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).

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

FDA 52

FDA FDA Approval Licensing Licensing 52

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.

Licensing 52

Licensing Licensing FDA Therapies 52

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.

Marketing 52

Marketing Engineering Therapies Disease 52

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.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

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. regarding its administration, preparation, storage, or safety). However, the guidance didn’t offer recommendations on promotional materials.

Biosimilars 40

Biosimilars Science FDA Licensing 40

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.

Licensing 40

Licensing Licensing Pharmaceutical Companies Engineering 40

FDA Law Blog: Biosimilars

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. As one might expect, the lion’s share of the registered facilities—over 2,000 of the total—are located here in the U.S.

FDA 52

FDA Licensing Licensing Laboratories 52

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

Licensing 52

Licensing Licensing DNA Vaccine 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Licensing 40

Licensing Licensing Clinical Development Pharmaceutical Companies 40

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

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. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

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.

Treatment 40

Treatment Disease Pharmaceuticals FDA 40

New Drug Approvals

SEPTEMBER 8, 2024

2] Palopegteriparatide was granted an orphan drug designation by the US Food and Drug Administration (FDA) in 2018, [7] and by the EMA in 2020. [8] Palopegteriparatide is a pegylated synthetic peptide (molecular weight: ca. 48,000) consisting of 34 amino acid residues. 1] [2] It is a transiently pegylated parathyroid hormone. [4]

FDA 62

FDA International Trials FDA Approval 62

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.,

Trials 52

Trials FDA Disease Licensing 52

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.

Vaccine 52

Vaccine Clinical Trials Disease Licensing 52

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.

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

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.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

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].

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

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.

Cell Biology 52

Cell Biology Clinical Trials Production Licensing 52

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.

Biosimilars 40

Biosimilars FDA Production Licensing 40

New Drug Approvals

SEPTEMBER 6, 2024

Retrieved 21 August 2024. ^ World Health Organization (2018). . ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer” Johnson & Johnson (Press release). 20 August 2024. hdl : 10665/330941.

FDA Approval 48

FDA Approval FDA International Treatment 48

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%

Licensing 40

Licensing Licensing Production Treatment 40

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.

Research 52

Research Licensing Licensing Drug Development 52

NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. 2018 Feb 12. Such studies suggested that 10 percent or less of newly approved drugs were based on academic patents.

Research 52

Research Science FDA Pharmaceutical Companies 52

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.

Licensing 40

Licensing Licensing Packaging Production 40

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. .

FDA 52

FDA Clinical Trials Treatment Pharmaceuticals 52

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. Last updated: November 2018. Last updated: November 2018. References.

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. 2018; 10 (1): 34-45.

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab received Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype in September 2018.

Treatment 52

Treatment FDA Trials Clinical Trials 52

Practical Cheminformatics

DECEMBER 7, 2023

Mark Murcko’s 2018 paper in J Med. It should be noted that not all biotechs skimp on software licenses. In my experience, the most successful drug discovery project leaders are curious people with broad scientific knowledge. There are many ways to broaden your skills. Read papers from areas outside your discipline.

Computational Chemistry 87

Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies 87

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.

Science 72

Science Clinical Trials Trials Medical Schools 72

The Pharma Data

FEBRUARY 5, 2021

American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. N= 3,525 total study population.

Treatment 52

Treatment FDA Licensing Licensing 52

The Pharma Data

NOVEMBER 8, 2020

Bristol Myers Squibb has a target action date of November 16 for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy for adults with r/r large B-cell lymphoma after at least two previous therapies. Bristol Myers Squibb picked up liso-cel when it acquired Celgene.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

New Drug Approvals

SEPTEMBER 10, 2024

April 2018). LC-MS: m/z 415 (M+H) +.Compound Compound 6-(6-Chloropyridin-2-yl)-N 2 ,N 4 -bis(1,1,1-trifluoropropan-2-yl)-1,3,5-triazine-2,4-diamine 1 H NMR (400 MHz, CDCl 3 ) δ 8.29-8.16 8.16 (m, 1H), 7.72 (d, J=7.6 Hz, 1H), 7.41 (d, J=7.9 Hz, 1H), 5.70-5.13 5.13 (m, 2H), 5.09-4.71 4.71 (m, 2H), 1.34 (m, 6H). LC-MS: m/z 415 (M+H) +.

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

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.

Drugs 52

Drugs Licensing Licensing Research 52