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billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and DrugAdministration approval for the non-Hodgkin lymphoma drug by a Dec. 31, 2020, deadline. 31, 2020, deadline.
According to EY, there were 69 deals worth $128 billion in 2020 and 90 deals worth $108 billion in 2021. Meanwhile, the Food and DrugAdministration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications.
It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 million (95% CI, $683.6
The US Food and DrugAdministration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.
A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and DrugAdministration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Then there is the cost of generic drugs.
The US Food and DrugAdministration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.
Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and DrugAdministration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.
In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.
A study of the causes of warning letters issued by the US Food and DrugAdministration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
The US Food and DrugAdministration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
QBiotics, a biotech firm in Australia, initially identified tigilanol tiglate as potentially useful for drug development. To develop the drug, researchers used a Chinese herbal medicine called Croton tiglium (purging croton), which has an active pharmaceutical ingredient (API) called phorbol.
The US Food and DrugAdministration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.
The US Food and DrugAdministration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. The EUA amendments by the FDA are based on the totality of available data. In August, Moderna sought FDA EUA for the BA.4/BA.5
There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth.
The US Food and DrugAdministration (FDA) granted final approval to the therapy in May 2023. The regulatory approval was based on the findings from the pivotal Phase III REST-ON clinical trial completed in March 2020.
The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. RelieVRx became the first FDA-authorised treatment for pain delivered at the patient’s home through virtual reality (VR) in November 2021.
In June this year, it was announced that the US Food and DrugAdministration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.
In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and DrugAdministration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.
Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.
Reducing severity of COVID-19 with monoclonal antibodies Between 2020 and 2022, the US Food and DrugAdministration (FDA) granted emergency use authorisation to five different COVID-19 monoclonal antibody treatments. The findings showed that the overall risk for hospitalisation or death at 28 days was 4.6
Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.
The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and DrugAdministration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .
The US Food and DrugAdministration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.
In reviewing both the revised ISO standard and FDA study discussed, it is clear robust evaluation of toxicological substances such as extractables and leachables remain a key part of device-drug combination product and medical device safety assessments.
The study compared outcomes for 110 patients treated with remdesivir and dexamethasone and 81 treated with both those medications plus baricitinib at Saint Peter’s University Hospital in New Jersey, USA, between June 2020 and June 2021. .
Adjuvanted vaccine Arexvy has been approved by the US Food and DrugAdministration (FDA). Approval of GSK’s RSV vaccine The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals. Now, the FDA has granted this milestone to GSK’s Arexvy. Could GSK offer the first RSV older adult vaccine?
1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and DrugAdministration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.
The US Food and DrugAdministration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.
Avadel Pharmaceuticals has received final approval from the US Food and DrugAdministration (FDA) for LUMRYZ to treat cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. It has also secured orphan drug exclusivity from the FDA until 1 May 2030.
In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID.
The US Food and DrugAdministration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. It was also granted Orphan Drug Designation during the same time.
Currently close to 80 percent of participants in clinical research trials are white, according to the Food and DrugAdministration (FDA). To address this issue, the BMSF created the Winn Award Program in 2020 as part of its commitment to health equity, inclusion and diversity.
In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and DrugAdministration (FDA) requires a patient follow up period of at least 10-15 years.
RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.
An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). US Food and DrugAdministration. Available from: [link].
Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.
MicroPort Navibot has received 510(K) clearance from the Food and DrugAdministration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. NaviBot is subsidiary of MicroPort MedBot. About MicroPort MedBot Shanghai MicroPort MedBot (Group) Co.,
A US Food and DrugAdministration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.
In the past year, Hemgenix has been granted approval by the US Food and DrugAdministration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). GlobalData is the parent company of Pharmaceutical Technology.
Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and DrugAdministration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.
The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.
The US Food and DrugAdministration (FDA) is currently reviewing a biologic licence application (BLA) for the vaccine candidate under priority review. The FDA awarded fast track designation for VLA1553 in 2018, and breakthrough therapy designation in 2021. Valneva plans to make further regulatory submissions.
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