The Pharma Data

SEPTEMBER 9, 2020

CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Stroke Research and Treatment, Hindawi, 27 Nov.

Treatment 52

Treatment Production Science Disease 52

The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

Treatment 52

Treatment DNA Trials Therapies 52

The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

Treatment 52

Treatment Pharmaceutical Companies Therapies Virus 52

Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. She also does not believe that the problems with Europe’s medicines can be solved with regulation. If you measure everything on faster, I’m not sure Europe will always come out ahead.”

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Drug Discovery World

APRIL 14, 2023

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

Drug Target Review

APRIL 3, 2024

So far, GDF-15 has mainly been known as an important factor in feto-maternal tolerance and a regulator of nausea, anorexia, and food aversion in different diseases, including cancer and the pregnancy complication hyperemesis gravidarum. Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

Science 105

Science Clinical Development DNA Treatment 105

The Pharma Data

MARCH 3, 2022

There is no current oral treatment for this disease. The United States Food and Drug Administration approved verapamil for the treatment of high blood pressure in 1981. The top serum protein altered by verapamil treatment was chromogranin A, or CHGA, which was downregulated with treatment.

RNA 52

RNA Treatment Disease Regulations 52

Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. Dewpoint Therapeutics, a platform drug discovery company founded in 2018, has been at the forefront of this exciting field.

Disease 98

Disease Small Molecule Cell Biology Medical Schools 98

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. The integration of technology in healthcare not only promises advancements but also raises concerns about security, regulation and potential disparities in access.

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. 15(9):700-706 (2018) [link] Deshmukh V, et al. A regenerative approach to the treatment of multiple sclerosis. TS has been studied through the generation of “assembloids”, glutamatergic and GABAergic organoids fused together.

Targeted Protein Degradation 58

Targeted Protein Degradation Drugs FDA Approval Disease 58

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations 40

Regulations Compliance Government Production 40

Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

FDA 40

FDA Drugs Regulations Biosimilars 40

The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., vice president and head, global oncology development, AbbVie.

Treatment 40

Treatment Trials Therapies Clinical Trials 40

Drug Discovery World

JULY 11, 2022

Clinical trial sponsors need to coordinate the delivery of investigational medicinal products to clinical sites and the collection of samples from participants after they receive treatment. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5.

Therapies 130

Therapies Clinical Trials Production Trials 130

Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. I work on a rare disease called primary mitochondrial myopathy, for which there is currently no approved treatment.

Cell Biology 107

Cell Biology Pharmaceuticals Science International 107

The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Both treatments were administered subcutaneously at week 0, 2, and 4.

Treatment 52

Treatment Disease Therapies FDA 52

The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. ” Market Abuse Regulation (MAR) Disclosure. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” [link]. .

Pharmaceuticals 40

Pharmaceuticals Engineering Regulations Pharmaceutical Companies 40

Drug Target Review

JANUARY 5, 2024

and the work reported in: Bosch DE, Jeck WR, and Siderovski DP ‘Self-activating G protein alpha subunits engage seven-transmembrane regulator of G protein signaling (RGS) proteins and a Rho guanine nucleotide exchange factor effector in the amoeba Naegleria fowleri.’ NIH R01 DA048153 (to D.P.S.), Epub 20230720. doi: 10.1128/jcm.01269-22.

Small Molecule 59

Small Molecule Drugs Biochemical Assays Regulations 59

The Pharma Data

MARCH 23, 2022

Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase. But targeting Ebola virus polymerase has proven tough.

Virus 52

Virus Small Molecule Protein Production RNA 52

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

Disease 52

Disease Clinical Trials Trials Treatment 52

The Pharma Data

OCTOBER 29, 2020

Government to Cover COVID-19 Vaccine, Treatments. Centers for Medicare and Medicaid Services, also increase what Medicare pays hospitals for COVID-19 treatments. The regulations take effect immediately, the AP said. since 2018 looking for traces of opioids. The rules, from the U.S.

Vaccine 40

Vaccine Virus Government Trials 40

The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

FDA 52

FDA Clinical Trials Trials Treatment 52

Agency IQ

NOVEMBER 3, 2023

The rule also proposes a ban on treatments for disposal of TCE. OCT 30, 2023 6:28 PM CDT TCE and regulation under TSCA Trichloroethylene also known as TCE (CAS RN 79-01-6) is a volatile organic compound used mostly in industrial and commercial processes. BY PATRICIA ISCARO, ESQ. | These would be established on a case-by-case basis.

Compliance 40

Compliance Treatment Engineering Production 40

Agency IQ

JULY 7, 2023

regulators have previously discussed , using RWE “for regulatory decision-making is already a reality, and there is increasing interest in using big data and advanced analytics as a complementary source of evidence.” Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

Regulations 40

Regulations Production Research Government 40

The Pharma Data

OCTOBER 15, 2020

It demonstrates that flexible Blue Light Cystoscopy helped resolve a substantial amount of cases by complete removal on-site or direct referral to intravesical treatment, providing increased efficacy to manage non-muscle-invasive bladder cancer (NMIBC) in the office setting. OSLO, Norway , Oct. Here is a link to the poster.

Treatment 52

Treatment Production Regulations Therapies 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

Drugs 45

Drugs Biosimilars Production Treatment 45

The Pharma Data

NOVEMBER 9, 2020

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. Psychedelic compounds are emerging as a new class of drug with potential for significant impact in the treatment of mental health related medical indications such as depression, anxiety, addiction, anorexia and post-traumatic stress disorder.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

The Pharma Data

AUGUST 8, 2020

Lilly earned Chinese rights to Tyvyt through a pact the two signed in 2015, and the drug was first approved in December 2018 in third-line classic Hodgkin lymphoma. BeiGene’s application for that indication was accepted by Chinese regulators in June.

Trials 52

Trials Pharmacy Hospitals International 52

Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.”

Vaccine 132

Vaccine Trials Disease Virus 132

Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

Therapies 246

Therapies Virus Treatment Engineering 246

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

Government 40

Government FDA Biosimilars Regulations 40

The Pharma Data

JANUARY 19, 2021

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council as supplemented by Commission Delegated Regulation (EU) 2019/980 (the “Prospectus Regulation”).

Regulations 52

Regulations Clinical Trials Trials Marketing 52

Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

The Pharma Data

DECEMBER 17, 2020

In this study, data from the RADARS ® System’s Survey of Non-Medical Use of Prescription Drugs (NMURx) Program online cross-sectional general population national surveys are analyzed from 2018 from four countries, Germany, Italy, Spain, and the UK, with 45,000 total responses.

Government 52

Government Production Pharmaceuticals Pharmaceutical Companies 52