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Clinical Trials

Set Alert for Clinical Trials

AstraZeneca Finds Two More Potential Partners For Imfinzi

Adding oleclumab and monalizumab to the PD-L1 inhibitor improved PFS, while another study showed improved real-world outcomes.

Cancer Biologics

Bayer Bigs Up Vitrakvi In Comparison With Roche's Rozlytrek

In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.

Cancer Clinical Trials

First Lumakras Combo Data Show Boosted Efficacy For Amgen Drug In CRC

Amgen’s KRAS G12C inhibitor in combination with the company’s Vectibix generated a 27% overall response rate, nearly tripling the responses seen with Lumakras monotherapy in colorectal cancer.

Clinical Trials Personalized Medicine

Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

Clinical Trials Drug Approval Standards

Gilead Builds Up Trodelvy Data In TNBC Ahead Of Competition

Phase III sub-analyses presented at ESMO show the drug providing a survival benefit in a complex subpopulation, as well as improvements to quality of life.

Cancer Biologics

Moderna Unveils COVID-19 Booster Data As Pfizer Goes Before Skeptical Regulators

Moderna is hot on the heels of Pfizer with booster data for its COVID-19 vaccine, and could benefit from its rival being first to face potential skepticism from the US FDA over booster data for its vaccine.

Companies Clinical Trials

Provepharm’s CEO Plans Fresh Acquisitions After Raising €120m

France’s Provepharm Life Solutions, which finds new uses for known mature molecules, in particular antidotes and surgical dyes, by improving their efficacy and maximizing their therapeutic potential, has fresh funds to expand its portfolio.

Business Strategies Clinical Trials

Roche Gives The Stage To A New Generation Of Cancer Drugs

With big oncology losses largely in the rearview mirror, Roche is trying to sell investors on its next wave of cancer drugs; R&D overview pushes message of pipeline renewal.

Cancer Research & Development

Theravance To Slash Headcount By 75% After Latest Clinical Trial Setback

The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.

Business Strategies Research & Development

UK Chooses Pfizer And Moderna For COVID-19 Boosters, But Questions Remain On Unpublished Trial Data

The UK’s choice of the mRNA vaccines as COVID-19 boosters is no surprise – but not releasing the key study data behind the decision is.

Coronavirus COVID-19 Vaccines

Provention Maps Possible Regulatory Path For Troubled Teplizumab

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

Companies Regulation

TB Alliance-Lupin Deal To Improve Pretomanid Access But India Unlikely To Benefit For Now

While Viatris says it has sufficient capacity to meet current and future demand for tuberculosis drug pretomanid, TB Alliance has signed a non-exclusive license with Lupin. This is the second tie-up with an Indian manufacturer but the local restricted use approval means countries other than India are likely to benefit for now.

Commercial Manufacturing
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