Pharmaceutical Technology

JULY 31, 2023

Mithra Pharmaceuticals is in line to receive €17.05m ($18.8m) in licencing fees, and milestone-based payments.

Licensing 130

Licensing Licensing Marketing Drugs 130

Pharmaceutical Technology

JULY 28, 2022

Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US. The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis.

Licensing 147

Licensing Licensing Clinical Trials Clinical Trials 147

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. Gilead markets both Truvada and its successor Descovy.

Drugs 264

Drugs FDA Approval Containment Licensing 264

XTalks

DECEMBER 4, 2024

Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” ” The company priced 2,750,000 shares of common stock at $4.00

Bioavailability 111

Bioavailability Genetic Disease Marketing RNA 111

Pharmaceutical Technology

OCTOBER 5, 2023

Advanz Pharma has signed an agreement to licence Dimerix’s DMX-200 for marketing in the UK, Australia and New Zealand among others.

Licensing 130

Licensing Licensing Drugs Marketing 130

Bio Pharma Dive

AUGUST 1, 2023

Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.

Licensing 130

Licensing Licensing Drugs Production 130

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JANUARY 23, 2023

Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary HUTCHMED to develop and market the latter’s fruquintinib. The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. The submission is planned to be completed in the first half of this year.

Licensing 130

Licensing Licensing Sales Medicine 130

Bio Pharma Dive

FEBRUARY 14, 2024

The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.

Licensing 176

Licensing Licensing Marketing Drugs 176

Pharmaceutical Technology

JULY 19, 2023

The agreement covers licensing rights in North America for Duchenne muscular dystrophy and other future indications.

Licensing 130

Licensing Licensing Marketing Drugs 130

Bio Pharma Dive

APRIL 13, 2022

Antares Pharma's auto-injector technology is of particular interest to Halozyme, which believes that the various markets to which it could be applied represent billions of dollars in potential sales.

Drug Delivery 144

Drug Delivery Licensing Licensing Sales 144

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

Pharmaceutical Technology

APRIL 13, 2023

The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. The initial agreement between Dyadic and Rubic involved discovery, development, manufacturing, and distribution of Covid-19 vaccines by transferring and licensing of C1 platform technology.

Production 279

Production Vaccination Vaccine Protein 279

pharmaphorum

NOVEMBER 23, 2021

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. Sanofi is the first pharma company to partner with Baidu on its LinearDesign AI platform, which has been developed specifically to optimise the sequence of mRNA-based vaccines and drugs.

Licensing 105

Licensing Licensing Vaccination Vaccine 105

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

OCTOBER 23, 2023

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

Manufacturing 130

Manufacturing Marketing Licensing Licensing 130

Bio Pharma Dive

MARCH 13, 2023

The deal builds on a licensing agreement between Sanofi and Provention to market the first-of-its-kind treatment, called Tzield and approved to slow the disease’s progression.

Licensing 130

Licensing Licensing Drugs Marketing 130

Pharmaceutical Technology

JULY 21, 2022

In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca. The drug combination is anticipated to be made available in August and could only be used in compliance with the necessary conditions of the Swiss Society of Infectious Diseases (SSI).

Antibody 264

Antibody Compliance Clinical Trials Clinical Trials 264

Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. As Trodelvy will have the first-in-class advantage in the HER2-negative setting, dato-DXd would have to demonstrate superior efficacy to dominate this market.

HR 162

HR Marketing Hormones FDA Approval 162

Pharmaceutical Technology

MAY 3, 2023

Aurinia Pharmaceuticals has received marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) for Lupkynis (voclosporin), along with a background immunosuppressive therapy. Lupkynis has also received orphan drug designation in Switzerland. This promotes podocyte stability in the kidneys.

Marketing 130

Marketing Licensing Licensing Production 130

Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.

Antibody 130

Antibody Development Drugs Licensing 130

Pharmaceutical Technology

MAY 24, 2023

Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. The therapy is given three times a week and repeated every four weeks.

Marketing 130

Marketing Licensing Licensing Antibody 130

Pharmaceutical Technology

JULY 4, 2022

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement.

Antibody 279

Antibody Genotype Development Licensing 279

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JUNE 5, 2023

Pint-Pharma will obtain and maintain all marketing authorisations and will commercialise BESREMi in the region. It holds orphan drug designation in the US to treat PV. In 2019, the European Medicines Agency approved the therapy, which has also been licensed in Japan, Taiwan and South Korea.

Marketing 130

Marketing Licensing Licensing Sales 130

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

Marketing 97

Marketing Research Trials Clinical Trials 97

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

Marketing 130

Marketing Gene Editing Production Sales 130

Pharmaceutical Technology

MAY 1, 2023

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

Licensing 162

Licensing Licensing Sales Packaging 162

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

Development 242

Development Bioequivalency Generic Drugs Production 242

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).

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.

Drugs 130

Drugs Pharma Companies Medicine Production 130

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

Generic Drugs 187

Generic Drugs Manufacturing Drugs Production 187