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Takeda withdraws its FDA application for a dengue vaccine due to data disagreements with the authority

Takeda withdraws its FDA application for a dengue vaccine due to data disagreements with the authority

SG Tylor

Source: Takeda Takeda announced on 11 July that it is withdrawing its application for the dengue vaccine candidate, TAK-003, from ...

After 7 patient fatalities and 5 other serious adverse events, ADC suspends the Zynlonta research

After 7 patient fatalities and 5 other serious adverse events, ADC suspends the Zynlonta research

SG Tylor

Source – ADC Therapeutics ADC Therapeutics has halted enrollment in a Phase II combination trial for Zynlonta following the investigation ...

Moderna Files Two New Patent Lawsuits Against mRNA Competitors Pfizer and BioNTech

Moderna Files Two New Patent Lawsuits Against mRNA Competitors Pfizer and BioNTech

SG Tylor

In the ongoing patent disputes surrounding COVID-19 vaccines, Moderna has expanded its legal battle against Pfizer and BioNTech by filing ...

IA Gemcitabine Provides Survival Benefit in Patients with Locally Advanced Pancreatic Cancer

IA Gemcitabine Provides Survival Benefit in Patients with Locally Advanced Pancreatic Cancer

SG Tylor

Source –  RenovoRx The interim results of the Phase III TIGeR-PaC study (NCT03257033) presented at the 2023 European Society of ...

Insufficient use of gene sequencing for lung cancer in Europe

Insufficient use of gene sequencing for lung cancer in Europe

SG Tylor

A recent report highlights that while next-generation sequencing (NGS) has the potential to improve patient outcomes and save money for ...

Future NHS Award goes to an AI-based tool for heart disease

Future NHS Award goes to an AI-based tool for heart disease

SG Tylor

A digital tool created by NHS researchers to expedite the diagnosis of heart disease has been honored with the Future ...

GLP-1 medications from Novo Nordisk are being examined in Europe following reports suggest potential suicide risks

GLP-1 medications from Novo Nordisk are being examined in Europe following reports suggest potential suicide risks

SG Tylor

Following reports of two cases of suicidal thoughts and one case of self-harm among users in Iceland, the European Medicines ...

Samsung Biologics Inks $391M Deal with Novartis for Drug Production

After extending its Pfizer collaboration, Samsung Biologics signs a $391M manufacturing agreement with Novartis

SG Tylor

Shortly after finalizing two deals worth $897 million with Pfizer, Samsung Biologics has expanded its partnership with Novartis, adding hundreds ...

Roche's Columvi (glofitamab) for patients with R_R diffuse large B-cell lymphoma has received approval from the European Commission

Roche’s Columvi (glofitamab) for patients with R/R diffuse large B-cell lymphoma has received approval from the European Commission

SG Tylor

Source – Roche On 11 July 2023 Roche announced that the European Commission (EC) has given conditional approval for Columvi ...

Paxalisib With Radiation Receives Fast Track Designation from FDA for Brain Metastases

Paxalisib With Radiation Receives Fast Track Designation from FDA for Brain Metastases

SG Tylor

The FDA has granted fast track designation to the combination of paxalisib (GDC-0084) and radiation for the treatment of patients ...

Humira biosimilar to be made available by RxPreferred via Mark Cuban's online pharmacy

Humira biosimilar to be made available by RxPreferred via Mark Cuban’s online pharmacy

SG Tylor

Pharmacy benefits manager (PBM) RxPreferred has unveiled its plan to provide the Humira biosimilar Yusimry through Mark Cuban Cost Plus ...

Novavax's Covid vaccine receives a unanimous EU approval

Novavax’s Covid vaccine receives a unanimous EU approval

SG Tylor

Source –  Novavax Novavax received full Marketing Authorization (MA) from the European Commission for its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373). This ...

FDA criticizes Intas and Ipca for manufacturing flaws at three Indian factories

FDA criticizes Intas and Ipca for manufacturing flaws at three Indian factories

SG Tylor

Following a slowdown in FDA inspections in recent years due to the pandemic, inspections are now back in full swing, ...

New lawsuits from Novo Nordisk are filed against synthetic versions of Wegovy and Ozempic

New lawsuits from Novo Nordisk are filed against synthetic versions of Wegovy and Ozempic

SG Tylor

Source – FDA The increasing demand for GLP-1 drugs, which can lead to significant weight loss, has resulted in unauthorized ...

Following a report of an inhaler leak, Cipla recalls six batches of the asthma medication albuterol

Following a report of an inhaler leak, Cipla recalls six batches of the asthma medication albuterol

SG Tylor

Source – Cipla On July 10 2023, Cipla, a pharmaceutical company that recently received a 23-page Form 483 filing from ...

Sarepta Therapeutics Sells Rare Pediatric Disease Priority Review Voucher for $102 Million to Boost Research and Development. Pharmtales - Latest Pharma News and Insights

Sarepta Therapeutics Sells Rare Pediatric Disease Priority Review Voucher for $102 Million to Boost Research and Development

SG Tylor

Source – Sarepta Therapeutics On July 5, 2023, Sarepta Therapeutics, a leading company in precision genetic medicine for rare diseases, ...

