List view / Grid view

US Food and Drug Administration (FDA)

First patient dosed with novel RNA modifying enzyme inhibitor

Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic

8 September 2021 | By Anna Begley (European Pharmaceutical Review)

Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.

news

FDA reaches over 100 Competitive Generic Therapy approvals

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.

news

EC approves Ultomiris for children and adolescents with PNH

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).

Scared woman holding head in hands, indicating schizophrenia

news

FDA approves Invega Hayfera^™ for the treatment of schizophrenia

2 September 2021 | By Anna Begley (European Pharmaceutical Review)

Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.

Man clutching heart, implying heart failure

news

Jardiance^® displays 21 percent risk reduction in heart failure patients

31 August 2021 | By Anna Begley (European Pharmaceutical Review)

Jardiance displayed a 21 percent risk reduction in adults with heart failure with preserved ejection fraction in Phase III study.

article

‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery

31 August 2021 | By Brian Finrow (Lumen Bioscience), Craig Behnke (Lumen Bioscience)

Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new…

Photomicrograph of diffuse B-cell lymphoma

news

Minjuvi^® receives EC approval to treat large B-cell lymphoma

27 August 2021 | By Anna Begley (European Pharmaceutical Review)

European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.

news

Vaxneuvance™ meets immunogenicity and safety endpoints in Phase III trial

27 August 2021 | By Anna Begley (European Pharmaceutical Review)

Merck announces positive results from a Phase III study evaluating Vaxneuvance™ against a pneumococcal conjugate vaccine in infants.

news

FDA application to be submitted for Comirnaty^® booster dose

26 August 2021 | By Anna Begley (European Pharmaceutical Review)

Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.

tablets and capsules surrounding an overflowing spoonful of sugar on a red background - idea of paediatric medicines

article

Paediatric medicines: just a spoonful of sugar?

26 August 2021 | By Dave Elder (David P Elder Constultancy)

Here, Dave Elder discusses the ever increasing importance of child-friendly medications and the specific challenges associated with their development.

Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].

news

Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine

24 August 2021 | By Anna Begley (European Pharmaceutical Review)

Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.

Illustration of pharmacy shelves with over the counter (OTC) drugs on them

article

Meeting the challenge of cost-effective OTC drug manufacture with powder testing

20 August 2021 | By Jamie Clayton

Sharper manufacturing practice is often essential to rigorously optimise production economics and compete effectively in the over-the counter (OTC) marketplace. This article describes the application of powder testing to improve the manufacturing efficiency of OTC products detailing work by Pfizer and GlaxoSmithKline (GSK), companies with extensive OTC portfolios.

blood plasma in an IV bag held up by doctor wearing PPE

news

Study shows no benefit of convalescent plasma for COVID-19 patients

19 August 2021 | By Anna Begley (European Pharmaceutical Review)

An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.

news

FDA approves Jardiance^® for heart failure with reduced ejection fraction

19 August 2021 | By Anna Begley (European Pharmaceutical Review)

The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.

Endometrial adenocarcinoma under the microscope

news

FDA approve GSK’s Jemperli for patients with dMMR solid tumours

18 August 2021 | By Anna Begley (European Pharmaceutical Review)

GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.

Cookie	Description
cookielawinfo-checkbox-advertising-targeting	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics	This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance	This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID	This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged	This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.

Cookie	Description
cf_ob_info	This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob	This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only	This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush	This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db	This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC	This cookie is set by Youtube and is used to track the views of embedded videos.

Cookie	Description
bcookie	This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS	This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang	This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc	This cookie is set by LinkedIn and used for routing.
lissc	This cookie is set by LinkedIn share Buttons and ad tags.
vuid	We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId	This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule	This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session	This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues	This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga	This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat	This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid	This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.

Cookie	Description
advanced_ads_browser_width	This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions	This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info	This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer	This cookie is set by Advanced Ads and sets the referrer URL.
bscookie	This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE	This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr	This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory	This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE	This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.

Recommended

US Food and Drug Administration (FDA)