Merck sells consumer healthcare unit to P&G

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Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.

Merck said last year that is was mulling over the future of its consumer health division, and that a sale would help it execute its science and technology focused strategy.

Stefan Oschmann, chairman of the executive board and Merck’s chief executive, said the move “is a clear demonstration of our continued commitment to actively shape our portfolio as a leading science and technology company.”

“Consumer Health is a strong business that deserves the best possible opportunities for its future development. With P&G we have found a strong, highly recognised player who has the necessary scale to successfully drive the business going forward.”

Merck said sales from its consumer health unit grew organically by 6 percent between 2015 and 2017, “outpacing the consumer health market’s growth of approximately 4 percent over the same period”. The business pulled in new sales of around $911 million last year.

“We like the steady, broad-based growth of the OTC healthcare market and are pleased to add Merck’s Consumer Health portfolio and people to the P&G family,” added David Taylor, P&G Chairman of the board, president and chief executive.

The transaction, which is expected to close by the end of the fourth quarter 2018, is subject to regulatory approvals and other customary closing conditions.

As part of the transaction, around 3,300 employees are expected to transition to P&G, subject to prior works council consultation where required.

 

Source – Pharma Times

Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)

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Product information
MDR number

MDR 049-12/17

Company name

Techdow Europe AB

Product description

Inhixa solution for injection in pre-filled syringe 2,000 IU (20 mg) in 0.2 mL; 4,000 IU (40 mg) in 0.4 mL; 6,000 IU (60 mg) in 0.6 mL; 8,000 IU (80 mg) in 0.8 mL; 10,000 IU (100 mg) in 1.0 mL.

Marketing Authorisation number

EU/1/16/1132/012
EU/1/16/1132/014
EU/1/16/1132/016
EU/1/16/1132/018
EU/1/16/1132/020

Brief description of the problem

Techdow Europe AB has issued the Direct Healthcare Professional Communication (DHCP) attached due to rare cases of premature self-activation of the safety device in unused, unopened pre-filled Inhixa syringes as shown in the DHCP diagrams. When premature activation has occurred, administration is not possible.
Advice for healthcare professionals

To minimise the risk of missed doses:

Pharmacists should visually check all Inhixa syringes before dispensing to check if they are affected by the self-activation defect as shown in the DHCP diagrams. Do not open the syringe blisters.
Individual syringes that are affected by the self-activation defect should not be dispensed to patients.
Pharmacists should make sure they have sufficient stock of Inhixa available as replacements.

Manufacturing issues stoke fears of EpiPen shortage in Britain

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Manufacturing problems have created a shortage of Mylan’s EpiPens in Britain, forcing the company to ration the devices allergy patients rely on to treat anaphylactic shock.

The company announced it will ration the devices, which contain doses of adrenaline, the Daily Mail reported. A spokesperson for the company told the newspaper the shortage is the result of manufacturing delays at a subsidiary firm owned by Pfizer. Mylan has previously warned of global supply issues with the device.

The spokesperson, who was not named, told the the Daily Mail the company is currently unable to determine “when the supply constraint will be fully resolved.”

An unnamed Pfizer spokesperson said, “We understand how important this potentially life-saving product is to patients,” adding that it is “working tirelessly to increase production and expedite shipments as rapidly as possible.”

The shortage could affect tens of thousands of patients in the country.

EpiPen competitors Bausch+Lomb, maker of Emerade, along with Denmark’s ALKAbelló, maker of Jext, are rushing to make up the shortfall of the treatment, the newspaper said.

Last summer, Mylan came under intense criticism for its repeated price hikes on EpiPen, which had taken the lifesaving injector’s list price up several hundred percent over previous years. As a result of the controversy, Mylan beefed up its patient access program and rolled out a cheaper authorized generic.

Source: Fierce Pharma

Mesna 100mg/ml solution for injection/infusion, 5 x 4ml – Product Recall

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Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)

Product information

CLDA number

CLDA (18)A/01

MDR number

101-03/18

Company name

Claris Lifesciences UK Limited

Product description

Mesna 100mg/ml solution for injection/infusion, 5 x 4ml

PL 20568/0044

Batch Number/Expiry

Batch No. Expiry date
B560240 April 2019

Claris Lifesciences UK Limited is recalling the above batch due to stability issues.

 

New measures to avoid valproate exposure in pregnancy

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MHRA Statement in response to CMDH announcement of new restrictions on the prescribing of valproate medicines (Epilim, Depakote and other generic brands).

Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines Division said:

We welcome the CMDH endorsement of the strengthened regulatory position on valproate medicines which we have been championing through the Europe-wide review.

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

These new regulatory measures also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy, and a ban on the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available.

Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is important women don’t stop taking valproate without first discussing it with their doctor.

This regulatory position has been developed through close collaboration with professional bodies, health system organisations, and patient and campaign groups.

I would like to particularly thank the families of the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.

Source – MHRA

GlaxoSmithKline in pole position in Pfizer race

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GlaxoSmithKline is in pole position to win the race for the consumer healthcare business of US pharma giant Pfizer, after it beat a rival bid from Reckitt Benckiser.

Pfizer hopes to secure as much as $20bn for the unit, which sells branded over-the-counter products such as Advil painkillers, Centrum multivitamins and Caltrate calcium supplement.

