The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

Science 52

Science Production Treatment FDA 52

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Spinal Muscular Atrophy (SMA). Multiple Sclerosis (MS).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52

Trials FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. It is now in a Phase I/IIa trial for adult NSCLC with EGFRex20ins mutations.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. “We About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). KENILWORTH, N.J.–(BUSINESS

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.

International 52

International Disease Clinical Trials Trials 52

The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. had fatal outcomes.

Trials 52

Trials Therapies Treatment Disease 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

AUGUST 6, 2020

Under the pact, AZ will transfer the vaccine’s technology to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.

Vaccine 52

Vaccine Licensing Licensing Immune Response 52

The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. billion EUR, up 5.8

Research 52

Research Treatment Clinical Trials Production 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. The Annual General Meeting will be held on April 29, 2021 in Lund, Sweden. LUND, Sweden , Dec. Chairman of the Nomination Committee.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

Clinical Trials 52

Clinical Trials Trials Disease Hospitals 52

The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021.

Disease 40

Disease International Research Therapies 40

The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

SEPTEMBER 6, 2021

The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”.

Trials 52

Trials Clinical Trials Treatment International 52

The Pharma Data

JANUARY 10, 2021

The DMC approved the proposal to open the expansion cohort at the highest dose in advance of unblinding data from the first three cohorts of the study, which is expected to take place in early 2021. SINGAPORE, Jan. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the SEC on April 16, 2020.

Clinical Trials 52

Clinical Trials Pharmaceuticals Trials Treatment 52

The Pharma Data

MARCH 23, 2021

Data presented at ENDO 2021 demonstrate clinically relevant weight loss, without weight regain, in people treated with semaglutide 2.4 Bagsværd, Denmark, 23 March 2021 – New results from the STEP phase 3a clinical trial programme demonstrated weight loss with investigational treatment of once-weekly subcutaneous semaglutide 2.4

Trials 52

Trials Clinical Trials Treatment Disease 52

The Pharma Data

JANUARY 3, 2021

. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. The Company expects to enroll the first subject in the first half of 2021 and provide preliminary safety and biomarker data in the second half of 2021.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

APRIL 6, 2021

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. and China for marginal zone lymphoma (MZL) based on clinical data of MZL patients enrolled in the CHRONOS-1 study.

Research 52

Research Small Molecule Treatment Clinical Trials 52

Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

MAY 31, 2022

BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer?AG, 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). AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of

Trials 52

Trials Disease Clinical Trials Engineering 52

LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Additional trials (e.g.,

Small Molecule 140

Small Molecule Trials Therapies Disease 140

Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. 2021 Jul 6;120(13):2644-56. 2021 Dec 1;9(12):1425-38. 2021 Jun 17;12:685370. 2021 Nov 1;41. in North America) in late 2017.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

Clinical Trials 52

Clinical Trials Trials Immune Response Vaccine 52

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

JANUARY 13, 2021

14, 2021 11:00 UTC. PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. study centers. ABOUT THE EXHALE STUDY.

Trials 52

Trials Small Molecule Clinical Trials Treatment 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Accessed April 2021].

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

JANUARY 14, 2021

15, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX) (NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021 , which will take place between 1pm and 5pm CET. STOCKHOLM , Jan.

Clinical Trials 40

Clinical Trials Disease Hospitals International 40

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. © 2021 Sorrento Therapeutics, Inc. SAN DIEGO, Jan.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

NOVEMBER 8, 2021

Data from the analyses were presented at the American Society of Nephrology (ASN)’s Order Week 2021 in two oral donations and two late- breaking bills. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52