The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

FDA 40

FDA Disease Treatment Therapies 40

The Pharma Data

DECEMBER 20, 2020

“We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We This press release contains forward-looking statements.

Immune Response 52

Immune Response Clinical Trials Therapies Trials 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” In the initial 275 patients, rates of adverse events (AEs) were similar among groups.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

OCTOBER 30, 2020

Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

Disease 40

Disease FDA Treatment Clinical Trials 40

The Pharma Data

DECEMBER 29, 2020

It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. high dose, 0.9%

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 29, 2020

Three cases of human leukocyte antigen (HLA)-sensitization have been reported, two as serious adverse events. An archived replay will be accessible for 30 days following the event. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc.

Vaccine 52

Vaccine Clinical Trials Disease Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

OCTOBER 28, 2020

Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% Senior Vice President and Head of Global Clinical Development at Regeneron. Senior Vice President and Head of Global Clinical Development at Regeneron. REGN-COV2 was well tolerated in the trial. high dose, 1.6%

Virus 40

Virus Trials Clinical Trials Production 40

Drug Discovery World

MARCH 6, 2024

While this is an oversimplification, often patients who share a specific mutation in their tumour can be treated in a similar fashion as they will share this common mechanistic aetiology for their disease, and this is relatively easy to detect using modern sequencing and clinical genomics tools.

Clinical Trials 162

Clinical Trials Pharmaceutical Companies Disease Trials 162

The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). R&D: Up-front payments related to license and collaboration agreements. (85).

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals FDA 52

The Pharma Data

OCTOBER 28, 2020

Preliminary results from the first five patients treated indicate substantial improvements in all patients in at least two disease domains including communication, behavior, sleep, gross motor function, and fine motor function as measured by the Clinical Global Impression of Improvement Scale for Angelman Syndrome (CGI-I-AS) at day 128.

Protein Expression 40

Protein Expression Production Therapies Treatment 40

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. Upon option exercise, Novartis would be responsible for all further development and commercialization activities.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

The Pharma Data

NOVEMBER 15, 2020

Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S. drug development initiative from 2012 to February 2019. About MultiStem ®. View source version on businesswire.com: [link].

Clinical Trials 40

Clinical Trials Trials Production International 40

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. CDC, Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. Source: Moderna, Inc. .

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

The Pharma Data

DECEMBER 27, 2020

XGEVA has also received conditional approval in China for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM), which was not eligible for 2020 NRDL considerations as it was approved after the cutoff date. In pre-clinical studies, binding to Fc?

Production 52

Production Therapies Treatment Drugs 52

The Pharma Data

DECEMBER 15, 2020

The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone; adverse event (AE) and severe adverse event (SAE) profiles were as expected with chemotherapy-based treatment regimens. a company that supports oncology drug development.

Clinical Trials 52

Clinical Trials Trials Treatment Therapies 52