Gilead buys German maker of hepatitis drug in $1.4B deal

 

• Gilead Sciences (NASDAQ:GILD) agrees to buy MYR GmbH and its new hepatitis drug for €1.15B ~($1.4B) in cash plus a potential future milestone payment of up to €300M.
• MYR's Hepcludex (bulevirtide) was conditionally approved by the European Medicines Agency in July for the treatment of chronic hepatitis delta virus infection in adults with compensated liver disease, and the company has since launched Hepcludex in France, Germany and Austria.
• Gilead has been using its considerable cash reserves to make a series of acquisitions and partnerships over the past year to boost its product pipeline, including its $21B purchase in September of breast cancer medication maker Immunomedics.
• https://seekingalpha.com/news/3643283-gilead-buys-german-maker-of-hepatitis-drug-in-1_4b-deal

Biocept liquid biopsy improves accuracy for monitoring metastatic breast cancer

 

• Biocept climbs (BIOC +12.8%) on market open, on announcement of results from a prospective study showing that the company's Target Selector liquid biopsy was highly accurate in monitoring HER2 alterations in patients with metastatic breast cancer.
• The company says that Target Selector has been shown to be a highly sensitive blood-based testing method for identifying changes in HER2 status, and is less invasive, more time & cost efficient compared to tissue biopsy.
• Also, results from a study analyzing cerebrospinal fluid samples announced last month, indicated that Biocept's Target Selector CSF assays are a viable and sensitive platform for circulating tumor cell detection and molecular analysis compared to the current standard of care.
• https://seekingalpha.com/news/3643314-biocepts-liquid-biopsy-shows-improved-accuracy-for-monitoring-progression-of-metastatic

Pfizer/BioNTech COVID vaccine trial data in New England Journal of Medicine

 

• Pfizer Inc. (PFE) and BioNTech SE (BNTX) announce the publication of their pivotal COVID-19 vaccine trial data in the New England Journal of Medicine.
• In the phase 3 trial, the two-dose regimen of 30 μg BNT162b2, given 21 days apart, was well-tolerated and demonstrated an efficacy of 95% against COVID-19, seven days or more after the second dose in those without prior-infection to COVID-19, the company said.
• Data from 43,448 participants, half of whom received BNT162b2 and the other half received placebo, indicate it was well tolerated, and the Partial protection began as early as 12 days after the first dose.
• “As COVID-19 cases continue to rise and ravage the lives of so many people, we hope that these data will build confidence in the global health opportunity for vaccines to help us combat this devastating pandemic,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
• “Sharing further data from the Phase 3 trial in a renowned peer-reviewed journal underlines our commitment to transparency and scientific rigor” added Özlem Türeci, M.D., Chief Medical Officer and Co-founder of BioNTech.
• The most common adverse events were transient, mild to moderate pain at the injection site, fatigue, and headache, which were resolved within two days. They were less common and milder in older adults than younger adults.
• The ongoing placebo-controlled, randomized, observer-blinded study has already vaccinated the vast majority of the targeted 44,000 participants with the second dose, and currently, the vaccine candidate is undergoing an expert panel review in the U.S. to win emergency use authorization by the FDA.
• https://seekingalpha.com/news/3643350-pfizer-biontech-covidminus-19-vaccine-trial-data-published-in-new-england-journal-of-medicine

AstrZeneca/Daiichi Sankyo Enhertu: ‘Impressive’ new data in HER2 breast cancer

 

• AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF +2.5%) have reported updated results from Phase 2 trial of Enhertu, which continued to demonstrate ‘impressive’ efficacy and durable responses in patients with HER2-positive metastatic breast cancer.
• Updated data demonstrated that patients treated with Enhertu achieved an objective response rate (ORR) of 61.4% and a median duration (DoR) of response of 20.8 months.
• In addition, median progression-free survival was 19.4 months, with an exploratory landmark analysis of overall survival also showed that an estimated 74% of patients remained alive at 18 months.
• Prior analysis at 11.1 months of follow-up found an ORR of 60.9% and a median DoR of 14.8 months, as well as a median PFS of 16.4 months.
• The overall safety and tolerability profiles of Enhertu were consistent with what has been previously reported, with few additional treatment discontinuations due to adverse events with longer treatment duration.
• AZ and Daiichi are continuing to study Enhertu in a number of ongoing Phase 3 trials in patients with HER2-expressing metastatic breast cancer.
• https://seekingalpha.com/news/3643387-azn-daiichi-sankyo-enhertu-scores-impressive-new-data-in-her2-breast-cancer-study

