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Talazoparib Plus Enzalutamide for HRR Gene-Altered mCRPC Receives FDA Approval

Talazoparib Plus Enzalutamide for HRR Gene-Altered mCRPC Receives FDA Approval

SG Tylor

Source – FDA On June 20, 2023, the combination of talazoparib (Talzenna) and enzalutamide (Xtandi) has been approved by the ...

Takeda Unveils Complete Phase III Trial Results for HYQVIA as Maintenance Therapy in CIDP at PNS Annual Meeting

Takeda Unveils Complete Phase III Trial Results for HYQVIA as Maintenance Therapy in CIDP at PNS Annual Meeting

SG Tylor

Source: Takeda Takeda on June 20, 2023, released the complete findings from the pivotal Phase III ADVANCE-CIDP 1 clinical trial, ...

Argenx receives FDA approval for the first gMG subcutaneous treatment

Argenx receives FDA approval for the first gMG subcutaneous treatment

SG Tylor

Source – Argenx  Argenx has claimed an FDA clearance that might increase its market share in the increasingly competitive market ...

CDC advisory group reviews GSK and Pfizer RSV vaccinations

CDC advisory group reviews GSK and Pfizer RSV vaccinations

SG Tylor

Source – Fierce Pharma On June 21, 2023,  the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease ...

Vyvanse Joins Adderall in Short Supply as Takeda's Rival Faces Shortages

Vyvanse Joins Adderall in Short Supply as Takeda’s Rival Faces Shortages

SG Tylor

Source – Fierce Pharma A competitor medication from Takeda is currently in low supply after a lengthy scarcity of the ...

The US FDA has approved the use of Jardiance (empagliflozin) to treat type II diabetes in children and adolescents aged 10 and older

The US FDA has approved the use of Jardiance (empagliflozin) to treat type II diabetes in children and adolescents aged 10 and older

SG Tylor

Source – Eli Lilly On June 21, 2023, Boehringer Ingelheim and Eli Lilly and Company announced that the US Food ...

BioSenic's stock declines as it discontinues bone-repair treatment

BioSenic’s stock declines as it discontinues bone-repair treatment

SG Tylor

Source – BioSenic A Phase II b study of ALLOB, a stem cell-derived treatment intended to quicken bone fracture repair, ...

Boehringer Ingelheim's Zantac arbitration is won by Sanofi

Boehringer Ingelheim’s Zantac arbitration is won by Sanofi

SG Tylor

Source – Sanofi On 20 June 2023 in Paris, Sanofi reports that the International Chamber of Commerce tribunal has rejected ...

Rani's 'robotic' tablet administers an injection of an osteoporosis medication

Rani’s ‘robotic’ tablet administers an injection of an osteoporosis medication

SG Tylor

Source – Rani Therapeutics In a first-in-human research, US biotech Rani Therapeutics demonstrated that its oral version of an osteoporosis ...

According to a poll, the expense of new cancer drugs is the main obstacle to their adoption in the US, and the knowledge of cell and gene therapies is lacking

High Cost of New Cancer Drugs and Lack of Awareness Impede Adoption in the US

SG Tylor

A new survey conducted by healthcare research firm Sermo revealed that oncologists in the United States perceive pricing as the ...

A monovalent COVID booster is advised by the FDA advisory group

A monovalent COVID booster is advised by the FDA advisory group

SG Tylor

The FDA advisory panel recently reached a unanimous conclusion regarding COVID-19 vaccinations for the upcoming autumn. They recommended a transition ...

FDA Accepts sNDA for NALIRIFOX as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma

FDA Accepts sNDA for NALIRIFOX as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma

SG Tylor

Source: Ipsen Pharma The FDA has accepted a supplemental new drug application (sNDA) for the combination of liposomal irinotecan, 5-fluorouracil, ...

Merck Completes Acquisition of Prometheus Biosciences, Expanding Pipeline with Potential Breakthrough Treatment

Merck Completes Acquisition of Prometheus Biosciences, Expanding Pipeline with Potential Breakthrough Treatment

SG Tylor

Source: Merck On June 16, 2023, Merck announced the successful completion of its acquisition of Prometheus Biosciences, making Prometheus a ...

Keytruda Triumphs: Promising Progression-Free Survival in HER2-Positive Gastric Cancer

Keytruda Triumphs: Promising Progression-Free Survival in HER2-Positive Gastric Cancer

SG Tylor

Source: Merck Merck’s renowned cancer drug, Keytruda, may soon see an updated label for its effectiveness in treating HER2-positive stomach ...

Groundbreaking Clinical Trial Confirms Effectiveness of Emgality in Preventing Episodic Migraines

Groundbreaking Clinical Trial Confirms Effectiveness of Emgality in Preventing Episodic Migraines

SG Tylor

Source: Eli Lilly and Company On June 16, 2023, Eli Lilly and Company released the findings of the CHALLENGE-MIG clinical ...