Both GSK and Reckitt submitted final offers this week ahead of a noon deadline on Wednesday, according to multiple people involved in the process.

If GSK does win the auction it would represent one of the biggest strategic moves so far from Emma Walmsley, who was appointed as chief executive of the British drugmaker last April.

It was unclear if other bidders had emerged in the final weeks of the auction, but attention throughout the sale process had focused on a bidding battle between GSK and Reckitt. Other companies including Johnson & Johnson and Nestlé also followed the process, but ultimately decided not to bid in earlier rounds.

Pfizer has maintained throughout that it was exploring a sell or spin of the business, meaning that if it does not select GSK it could dispose of the unit in another manner. It could also still decide to keep the business.

“An acquisition for the whole Pfizer consumer health business did not fit our acquisition criteria and an acquisition of part of the business was not possible,” Reckitt chief executive Rakesh Kapoor said in a statement late on Wednesday.

 

Source: FT

Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)

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AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure additional batches are also being recalled (EL(18)A/06)

Batch number/expiry

Batch Number Expiry Date Pack Size First Distribution
NG327 31/10/2018 4 x 112 Caps 13/10/2017
NG143 30/11/2018 4 x 112 Caps 19/07/2017
NK719 30/06/2018 4 x 112 Caps 12/10/2017
NJ972 30/06/2018 4 x 112 Caps 01/09/2017
NR730 31/07/2018 4 x 112 Caps 24/11/2017
NK591 30/04/2018 4 x 112 Caps 10/10/2017
NR497 30/04/2018 4 x 112 Caps 18/12/2017

Brief description of the problem

AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure, the other batches listed are also being recalled as they may exceed the limit before the end of their shelf life.
Advice for healthcare professionals

Stop dispensing the batches listed above. Return all remaining stock of these batches to your supplier using the supplier’s approved process.
Wholesalers

Quarantine any remaining stock of these batches and return to the original supplier for credit.
Medical Information enquiries

For medical information enquiries please contact AstraZeneca Medical Information: 0800 783 0033 or medical.informationuk@astrazeneca.com
Stock enquiries

For stock availability queries please contact AstraZeneca Supply Chain: 0800 783 0033 or andy.bailey@astrazeneca.com

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

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EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

Evidence indicates risk of serious inflammatory brain disorders

The European Medicines Agency (EMA) has recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.

A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune reactions affecting several other organs.

To protect patients’ health, EMA is recommending the immediate suspension of the medicine‘s marketing authorisation in the EU and a recall of batches from pharmacies and hospitals.

No new patients should start treatment with Zinbryta. Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6 months (see more details below).

EMA’s recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision.

The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine’s marketing authorisation and informed EMA of its intention to stop clinical studies.

Information for patients

If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Do not take another injection of Zinbryta.
Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting. These could be signs of a reaction to Zinbryta.
Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Information for healthcare professionals

Do not start any new patients on Zinbryta.
Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment. Consider alternative treatments as appropriate.
Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6 months after treatment has been stopped.
A recall of Zinbryta will take place from pharmacies and hospitals across the EU.
To date EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis. Most cases occurred within 8 months of starting treatment.

A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.

Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.

EMA will complete its in-depth review and make public the final outcome.

More about the medicine

Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis. Following a 2017 review of the medicine’s effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.

To date over 8,000 patients have been treated with Zinbryta worldwide. The majority of EU patients have been treated in Germany.

More about the procedure

The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.

The initial review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.

The PRAC’s recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision.

UK PM signals intent to remain with EMA

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Prime Minister Theresa May has unveiled the government’s desire for the UK to remain part of the European Medicines Agency following its departure from the European Union.

In a key speech on Brexit she revealed that the government will “explore with the EU the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”.

This, she said, would mean “abiding by the rules of those agencies and making an appropriate financial contribution”.

The UK is also committed to “establishing a far-reaching science and innovation pact with the EU”, that would facilitate the exchange of ideas and enable the UK to participate in key programmes alongside EU partners, the PM confirmed.

Healthcare and industry leaders welcomed the announcement.

“Every month, 45 million packs of medicines move from the UK to the EU – and 37 million come the other way. That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.

“It’s now critical that both sides prioritise patient safety in phase two of the negotiations. Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

Niall Dickson, co-chair of the Brexit Health Alliance, said remaining part of the European Medicines Agency “is the best way to make sure patients have quick access to the drugs and treatments they need”.

“For the Alliance, the key in all this is to put patients first – both the UK Government and European Commission must make public health and patient safety a priority in the negotiations. Nothing less will do.”

The news came as the Association of British Healthcare Industries called for “sensible trading agreements” to be in place the moment the UK leaves the EU to protect patient access to healthcare technologies.

The call comes on the back of research by the group showing that of the £5 billion worth of health technology used in the NHS in 2016, £3.2billion came directly from the EU.

“Complex, international supply chains mean that products can move across a currently frictionless UK/EU border many times in their lifecycle, for sourcing, assembly, packaging and sterilisation. The impact of delays and disruption to this process could pose a significant risk to patients if not correctly managed,” the group warned.

The UK also exports around £2 billion of health technologies to the EU; the same delays and disruptions pose a threat to the health of patients throughout Europe, the ABHI noted.

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