FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA.

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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. Artificial Life (2018). Nature Biotechnology (2018). Science (2018). Link Modelling and analysis of gene regulatory networks , by Karlebach G. &

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Agency IQ

AUGUST 25, 2023

Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.] Regulatory Context: Labeling for Biosimilar Products In 2018, the FDA released a guidance document entitled Labeling for Biosimilar Products. However, it also notes that it may be necessary to mention uses for non-approved conditions in order to ensure safe use.

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The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). 1) GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. Source link: [link].

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Codon

JANUARY 2, 2024

But the jury’s decision wasn’t the only blow dealt to Rainin: The company also lost their exclusive license to sell Gilson pipettes in the United States, which cost Rainin an estimated $19 million in lost revenue. In 2018, a bioengineering team in Chicago open-sourced blueprints for a 3D-printed, adjustable micropipette.

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The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda.

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The Pharma Data

JANUARY 3, 2021

The FDA accepted the Biologics License Application for ide-cel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, under priority review in September. The CVR hinged on U.S. regulatory approval of three drugs, Zeposia, ide-cel and liso-cel. 16 PDUFA date.

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The Pharma Data

MARCH 11, 2021

MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. For more information, please visit us at www.asieris.com.

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The Pharma Data

JANUARY 17, 2021

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Harr was also a director for Loxo Oncology.

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The Pharma Data

AUGUST 21, 2020

Tyvyt first earned its China nod in third-line classical Hodgkin lymphoma in late 2018, and the med’s looking at a potential new indication in previously untreated nonsquamous non-small cell lung cancer down the line. Lilly first licensed Tyvyt from Innovent in 2015. months experienced by the chemo group. Source link.

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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The Pharma Data

NOVEMBER 17, 2020

A Priority Review designation means the FDA will take action on a New Drug Application (NDA) or Biologics License Application (BLA) within six months, instead of the more typical 10 months. The drug also received Orphan Drug Designation from the FDA for ITP in October 2018. Sanofi’s Avalglucosidase Alfa for Pompe Disease.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

JANUARY 25, 2021

patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. 2018 Sep;28(9):766-777. Epub 2018 Jul 2. 2018 Oct 23;115(43):11066-11071. Epub 2018 Oct 4. This patent family includes one additional U.S. Neuromuscul Disord. 2018.06.012.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. As alleged by Gilead’s complaint , filed in the Eastern District of New York, licensed U.S. We purchased our products only from state-licensed suppliers who went through an extensive vendor vetting process.”.

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The Pharma Data

JUNE 26, 2021

About the Sanofi Pasteur and Translate Bio collaboratio n In June 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur, the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

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Molecule Blog

JUNE 11, 2021

We began exploring the combination of IP and NFTs with DeFi in 2018. When interest from potential investors reaches a certain maturity, the IP moves into a new licensing platform built on Web3.0. The legal contract is an IP license with language referencing blockchain transactions, addresses, and signatures.

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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. 17 September 2018. 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. .

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The Pharma Data

DECEMBER 2, 2020

Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. Horizon Discovery Group – U.K.-based

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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. Artificial Life (2018). Nature Biotechnology (2018). Science (2018). & Shamir R. Nature Reviews Molecular Cell Biology (2008).

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The Pharma Data

JANUARY 12, 2021

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. In either scenario, the Directors are confident that a successful outcome will be achieved to take the development of the CDX antibody forward toward clinical trials.

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The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

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Policy Prescription

MARCH 11, 2022

The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson , gets his pharmacist license back after it was revoked in 2019. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs. clinics in 2011.

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The Pharma Data

MARCH 1, 2022

The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. Syndesi’s Series A financing was co-led by Novo Holdings together with Fountain Healthcare Partners, with participation from Johnson & Johnson Innovation – JJDC, Inc., Source link: [link].

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National Drug & Alcohol Research Centre Blog

NOVEMBER 23, 2023

Despite this increasing evidence, a 2018 study of people who use drugs found Australia had one of the highest reported incidences of drug-dog encounters. These occurred most often at festivals, on public transport, and on licensed premises.

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The Pharma Data

NOVEMBER 17, 2020

of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. (b) The Prospectus stipulates that approximately 10.0%

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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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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The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

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The Pharma Data

DECEMBER 1, 2020

Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.

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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). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

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Molecule Blog

AUGUST 19, 2021

In a best case scenario, that technology is out-licensed to a pharmaceutical company and the remainder of the development carries on there. Molecule has been exploring a use case for combining IP and NFTs with DeFi in 2018, and this week, that use case was fully realised. Transacts the real-world legal rights/licenses of the IP (req.

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LifeSciVC

JANUARY 25, 2024

Getting funding and publishing papers in these two controversial fields was difficult, but the research teams I led there persevered for 15 years and succeeded in discovering new drugs that were licensed to pharma and biotech companies. Importantly, we were also able to publish the underlying work in high-quality journals.

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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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