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1

Arvinas’ experimental breast cancer drug fails to impress analysts

November 25, 2022 /in Business, R&D

Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”). The clinical-stage biopharma was originally set to unveil the Phase II data for its lead breast cancer medication, ARV-471, on Dec. 8, 2022. But Arvinas’ and Pfizer’s joint abstract was inadvertently published early for conference participants by SABCS. Arvinas’ stock price has since fallen by 18% over the first two days of the holiday-shortened week.

2

FDA grants priority review to Takeda’s dengue vaccine

November 25, 2022 /in Business, FDA/Regulatory, R&D

The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.

3

FDA cancels adcomm meeting on BioMarin’s hemophilia A gene therapy

November 25, 2022 /in FDA/Regulatory, R&D

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its Biologics License Application (BLA) for Roctavian (valoctocogene roxaparvovec), an AAV gene therapy for adults with severe hemophilia A.

4

U.S. FDA declines to approve Spectrum’s lung cancer drug

November 25, 2022 /in Business, FDA/Regulatory, R&D, Therapeutics

Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.

5

Researchers test mRNA technology for universal flu vaccine

November 24, 2022 /in R&D

An experimental vaccine provided broad protection against all 20 known influenza A and B virus subtypes in initial tests in mice and ferrets, potentially opening a pathway to a universal flu shot that might help prevent future pandemics, according to a U.S. study published on Thursday.

6

EU regulator warns of ‘disappointing’ vaccine booster uptake

November 24, 2022 /in Health, Therapeutics

Recent uptake of COVID-19 vaccine booster doses in the European Union has been “rather disappointing,” an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter.

7

Measles now an imminent global threat due to pandemic, say WHO and CDC

November 23, 2022 /in Health, R&D

There is now an imminent threat of measles spreading in various regions globally, as COVID-19 led to a steady decline in vaccination coverage and weakened surveillance of the disease, the World Health Organization (WHO) and the U.S. public health agency said on Wednesday.

8

South Africa’s Biovac in new oral cholera vaccine deal

November 23, 2022 /in Therapeutics

The partnership with non-profit IVI, headquartered in South Korea, aims to boost output and reduce vaccine shortages amid a spate of global outbreaks that spurred the World Health Organization to temporarily change its dosage regime.

9

FDA says Philips filed 21,000 reports on bad foam Aug-Oct.

November 23, 2022 /in Therapeutics

Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.

10

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving Amgen’s Prolia

November 22, 2022 /in Therapeutics

The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).

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