The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Agency IQ

APRIL 26, 2024

In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. However, the 2018 guidance it did not offer advice for interchangeable product labeling. The FDA published recommendations for interchangeable products separately in a completely new guidance , issued two years later.

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Drug Discovery World

SEPTEMBER 16, 2022

The UK also benefits from expedited pathways to development and adoption of novel medicines through the Innovative Licensing and Access Pathway, co-developed by the Medicines and Healthcare Products Regulatory Agency (MHRA), NICE and the Scottish Medicines Consortium (SMC).?- Neelam Patel, CEO of London cluster organisation, MedCity. .

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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Codon

MARCH 28, 2023

In 2018, Berger and collaborators demonstrated that their neural prosthesis could boost short-term memory performance (or episodic memory, the kind that most people with Alzheimer’s have trouble with) in people by 36 percent on specific recall tasks. The meeting took place before the launch of Neuralink, in July 2016.

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018.

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The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The FDA action converts the 2018 accelerated approval to full approval.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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Drug & Device Law

FEBRUARY 2, 2023

2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision. As much as we liked those parts of In re DePuy Orthopaedics, Inc., 3d 753 (5th Cir.

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