EU drug regulator: Cyberattack has not disrupted work on COVID vaccines

 The head of the European Union drug regulator said on Thursday the agency’s work assessing COVID-19 vaccines had not been disrupted by a cyberattack that took place in the past two weeks.

U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday documents related to the development of their COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on the European Medicines Agency (EMA).

The EMA had disclosed the attack hours earlier but gave no details about when or how it took place, who was responsible or what information was compromised.

“We have been subject to a cyber attack over the last couple of weeks,” Emer Cooke told EU lawmakers during a hearing on Thursday. “I can assure you that this will not affect the timeline for delivery of vaccines and that we are fully functional.”

Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and the EMA “has assured us that the cyber attack will have no impact on the timeline for its review”.

The agency has said it will decide on a possible conditional approval of the Pfizer-BioNTech COVID-19 vaccine by Dec. 29.

Hacking attempts against healthcare and medical organisations have intensified during the COVID-19 pandemic as attackers ranging from state-backed spies to cyber criminals hunt for information.

https://www.reuters.com/article/health-coronavirus-eu-cyberattack/eu-drug-regulator-says-cyberattack-has-not-disrupted-work-on-covid-vaccines-idUSKBN28K1XW

Data from Pfizer/BioNTech, Moderna for COVID-19 vaccines 'very robust'-EMA

 The data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their COVID-19 vaccine candidates is “very robust”, its executive director said on Thursday.

“We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy,” Emer Cooke said at a committee meeting of the European Parliament.

The agency is expected to complete reviews by Dec. 29 for the Pfizer/BioNTech vaccine and by Jan. 12 for the Moderna vaccine “at the latest”.

Cooke said that the approval decision dates could change, depending on the assessment.

“We cannot guarantee that there will be a positive outcome at this stage” Cooke said, adding that the agency’s experts had to examine very large data sets.

“We have to make sure we analyse those data correctly,” she said.

Cooke added that EMA analysts were also checking data against the new information that emerged in Britain on Wednesday when two people had anaphylaxis and one a possible allergic reaction after the rollout of the Pfizer/BioNTech vaccine began.

She added that she expected AstraZeneca and Johnson & Johnson to submit in the first quarter of next year their applications for a marketing authorisation of their COVID-19 vaccine candidates.

The agency has been assessing preliminary data of the AstraZeneca shot since early October, and Johnson & Johnson’s data since early December.

https://www.reuters.com/article/health-coronavirus-vaccines/data-from-pfizer-biontech-moderna-for-covid-19-vaccines-very-robust-ema-idUSKBN28K1V3

Moderna begins study of COVID-19 vaccine in adolescents

 Moderna Inc said on Thursday it had dosed the first participants in a mid-to-late stage study testing its COVID-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year.

The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company’s vaccine candidate, mRNA-1273, given 28 days apart.

Moderna has submitted applications seeking emergency use authorization (EUA) in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective in adults with no serious safety concerns.

Rival Pfizer/BioNTech have also sought EUA after their coronavirus vaccine’s two-dose regimen proved 95% effective against COVID-19 and had no major safety issues.

Meanwhile, a panel of outside advisers to the U.S. Food and Drug Administration will meet on Thursday to discuss whether to recommend the use of Pfizer’s vaccine for people aged 16 and older.

A similar meeting of advisers to the FDA is scheduled for Dec. 17 to discuss Moderna’s vaccine.

Moderna’s adolescents study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services.

“Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year,” Chief Executive Officer Stephane Bancel said in a statement.

Pfizer is also studying its vaccine candidate in participants as young as 12.

https://www.reuters.com/article/health-coronavirus-moderna/moderna-begins-study-of-covid-19-vaccine-in-adolescents-idUSKBN28K1GC