The FDA supports a biomarker for aggressive fibrotic tumors

The FDA supports a biomarker for aggressive fibrotic tumors

SG Tylor

Source: Nordic Bio The FDA has granted its backing to a blood test that may be able to determine if ...

AbbVie claims that Coherus violated the Humira patent settlement by working with Mark Cuban's pharmaceutical company

AbbVie claims that Coherus violated the Humira patent settlement by working with Mark Cuban’s pharmaceutical company

SG Tylor

AbbVie says that Coherus breached a licensing agreement that controls the commercialization of the biosimilar in a regulatory filing. The ...

FDA committee to talk about choosing the right strain for the subsequent round of COVID-19 boosts

FDA committee to talk about choosing the right strain for the subsequent round of COVID-19 boosts

SG Tylor

Source – FDA The FDA’s Advisory Committee on Vaccines and Related Biological Products will meet on 15 June to discuss ...

Ex-baseball player hired by AbbVie to help de-stigmatize bowel condition as part of their post-Humira growth strategy

Ex-baseball player hired by AbbVie to help de-stigmatize bowel condition as part of their post-Humira growth strategy

SG Tylor

In his second season playing professional baseball, Fowler, who won the World Series with the Chicago Cubs in 2016, had ...

In a heated dispute over blood cancer treatment, AbbVie sues BeiGene over a brand-new Imbruvica patent

In a heated dispute over blood cancer treatment, AbbVie sues BeiGene over a brand-new Imbruvica patent

SG Tylor

AbbVie’s Pharmacyclics division claims that BeiGene’s Bruki Nsa violates a patent on its blood cancer medication Imbruvica in a recent ...

Skyrizi from AbbVie wins a maintenance trial for ulcerative colitis and is poised to receive FDA approval

Skyrizi from AbbVie wins a maintenance trial for ulcerative colitis and is poised to receive FDA approval

SG Tylor

Source – Abbvie On 16 June 2023, Risankizumab (SKYRIZI, 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint ...

Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

SG Tylor

Source – Roche Columvi (Glofitamab-gxbm) has been given expedited clearance by the FDA for the treatment of adult patients with ...

98% ORR in Early-Stage Classical Hodgkin Lymphoma with Brentuximab Vedotin + Nivolumab/Chemo

98% ORR in Early-Stage Classical Hodgkin Lymphoma with Brentuximab Vedotin + Nivolumab/Chemo

SG Tylor

Source – Seagen Frontline treatment with the combination of brentuximab vedotin (Adcetris), nivolumab (Opdivo), doxorubicin, and dacarbazine led to an ...

FDA Prolongates PDUFA Nirogacestat's NDA for desmoid tumors is three months from today

FDA Prolongates PDUFA Nirogacestat’s NDA for desmoid tumors is three months

SG Tylor

Source – SpringWorks According to SpringWorks Therapeutics on June 7, 2023,  the FDA has extended the Prescription Drug User Fee ...

Clinical Activity Is Induced by Ziftomenib in NPM1-mutant R/R AM

Clinical Activity is Induced by Ziftomenib in NPM1-mutant R/R AML

SG Tylor

Source – Kura Oncology Phase I data from the KOMET-001 trial (NCT04067336) showed that treatment with Ziftomenib, a menin-MLL (KMT2A) ...

Companion Diagnostic for Encorafenib + Cetuximab in BRAF V600E alteration in mCRC Receives FDA Approval

Companion Diagnostic for Encorafenib + Cetuximab in BRAF V600E alteration in mCRC Receives FDA Approval

SG Tylor

Source – Foundation Medicine In order to identify patients with metastatic colorectal cancer (mCRC) who could be candidates to receive ...

Kura makes a $100 million offer when AML is caused by a Menin inhibitor

Kura makes a $100 million offer when AML is caused by a Menin inhibitor

SG Tylor

Source – Kura Oncology Safety problems had previously slowed down the development of Kura Oncology’s Menin inhibitor Ziftomenib for acute ...

Trial of 2seventy Bio's AML cell treatment was put on hold following a death

Trial of 2seventy Bio’s AML cell treatment was put on hold following a death

SG Tylor

Source – 2seventy bio On June 14, 2023, as a result of Seattle Children’s Therapeutics pausing a clinical study of ...

To support women's health programmes in Latin America and the Caribbean, Organon partners with a bank

To support women’s health programmes in Latin America and the Caribbean, Organon partners with a bank

SG Tylor

Source: Organon Organon, a women’s health company, set objectives for increasing access to healthcare last summer in its inaugural environmental, ...

Acadia plans a Phase III study for a Prader-Willi syndrome candidate following an FDA meeting

Acadia plans a Phase III study for a Prader-Willi syndrome candidate following an FDA meeting

SG Tylor

Source – Acadia Pharmaceuticals ACP-101, also known as intranasal carbetocin, has been chosen by Acadia to move forward into a ...