The Pharma Data

OCTOBER 26, 2020

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. The trial was paused earlier this month due to a safety issue.

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The Pharma Data

DECEMBER 14, 2020

Researchers with the UK’s multi-armed RECOVERY trial have determined that the widely used antibiotic azithromycin was not beneficial for patients hospitalized with COVID-19 and are discontinuing their evaluation of the drug. Further results from the other arms of the trial are anticipated “over the next couple of months,” Horby said.

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

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Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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The Pharma Data

OCTOBER 20, 2020

20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. © 2020 HealthDay. TUESDAY, Oct.

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The Pharma Data

DECEMBER 8, 2020

Johnson & Johnson subsidiary Janssen has unveiled longer-term results from its phase 1b/2 study of ciltacabtagene autoleucel (cilta-cel) showing the drug, which is being studied as a treatment for patients with relapsed and/or refractory multiple myeloma, kept a large number of participants alive and progression-free.

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The Pharma Data

SEPTEMBER 1, 2020

Daiichi Sankyo has unveiled promising new benefit for Nilemdo (bempedoic acid) at the ESC Congress 2020 over the weekend for the management of low-density lipoprotein cholesterol (LDL-C) when added to other standards of care. In this extension trial, 970 participants received Nilemdo and 492 received placebo.

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The Pharma Data

NOVEMBER 2, 2020

CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / ADial Pharmaceuticals , Inc. 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.

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The Pharma Data

OCTOBER 22, 2020

CRISPR Therapeutics has reported positive results for a phase 1 study evaluating CTX110, its chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed or refractory nonHodgkin’s lymphoma in patients who have received at least two prior lines of therapy. Source link.

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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. In October 2020 , Grifols, together with other companies and various U.S.

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The Pharma Data

NOVEMBER 16, 2020

17, 2020 11:00 UTC. has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. Alexander, MD, DMD, FICS.

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The Pharma Data

OCTOBER 26, 2020

British drugmaker Evgen Pharma has won approval to start a late-stage clinical trial in the UK to evaluate its respiratory treatment, SFX-01, for COVID-19 patients.

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The Pharma Data

DECEMBER 30, 2020

Long-term safety profile consistent with previously completed controlled trials. 31, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. NDA on track for submission in 1Q 2021.

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex., The Houston, Tex., Source link.

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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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New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). and Europe.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. 22, 2020– Gilead Sciences, Inc. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. . 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. galactosidase-A product candidate under development for the treatment of Fabry disease.

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The Pharma Data

SEPTEMBER 15, 2020

Biopharma and pharmaceutical companies developing treatments and vaccines have long faced operational challenges that cost time and money while draining resources from the important work of changing lives. In spring 2020, Avantor’s clinical services team provided treatment developers with support for a fast-track study.

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The Pharma Data

DECEMBER 15, 2020

Less Invasive Treatment Feasible for Early-Stage Rectal Cancer. 15, 2020 — Short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC) achieves a high level of organ preservation and improved quality of life, according to a study published online Dec. © 2020 HealthDay.

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The Pharma Data

OCTOBER 27, 2020

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. © 2020 HealthDay. Posted: October 2020. Professional. TUESDAY, Oct.

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

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The Pharma Data

APRIL 17, 2021

Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy. today announced that China’s National Medical Products Administration (NMPA) has approved TECFIDERA ® (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS).

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The Pharma Data

NOVEMBER 23, 2020

FDA Authorizes Use of Monoclonal Antibody Treatment for COVID-19. 23, 2020 — A combination of two monoclonal antibodies was granted emergency use authorization (EUA) for the treatment of mild-to-moderate COVID-19, the U.S. © 2020 HealthDay. Posted: November 2020. Professional. MONDAY, Nov. More Information.

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The Pharma Data

DECEMBER 31, 2020

Monthly News Roundup – December 2020. In the Phase 3 HERO study , treatment with Orgovyx led to sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% Orladeyo should not be used for the treatment of acute HAE attacks. Professional. In December, the U.S.

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The Pharma Data

DECEMBER 23, 2020

23, 2020 — Because COVID-19 is known to raise the odds for dangerous blood clots, blood thinners have quickly become part of routine care for many hospitalized patients. The three trials are being conducted on four continents. WEDNESDAY, Dec.

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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

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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Broad Institute

NOVEMBER 6, 2024

Launched in 2017, this is a first-of-its-kind program in North America focused on improving the diagnosis, treatment, and understanding of serious immunotherapy complications, which can affect nearly every organ system.

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The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

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The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — CNS PHARMACEUTICALS AG , Inc. NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company’s U.S.

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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

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

NOVEMBER 11, 2020

Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to United Kingdom regulatory agency. Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency. 12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. BOSTON, Nov.

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The Pharma Data

NOVEMBER 10, 2020

Innovent has established a robust pipeline of 23 valuable assets, including four launched products, four products in pivotal trials, and multiple prioritized assets such as CD47, PDL1/CD47, TIGIT, VEGF/complement protein etc. that are fast progressing clinical trials. SAN FRANCISCO and SUZHOU, China , Nov.

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The Pharma Data

DECEMBER 5, 2020

–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?) CAMBRIDGE, Mass.–(BUSINESS

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