BioPharma Drive: Drug Pricing

AUGUST 28, 2023

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

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Drug Discovery World

SEPTEMBER 27, 2023

The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an autologous stem cell transplant (ASCT) is unsuitable. Seven years of trial data DLd is licensed and has been available for use in Europe since 2019.

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Drug Discovery World

NOVEMBER 1, 2022

Its snapshot report aimed to provide both an overview of the sector in Australia to determine how the sector has changed since this data was collected in 2017 and 2019 2. . The number of employees behind our biotech companies has also expanded, increasing 21% compared with 2019 from approximately 87,397 people in 2019 to 105,569 in 2022.

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Drug Discovery World

OCTOBER 31, 2023

It has been used experimentally in international trials 1 , but researchers are hopeful that further use and evaluation in the UK will accelerate drug development for hard-to-treat neurodegenerative diseases. Currently, 15 trials of the new potential therapies for ALS have included NfL as an endpoint 8.

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Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). How does the DCI mechanism compare to the design of other drugs for cancer treatment?

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Drug Discovery World

AUGUST 14, 2023

Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at AmerisourceBergen, and Cori Gorman, Senior Director of CMC and Regulatory Affairs at Biopharma Excellence, offer advice on navigating the different and sometimes contradictory regulatory requirements in the US and EU. billion in 2020 to $15.5

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PLOS: DNA Science

OCTOBER 12, 2023

In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

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Drug Discovery World

SEPTEMBER 26, 2022

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. . Official comments . N Engl J Med. 2021;384: 1800-1809. Corren J, et al.

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. SAMSHA published an “ evidence-based resource guide ” on substance use disorder treatment in June 2020.

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The Pharma Data

NOVEMBER 2, 2020

(NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial. 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.

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The Pharma Data

OCTOBER 27, 2020

Dry AMD is one of the leading causes of vision loss globally and gene therapies hold tremendous promise for this disease. Delivering gene therapy directly to the site of disease through a subretinal injection is a proven approach; however, the current method requires a vitrectomy. There are currently no approved treatments for dry AMD.

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The Pharma Data

MAY 31, 2022

the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of Lozano, O.C.,

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®.

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The Pharma Data

SEPTEMBER 27, 2021

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe regional enteritis. The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to standard and/or biologic therapy.

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The Pharma Data

APRIL 19, 2022

Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies. — Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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The Pharma Data

AUGUST 4, 2020

Therapy has been approved to treat advanced NTRK fusion-positive solid tumours. The European Commission (EC) has granted conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment of advanced solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

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The Pharma Data

MARCH 9, 2021

The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy 4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings 2,3.

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The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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The Pharma Data

JUNE 28, 2021

“Despite available treatments, many people with moderate to severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. . We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”

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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. Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care).

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The Pharma Data

APRIL 17, 2021

New findings from MS PATHS show that treatment with TYSABRI ® (natalizumab) can lead to meaningful improvements in mental and social health compared to Ocrevus ® (ocrelizumab). Real-world data from VUMERITY ® (diroximel fumarate) reinforce the treatment’s positive gastrointestinal tolerability profile. CAMBRIDGE, Mass.,

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. 25% for dry eye disease treatment.

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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).

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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The Pharma Data

DECEMBER 2, 2020

(NYSE: PFE) today announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors. About the BASIS study. About the BASIS study.

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The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days. Kimberly Smith, M.D.,

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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The Pharma Data

JANUARY 15, 2021

for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. .–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. In the U.S., Sammons Cancer Center and the W.W. Caruth, Jr.

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The Pharma Data

JANUARY 19, 2021

20, 2021 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). SAN DIEGO, Jan. Dr. Dennis J. The company’s subsidiary, U.S.

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The Pharma Data

SEPTEMBER 6, 2020

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 2 In the 27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%), with an 11% CR rate.

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Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. 1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. Molecular Therapy 20 , 1831-1832 (2012). e419 (2023).

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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