European Commission Grants Approval for ORKAMBI to Treat Cystic Fibrosis in Children. Pharmtales - Latest Pharma News and Insights

European Commission Grants Approval for ORKAMBI to Treat Cystic Fibrosis in Children Aged 1 to <2 Years

SG Tylor

Source –  Vertex Pharmaceuticals On July 5, 2023, Vertex Pharmaceuticals announced that the European Commission has granted approval for the ...

Novartis to Appeal Court Decision on Entresto Combination Patent; Confirms 2023 Guidance and Mid-Term Outlook. Pharmtales - Latest Pharma News and Insights

Novartis to Appeal Court Decision on Entresto Combination Patent; Confirms 2023 Guidance and Mid-Term Outlook

SG Tylor

Source: Novartis On July 7, 2023, Novartis received a negative decision from the US District Court regarding the validity of ...

Long-Term Results from MIRROR Trial: KRYSTEXXA Injection Combined with Methotrexate Reveals Promising Outcomes

Long-Term Results from MIRROR Trial: KRYSTEXXA Injection Combined with Methotrexate Reveals Promising Outcomes

SG Tylor

Source – Horizon On July 6, 2023, Horizon Therapeutics announced the publication of long-term data from the MIRROR randomized controlled ...

LifeArc's project for rare diseases will spend £100 million on patient care

LifeArc’s project for rare diseases will spend £100 million on patient care

SG Tylor

Source – LifeArc LifeArc, a self-funded non-profit medical research organization and charity, has announced the launch of the Rare Disease ...

New Study Demonstrates Psilocybin as Affordable and Effective Treatment for Major Depression

New Study Demonstrates Psilocybin as Affordable and Effective Treatment for Major Depression

SG Tylor

Research conducted by Clerkenwell Health and the University of Greenwich suggests that psilocybin, a psychedelic compound found in certain mushrooms, ...

FDA approves Astellas' zolbetuximab BLA for priority review

FDA approves Astellas’ zolbetuximab BLA for priority review

SG Tylor

Source – Astellas Pharma On July 6 2023, Astellas Pharma announced that the US Food and Drug Administration (FDA) has ...

Epcoritamab Receives FDA Approval – A Game-Changer in Cancer Treatment

FDA Grants Approval to Epcoritamab– Redefining the Future of DLBCL

SG Tylor

In the world of cancer treatment, groundbreaking advancements are constantly being made, offering new hope for patients and their loved ...

Bernie Sanders suggests placing price limitations on medications created with public funding - Latest USA Pharma News

Bernie Sanders suggests placing price limitations on medications created with public funding

SG Tylor

Following his appointment as chairman of the Senate Health, Education, Labor, and Pensions Committee, Senator Bernie Sanders from Vermont, a ...

Eisai and Biogen Embark on Full Launch of Leqembi Following Alzheimer's Approval - Lates USA Pharma News By Pharmtales

Eisai and Biogen Embark on Full Launch of Leqembi Following Alzheimer’s Approval

SG Tylor

Source – Eisai On July 6, 2023, Eisai and Biogen received full approval from the FDA for their Alzheimer’s disease ...

Pirtobrutinib Shows Promise as a Novel CLL_SLL Treatment for Patients Previously Treated with BTK Inhibitors - Lates USA Pharma News By Pharmtales

Pirtobrutinib Shows Promise as a Novel CLL/SLL Treatment for Patients Previously Treated with BTK Inhibitors

SG Tylor

Source – Eli Lilly On July 6, 2023,  Eli Lilly and Company’s oncology unit announced that The New England Journal ...

Moderna Submits Global Regulatory Applications for its RSV Vaccine, mRNA-1345 - USA Pharma News By Pharmtales

Moderna Submits Global Regulatory Applications for its RSV Vaccine, mRNA-1345

SG Tylor

Source – Moderna On July 5, 2023 Moderna, a biotech company at the forefront of mRNA vaccines, shared an update ...

relapsed-refractory-marginal-zone-lymphoma-reacts-abivertinib

Relapsed/Refractory Marginal Zone Lymphoma Reacts to Abivertinib

SG Tylor

A Phase IIa trial conducted in China demonstrated that treatment with the irreversible BTK inhibitor abivertinib (Fujovee) resulted in responses ...

Positive new Phase III MRI results from the NMOSD study UPLIZNA

Positive new Phase III MRI results from the NMOSD study UPLIZNA

SG Tylor

Source – Horizon Therapeutics Horizon Therapeutics unveiled positive MRI data from a Phase III clinical trial of UPLIZNA (inebilizumab) at ...

Moderna to research and manufacture mRNA meds in China under $1B agreement

Moderna to research and manufacture mRNA meds in China under $1B agreement

SG Tylor

Despite ongoing political tensions between the United States and China, foreign investments in the pharmaceutical sector are progressing in China. ...