Category Archives: News

Feb 21
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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

Feb 20
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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

Feb 19
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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

Feb 19
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Esmya: no new treatment courses prescribed until further notice

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Temporary safety measures have been introduced whilst the EMA review is ongoing following a further case of serious liver injury requiring liver transplant. In December 2017, the European Medicines Agency started a review of Esmya (Ulipristal acetate) for uterine fibroids after it was reported that four cases of serious liver injury had occurred after its use. In three of the cases a liver transplant was needed.

As of February 2018, temporary safety measures have been introduced whilst the review is ongoing following a further case of serious liver injury requiring liver transplant.

The advice is that no new treatment courses should be prescribed until further notice. Those who are already taking Esmya or have recently stopped, it is advisable that they have blood tests to monitor their liver function at least once a month whilst taking the medicine. Treatment with Esmya will be stopped if these blood tests show signs of a possible problem.

If women experience symptoms associated with liver problems (nausea, vomiting, feeling ill, lack of appetite, weakness, upper abdominal pain, yellowing of the skin/eyes) then they must stop treatment and seek medical attention immediately.

Esmya is used to treat moderate to severe uterine fibroids in adult women who have not yet reached the menopause. It is normally taken for up to three months but the course can be repeated.

It’s important to note that there are no concerns for individuals who have taken the emergency contraception ellaOne which also contains Ulipristal acetate. EllaOne is a single use medicine and as no cases of serious liver injury have been reported with its use to date there are currently no similar concerns with this medicine.

https://www.gov.uk/government/news/esmya-no-new-treatment-courses-prescribed-until-further-notice

Apr 03
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EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

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The European Medicines Agency (EMA) has suggested suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for consent of generic medicines. The list of medicines suggested for check can be found here. The deferrals can be lifted once alternative data establishing bioequivalence are provided.

Substitute supporting data have already been provided for several of the medicines studied. Therefore, the CHMP suggested that these medicines can remain on the market. The list of medicines recommended to remain on the market is available here.

The Agency also endorsed that medicines not yet authorized but which are being assessed on the basis of bioequivalence studies from these sites should not be authorized until bioequivalence is verified using alternative data.

Micro Therapeutic Research Labs is a contract research organization (CRO) which conducts the diagnostic and clinical parts of bioequivalence studies, some of which are used to support marketing authorization applications of medicines in the EU.

The review of medicines studied by Micro Therapeutic Research Labs was started after reviews to check amenability with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling.

The review, by EMA’s Committee for Medicinal Products for Human Use (CHMP), determined that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorization in the EU. However, there is no indication of harm or lack of efficiency of medicines authorized and being assessed in the EU on the basis of studies at the sites.

Some of the medicines which have been suggested for deferral may be of critical importance in certain EU Member States. The CHMP’s approval concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.

Date: 24th March 2017