The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JUNE 29, 2021

ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training. Importantly, people with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments.”.

Treatment 52

Treatment Therapies Disease Clinical Development 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

DECEMBER 13, 2020

Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved treatment outcomes.

Clinical Development 40

Clinical Development Clinical Trials Therapies Trials 40

The Pharma Data

JUNE 30, 2021

The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

DECEMBER 9, 2020

Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. .

FDA Approval 52

FDA Approval Clinical Development Therapies Vaccine 52

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. 2018 Mar;17(3):167–81.

Drugs 111

Drugs FDA Disease Animal Testing 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. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men. Noria) and PSMA Therapeutics Inc.

Small Molecule 52

Small Molecule Licensing Licensing Therapies 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

APRIL 29, 2022

The data showed an estimated 91% of infants (n=58) treated with Evrysdi were alive after three years of treatment. The Evrysdi-treated infants continued to improve or maintain motor functions, including the ability to swallow, sit without support, stand with support and walk while holding on, between two and three years of treatment.

Treatment 52

Treatment Clinical Trials Trials Clinical Development 52

The Pharma Data

JANUARY 14, 2021

We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A. Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

These Phase 2 results strongly support the continued development of dexpramipexole as a potential first-in-class oral agent for the treatment of eosinophilic asthma,” said Michael Bozik, M.D., Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma.

Trials 52

Trials Small Molecule Clinical Trials Treatment 52

The Pharma Data

DECEMBER 13, 2020

We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic 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 1, 2020

333-228656) previously filed with the Securities and Exchange Commission (the “SEC”) on December 3, 2018, and declared effective by the SEC on December 26, 2018. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Clinical Development 52

The Pharma Data

FEBRUARY 22, 2022

Then, she served on the Board of Directors of Capgemini for two years (2016-2018) before being appointed to her current position as Group CFO. He began his oncology development career at Rhône Poulenc Rorer Inc. In 1999, he joined the Aventis Group as Senior Director, Oncology Global Clinical Development.

Clinical Trials 52

Clinical Trials DNA Science Clinical Development 52

The Pharma Data

MARCH 11, 2021

Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 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. ” About Photocure ASA. About Non-Muscle Invasive Bladder Cancer (NMIBC).

Licensing 40

Licensing Licensing Clinical Development Pharmaceutical Companies 40

PPD

OCTOBER 24, 2024

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. Public awareness: Education campaigns to raise awareness about HBV transmission and prevention.

Vaccine 52

Vaccine Virus Treatment Disease 52

The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. All infants were alive at 12 months without permanent ventilation.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

Small Molecule 52

Small Molecule Licensing Licensing Disease 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. P6: Neuromuscular Disorders and Clinical Trials. Spinal Muscular Atrophy (SMA). Abstract Title.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

JULY 22, 2021

NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. On October 31, 2018 , Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Alkermes has a target action date of November 15 for ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

JANUARY 13, 2021

We believe that it is an important immunotherapy and demonstrates our work at BeiGene to bring innovative, impactful, and quality treatments to patients in need.”. We are grateful to have a new treatment available in the front-line setting for patients with advanced squamous non-small cell lung cancer,” said Jie Wang, M.D.,

Production 52

Production Trials Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. . . SAN FRANCISCO , U.S. and SUZHOU, China , Nov. ” About Letaplimab.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Both treatments were administered subcutaneously at week 0, 2, and 4.

Treatment 52

Treatment Disease Therapies FDA 52

The Pharma Data

SEPTEMBER 9, 2021

The MANDALA and DENALI trials demonstrate an albuterol/budesonide rescue inhaler can address inflammation and prevent exacerbations, making PT027 an important potential new treatment option for patients.”. 4 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.

Trials 52

Trials Treatment Disease Therapies 52

The Pharma Data

SEPTEMBER 11, 2020

Marie Curie discovered radium’s radioactive properties and championed its use in the treatment of cancer. The approach is a staple of cancer therapy today but is limited to spot treatment. In addition, future scans can help doctors determine if the medicine is working as treatment progresses. “We A foundational pillar.

Therapies 52

Therapies Doctors Treatment Clinical Trials 52

The Pharma Data

DECEMBER 2, 2020

Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

MARCH 5, 2021

Across all treatment arms, the most commonly reported adverse events were gastrointestinal-related. Semaglutide is a GLP-1 receptor agonist for the treatment of type 2 diabetes. “Newer treatment options may help people with type 2 diabetes achieve their A1C and weight loss goals. . Percent of participants.

Clinical Trials 52

Clinical Trials Treatment Trials Clinical Development 52

The Pharma Data

DECEMBER 3, 2020

Monti is a pioneer in the research and development of neuroactive steroids known as pherines, which includes VistaGen’s intranasal treatment candidate PH94B for anxiety disorders and PH10 for depression. Zai Lab – Alan Sandler was appointed to the newly created role of president and head of Global Development in Oncology.

Pharmaceuticals 52

Pharmaceuticals Clinical Development Medical Schools Pharmacy 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. . .

Pharmaceuticals 40

Pharmaceuticals Marketing Production Therapies 40

The Pharma Data

OCTOBER 26, 2020

The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. PBMC and tissue samples were collected longitudinally prior to and during the treatment period.

Vaccine 40

Vaccine Trials Treatment Virus 40

The Pharma Data

MARCH 16, 2021

“There is a continued need for additional treatments that can provide people living with ulcerative colitis relief from their most challenging symptoms,” said William J. ” In LUCENT-1, mirikizumab met the primary endpoint of clinical remission at Week 12 compared to placebo (p<0.0001). ” About Mirikizumab.

Treatment 40

Treatment Disease Clinical Trials Trials 40

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.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 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. About CHRONOS-3.

Treatment 52

Treatment Therapies Trials Disease 52