MHRA gives Bavencio, Inlyta combo Early Access to Medicines status

Pharmatimes | July 22, 2019

MHRA gives Bavencio, Inlyta combo Early Access to Medicines status
Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC), and is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility. The combination was approved by the FDA in May this year based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups. There is a significant unmet need for RCC first-line treatments that delay progression and have an acceptable safety profile, as approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

Spotlight

Blockchain owns its reputation by providing many valuable advantages for everyday business and more complex operations. In this article, we want to disclose how the technology could be and already is implemented in the pharmaceutical industry. Moreover, we will discuss track and trace potential in this topic.


Other News

Intent Data in the Age of Data Regulation

DECK 7 | March 23, 2020

Since the implementation of Data Protection Act in 2018, the approach behind the use of data has changed dramatically. Our clients and customers don’t just want a great experience, they also want to make sure they can trust us. Tweet This! And it makes perfect sense in the present time and space. But as data is considered a key factor in positive customer experience, the U.S. brands and agencies have found it to be increasingly complicated to earn customer trust while remaining compliant. In an article by John Snyder, CEO at Grapeshot, for Adexchanger, he says that the GDPR will remove 75% of third-party data and what’s left will be more expensive. This has caused the power dynamic between brands and agencies to evolve over time.

Read More

TScan and Novartis partner to develop cancer therapies

Pharmaceutical Technology | April 16, 2020

Biopharmaceutical firm TScan Therapeutics has signed an agreement with Novartis to discover and develop therapies for the treatment of cancer. The companies aim to work on TCR-engineered T-cell therapies for solid tumours. TScan’s platform will identify cancer antigens that could be targeted by TCR-based treatments. As part of the deal, TScan will find and characterise TCRs while Novartis will hold an option to licence and develop TCRs for up to three new targets. Furthermore, Novartis will have rights of first negotiation for more targets and TCRs resulting from the alliance. TScan may develop TCRs that act on targets not licensed by Novartis. TScan Therapeutics president and CEO David Southwell said: “As one of the only companies able to efficiently discover novel cancer antigens that can be targeted with TCR-based therapies, we are delighted to be collaborating with Novartis to develop important TCR treatments.

Read More

BeiGene reports positive Phase III interim analysis for lung cancer drug

MedCity News | April 14, 2020

Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday. Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with platinum chemotherapy and pemetrexed, compared with those receiving chemotherapy and pemetrexed alone. However, it did not disclose the data. The company said it plans to file for approval of the drug with Chinese drug regulators and present data from the study at upcoming medical conferences. Shares of BeiGene were up around 6% on the Nasdaq in Tuesday afternoon trading, following the after-hours announcement.

Read More

Would-be coronavirus drugs are cheap to make

Science | April 10, 2020

With a vaccine for the novel coronavirus still likely a year or more away, the first weapon against the virus could be one of the drugs now in clinical trials with COVID-19 patients. A new analysis out today shows that many of these drugs, which are currently manufactured or in development to treat other diseases, can be made for $1 a day per patient, or less. If any prove effective against the novel coronavirus, a coordinated international effort will be needed to ensure they are made affordable for people worldwide, the researchers argue. Scientists worldwide are conducting clinical trials on at least a dozen potential treatments for COVID-19. Some compounds have been on the market for decades, such as chloroquine and hydroxychloroquine used to combat malaria and lupus. That makes it relatively straightforward to estimate the minimum cost of making them, says Andrew Hill, a drug pricing specialist at the University of Liverpool.

Read More

Spotlight

Blockchain owns its reputation by providing many valuable advantages for everyday business and more complex operations. In this article, we want to disclose how the technology could be and already is implemented in the pharmaceutical industry. Moreover, we will discuss track and trace potential in this topic.

Resources