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

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 biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. However, the use of hormone replacement therapy comes with its set of challenges.

Hormones 244

Hormones FDA Approval Licensing Licensing 244

pharmaphorum

NOVEMBER 24, 2020

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

FDA Approval 106

FDA Approval Medicine Licensing Licensing 106

XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy. AstraZeneca is also venturing into cell therapy and genetic medicine.

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

OCTOBER 22, 2024

The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. At the end of May, the FDA accepted the Japanese company’s resubmission of its biologics license application (BLA) for the drug.

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

BioSpace

JUNE 5, 2022

GSK's MMR vaccine is only the second to be approved in the United States for protection against measles, mumps and rubella. The first, licensed to Merck, was approved in 1971.

FDA Approval 96

FDA Approval Vaccination Vaccine Licensing 96

XTalks

JULY 25, 2023

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Additionally, 533 participants received at least one dose of the comparator-licensed anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed). Overall, 66.3

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

BioSpace

SEPTEMBER 28, 2023

Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.

FDA Approval 92

FDA Approval Licensing Licensing Regulation 92

BioSpace

JULY 28, 2021

Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Licensing 98

XTalks

JULY 14, 2022

In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

pharmaphorum

DECEMBER 4, 2020

CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC. The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Drugs 93

Fierce Pharma

OCTOBER 24, 2023

The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent. . | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

FDA Approval 93

FDA Approval Vaccination Vaccine Licensing 93

Scienmag

AUGUST 5, 2020

Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink.

FDA Approval 55

FDA Approval Licensing Licensing Engineer 55

Scienmag

MARCH 28, 2021

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. March 29, 2021) – The U.S.

Production 76

Production FDA Approval Licensing Licensing 76

BioTech 365

APRIL 21, 2021

KemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS™ Per License Agreement with Affiliate of Gurnet Point Capital KemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS™ Per License Agreement with Affiliate … Continue reading →

FDA Approval 40

FDA Approval Licensing Licensing 40

BioTech 365

MARCH 16, 2021

FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases in Dogs and Cats FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases … Continue reading →

FDA Approval 40

FDA Approval Licensing Licensing Development 40

Pharmaceutical Technology

APRIL 17, 2023

STS101 combines Satsuma’s nasal powder formulation and Shin Nippon Biomedical Laboratories’ (SNBL) delivery device technology, which was licensed by Satsuma. SNBL has also signed a definitive agreement to acquire Satsuma Pharmaceuticals. per share in cash, along with one non-tradeable contingent value right (CVR) of up to $5.77

Drugs 147

Drugs Drug Delivery FDA Approval Licensing 147

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

FEBRUARY 4, 2025

Related: FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease Maze stands out in the biotech space with its Compass platform, which analyzes genetic data to identify disease-linked variants. To further expand its research, Maze has entered several strategic partnerships and licensing agreements.

Clinical Trials 66

Clinical Trials Clinical Trials Trials Genetics 66

pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.

Licensing 65

Licensing Licensing Sales FDA Approval 65

Pharmaceutical Technology

MAY 30, 2023

Medsenic reached licensing, marketing and supply agreements with Phebra for OATO in May 2021. Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of arsenic trioxide (OATO).

Clinical Supply 130

Clinical Supply FDA Approval Licensing Licensing 130

Fierce Pharma

NOVEMBER 9, 2023

AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for Hutchmed-developed colorectal cancer drug Fruzaqla.

FDA Approval 69

FDA Approval Licensing Licensing Drugs 69

pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

Licensing 52

Licensing Licensing FDA Approval Trials 52

XTalks

DECEMBER 7, 2022

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). The median time to complete remission was 1.9 billion deal.

FDA Approval 52

FDA Approval Drugs Licensing Licensing 52

BioTech 365

JANUARY 25, 2022

Ignis Therapeutics Licenses NeuroSigma eTNS Technology for ADHD in a Significant China Licensing Transaction Ignis Therapeutics Licenses NeuroSigma eTNS Technology for ADHD in a Significant China Licensing Transaction Ignis obtains rights to develop and commercialize NeuroSigma’s FDA-approved Monarch eTNS System in China … Continue reading → (..)

Licensing 40

Licensing Licensing FDA Approval Development 40

XTalks

AUGUST 10, 2022

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer.

Life Science 52

Life Science FDA Approval Drugs Licensing 52

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

pharmaphorum

NOVEMBER 24, 2020

Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year. Alnylam licensed inclisiran to The Medicines Company, which was bought last year by Novartis for $9.7

FDA Approval 52

FDA Approval Gene Silencing Drugs RNA 52

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

Pharmaceutical Technology

MARCH 27, 2023

Iovance Bioterapeutics announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for Lifileucel. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

FDA Approval 130

FDA Approval Licensing Licensing Trials 130

XTalks

DECEMBER 18, 2024

In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis. It also received the FDAs rare pediatric disease priority review voucher along with the approval, which will help expedite the agencys assessment of another application.

Genetics 116

Genetics Hormones Trials Drugs 116

BioSpace

DECEMBER 12, 2023

The deal follows the FDA approval of Vertex’s gene-editing sickle cell treatment and Editas’ earlier legal battle over rights to the technology.

Gene Editing 57

Gene Editing Licensing Licensing FDA Approval 57

XTalks

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). Last year, the FDA approved the first generic version of Restasis.

FDA Approval 98

FDA Approval Gene Therapy Gene Marketing 98

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