NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

In an analysis of more than 28 million papers in the PubMed.gov database , researchers found NIH contributed to published research that was associated with every single one of the 210 new drugs approved by the Food and Drug Administration from 2010 through 2016 [1]. Reference: [1] Contribution of NIH funding to new drug approvals 2010-2016.

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LifeSciVC

JULY 6, 2023

By Mike Cloonan, CEO of Sionna Therapeutics In 2016, following robust discovery efforts by Pfizer and others, the NBD1 domain of the CFTR protein was largely considered undruggable. Fortunately, Sanofi Genzyme was willing to out license these assets to an internal team including Dr. Hurlbut and Dr. Mark Munson, who was the U.S.

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The Pharma Data

MAY 16, 2021

Description: Copyright ©2016 JuicingforYourManhood.com All Rights Reserved. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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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. September 2016). Archived (PDF) from the original on 22 April 2016. Retrieved 11 April 2016 – via PR Newswire. 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C.,

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. ” About the License Agreement. Effective 4 January 2021 , the License Agreement is terminated. TOKYO and CAMBRIDGE, England , Jan.

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The Pharma Data

MAY 16, 2021

Description: Copyright ©2016 JuicingforYourManhood.com All Rights Reserved. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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The Pharma Data

MAY 13, 2021

All Material Copyright © 2016 -document.write(new Date().getFullYear()) other licensed healthcare provider. Click the button below to read the secret to lose up to 40 pounds per month ! I have a very special offer for you … Get full access to NoNonsenseTed. getFullYear()) NonNonsenseTed.com. by the author of the product.

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The Pharma Data

NOVEMBER 13, 2020

The EUL procedure assesses the suitability of yet to be licensed health products during public health emergencies, such as polio and COVID. Type 2 cVDPVs are currently the most prevalent form of the vaccine-derived virus. The EUL procedure and how it could help to speed up access to a future COVID-19 vaccine.

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The Pharma Data

SEPTEMBER 14, 2020

AstraZeneca’s Tagrisso (osimertinib) has been recommended for use within NHS England, in line with its licensed indication, for adults with untreated locally-advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Source link.

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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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Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. There is also a growing body of successful treatments in the U.S., Phage therapies are sold at a pharmacy in Georgia.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. 2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] December 2008. [2] Scott RA, Freitag DF, Li L, Chu AY, Ehm MG, Wareham NJ, Waterworth DM, et al. Sci Transl Med.

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. NASH and type 2 diabetes, as well as for a number of cancers. ii It is projected that by 2030, close to half of the U.S.

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The Pharma Data

NOVEMBER 22, 2020

In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.

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Clinical Trials Licensing Licensing Trials 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA borrowed this definition from 21 C.F.R.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application.

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Agency IQ

AUGUST 4, 2023

Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. However, labeling requirements depend on the type of license of the medicine. wide license: The requirements of the E.U. only licenses will be converted to U.K.-wide

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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. 2016; 61 (1): e01020-16. About AstraZeneca.

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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.

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The Pharma Data

AUGUST 1, 2021

Results from the TULIP-2 Phase III trial were published in The New England Journal of Medicine in January 2020, results from the TULIP-1 Phase III trial were published in The Lancet Rheumatology in December 2019 and results from the MUSE Phase II trial were published in Arthritis & Rheumatology in November 2016.

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Codon

MAY 11, 2023

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. ( Also referred to as three-person in vitro fertilization.

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Codon

MAY 11, 2023

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. ( Also referred to as three-person in vitro fertilization.

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Vaccine Engineering Licensing Licensing 52

The Premier Consulting Blog

OCTOBER 21, 2024

Recent case studies Ocaliva® (Obeticholic Acid) : This drug received an initial accelerated approval on May 27, 2016, for the treatment of primary biliary cholangitis. In September 2024, the FDA gathered an advisory committee to acquire expert advice on the final results of the completed confirmatory trials.

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The Pharma Data

JUNE 18, 2021

Annual epidemiological report for 2016. during 2015-2016. 2011;364(21):2016-2025. October 24th, 2018. 6 European Centre for Disease Prevention and Control. Invasive pneumococcal disease. Stockholm: ECDC; 2018. 7 Beall B, Chochua S, Gertz RE Jr, et al. Front Microbiol. 2018;19(9). 8 Baisells E, Guillot L, Nair H, et al.

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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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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. licensure of a cholera vaccine in 2016, established correlates of protection for influenza that same year, and helped accelerate approval of paratyphoid vaccines in 2019.

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The Pharma Data

FEBRUARY 13, 2022

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.

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The Pharma Data

DECEMBER 15, 2020

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration.

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Codon

MARCH 28, 2023

The meeting took place before the launch of Neuralink, in July 2016. DARPA invested more than $200 million in support of the White House’s Brain Research through Advancing Innovative Neurotechnologies ( BRAIN ) Initiative between 2014 and 2016 alone. The company was not publicly unveiled until the following year.)

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Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

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Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

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Agency IQ

SEPTEMBER 29, 2023

These work in conjunction with the General Data Protection Regulation (GDPR; Regulation (EU) 2016/679 ). Finally, definitions for trade secret and trade secret holder come from the direction on the protection of trade secrets ( Directive (EU) 2016/943 ). Data intermediation service is defined in Regulation (EU) 2022/868.

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The Pharma Data

DECEMBER 15, 2020

The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA ® and BioLineRx was the study sponsor and owns all rights to motixafortide. Kenilworth, N.J. , About BioLineRx BioLineRx Ltd.

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Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). This minimal cell, first reported in 2016, was about half as fit as a normal M. mycoides cell. They grow slowly and generally look sluggish.

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Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). This minimal cell, first reported in 2016, was about half as fit as a normal M. mycoides cell. They grow slowly and generally look sluggish.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2016; 71 (4): 339-346. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. J Allergy Clin Immunol.

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