The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Food & Drug Administration.

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Treatment Clinical Pharmacology Drugs Clinical Development 52

The Pharma Data

MAY 31, 2022

“More than 10 million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease,” said Carole Ho, M.D., BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali.

Disease 52

Disease Small Molecule Engineering Biosimilars 52

The Pharma Data

MARCH 28, 2022

Based on these results, the BIIB078 clinical development program will be discontinued, including its ongoing open-label extension study. “We Vice President and Head of the Neuromuscular Development Unit at Biogen. “We Vice President and Head of the Neuromuscular Development Unit at Biogen. Biogen Inc.

RNA 52

RNA Therapies Disease Biosimilars 52

Vial

APRIL 10, 2024

IQVIA’s core strengths lie in its specialized global IT infrastructure tailored for healthcare, analytics-driven clinical development, a robust ecosystem of real-world solutions, and an expanding suite of proprietary clinical and commercial applications.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JUNE 1, 2022

Zuranolone 50 mg was generally well-tolerated and demonstrated a safety profile consistent with that observed in the clinical development program to date. Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. Food & Drug Administration.

Biosimilars 52

Biosimilars Treatment Therapies Disease 52

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., of total revenue).

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

The Pharma Data

APRIL 11, 2021

under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Abstract: CT001. About Copanlisib.

Treatment 52

Treatment Therapies Trials Disease 52

The Pharma Data

OCTOBER 27, 2020

Upon option exercise, Novartis would be responsible for all further development and commercialization activities. During the clinical development stage, Molecular Partners will provide clinical supply.

Therapies 40

Therapies Virus Treatment Clinical Trials 40

Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

The Pharma Data

SEPTEMBER 16, 2020

Additionally, data from Amgen ‘s bispecific T cell engager (BiTE ® ) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 20 and AMG 160, Monday Sept. Reese , M.D.,

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

Therapies 40

Therapies Clinical Trials Production Treatment 40

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Regulation Link Description of the Guideline Action Planned Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus Addresses the E.U.’s

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

The Pharma Data

SEPTEMBER 20, 2020

and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1 , 2020). Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. PDT , David M.

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Please see full Prescribing Information including Medication Guide. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

MAY 3, 2021

Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims ( STAT ). Avrobio changes course after FDA closes path for speedy gene therapy approval ( BioPharmaDive ). ICH plots major overhaul of good clinical practice guideline ( Endpoints ). Medtech.

Vaccine 52

Vaccine Biosimilars FDA Regulations 52