EMA Archives - Medical Design Sourcing

AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies

Epcoritamab Image courtesy of Genmab

The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab.

Epcoritamab for relapsed/refractory diffuse large B-cell lymphoma

Epcoritamab is an investigational bispecific antibody for adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. CHMP made the decision after reviewing data from the pivotal EPCORE NHL-1 phase 1/2 trial showing an overall response rate of 63.1% with epcoritamab monotherapy in DLBCL patients. If approved, epcoritamab would be the first subcutaneous bispecif…

The ‘Iron man suit’ for QA Managers: Quality management software taps power of ChatGPT

Gone are the days when Microsoft’s animated paperclip, Clippy, popped up on your screen with helpful — and sometimes annoying — tips and tricks for your Word document. Now, the Israeli eQMS compliance provider Dot Compliance has launched what it hails as an industry-first electronic Quality Management System (eQMS) for life sciences with a prominent generative AI-enhanced digital assistant that could take intelligent assistance to new heights. “It’s not just ChatGPT. It’s many other algorithms that are evolving,” said Doron Sitbon, founder and CEO of the company.

Transforming quality assurance with AI-driven quality management software

Rather than Clippy, Sitbon uses another metaphor to illustrate the company’s ChatGPT-enhanced “Dottie” capabilities for its QMS Xpress quality management software. “I think of it as an Iron Man suit for a [quality assurance] manager,” Sitbon quipped. The Dottie digital assistan…

Oncopeptides’ Pepaxti wins positive opinion from CHMP for multiple myeloma patients

Oncopeptides AB (Nasdaq Stockholm:ONCO) has won a unanimous positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Pepaxti (melphalan flufenamide) in the EU.

The European Commission will make a final decision on the drug candidate in the next 60 days.

An approval would make the drug available throughout the EU and in Iceland, Liechtenstein and Norway.

Stockholm-based Oncopeptides received FDA approval for the drug, marketed as Pepaxto, combined with dexamethasone for some adult patients with relapsed or refractory multiple myeloma on February 26, 2021.

Oncopeptides voluntarily withdrew the drug after the Phase 3 study on October 22, 2021, after analyzing data from the Phase 3 OCEAN study.

In March 2022, Oncopeptides rescinded its prior letter asking for voluntary withdrawal of melphalan flufenamide in the U.S. In a press release, the company explained that further data rev…

Valneva aims to salvage COVID-19 vaccine deal with EU

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) is hoping to change the European Commission’s (EC) mind after regulators notified the firm that they intend to terminate an Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine candidate VLA2001.

VALN shares fell 15% to $20.00.

In February, Valneva announced that it expected authorization for the vaccine in the European Union in April. Regulators from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had sent the company several questions about the vaccine candidate. Valneva said then that it swiftly answered them.

EMA accepted the filing of the Marketing Authorization Application on May 19.

After the European Commission received Valneva’s remediation plan, Valneva hopes to have further discussions with regulators interested in its inactivated, adjuvanted whole-virus vaccine.

Valneva ind…

Biogen gives up seeking European approval for aducanumab

After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.

Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.

At that time, Biogen announced that it would fight the decision.

In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”

“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences …

Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate.

The firm announced on February 25 that CHMP had sent the company a series of questions as part of its initial assessment, to which it responded within two working days.

It anticipates that it can swiftly respond to the latest batch of questions.

Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.

In such a case, the company would supply European countries with the vaccine in the second quarter of the year.

Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.

The company says t…

Sanofi and GSK aim to commercialize COVID-19 vaccine

In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited.

Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and European Medicines Agency (EMA).

In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.

A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.

The companies note that the research was carried out while challenging variants of concern were circulating. “No other global Phase 3 efficacy study…

EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.”

The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December 13-16.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Dr. Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen, in a press release.

In the U.S., aducanumab has seen several setbacks in recent months.

In August, the Department of Veterans Affairs (VA) decided not to include aducanumab in its drug formulary. The VA…

AbbVie wins CHMP positive opinion to use Skyrizi as an active psoriatic arthritis treatment

AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis.

The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.

CHMP recommended an initial 150-mg of subcutaneous injection of Skyrizi followed by subsequent doses at four weeks and then every 12 weeks after that.

In the U.S., the drug is indicated for certain adults with moderate-to-severe plaque psoriasis. FDA approved the drug in 2019.

In April, North Chicago–based AbbVie announced that it had submitted paperwork to the FDA for the indication of psoriatic arthritis.

Approval for psoriatic arthritis in Europe and the U.S. would elevate AbbVie’s stature in tha…

High-performance ion mobility spectrometry is an efficient technique for cleaning validation

Image courtesy of Covalent Bonds

The rigorous cleaning of manufacturing equipment via well-defined standard operating procedures (SOPs) is one of the pharmaceutical industry’s primary defenses against contamination and adulteration. Cleaning validation confirms the efficacy of such procedures but can present challenges, generating large numbers of samples for analysis and potentially keeping equipment offline for too long, compromising productivity.

This article examines high-performance ion mobility spectrometry (HPIMS) as a technique for cleaning validation, comparing it with conventional alternatives. Experimental data illustrate the linearity, reproducibility, and detection limits of HPIMS for relevant compounds, which offers rapid, inexpensive, high sensitivity, at-line measurement for cleaning validation.

Meeting regulatory requirements for cleaning validation

FDA regulations provide a clear and…

Pfizer and BioNTech seek EMA nod for younger adolescents

Image courtesy of Wikipedia

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.

BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.

The companies also plan on asking other international regu…

Early Pfizer COVID-19 vaccine doses may have had potency problems

Image courtesy of Wikipedia

Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ.

The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020.

A Pfizer spokesperson acknowledged the leaked documents, stressing that any questions EMA had related to the vaccine have been resolved transparently.

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