The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR. star.edu.sg.

Licensing 52

Licensing Licensing Therapies Science 52

The Pharma Data

JANUARY 31, 2021

–( BUSINESS WIRE )– Gilead Sciences, Inc. While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. About Gilead Sciences. Gilead Sciences, Inc.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

The Pharma Data

MARCH 2, 2021

Bayer will introduce Vynyty Citrus ® , its latest biological and pheromone-based crop protection product to control pests on citrus farms during the International Symposium on Horticulture in Europe – SHE2021 , March 8-11. Bob Reiter, Head of Research and Development for Bayer Crop Science is a SHE2021 featured speaker.

Production 52

Production International Science Licensing 52

The Pharma Data

AUGUST 17, 2020

. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. About DF6002.

Licensing 52

Licensing Licensing Production Clinical Trials 52

Agency IQ

JUNE 2, 2023

What we expect to be talking about in June: Supply chain information: Under the FDORA legislation, holders of Biologics License Applications are required to submit a one-time report to the FDA on June 25, 2023 regarding which of their biologic products are available for sale or have been withdrawn from the market.

FDA 52

FDA Science Licensing Licensing 52

The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. On December 18, 2020 – The Company issued the following press release: “Tauriga Sciences Inc. ABOUT TAURIGA SCIENCES INC. Tauriga Sciences, Inc. Contact: Tauriga Sciences, Inc. NEW YORK, NY, Dec.

Science 52

Science Pharmaceuticals Clinical Development Production 52

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 126

Therapies Virus DNA Clinical Trials 126

The Pharma Data

NOVEMBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. ABOUT TAURIGA SCIENCES INC. . Tauriga Sciences, Inc. Tauriga Sciences, Inc.

Science 52

Science Production Licensing Licensing 52

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

FDA Approval 52

FDA Approval Licensing Licensing FDA 52

The Pharma Data

DECEMBER 20, 2020

Under the Agreement, Peijia is entitled to, among other things, manufacture, develop, and commercialize the products in the greater China region, and HighLife is in return entitled to receive an upfront fee and subsequent milestone payments. “We always strive to provide more innovative products and solutions for patients.

Licensing 40

Licensing Licensing Production Treatment 40

The Pharma Data

JUNE 14, 2023

About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

Licensing 40

Licensing Licensing Small Molecule Science 40

Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.” A new research paper, co-authored by PETA Science Consortium International e.V., Toxicological Sciences.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Perficient: Drug Development

SEPTEMBER 19, 2023

This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

Licensing 59

Licensing Licensing Production Marketing 59

Fierce BioTech

DECEMBER 13, 2023

7 “Make or Break” Factors for Emerging Biopharma Companies This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development.

Licensing 52

Licensing Licensing Science Production 52

Codon

JULY 14, 2024

receives a blood transfusion or a blood product every two seconds. But currently, traditional blood transfusions face significant challenges, including a dwindling pool of donors and a limited shelf life for stored blood products. According to the American Red Cross, someone in the U.S. to the European and Pacific fronts unfeasible.

Production 138

Production Clinical Trials Trials Therapies 138

The Pharma Data

JANUARY 19, 2021

– January 20, 2021) – BioHarvest Sciences Inc. About BioHarvest Sciences Inc. Based in Vancouver BC, BioHarvest Sciences Inc. The Company’s technology is non-GMO and has already been validated by VINIA®, the red grapes cells functional food/dietary supplement produced and sold by BioHarvest Sciences Inc.

Science 40

Science Production Licensing Licensing 40

Drug Hunter

APRIL 20, 2023

3: YCT529 (University of Minnesota, Georg lab, licensed by YourChoice Therapeutics, 13%) In third place was YCT529 , from UMN/YourChoice Therapeutics. As a non-hormonal oral drug, YCT529 targets RARalpha , which is involved in both Vitamin A metabolism and sperm production, and appears to work tolerably and reversibly in preclinical studies.

