throughout the UK diverting medicines.

Between 2013 and 2016 an estimated £115-200m of medicines were diverted from the legitimate supply chain onto the criminal market, putting thousands of vulnerable people at risk.

The independent review into dependence and addiction to prescription drugs, recently announced by the Department of Health and Social Care, highlights the scale of the problem. The review will be looking into the results of a recent Home Office survey which found 7.6% of adults had taken a prescription-only painkiller not prescribed to them.

Arrests have been made for offences such as possession with intent to supply a controlled drug, and offences under the Proceeds of Crime Act.

The focus of our investigation is Prescription-Only Medicines such as benzodiazepines and anxiolytics including Diazepam and Zopiclone as well as the painkiller Tramadol.

These medicines are being sold through websites acting illegally, and people should be careful when buying medicines online. Criminals are known to exploit vulnerable people by selling medicines through unregulated websites and stealing their credit card details.

Self-diagnosis and self-medication can be dangerous. All of the Prescription-Only medicines currently being investigated have the potential to result in addiction. However, when these are appropriately prescribed there are measures in place to reduce this risk including restrictions on the dose or duration of treatment.

There is no indication this criminality has led to medicines shortages or issues with the legitimate supply of medicines to the public and medicines supplied with a prescription, through registered pharmacies, are unaffected.

Alastair Jeffrey, MHRA Head of Enforcement, said:

Selling medicines outside of the regulated supply chain is a serious criminal offence and we are working relentlessly with regulatory and law enforcement colleagues to identify and prosecute all those involved in this activity.

The medicines being sold are potent and should only be taken under medical supervision. Criminals involved are exploiting people when they are at their most vulnerable; their only objective is to make money.

We will continue to concentrate our efforts on identifying the criminals involved and ensure they are prosecuted through the courts.

Victoria Atkins MP, Minister for Crime, Safeguarding and Vulnerability said:

I welcome this investigation by the MHRA, which shows there is no hiding place for criminals who try to sell prescription drugs illegally.

Drug misuse can cause untold harm and devastate lives and this Government will take whatever action is necessary to keep our families and communities safe.

Our Drug Strategy sets out a balanced approach which brings together police, health, community and global partners to tackle the illicit drug trade, protect the most vulnerable and help those with a drug dependency to recover and turn their lives around.

Duncan Rudkin, Chief Executive of General Pharmaceutical Council:

We are working closely with the MHRA on the ongoing investigations into these very serious criminal offences. We have already taken action to suspend five pharmacists under interim orders and are actively reviewing at each stage of the investigations whether we need to take further action to protect the public.

We would also strongly urge people not to take any prescription medicines unless they have a valid prescription, as they could be putting their health at serious risk.

People wishing to report criminal activity relating to the diversion of these medicines should report this to us to our case referrals email address: CaseReferrals@mhra.gov.uk. You may also provide information anonymously through Crimestoppers

Merck and Pfizer’s immunotherapy fails in late-stage trial

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Merck KGaA and Pfizer’s cancer immunotherapy Bavencio (avelumab) has failed to meet its primary endpoint in a lung cancer trial.

In the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy, the drug did not meet its prespecified endpoint of improving overall survival in patients with PD-L1+ tumours.

In a statement Merck added that the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded this trial outcome.

However, improvements in OS versus the control arm were observed in the moderate-to-high PD-L1+ expression and high PD-L1+ expression population.

“We are committed to understanding the data in the context of the subpopulations and the impact of access to other immune checkpoint inhibitors,” said Chris Boshoff, senior vice president and head of immuno-oncology, early development and translational oncology, Pfizer Global Product Development. “We will continue to progress the broad avelumab program, exploring various indications.”

Source: Pharmatimes