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Community Scoop » Pfizer And BioNTech Achieve Approval By Medsafe For Their Vaccine Against COVID-19

Press Release – Joint Press Release
Pfizer New Zealand and BioNTech today welcomed the drug safety regulator Medsafe in New Zealand granting Provisional Consent for their COVID-19 mRNA vaccine COMIRNATY. Pfizer is the Market Authorisation Holder in New Zealand. The distribution of the …
Pfizer and BioNTech Achieve Approval by Medsafe For Their Vaccine Against COVID-19
New Zealand drug safety regulator Medsafe, approves supply of COVID-19 mRNA vaccine
COMIRNATY™ to New Zealand.
Pfizer & BioNTech are ready to deliver the 1.5 million doses to New Zealand over 2021, allowing for 750,000 New Zealanders to be vaccinated.
Pfizer has a robust and reliable distribution network to deliver our vaccine to New Zealanders over 2021. ....

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Pfizer reports fourth-quarter and full-year 2020 results and releases 5-YEAR pipeline metrics

5%
Below are specific updates on pipeline assets since our previous earnings announcement on October 27, 2020:
Abrocitinib (PF-04965842) In November 2020, Pfizer announced positive top-line results from the fifth Phase 3 trial of abrocitinib, JADE REGIMEN, a 52-week study which investigated abrocitinib in patients 12 and older with moderate to severe atopic dermatitis (AD) following response to initial open label induction treatment with abrocitinib 200 mg. Patients were randomized into one of three arms: 200 mg, 100 mg or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment compared to those randomized to placebo. Both doses also met the key secondary endpoint of a larger percentage of patients maintaining an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo. ....

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Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature

Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature
New York, NY and Mainz, Germany, February 1, 2021 (GLOBE NEWSWIRE)
BioNTech SE (Nasdaq: BNTX) today announced that preclinical data in non-human primate and mouse models from Pfizer and BioNTech’s mRNA-based vaccine candidates, BNT162b1 and BNT162b2, for the prevention of COVID-19 were published in the journal
Nature. Some of these data were initially made available to the public on September 9, 2020 via the online preprint server,
bioRxiv. For additional details, please read the previously issued
The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. Additionally, the vaccine candidates protected macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respi ....

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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

Published: Jan 26, 2021
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline
on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain)
over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021
BASEL, Switzerland and NEW YORK, Jan. 26, 2021 (GLOBE NEWSWIRE) Myovant Sciences (NYSE: MYOV) and Pfizer Inc.. (NYSE: PFE) today announced that the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-m ....

United States , San Francisco , Albert Liao , Bryan Crowe , Steve Danehy , James Rusnak , Chuck Triano , Linda Giudice , Juan Camilo Arjona Ferreira , University Of California , Program Steering Committee Member , Reproductive Sciences , Global Product Development At Pfizer , Pfizer Inc , Virtual Congress , Myovant Sciences Forward , American Society For Reproductive Medicine , Myovant Sciences , Drug Administration , Exchange Commission , Myovant Sciences Contacts , Myovant Sciences Inc , Sumitomo Dainippon Pharma Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Numerical Rating Scale ,

Pfizer shares co-primary endpoint results

1.48 (1.04, 2.09)
BID=twice daily; CI=confidence interval; HR=hazard ratio; IR=incidence rate; NMSC=non-melanoma skin cancer; TNFi=Tumor Necrosis Factor inhibitor.
( ) Based on Cox proportional hazard model
( )The 10 mg BID treatment group includes patients that were switched from 10 mg BID to 5 mg BID as a result of a study modification in February 2019.
( ) The risk period included all available follow-up regardless of treatment exposure.
( ) The non-inferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFi since the upper limit of the 95% CI exceeded the pre-specified non-inferiority criterion of 1.8, ie, 2.09 >1.8.
“Providing information on the safe and effective use of our medicines is imperative,” said Tamas Koncz, M.D., Ph.D., Chief Medical Officer, Inflammation and Immunology, Pfizer. “We believe that extensive additional analyses of these study data, and communicating them as soon as poss ....

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