Small Molecule 130

Small Molecule Clinical Trials Trials Licensing 130

thought leadership

NOVEMBER 12, 2024

A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework , set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for pharmaceutical development and licensing in the United Kingdom (UK).

Licensing 52

Licensing Licensing Pharmaceuticals Production 52

The Pharma Data

SEPTEMBER 28, 2021

Steps the FDA will fancy make sure the safety and efficacy of those products for children: First, vaccine manufacturers have reported that the required clinical trials involving children as participants are currently underway. we’ve to let the science and data guide us.

Vaccine 52

Vaccine FDA Science Clinical Trials 52

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. 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).

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

NOVEMBER 9, 2021

percent to 2.089 billion euros / Crop Science reports strong increase in sales and earnings / Pharmaceuticals and Consumer Health again post considerable sales growth / Core earnings per share advance by 29.6 Business at the Consumer Health Division was over in all regions and product orders. Group sales rise by 14.3 percent to 1.05

Licensing 52

Licensing Licensing Science Production 52

Perficient: Drug Development

JANUARY 24, 2024

With that being said, I’ve had a lot of experience with healthcare companies, both payers, providers and life sciences organizations dealing with HIPAA regulations over the last decade and having seen the direction Sitecore has been moving to support healthcare companies, I wanted to share some of that knowledge and information.

Licensing 96

Licensing Licensing Production Regulations 96

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. About Burning Rock.

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

JANUARY 12, 2021

Boehringer Ingelheim has announced it has signed a collaboration and licensing deal with Enara Bio to advance novel targeted cancer immunotherapies. Under terms of the collaboration agreement, Enara gives Boehringer the option to license Dark Antigens for discovery and validation by Enara. Michael Vi/Shutterstock.

Research 52

Research Licensing Licensing Vaccine 52

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes. switching studies).

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

MAY 31, 2024

AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors. Put more simply, the term refers to approaches utilized within or by drug and biological products that have potential to be used in subsequent products without an adverse effect on quality, manufacturing, or safety.

Science 40

Science FDA Production Licensing 40

The Pharma Data

MAY 2, 2022

– Gilead to License Exclusive Worldwide Rights to the Investigational Candidate DF7001, a 5T4-Targeting NK Cell Engager for Solid Tumors –. – Gilead to Have Options to License Several Additional NK Cell Engager Programs –. Gilead Sciences, Inc. About Gilead Sciences. Gilead Sciences, Inc. About Dragonfly.

Licensing 52

Licensing Licensing Research Protein Expression 52

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

At the same time, the cannabis industry is producing an ever-wider array of products with varying and sometimes very high concentrations of delta-9-tetrahydrocannabinol (THC) Greater harms from cannabis use are associated with regular consumption of high-THC doses. They also could include different forms of taxation and even state monopolies.

Research 78

Research Production Licensing Licensing 78

The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. “In

Production 52

Production Trials Clinical Trials Treatment 52

The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure . generic version of the product. These are challenges not only for ViiV Healthcare but also for any future generic licensees. About ViiV Healthcare.

Licensing 52

Licensing Licensing Treatment Production 52

Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

FDA 40

FDA Science Regulations Production 40

PLOS: DNA Science

SEPTEMBER 7, 2023

My Career I’ve been writing life science tomes for a long time. A revision takes two years, one for updating and addressing reviewers’ suggestions, another for “production,” from copyediting through final pages. Now, college tuition includes a fee to license an e-textbook for a limited time.

DNA 98

DNA Science Therapies Licensing 98

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.”

Regulations 40

Regulations FDA Science Production 40

The Pharma Data

MARCH 11, 2021

Speaking at the virtual Capital Markets Day on Wednesday, CEO Werner Baumann emphasized Bayer’s long-term growth perspectives: “Bayer is a leading life science company, uniquely positioned at the intersection of health and nutrition – with attractive prospects for growth, earnings and cash flow.”

Science 52

Science Pharmaceuticals Licensing Licensing 52

Agency IQ

AUGUST 2, 2024

Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)

FDA 40

FDA Science Regulations Biosimilars 40