The Pharma Data

AUGUST 19, 2020

19, 2020 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. • Anthrax Vaccines. Adjusted Net Income (1).

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The Pharma Data

FEBRUARY 8, 2021

2 The study included patients with mCSPC with both low- and high-volume disease, those who were newly diagnosed, and those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for mCSPC. About the Janssen Pharmaceutical Companies of Johnson & Johnson.

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Drug Discovery World

AUGUST 1, 2023

As per a definition provided by AstraZeneca: “Once inside, ASOs bind with high specificity to target mRNA or pre-mRNA, inducing its degradation – effectively silencing it – to prevent its translation into a detrimental protein product. Though some genetic mutations are harmful, others can be protective.

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Drug Discovery World

FEBRUARY 14, 2023

DDW Editor Reece Armstrong speaks to Peter Walters, Director Advanced Therapies, CRB, and Grace Linton , Director Process Architecture, CRB about automation within laboratory settings and its effect on the pharmaceutical industry. RA: How are labs utilising automated systems in regard to personalised medicines?

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Drug Discovery World

JANUARY 5, 2023

In the past two years, EU regulatory authorities accelerated processes so that vaccines and medicines could be brought to market more quickly. Enhanced data flows – internally and externally in exchanges with regulators, supply-chain partners, healthcare providers and ultimately patients – will pave the way for process transformation.

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Agency IQ

JULY 12, 2024

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Following this regulation, the EMA now coordinates shortage prevention, management and communication efforts among Member States.

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Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . In the renal gene therapy field the most exciting research is definitely in the UK. Last year, Pfizer opened a $68.5

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Agency IQ

JUNE 9, 2023

In 2006, the ICH released its S8 Guideline on Immunotoxicity Studies for Human Pharmaceuticals , which provided recommendations on how companies should test pharmaceuticals for “unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.”

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The Pharma Data

JULY 6, 2021

Profit growth is expected to be underpinned by a combination of strong revenue growth from new vaccines and specialty medicines, improving operational performance and benefits from the transformation. As announced at the Investor Update, New GSK will disclose revenues of Vaccines and Specialty Medicines. Reporting definitions.

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The Pharma Data

OCTOBER 9, 2021

years of exposure 3 Design of a new open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in MS-patients treated with Kesimpta 4 , and new findings from open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in secondary progressive MS (SPMS) patients treated with Mayzent will be presented 5.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. covered insulin product or vaccine).

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Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. The regulators were off to a slow start, with just three total approvals in the first two months of 2024.

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The Pharma Data

MAY 13, 2021

Before I show you what this breakthrough pain solution is, I want to let you in on the “dirty little secret” of the pharmaceutical industry. ” Here’s The Dirty Little Secret Of The Pharmaceutical Industry. Why did the big pharmaceuticals maker under express or hide the potential for addictions with opiates.

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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The Pharma Data

AUGUST 24, 2020

The announcement came a day after President Donald Trump accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons, and on the eve of the Republican National Convention, where Mr Trump will launch his campaign to win a second term in the White House.

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Drug & Device Law

AUGUST 28, 2023

1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. There is a reason that a physician’s prescription is required for this kind of product – by definition, it comes with sufficient risks that medical supervision is necessary to approve its use. E.g. , Estee Lauder, Inc. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. 16, 2023) ( Hippo III ), for our product liability clients, which are significant enough. That’s why Buckman Co.

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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc. Geri-Care Pharmaceuticals Corp. , FDA , 78 F.4th 4th 210 (5th Cir. Avoiding barnyard expletives – we shoveled Shikada here. 3d , 2023 WL 4191651 (C.D.

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