AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

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Pharmaceutical Technology

AUGUST 1, 2023

Renaissance Pharma has signed an agreement to in-license St Jude Children’s Research Hospital’s Hu14.18K322A (Hu14.18).

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Pharmaceutical Technology

OCTOBER 4, 2022

Developed under joint research between Shionogi and Hokkaido University, the antiviral averts SARS-CoV-2 replication by hindering 3CL protease. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology. An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.

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STAT News

SEPTEMBER 23, 2022

A move by Optum to change longstanding practices for licensing data to academic institutions has sparked an outcry among researchers, who argue the move will make accessing data so costly and difficult that universities will scale back their research programs.

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Pharmaceutical Technology

MARCH 21, 2023

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics.

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Bio Pharma Dive

JANUARY 6, 2023

The drugmaker said it is considering licensing out some assets to shorten development timelines, and will stop work on early viral-based gene therapies.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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Bio Pharma Dive

FEBRUARY 24, 2023

The pharma is handing back rights to an experimental medicine for the liver disease that had been licensed from biotech Pliant Therapeutics.

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Pharma Times

DECEMBER 21, 2021

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

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Pharmaceutical Technology

APRIL 21, 2023

In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression. The companies signed another research collaboration agreement for multi-target antibody discovery in January 2023.

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Worldwide Clinical Trials

OCTOBER 26, 2022

Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now.

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Bio Pharma Dive

NOVEMBER 27, 2024

A broad licensing and research alliance will hand Sarepta four clinical-stage candidates, while Arrowhead receives $500 million in cash and another $325 million in equity investment.

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Pharmaceutical Technology

DECEMBER 19, 2022

Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

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Pharmaceutical Technology

JUNE 19, 2024

Ascidian has entered a research partnership and licensing agreement with Roche to develop RNA therapies for neurological diseases.

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Pharmaceutical Technology

OCTOBER 21, 2022

Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers. Roche also holds an option for licensing second arenaviral cancer immunotherapy.

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Pharmaceutical Technology

MAY 10, 2023

According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

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Pharmaceutical Technology

AUGUST 1, 2022

The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC). They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 30, 2023

Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 14, 2023

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 12, 2023

The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some (..)

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 21, 2024

A unified licensing authority titled as Indian Drug Regulatory Authority (IDRA) will garner the much needed recognition globally like US FDA or EMA, said Dr BR Jagashetty, former National […] India must now move towards looking to merge its Central and state enforcement wings and form a single authority.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 6, 2022

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA). Post market research for monitoring drug safety. Why are Post- Marketing studies conducted.

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Pharmaceutical Technology

OCTOBER 21, 2022

With the takeover, AbbVie will gain access to the HEPTAD platform, which would complement its existing expertise in biotherapeutics research. . AbbVie discovery research vice-president and global head Jonathon Sedgwick said: “We are excited to bring the innovative science behind DJS-002 and the talented team at DJS to AbbVie.

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XTalks

AUGUST 9, 2022

Innova Medical Group, the world’s largest COVID-19 test provider, has secured the licensing rights for commercializing a new COVID-19 testing technology developed at the University of Birmingham. Innova Medical Group, which secured the licensing rights for the test, is the world’s largest provider of lateral flow tests.

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Bio Pharma Dive

AUGUST 3, 2023

A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.

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pharmaphorum

SEPTEMBER 29, 2020

Cell therapy research has been built on collaborations amongst scientists and entrepreneurs, providing early proof of concept for modalities thought to be too difficult to commercialise but with a strong potential for patient benefit”.

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Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Pharmaceutical Technology

APRIL 3, 2023

The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. Our research group has been collaborating with Ablaze on an investigator-initiated trial of a radiopharmaceutical drug candidate targeted on PSMA.”

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Pharmaceutical Technology

APRIL 14, 2023

Ginkgo Bioworks (Ginkgo) and the Wisconsin Alumni Research Foundation (WARF) have collaborated to discover next-generation GD2 CAR T-cell therapies to treat solid tumours. WARF is the patenting and licensing organisation for the University of Wisconsin–Madison in the US.

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Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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