New Drug Approvals

SEPTEMBER 29, 2024

In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). 2013 Jan 1;36(4):665-77. Periodontitis has been linked epidemiologically to cognitive impairment, and P. gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al.,

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The Pharma Data

MARCH 25, 2021

The Advisory Committee’s discussions were based on the Biologics License Application (BLA) currently under review by the FDA. In 2013, Pfizer and Lilly entered into a collaboration to develop and commercialize tanezumab. We will continue to work with the FDA as the agency continues its review of our application.”.

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The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. Elsevier Saunders; 2013, Philadelphia, PA. 2013:442-457. 2014;32(20):2375-81.

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The Pharma Data

OCTOBER 6, 2021

In 2013, Janssen collaborated with Professor Johan Neyts and Suzanne Kaptein at the KU Leuven Rega Institute and Patrick Chaltin at Centre for Drug Design and Discovery (CD3), as well as their respective teams, to identify a compound series capable of inhibiting the virus in lab-grown cells and animals. Janssen Pharmaceutica, N.V.

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FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. Draft Guidance III.B.2(e)

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The Pharma Data

MARCH 25, 2021

The Advisory Committee’s discussions were based on the Biologics License Application (BLA) currently under review by the FDA. In 2013, Pfizer and Lilly entered into a collaboration to develop and commercialize tanezumab. We will continue to work with the FDA as the agency continues its review of our application.”.

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Treatment Therapies FDA Licensing 52

Agency IQ

MARCH 25, 2024

As explained in a 2013 Government Accountability Office report, the intent of the CPG was to “identify those circumstances under which the agency believed establishments with retail pharmacy licenses were engaged in ‘manufacturing, distributing, and promoting unapproved new drugs’ in a manner outside the traditional pharmacy practice of compounding.”

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The Pharma Data

DECEMBER 22, 2020

Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Headquartered in the United States , Rakuten Medical has 6 locations in 5 countries, including Japan , the Netherlands , Germany and Taiwan. About ASP-1929.

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The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2013; 57 (12): 6147-53. About AstraZeneca.

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Advarra

JULY 19, 2022

Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Food Safety and Applied Nutrition (CFSAN), September 2013, Clinical/Medical. NOTE: A stay is in effect for parts of subsection VI.D of this guidance.

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Packaging FDA Trials Regulations 52

PPD

JULY 9, 2024

How the flex hub model saves one developer time and money As an example of the value that our flex hub model brings to biotech and pharmaceutical developers, here is a brief look at one long-term partnership in place since 2013. Ready to implement an FSP engagement as the ideal solution for all your lifecycle maintenance requirements?

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Codon

MAY 11, 2023

The first lab-grown burger was made for $330,000 back in 2013. In one instance, “a user heard the words ‘I don’t have my driver’s license yet.’ Their technology has already been licensed to Agragene , a pest control company specializing in agriculture. ( Despite the trouble, there is hope.

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Codon

MAY 11, 2023

The first lab-grown burger was made for $330,000 back in 2013. In one instance, “a user heard the words ‘I don’t have my driver’s license yet.’ Their technology has already been licensed to Agragene , a pest control company specializing in agriculture. ( Despite the trouble, there is hope.

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Vaccine Engineering Licensing Licensing 52

Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.”

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The Pharma Data

JANUARY 7, 2021

About ASP-1929 Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Headquartered in the United States , Rakuten Medical has 6 locations in 5 countries, including Japan , the Netherlands , Germany and Taiwan.

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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Codon

JULY 14, 2024

Biotechnology Journal (2013). It is licensed in Russia and South Africa and is included in a few compassionate use programs across the globe, meaning it can be used clinically in cases where patients have few remaining options. A cost analysis to make one unit of red blood cells from stem cells. Data from Rousseau G.F.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Adv Studies Pharm. Types of MS.

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Codon

JUNE 30, 2024

In sanctioning a patent for new forms of life created in the laboratory, the Supreme Court gave no license to create a race of supermen or a strain of bacteria to spread epidemic in the world. A year later, in 2013, in Association for Molecular Pathology v. It settled a narrow point of patent law.” Myriad Genetics, Inc.,

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The Pharma Data

NOVEMBER 29, 2020

To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. Available at: [link] 2 Nephrol Dial Transplant (2013) 28: 2908–2918 3 Centers for Disease Control and Prevention. 1 Gilbert C and Boivin G. Human Cytomegalovirus Resistance to Antiviral Drugs.

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Agency IQ

JANUARY 26, 2024

Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.

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Agency IQ

JUNE 2, 2023

However, only licensed blood establishments would be required to submit PMI to FDA for approval.” It’s worth noting that FDA’s definition of approval includes efficacy supplements, and not just the date of first approval.

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FDA FDA Approval Production Regulations 40

FDA Law Blog: Biosimilars

JUNE 17, 2024

Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA). The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog.

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. About BioLineRx BioLineRx Ltd.

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The Pharma Data

DECEMBER 27, 2020

We also market or plan to market in China additional oncology products licensed from Amgen Inc., 2013 Feb 7;121(6):893. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA ® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. 2012 Aug 2;120(5):947-59.

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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 Licensing and royalty revenue. The increase was also driven by VASCEPA sales outside of the United States of approximately $0.5 million and $8.9 million and $5.7 million and $1.1

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New Drug Approvals

JULY 10, 2023

It is released upon acute lung injury and upregulation of transient receptor potential (TRP) channels. While zavegepant is a highly soluble molecule, its bioavailability characteristics may render it challenging to prepare the drug in an oral dosage form. Click here to purchase.

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New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 1 January 2013. 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6] 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C., Grogan, D. . 24 August 2022.

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Agency IQ

JUNE 16, 2023

2) Update delivery timing and methods to require community water systems that serve 10,000 or more persons to provide reports biannually; and allow electronic delivery methods consistent with the “Safe Drinking Water Act–Consumer Confidence Report Rule Delivery Options” issued by the EPA on January 3, 2013.

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Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. Many studies have also employed a follow-up session for the participant to discuss their experience with the practitioner.

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LifeSciVC

OCTOBER 28, 2024

In-licensing molecules from other players, due to a partner’s strategic shifts, budget challenges, or geographic access, can be a great way to jumpstart early stage companies around more advanced assets. The 2013-2021 period was an incredible secular bull market for biotech, with only a few challenging quarters (e.g.,

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2013). Annual Review of Chemical and Biomolecular Engineering (2013). Link →DNA cloning: A personal view after 40 years , by Cohen S.N. & Charpentier E.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Nature Methods (2013). PNAS (2013). Molecular Systems Biology (2013). Annual Review of Chemical and Biomolecular Engineering (2013).

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DNA Cell Biology Engineering Molecular Biology 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2024

In a landmark 2013 decision , a unanimous Supreme Court held that a naturally occurring DNA segment, even when isolated, is a product of nature and therefore does not meet the subject matter eligibility requirement for patentability.

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Codon

APRIL 19, 2023

In 2013, a Fusarium fungus — called Tropical Race 4 — was identified in Mozambique. This technology is already being used to make low-caffeine coffee and rice with higher yields , and it has been licensed to an animal engineering company that is making chickens resistant to Avian flu.

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DNA RNA Engineering Regulations 52

Codon

APRIL 19, 2023

In 2013, a Fusarium fungus — called Tropical Race 4 — was identified in Mozambique. This technology is already being used to make low-caffeine coffee and rice with higher yields , and it has been licensed to an animal engineering company that is making chickens resistant to Avian flu.

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DNA RNA Engineering Regulations 52