The Pharma Data

DECEMBER 9, 2020

This acquisition will significantly strengthen Boehringer Ingelheim’s focus on targeted cancer cell therapies, gaining the company access to NBE’s innovative immune-stimulatory iADC platform. . It has shown remarkably high safety and tolerability measure during non-clinical development. . billion US. .

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PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.

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Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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Disease Clinical Trials Therapies Science 111

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. About Targeted Alpha Therapies (TAT) at Bayer Targeted Alpha Therapies (TAT) are an emerging class of radionuclide therapy for various difficult to treat tumors.

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Small Molecule Licensing Licensing Therapies 52

The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.” 2018.011.

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FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

JUNE 28, 2021

Senior Vice President and Head of Oncology Development at Bayer. “We We are excited about the potential of this combination therapy based on the findings from CHRONOS-3 and we look forward to working with global regulatory authorities.”. Fields, M.D., In China, the filing for this indication was granted priority review.

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Treatment Therapies Trials Clinical Development 52

The Pharma Data

SEPTEMBER 11, 2020

Now, a new form of nuclear medicine is on the scene and it looks nothing like the radiation therapy of the past. Targeted radioligand therapy harnesses the power of radioactive atoms and delivers it directly to cancer cells no matter where they are in the body. Targeted radioligand therapy expands on these capabilities.

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Therapies Doctors Treatment Clinical Trials 52

The Pharma Data

MAY 2, 2023

including Executive Vice President and Chief Financial Officer from 2018 through the company’s sale to ICON plc, and previously as Senior Vice President, Accounting and Corporate Controller from 2008 to 2018. a clinical trial data collection company, from November 2021 to present.

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The Pharma Data

JULY 22, 2021

This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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Small Molecule Engineering Clinical Development Pharmaceuticals 52

The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

JANUARY 25, 2021

“This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. Because of high tumor recurrence after TURBT, intravesical chemo- or immuno-therapies are required after the procedure.

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Licensing Licensing Clinical Development Pharmaceutical Companies 40

The Pharma Data

MARCH 1, 2022

“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Source link: [link].

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Small Molecule Licensing Licensing Disease 52

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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Vaccine Immune Response Virus RNA 52

The Pharma Data

JUNE 29, 2021

The Phase III SAkuraSky study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. The Phase III clinical development programme for ENSPRYNG included two studies: SAkuraStar and SAkuraSky. Europe and Japan.

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Treatment Therapies Disease Clinical Development 52

The Pharma Data

NOVEMBER 1, 2020

. Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs. 6 Globocan 2018 [link] 7 Chang L, et al. . .

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The Pharma Data

JANUARY 20, 2021

Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, today announced the pricing of an underwritten public offering of 14,285,714 shares of its common stock at a price to the public of $7.00 SOUTH SAN FRANCISCO, Calif.,

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Clinical Development Therapies Drugs Science 40

PPD

OCTOBER 24, 2024

Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection. Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.

Vaccine 52

Vaccine Virus Treatment Disease 52

The Pharma Data

JANUARY 13, 2021

This press release contains “forward-looking statements,” including statements relating to planned regulatory filings and clinical development programs. 2018 Aug 2;132(5):501-509. The study was conducted at 28 U.S. study centers. Measuring Eosinophils to Make Treatment Decisions in Asthma. 2016 Sep;150(3):485-7.

Trials 52

Trials Small Molecule Clinical Trials Treatment 52

The Pharma Data

SEPTEMBER 9, 2020

The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018. 0.86, p=0.015). 2 points on the Expanded Disability Status Scale.

Treatment 52

Treatment Disease Therapies FDA 52

PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

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Clinical Development Clinical Trials International Trials 52

The Pharma Data

JANUARY 18, 2021

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. ZTlido ® was approved by the FDA on February 28, 2018. for the treatment of post-herpetic neuralgia. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.

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Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

JANUARY 14, 2021

NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. .–( BUSINESS WIRE )– Five Prime Therapeutics, Inc.

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Trials Treatment Therapies Clinical Trials 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

SEPTEMBER 9, 2021

The trial included 1,001 patients with mild to moderate asthma previously treated either with a SABA as needed alone or in addition to low-dose maintenance ICS therapy. 12 Repeated courses of OCS therapy are associated with an increased risk of systemic side effects including pneumonia, osteoporosis and type 2 diabetes.

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Trials Treatment Disease Therapies 52

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. For more information, please visit our website: www.cloverbiopharma.com. About Dynavax.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 21, 2021

Escolar was the principal medical consultant for Genzyme’s pivotal trial for Myozyme, an enzyme replacement therapy approved to treat adult-onset Pompe disease. since May 2018. Before Acceleron, Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc.

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Laboratories Pharmaceuticals Engineering Clinical Development 52

The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. “We In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5%

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

The Pharma Data

OCTOBER 26, 2020

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

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The Pharma Data

OCTOBER 26, 2020

Responses were observed in all primary tumor types and across all lines of prior therapy. Responses were observed in all primary tumor types and across all lines of prior therapy. In particular, in the patient with CR, lesions disappearance was accompanied by the development of a strong T-cell response against E6 and E7.

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Vaccine Trials Treatment Virus 40

The Pharma Data

APRIL 7, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

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Trials Clinical Trials Treatment Therapies 40

The Pharma Data

SEPTEMBER 2, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. From the success of our first-in-class B-cell MS therapy OCREVUS, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of ENSPRYNG.”.

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Clinical Trials Disease Treatment Therapies 52

The Pharma Data

DECEMBER 15, 2020

A total of 43 patients initially diagnosed with unresectable stage IV metastatic PDAC, who had progressed following first-line gemcitabine-based therapy, were enrolled in the triple combination arm. BioLineRx plans to present the full data set at an upcoming medical conference. Kenilworth, N.J. , These results are being announced today.

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Clinical Trials Trials Treatment Therapies 40

The Pharma Data

JANUARY 13, 2021

v Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Accessed December 2020. v Zhang, T., Tang, Z., … Li, K.

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