Pharma

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After an FDA inspection at an Indian manufacturing facility, Lupin turns off the light

After an FDA inspection at an Indian manufacturing facility, Lupin turns off the light

SG Tylor

Source – Lupin Lupin, a major generics company, has received a relatively mild rebuke from the US Food and Drug ...

How will Medicare be affected by the cost of Leqembi from Eisai and Biogen? Sen. Sanders is curious

How will Medicare be affected by the cost of Leqembi from Eisai and Biogen? Sen. Sanders is curious

SG Tylor

Senator Bernie Sanders (I-Vt.) is increasing his pressure on the US Department of Health and Human Services (HHS) regarding the ...

Promising Phase III Results: OCREVUS (Ocrelizumab) Subcutaneous Injection Offers Convenient and Efficient Treatment for Multiple Sclerosis

Promising Phase III Results: OCREVUS (Ocrelizumab) Subcutaneous Injection Offers Convenient and Efficient Treatment for Multiple Sclerosis

SG Tylor

Source – Roche On 13 July Roche announced positive results from the Phase III OCARINA II trial, which investigated the ...

Daratumumab in Multiple Myeloma - A Breakthrough Treatment Explained

Daratumumab in Multiple Myeloma: What You Need to Know

SG Tylor

Multiple myeloma is a serious and incurable blood cancer that affects millions of people worldwide. But there is hope. A ...

Third Line Treatment For Multiple Myeloma What You Need to Know

Third Line Treatment For Multiple Myeloma: What You Need to Know

SG Tylor

Multiple myeloma is a type of blood cancer that affects plasma cells, which are responsible for producing antibodies. When plasma ...

Second-Line Treatment of Multiple Myeloma Current and Future Options

Second-line treatment of multiple myeloma: current choices and future prospects

SG Tylor

This blog will discuss the second-line treatment of multiple myeloma, a blood cancer that affects antibody-producing plasma cells. Multiple myeloma ...

First-Line Treatment of Multiple Myeloma A Comprehensive Guide

First-Line Treatment of Multiple Myeloma: What You Need to Know

SG Tylor

Multiple myeloma is a type of blood cancer that affects plasma cells, which are responsible for producing antibodies. It is ...

Multiple Myeloma Causes, Symptoms, Diagnosis, Prognosis, and Treatment Options

Multiple Myeloma: What You Need to Know About This Rare Blood Cancer

SG Tylor

Imagine having a type of white blood cell that is supposed to protect you from infections, but instead turns against ...

The Safety of THIO Sequenced With Cemiplimab in NSCLC Remains Promising

The Safety of THIO Sequenced With Cemiplimab in NSCLC Remains Promising

SG Tylor

Source – MAIA Biotechnology Two patients with advanced non-small cell lung cancer (NSCLC) have not experienced disease progression for 12.2 ...

Avutometinib_Defactinib Phase III Confirmatory Study in LGSOC Completes Design

Avutometinib/Defactinib Phase III Confirmatory Study in LGSOC Completes Design

SG Tylor

Source –  Verastem Oncology The FDA and Verastem Oncology have finalized the design of a Phase III clinical trial to ...

In unresectable_metastatic urothelial carcinoma, upfront nivolumab_chemotherapy prolongs survival

In unresectable/metastatic urothelial carcinoma, upfront nivolumab/chemotherapy prolongs survival

SG Tylor

Source –Bristol-Myers Squibb Nivolumab plus chemotherapy showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival ...

VPAS negotiations are prohibited by the UK High Court from taking place

VPAS negotiations are prohibited by the UK High Court from taking place

SG Tylor

The British Generic Manufacturers Association (BGMA) has been denied a seat at the negotiation table for the new Voluntary Scheme ...

BMS purchases the Prothena Alzheimer's medication in a $2.2 billion transaction

BMS purchases the Prothena Alzheimer’s medication in a $2.2 billion transaction

SG Tylor

Source: Prothena Bristol-Myers Squibb has taken an option on a tau protein-targeting antibody in early-stage clinical development from Prothena on ...

Sensorion Seeks Approval for Clinical Trial of OTOF-GT Gene Therapy Candidate in the UK

Sensorion Seeks Approval for Clinical Trial of OTOF-GT Gene Therapy Candidate in the UK

SG Tylor

Source – Sensorion On July 10, Sensorion filed its first regulatory application to start human testing of OTOF-GT, a gene ...

Better receives FDA approval for its primary DTx medication

Better receives FDA approval for its primary DTx medication

SG Tylor

Source –Better Therapeutics On 10 July, Digital health company Better Therapeutics received FDA approval for its lead digital therapeutic (DTx), ...

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 ...