Pfizer and Biontech Nab Covid-19 Vaccine Authorization from U.K. For First-ever Marketed mRNA shot

Pfizer | December 03, 2020

The two organizations' BNT162b2 has become the primary COVID-19 immunization permitted in the Western world as medication controllers in the U.K. given out a crisis use approval on Wednesday, in front of choices by the U.S. also, Europe, which are normal soon.

For the more extensive immunization world, the Medicines and Healthcare items Regulatory Agency's choice methods the world currently has the principal mRNA shot approved for far reaching use, opening up a fresh out of the box new part for antibody advancement.

The principal portions will be conveyed to the U.K. quickly, the organizations said. A representative at the U.K's. Department of Health and Social Care said the antibody will be made accessible the nation over from one week from now. The U.K. has requested 40 million portions of the antibody—enough to immunize 20 million individuals—through an arrangement endorsed in July and extended in October.

"As we envision further approvals and endorsements, we are centered around moving with a similar degree of criticalness to securely flexibly an excellent immunization around the globe. With a great many individuals turning out to be tainted, each day matters in the aggregate competition to end this staggering pandemic," Pfizer CEO Albert Bourla, Ph.D., said in an explanation, calling the U.K. gesture a "noteworthy second."

Pfizer has appointed COVID-19 antibody assembling to three destinations in the U.S. also, one in Belgium. BioNTech has offices in Mainz and Idar-Oberstein in Germany, which have been delivering dosages for clinical preliminaries. The German biotech as of late purchased a Novartis plant in Marburg, Germany, to quicken business assembling of the COVID-19 immunization. In general, the two organizations have said they can create up to 50 million dosages in 2020 and up to 1.3 billion portions in 2021.


About the manufacturing process of pharmaceutical. (This video contains outdated information! Original publishing date: 2014.)


About the manufacturing process of pharmaceutical. (This video contains outdated information! Original publishing date: 2014.)

Related News

Apricus Health Partners with Medicare Advantage Plan Devoted Health and Full-Service Retail Pharmacy Liton Rx

Apricus Health | November 04, 2020

Apricus Health, an innovative healthcare company delivering high impact, relationship-based care, today announced two new partnerships that provide its members with extraordinary services. Medicare Advantage plan provider Devoted Health and full-service retail pharmacy Liton Rx are now partnering with the Apricus Health Network which is designed by Arizona physicians. "We are committed to helping our members with a range of quality services to improve health outcomes and significantly lower costs for patients and payers," said Dr. Kishlay Anand, CEO and co-founder of Apricus Health. "Our new partnerships with Devoted Health and Liton Rx, further that mission, with both organizations sharing our core value of emphasizing extraordinary customer service."

Read More


Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

Read More


Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US

Hikma Pharmaceuticals PLC | September 21, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, announces the signing of an exclusive US license agreement with FAES Farma S.A. to commercialise Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval. Hikma will provide FAES with an upfront payment, regulatory approval and commercial milestone payments as well as royalties. The agreement builds upon Hikma and FAES Farma's existing partnership on Bilastine in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries. We are pleased to form this partnership with FAES Farma for Bilastine, which builds on our growing position in the allergy market and further advances our objective of strengthening our specialty business in the US. Since its first launch in Europe in 2011, Bilastine has been successfully commercialised as a leading allergy brand in more than 100 countries. By introducing Bilastine in the US, Hikma is further solidifying its presence in the allergy market, and we will leverage our existing salesforce promoting our specialty portfolio, including our partnership with Eyevance Pharmaceuticals for the co-promotion of ZERVIATE® and our forthcoming branded seasonal allergic rhinitis nasal spray Ryaltris™. We look forward to bringing this new treatment option to US patients. - Brian Hoffmann, President of Hikma Generics. About Bilastine Bilastine is a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Bilastine is currently approved in more than 120 countries and achieved more than €290 million in worldwide sales in 2020. If approved by the FDA, Bilastine would be the first New Chemical Entity antihistamine approved in the US since 2007. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world.

Read More