The Checkup by Singlecare

MARCH 8, 2024

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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PharmaShots

MAY 23, 2023

Was ranked the highest among the list of companies developing Cell & Gene therapy, followed by Novartis with a revenue of $50.54B and Spark Therapeutics with a revenue of $49.27B PharmaShots brings an informative report on the Top 20 Cell and Gene Therapy Companies based on the total Revenue generated in the year 2022 Total Revenue: $0.5M

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 58

pharmaphorum

MARCH 21, 2022

Over the past five years, medical XR companies that were smaller start-ups have evolved into multimillion-dollar enterprises, partnering with pharmaceutical companies to supply digital therapeutic solutions using 3D immersive technology. In 2021, the behavioural health company and Sumitomo Dainippon Pharma Co.

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Hospitals Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

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Pharmafile

MARCH 22, 2023

Swiss biotech company Roche has announced a collaboration with US pharmaceutical company Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), which will be used to test for Alzheimer’s disease before symptoms arise. In July 2022, EAPP was awarded FDA Breakthrough Device Designation. read more

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Pharmaceutical Companies Pharmaceutical Companies FDA Communication 69

Pharmaceutical Technology

DECEMBER 22, 2022

Below you can find all the winners from the 2022 Excellence Awards which celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change. Pfizer wins the M&A award after a string of significant deals were finalised in 2022.

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FDA Insurance Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 27, 2022

In 2022, Russia’s war on Ukraine struck the supply chain, eventually slowing manufacturing and causing shortages for multiple pharmaceutical companies. The data indicates that the number of announced and completed deals plateaued in the first half of the year, but picked up some steam within the latter period of 2022.

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FDA Pharmaceutical Companies Pharmaceutical Companies Vaccines 52

STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports. Or you may want to take stock of your life. Well, whatever you do, have a grand time.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. A decision from the FDA is possible for later this year, with Lilly currently finalizing an application for fast-track approval.

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Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 98

European Pharmaceutical Review

MAY 17, 2023

billion in 2022. QMS are the integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured and distributed in compliance with regulatory requirements and meet the desired quality standards. This is compared to a value of $1.48

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Pharmaceutical Companies Pharmaceutical Companies FDA 82

European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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Pharmaceutical Companies Pharmaceutical Companies FDA 82

Pharma Marketing Network

MAY 3, 2023

First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs. References: 1. Food and Drug Administration. Marketing and Advertising.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Cited 25 September 2022].

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FDA Dosage Pharmaceutical Companies Pharmaceutical Companies 76

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). It was co-created by Shionogi and Hokkaido University.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 59

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. In recent years, several drugs for Alzheimer’s have been developed, but none have been able to gain approval from the FDA. FDA Approves Leqembi for the Treatment of Alzheimer’s Disease.

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Pharmaceutical Technology

APRIL 17, 2023

Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). In 2022, the company acquired CannQuit and ReneCann products as part of the acquisition of APIRx Pharmaceuticals.

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Immunization Pharmaceutical Companies Pharmaceutical Companies FDA 52

European Pharmaceutical Review

NOVEMBER 16, 2022

Pharmaceutical company Indivior has announced it will acquire Opiant Pharmaceuticals , Inc. It received US Food and Drug Administration (FDA) Fast Track Designation in 2021 and is expected to complete its New Drug Application (NDA) submission in late 2022, with launch in the US expected in the following months.

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Pharmaceutical Companies Pharmaceutical Companies FDA 91

The Checkup by Singlecare

JULY 20, 2023

In addition to making a significant clinical difference in patients’ lives, they also generate substantial profits for pharmaceutical companies. Blockbuster drugs often shape research and development in the pharmaceutical industry, paving the way for newer medications. It has not yet received FDA approval.

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European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.

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Vaccines FDA Research Laboratories Documentation 127

PharmaShots

MARCH 29, 2023

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Currently, the drug is not accessible in generic form.

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FDA Chemotherapy Immunization Dosage 49

The Checkup by Singlecare

NOVEMBER 14, 2022

Food and Drug Administration (FDA) has assigned “currently in shortage” status to oral powder for suspension amoxicillin. 28, the FDA listed 23 amoxicillin products on its current drug shortages page due to increased demand for the drug. . The FDA has not stated when they expect the shortage to conclude. . In fact, as of Oct.

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Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

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pharmaphorum

NOVEMBER 11, 2022

Viehbacher led Sanofi between 2008 and 2014 and has decades of experience with both large pharmaceutical companies and small biotechs. A veritable ‘industry veteran’, he spent 20 years at GSK before Sanofi, where he helped reshape the company’s drug portfolio. — Bloomberg (@business) November 10, 2022. to $289.01

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Insurance Pharmaceutical Companies Pharmaceutical Companies FDA 40

Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

The Checkup by Singlecare

APRIL 19, 2024

Farxiga is an oral prescription drug containing the active ingredient dapagliflozin and made by the pharmaceutical company AstraZeneca. The initial FDA approval of Farxiga for heart failure was for people with heart failure with a reduced ejection fraction. In 2022, another trial was published in NEJM.

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pharmaphorum

MAY 5, 2021

“The public believes that pharmaceutical companies should be fairly compensated for developing vaccines, but should be prevented from holding a monopoly on the jabs,” says the Alliance, adding that people “don’t want big pharma to hold monopolies on vaccines that were developed largely with public money.”

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Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 105

BuzzRx

OCTOBER 31, 2022

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. FDA guidelines. It is unclear how long this recall will last.

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European Pharmaceutical Review

MARCH 7, 2024

billion between 2022 to 2027. Lastly, there is growing prominence and interest in radioligand therapeutics within major pharmaceutical companies, who are increasingly investing in this field, evident through recent acquisitions of Point Biopharma and RayzeBio.

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Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

Pharmaceutical Technology

JUNE 5, 2023

Cybersecurity challenges As per a Healthcare Information and Management Systems Society (HIMSS) 2022 survey, there is a need for greater awareness on Health Insurance Portability and Accountability Act (HIPAA) and data privacy along with other measures. Pharmaceutical companies that are publicly traded will need to pay attention,” warns Kim.

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European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. ISPE GAMP 5 Second Edition : A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2022.

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STAT

JULY 6, 2023

On one side is the Pharmaceutical Care Management Association, the trade association representing pharmacy benefit managers, which argues that pharmaceutical companies are responsible for high drug prices. But overall, the industry is shedding jobs at a prodigious rate.

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European Pharmaceutical Review

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. The Analyst , 2022. 15, s.l. :

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Pharmaceutical Companies Pharmaceutical Companies FDA 90

pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Nursing Homes Department of Veterans Affairs FDA Dosage 77

Pharmaceutical Technology

DECEMBER 9, 2022

Rankings 2022. Pharmaceutical Technology Excellence Rankings – The Verdict. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods.

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The Checkup by Singlecare

APRIL 16, 2024

It is a biologic medication and monoclonal antibody made by the pharmaceutical company Janssen Biotech. According to the manufacturer’s website , as of March 2022, the list price (price set by the manufacturer) of Stelara 90 mg is $25,497.12 Stelara works by blocking proteins in the immune system that cause inflammation.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Source: GlobalData Pharmaceutical Intelligence Center.

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