Bio Pharma Dive

MARCH 30, 2023

The licensing deal for the FDA-approved medicine, Brexafemme, includes milestone payments that could add up to $503 million.

FDA Approval 162

FDA Approval Medicine Licensing Licensing 162

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 Trials Licensing 52

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 Antibody Insulin Drugs 98

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 Antibody Drugs Trials 264

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).

FDA Approval 130

FDA Approval Clinical Supply Licensing Licensing 130

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 94

FDA Approval Gene Expression Clinical Trials Clinical Trials 94

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 Drugs Trials 105

Pharmaceutical Technology

APRIL 25, 2023

Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Drugs 130

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 94

FDA Approval Gene Therapy Gene Clinical Trials 94

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

Drug Discovery World

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). . The company also offers financial assistance options to eligible patients for out-of-pocket costs. . .

FDA Approval 52

FDA Approval Antibody Drugs Medicine 52

XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody Drugs 105

Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. The ROFN is exercisable by Sanofi until 30 June next year.

FDA Approval 299

FDA Approval Antibody Drugs Medicine 299

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 105

FDA Approval Medicine Drugs Licensing 105

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.

FDA Approval 52

FDA Approval Life Science Drugs Antibody 52

XTalks

JUNE 20, 2022

Amvuttra’s FDA approval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. The condition has very limited treatment options.

FDA Approval 98

FDA Approval Protein Genetics RNA 98

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 FDA Approval Drug Delivery Licensing 147

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore was granted the approval for Kimmtrak several weeks ahead of the scheduled PDUFA date of February 23. Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore.

FDA Approval 98

FDA Approval Protein Medicine Drugs 98

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 Clinical Trials 52

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

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 98

FDA Approval Vaccination Vaccine Licensing 98

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 52

FDA Approval Licensing Licensing Drugs 52

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 Medicine 55

Pharmaceutical Technology

MARCH 27, 2023

Since its publication on 21 December 2022, it has predicted the following events correctly: The FDA approved GlaxoSmithKline’s (Brentford, UK) Jesduvroq (daprodustat) on 1 February 2023, for the once-daily treatment of anaemia caused by chronic kidney disease in adults administered dialysis for at least four months.

Drugs 130

Drugs FDA Approval Clinical Trials Clinical Trials 130

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 Antibody Drugs Licensing 93

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.

FDA Approval 52

FDA Approval Licensing Licensing Drugs 52

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 Drugs Gene Silencing RNA 52

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 Drugs Trials Medicine 130

Pharmaceutical Technology

MARCH 6, 2023

Coherus Biosciences subsequently acquired the rights to commercialise Tuoyi in the US and Canada, and a revised biologics license application (BLA) was submitted to the FDA in July 2022 under priority review. Tuoyi also enjoys an FDA breakthrough therapy designation.

FDA Approval 130

FDA Approval Antibody Trials HR 130

Pharmaceutical Technology

MARCH 31, 2023

It will also receive an additional $15m in milestone payments, upon receipt of US FDA approval for an additional indication. The company will receive up to $245.5m in specific development, regulatory and commercial milestones related to IC indications. Additionally, GSK will pay up to $242.5m

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Drugs 130

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

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Jazz Pharmaceuticals announced the U.S.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

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

MARCH 21, 2023

Daybue’s FDA approval was accompanied by a Rare Pediatric Disease Priority Review Voucher, which can be used to obtain priority review for a subsequent application. Daybue’s FDA approval was supported by results from the pivotal Phase III LAVENDER study that involved 187 female patients five to 20 years of age with Rett syndrome.

FDA Approval 89

FDA Approval Gene Therapy Gene Clinical Trials 89

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

Pharma Times

AUGUST 24, 2021

Biologics License Application approved to prevent COVID-19 in individuals 16 years of age and older

FDA Approval 121

FDA Approval Vaccination Vaccine Licensing 121